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COVID-19 Evidence Support Team EVIDENCE SEARCH REPORT

Review Question: How effective are COVID-19 ? Context: Benefits following dose/second dose; how well it prevents ; evidence of limiting viral replication or spread; preventing hospitalization; preventing ventilation; preventing “long COVID” (long term symptoms), duration of immunity (natural and vaccinated). FDA cold chain changes. Effectiveness against any and all variants. Booster doses for variants. Mixing types.

Does not include vaccine willingness/acceptance (to be run as a separate search) Review Code: INF031801v5 ESR Complete Date: May 28, 2021

Cite As: Miller, L., Howell-Spooner, B. How effective are COVID-19 vaccines? 2021 May 28, Document no.: INF031801v5 ESR. In: COVID-19 Rapid Evidence Reviews [Internet]. SK: SK COVID Evidence Support Team, c2021. 94 p. (CEST evidence search report).

Librarian Notes & Comments Hello All, We’ve run this update for the databases from May 15th to May 26th, and searched for grey literature between May 14th and May 28th. Thanks, Brianna and Lukas

Search Results: Guidelines, Summaries & Other Grey Literature

Government Health Canada  Recommendation on the use of the Pfizer-BioNTech COVID-19 vaccine in adolescents 12 to 18 years of age. May 18, 2021. https://www.canada.ca/en/public- health/services//national-advisory-committee-on-immunization- naci/recommendation-use-pfizer-biontech-covid-19-vaccine-adolescents.html

Public Health Ontario Disclaimer This information is provided as a service by the Saskatchewan Health Authority and University of Saskatchewan Libraries. Professional librarians conduct searches of the literature. Results are subject to the limitation s of the databases and the specificity, broadness and appropriateness of the search parameters presented by the requester. The Libraries do not represent in any matter that retrieved citations are complete, accurate or otherwise to be relied upon. The sear ch results are only valid as of the date and time at which the search is conducted. The Libraries do not accept responsibility for any loss or damage aris ing from the use of, or reliance on, search results.

 Confirmed Cases of COVID-19 Following in Ontario: December 14, 2020 to April 17, 2021. May 20, 2021. https://www.publichealthontario.ca/-/media/documents/ncov/epi/covid- 19-epi-confirmed-cases-post-vaccination.pdf?la=en

National Health Library & Knowledge Service  What is the efficacy of COVID-19 in preventing disease transmission to the vaccinated?. May 28, 2021. https://hselibrary.ie/what-is-the-efficacy-of-covid-19-vaccinations- in-preventing-disease-transmission-to-the-non-vaccinated/

UK Government  Vaccines highly effective against B.1.617.2 variant after 2 doses. May 22, 2021. https://www.gov.uk/government/news/vaccines-highly-effective-against-b-1-617-2-variant- after-2-doses  PHE monitoring of the effectiveness of COVID -19 vaccination. May 26, 2021. https://www.gov.uk/government/publications/phe-monitoring-of-the-effectiveness-of-covid- 19-vaccination

FDA  FDA In Brief: FDA Authorizes Longer Time for Refrigerator Storage of Thawed Pfizer-BioNTech COVID-19 Vaccine Prior to Dilution, Making Vaccine More Widely Available. May 19, 2021. https://www.fda.gov/news-events/press-announcements/fda-brief-fda-authorizes-longer-time- refrigerator-storage-thawed-pfizer-biontech-covid-19-vaccine

CDC  COVID-19 Vaccine Breakthrough Infections Reported to CDC – United States, January 1 – April 20, 2021. May 28, 2021. https://www.cdc.gov/mmwr/volumes/70/wr/mm7021e3.htm?s_cid=mm7021e3_x  COVID-19 Vaccines for Children and Teens. May 26, 2021. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/adolescents.html  The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Pfizer- BioNTech COVID-19 Vaccine in Adolescents Aged 12-15 Years – United States, May 2021. May 21, 2021. https://www.cdc.gov/mmwr/volumes/70/wr/mm7020e1.htm?s_cid=mm7020e1_x  Interim Estimates of Vaccine Effectiveness of Pfizer-BioNTech and Moderna COVID-19 Vaccines Among Health Care Personnel – 33 U.S. Sites, January-March 2021. May 21, 2021. https://www.cdc.gov/mmwr/volumes/70/wr/mm7020e2.htm?s_cid=mm7020e2_w o Librarian’s Note: Released as an Early Release on May 14, 2021. d  Largest CDC COVID-19 Vaccine Effectiveness Study in Health Workers Shows mRNA Vaccines 94% Effective. May 14, 2021. https://www.cdc.gov/media/releases/2021/p0514-covid-19- vaccine-effectiveness.html

Agencies ECDC  Overview of EU/EEA country recommendations on COVID-19 vaccination with Vaxzevria, and a scoping review of evidence to guide decision-making. May 18, 2021. https://www.ecdc.europa.eu/en/publications-data/overview-eueea-country-recommendations- covid-19-vaccination-vaxzevria-and-scoping

Evidence Search Report: INF031801v5 ESR 2

European Medicines Agency  More flexible storage condition for BioNTech/Pfizer’s COVID-19 vaccine. May 17, 2021. https://www.ema.europa.eu/en/news/more-flexible-storage-conditions-biontechpfizers-covid- 19-vaccine

WHO  COVID-19 subcommittee of the WHO Global Advisory Committee on Vaccine Safety (GACVS) reviews cases of mild myocarditis reported with COVID-19 mRNA vaccines. May 26, 2021. https://www.who.int/news/item/26-05-2021-gacvs-myocarditis-reported-with-covid-19-mrna- vaccines

Research Centres COVID-19 Immunity Task Force  New Canada-Wide Research to Study Mixing-and-Matching COVID-19 vaccines. May 20, 2021. https://www.covid19immunitytaskforce.ca/new-canada-wide-research-to-study-mixing-and- matching-covid-19-vaccines/  Canadian researchers studying effectiveness and safety of COVID-19 vaccines during pregnancy. May 19, 2021. https://www.covid19immunitytaskforce.ca/canadian-researchers-studying- effectiveness-and-safety-of-covid-19-vaccines-during-pregnancy/

COVID-END  What is the efficacy and effectiveness of available COVID-19 vaccines for variants of concern. o May 21, 2021. https://www.mcmasterforum.org/docs/default-source/product- documents/living-evidence-syntheses/covid-19-living-evidence-synthesis-6.6---what-is- the-efficacy-and-effectiveness-of-available-covid-19-vaccines-in-general-and- specifically-for-variants-of-concern.pdf?sfvrsn=2b454a54_5 o May 17, 2021. https://www.mcmasterforum.org/docs/default-source/product- documents/living-evidence-syntheses/les6.5_vaccinesvariants_2021-05- 17.pdf?sfvrsn=b725295e_5

Strategy for Patient-Oriented Research  Transmissibility of COVID-19 among vaccinated individuals. May 25, 2021. https://sporevidencealliance.ca/wp-content/uploads/2021/05/Transmissibility-of-COVID-19- Among-Vaccinated-Individuals_2021.05.27.pdf

Search Results: News, Blogs, & Social Media

News CBC  Researchers claim mystery of rare clots tied to COVID-19 vaccines solved, but experts urge caution. May 28, 2021. https://www.cbc.ca/news/health/covid-19-vaccine-blood-clot-vitt- solution-research-1.6043185  Moderna touts its vaccine for 12 to 17 age group, citing trial data. May 25, 2021. https://www.cbc.ca/news/health/us-moderna-trial-youth-1.6039174

Evidence Search Report: INF031801v5 ESR 3  Canada’s change to Pfizer temperature has major implications on rollout. May 19, 2021. https://www.cbc.ca/news/health/pfizer-vaccine-canada-storage-temperature- 1.6031823  National vaccine advisory panel recommends Pfizer shot for anyone 12 and up: Tam. May 18, 2021. https://www.cbc.ca/news/health/covid-vaccine-12-naci-time-1.6031090  COVID vaccine made by Canada’s Medicago shows promising results in Phase 2 . May 18, 2021. https://www.cbc.ca/news/canada/montreal/medicago-montreal-covid-vaccine- 1.6031176  Sanofi, GlaxoSmithKline set to start Phase 3 trials for COVID-19 vaccine after earlier setback. May 17, 2021. https://www.cbc.ca/news/health/sanofi-glaxosmithkline-set-to-start-phase-3- trials-for-covid-19-vaccine-after-earlier-setback-1.6029502  Why Canada’s big bets on delaying, mixing doses of COVID1-9 vaccines could pay off. May 17, 2021. https://www.cbc.ca/news/health/canada-covid-vaccines-moderna-pfizer-1.6027657  Delayed second Pfizer-BioNTech shot produces more antibodies, U.K. study says. May 14, 2021. https://www.cbc.ca/news/health/covid-19-pfizer-second-dose-delay-more-antibodies-study- 1.6026765  Canada reports 28 cases of rare blood clots following AstraZeneca vaccinations. May 14, 2021. https://www.cbc.ca/news/politics/canada-28-cases-blood-clots-1.6025750

CIDRAP  COVID mRNA vaccines induce immune response in pregnant, lactating women. May 14, 2021. https://www.cidrap.umn.edu/news-perspective/2021/05/covid-mrna-vaccines-induce-immune- response-pregnant-lactating-women  More side effects noted after using 2 different COVID vaccines. May 13, 2021. https://www.cidrap.umn.edu/news-perspective/2021/05/more-side-effects-noted-after-using- 2-different-covid-vaccines

Globe and Mail  Canadian study to examine safety of mixing COVID-19 vaccines. May 20, 2021. https://www.theglobeandmail.com/canada/article-canadian-study-to-examine-safety-of- mixing-covid-19-vaccines/?cmpid=rss&utm_source=dlvr.it&utm_medium=twitter

CTV News  Preliminary results for Spanish study suggest mix and matching vaccine doses may increase antibodies. May 19, 2021. https://www.ctvnews.ca/health/coronavirus/preliminary-results- from-spanish-study-suggest-mix-and-matching-vaccine-doses-may-increase-antibodies- 1.5435789  U.K. begins ‘booster’ shot trial of 7 different COVID-19 vaccines. May 19, 2021. https://www.ctvnews.ca/health/coronavirus/u-k-begins-booster-shot-trial-of-7-different-covid- 19-vaccines-1.5434560  Two studies to examine safety of COVID-19 vaccine for pregnant and breastfeeding women. May 19, 2021. https://www.ctvnews.ca/health/coronavirus/two-studies-to-examine-safety-of- covid-19-vaccine-for-pregnant-and-breastfeeding-women-1.5435387

Global News  BioNTech vaccine should be up to 75% effective against India COVID-19 variant: CEO. May 20, 2021. https://globalnews.ca/news/7882376/biontech-covid-19-vaccine-india-variant/

Evidence Search Report: INF031801v5 ESR 4

National Post  Ontario health unites plan youth vaccinations, some offering shots to 12+ this week. May 19, 2021. https://nationalpost.com/pmn/news-pmn/canada-news-pmn/peel-region-youth-aged-12- and-older-eligible-for-covid-19-vaccines-tomorrow

Reuters  Spanish Study finds AstraZeneca vaccine followed by Pfizer dose is safe and effective. May 18, 2021. https://www.reuters.com/business/healthcare-pharmaceuticals/spanish-study-finds- astrazeneca-vaccine-followed-by-pfizer-dose-is-safe-2021-05-18/

Forbes  96% Of People Develop Covid Antibodies After Just One Shot Of Pfizer Or AstraZeneca Vaccine, U.K. Study Finds. May 18, 2021. https://www.forbes.com/sites/roberthart/2021/05/18/96-of- people-develop-covid-antibodies-after-just-one-shot-of-pfizer-or-astrazeneca-vaccine-uk-study- finds/?sh=11f71fb0699b

Newswire  Health Canada authorizes more flexible storage conditions for Pfizer-BioNTech COVID-19 vaccine. May 19, 2021. https://www.newswire.ca/news-releases/health-canada-authorizes- more-flexible-storage-conditions-for-pfizer-biontech-covid-19-vaccine-880476777.html  Medicago and GSK announce positive interim Phase 2 results for adjuvanted COVID-19 vaccine candidate. May 18, 2021. https://www.newswire.ca/news-releases/medicago-and-gsk- announce-positive-interim-phase-2-results-for-adjuvanted-covid-19-vaccine-candidate- 828894002.html

Nature  COVID vaccines can block variant hitting Asia, lab study finds. May 17, 2021. https://www.nature.com/articles/d41586-021-01329-9

Search Results: Journal Articles (includes preprints) Sorted by newest-oldest.

1. Aborode AT, Olofinsao OA, Osmond E, et al. Equal Access of COVID-19 Vaccine distribution in Africa: Challenges and Way Forward. J Med Virol. 2021;19:19. DOI: 10.1002/jmv.27095 10.1002/jmv.27095. ABSTRACT: The World Health Organization (WHO) in Africa and Africa Center Disease Control (Africa CDC) urge the international community and different countries in Africa to make sustainable and concrete action to ensure equal and easy access to the COVID-19 vaccines, as different countries in Africa are still struggling to develop a safe and effective strategy to make equal efforts in vaccine distribution if available. Africa CDC has beckoned on the international community to come together to help Africa with COVID-19 vaccines to make equal in the vaccine distribution among Africa countries as many cannot afford the vaccine costs due to the level of poverty and other negative factors. Africa Union has endorsed the need for Africa to develop a framework to actively engage in easy accessibility to COVID-19 vaccines, which will allow different countries in Africa to take easy steps that will strengthen the local vaccine distribution system, building workforce skills and knowledge, and enrich outreach services in Africa. The articles discusses the need for equal access in the distribution of COVID-19 vaccines in Africa,

Evidence Search Report: INF031801v5 ESR 5 the challenges and necessary recommendations that can help to mitigate these challenges. This article is protected by copyright. All rights reserved. URL: https://www.ncbi.nlm.nih.gov/pubmed/34009657 DOI: 10.1002/jmv.27095 10.1002/jmv.27095.

2. Abu Farha RK, Alzoubi KH, Khabour OF, et al. Exploring perception and hesitancy toward COVID-19 vaccine: A study from Jordan. Hum Vaccin Immunother. 2021:1-6. DOI: 10.1080/21645515.2021.1888633 10.1080/21645515.2021.1888633. ABSTRACT: Vaccination against COVID-19 may present the most effective strategy to control current viral . The success of delivering mass vaccination, on the scale of what would be applied to contain COVID-19, largely depends on the compliance of the public to programs mandated by public health officials. This study was aimed to evaluate the perception and possible hesitance of people in Jordan toward a tentative COVID-19 vaccine using self-administrated online survey. During the study period, a total of 1287 agreed to participate in the study. More than half of the participants (n = 734, 57%) were females and the majority (n = 893, 69%) had a University degree. Most of the participants (n = 871, 68%) believed that scientists have adequate tools to develop a safe and efficacious COVID-19 vaccine and two-third of them (n = 861, 67%) believed that developing vaccines would end the pandemic. However, around half of them (n = 665, 52%) reported not having adequate information on the benefits of COVID-19 vaccination. Preference of study participants to achieve immunity against COVID-19 using natural way was the most commonly reported reason to refuse vaccination (n = 826, 64%), followed by their concern about adverse effects associated with the vaccine (n = 781, 61%). In conclusion, the sampled participants showed an overall positive attitude toward receiving a COVID-19 vaccine. Educational campaigns using television and social media are recommended to better inform the public of the benefits of COVID-19 vaccine in reaching a "herd immunity" based strategy to control the current pandemic. URL: https://www.ncbi.nlm.nih.gov/pubmed/34014128 DOI: 10.1080/21645515.2021.1888633 10.1080/21645515.2021.1888633.

3. Abuown A, Ellis T, Miller J, et al. COVID-19 vaccination intent among London healthcare workers. Occup Med (Lond). 2021;18:18. DOI: 10.1093/occmed/kqab057 10.1093/occmed/kqab057. ABSTRACT: BACKGROUND: The 10-month timeline from conception to regulatory approval of the Pfizer-BioNTech vaccine against SARS-CoV-2 is unprecedented in modern medicine. However, the climate of the pandemic has also seen anti-vaccination sentiments flourish. AIMS: To determine the intent to accept COVID-19 vaccination among healthcare workers at a London Hospital Trust and examine variation in uptake between demographic groups. METHODS: We conducted a cross-sectional survey open to staff working at the trust. Staff rated on a five-point scale the likelihood of them accepting COVID-19 vaccination. RESULTS: We received 514 responses, representing 16% of the workforce. About 59% of staff intended to seek vaccination, 24% to reject and 17% were unsure. There was significantly reduced intended uptake in females, younger age groups, healthcare assistants, nurses, staff of black ethnic backgrounds and those who rejected influenza vaccination. Safety was the dominant concern. CONCLUSIONS: Our study finds COVID-19 vaccinate hesitancy is prevalent among healthcare workers at a London Hospital Trust. It is particularly concerning that hesitancy was highest amongst groups most exposed to COVID-19 and most at risk of severe disease. Reasons behind disparities in uptake must be addressed to protect staff and prevent deepening inequalities within the healthcare workforce. URL: https://www.ncbi.nlm.nih.gov/pubmed/34002797 DOI: 10.1093/occmed/kqab057 10.1093/occmed/kqab057.

4. Acuna-Zegarra MA, Diaz-Infante S, Baca-Carrasco D, et al. COVID-19 optimal vaccination policies: A modeling study on efficacy, natural and vaccine-induced immunity responses. Math Biosci. 2021;337(108614):108614. DOI: 10.1016/j.mbs.2021.108614 10.1016/j.mbs.2021.108614.

Evidence Search Report: INF031801v5 ESR 6 ABSTRACT: About a year into the pandemic, COVID-19 accumulates more than two million deaths worldwide. Despite non-pharmaceutical interventions such as social distance, mask-wearing, and restrictive lockdown, the daily confirmed cases remain growing. Vaccine developments from Pfizer, Moderna, and Gamaleya Institute reach more than 90% efficacy and sustain the vaccination campaigns in multiple countries. However, natural and vaccine-induced immunity responses remain poorly understood. There are great expectations, but the new SARS- CoV-2 variants demand to inquire if the vaccines will be highly protective or induce permanent immunity. Further, in the first quarter of 2021, vaccine supply is scarce. Consequently, some countries that are applying the Pfizer vaccine will delay its second required dose. Likewise, logistic supply, economic and political implications impose a set of grand challenges to develop vaccination policies. Therefore, health decision-makers require tools to evaluate hypothetical scenarios and evaluate admissible responses. Following some of the WHO-SAGE recommendations, we formulate an optimal control problem with mixed constraints to describe vaccination schedules. Our solution identifies vaccination policies that minimize the burden of COVID-19 quantified by the number of disability- adjusted years of life lost. These optimal policies ensure the vaccination coverage of a prescribed population fraction in a given time horizon and preserve hospitalization occupancy below a risk level. We explore "via simulation" plausible scenarios regarding efficacy, coverage, vaccine-induced, and natural immunity. Our simulations suggest that response regarding vaccine-induced immunity and reinfection periods would play a dominant role in mitigating COVID-19. URL: https://www.ncbi.nlm.nih.gov/pubmed/33961878 DOI: 10.1016/j.mbs.2021.108614 10.1016/j.mbs.2021.108614.

5. Adil Mahmoud Yousif N, Tsoungui Obama HCJ, Ngucho Mbeutchou YJ, et al. The impact of COVID-19 vaccination campaigns accounting for antibody-dependent enhancement. PLoS One. 2021;16(4):e0245417. DOI: 10.1371/journal.pone.0245417 10.1371/journal.pone.0245417. eCollection 2021. ABSTRACT: BACKGROUND: COVID-19 vaccines are approved, vaccination campaigns are launched, and worldwide return to normality seems within close reach. Nevertheless, concerns about the safety of COVID-19 vaccines arose, due to their fast emergency approval. In fact, the problem of antibody-dependent enhancement was raised in the context of COVID-19 vaccines. METHODS AND FINDINGS: We introduce a complex extension of the model underlying the pandemic preparedness tool CovidSim 1.1 (http://covidsim.eu/) to optimize vaccination strategies with regard to the onset of campaigns, vaccination coverage, vaccination schedules, vaccination rates, and efficiency of vaccines. Vaccines are not assumed to immunize perfectly. Some individuals fail to immunize, some reach only partial immunity, and-importantly-some develop antibody-dependent enhancement, which increases the likelihood of developing symptomatic and severe episodes (associated with higher case fatality) upon . Only a fraction of the population will be vaccinated, reflecting vaccination hesitancy or contraindications. The model is intended to facilitate decision making by exploring ranges of parameters rather than to be fitted by empirical data. We parameterized the model to reflect the situation in Germany and predict increasing incidence (and prevalence) in early 2021 followed by a decline by summer. Assuming contact reductions (curfews, , etc.) to be lifted in summer, disease incidence will peak again. Fast vaccine deployment contributes to reduce disease incidence in the first quarter of 2021, and delay the epidemic outbreak after the summer season. Higher vaccination coverage results in a delayed and reduced epidemic peak. A coverage of 75%-80% is necessary to prevent an epidemic peak without further contact reductions. CONCLUSIONS: With the vaccine becoming available, compliance with contact reductions is likely to fade. To prevent further economic damage from COVID-19, high levels of immunization need to be reached before next year's flu season, and vaccination strategies and disease management need to be flexibly adjusted. The predictive model can serve as a refined decision support tool for COVID-19 management. URL: https://www.ncbi.nlm.nih.gov/pubmed/33886573 DOI: 10.1371/journal.pone.0245417 10.1371/journal.pone.0245417. eCollection 2021.

6. Afarid M, Sanie-Jahromi F. Mesenchymal Stem Cells and COVID-19: Cure, Prevention, and Vaccination. Stem Cells Int. 2021;2021:6666370. DOI: 10.1155/2021/6666370 10.1155/2021/6666370. eCollection 2021.

Evidence Search Report: INF031801v5 ESR 7 ABSTRACT: COVID-19 disease has been a global health problem since late 2019. There are many concerns about the rapid spread of this disease, and yet, there is no approved treatment for COVID-19. Several biological interventions have been under study recently to investigate efficient treatment for this viral disease. Besides, many efforts have been made to find a safe way to prevent and vaccinate people against COVID-19 disease. In severe cases, patients suffer from acute respiratory distress syndrome usually associated with an increased level of inflammatory cytokines, called a cytokine storm. It seems that reequilibrating the hyperinflammatory response of the host and regeneration of damaged cells could be the main way to manage the disease. Mesenchymal stem cells (MSCs) have been recently under investigation in this regard, and the achieved clinical outcomes show promising evidence for stem cell-based therapy of COVID-19. MSCs are known for their potential for immunomodulation, defense against virus infection, and tissue regeneration. MSCs are a newly emerged platform for designing vaccines and show promising evidence in this area. In the present study, we provided a thorough research study on the most recent clinical studies based on stem cells in the treatment of COVID-19 while introducing stem cell exclusivities for use as an immune disorder or lung cell therapy and its potential application for protection and vaccination against COVID-19. URL: https://www.ncbi.nlm.nih.gov/pubmed/34035820 DOI: 10.1155/2021/6666370 10.1155/2021/6666370. eCollection 2021.

7. Afifi TO, Salmon S, Taillieu T, et al. Older adolescents and young adults willingness to receive the COVID-19 vaccine: Implications for informing public health strategies. Vaccine. 2021;12:12. DOI: 10.1016/j.vaccine.2021.05.026 10.1016/j.vaccine.2021.05.026. ABSTRACT: IMPORTANCE: The success in ending the COVID-19 pandemic rests partly on the mass uptake of the COVID-19 vaccine. Little work has been done to understand vaccine willingness among older adolescents and young adults. This is important since this age group may be less likely to adhere to public health guidelines. OBJECTIVE: To understand willingness of getting a vaccine and reasons for among a sample of older adolescents and young adults. DESIGN: Data were from the Well-Being and Experiences study (The WE Study), a longitudinal community-based sample of older adolescents and young adults collected from Winnipeg, Manitoba, Canada from 2017 to 2020 (n = 664). SETTING: The study setting was a community-based observational longitudinal study. PARTICIPANTS: Participants for the study were aged 14 to 17 years old at baseline in 2016-17 (n = 1000). Data were also collected on one parent/caregiver. Waves 2 (n = 747) and 3 (n = 664) were collected in 2019 and 2020, respectively. EXPOSURES: The main exposures were sociodemographic factors, health conditions, COVID-19 knowledge, and adversity history. MAIN OUTCOMES: The main outcomes were COVID-19 vaccine willingness, hesitancy, and reasons for hesitancy. RESULTS: Willingness to get a COVID-19 vaccine was 65.4%. Willingness did not differ by age, sex, or mental health conditions, but did differ for other sociodemographic characteristics, physical health conditions, COVID-19 knowledge, practicing social/physical distancing, and adversity history. The most common reasons for not wanting a vaccine were related to safety, knowledge, and effectiveness. Sex differences were noted. CONCLUSIONS AND RELEVANCE: Increasing uptake of the COVID-19 vaccine among older adolescents and young adults may rely on targeting individuals from households with lower income, financial burden, and adversity history, and generating public health messaging specifically aimed at vaccine safety, how it works to protect against illness, and why it is important to protect oneself against a COVID- 19 infection. URL: https://www.ncbi.nlm.nih.gov/pubmed/34023134 DOI: 10.1016/j.vaccine.2021.05.026 10.1016/j.vaccine.2021.05.026.

8. Agrati C, Castilletti C, Sacchi A, et al. Immunogenicity and safety of BNT162b2 COVID-19 vaccine in a chronic lymphocytic leukaemia patient. J Cell Mol Med. 2021;25:25. DOI: 10.1111/jcmm.16565 10.1111/jcmm.16565. URL: https://www.ncbi.nlm.nih.gov/pubmed/34032357 DOI: 10.1111/jcmm.16565 10.1111/jcmm.16565.

Evidence Search Report: INF031801v5 ESR 8 9. Al Kaabi N, Zhang Y, Xia S, et al. Effect of 2 Inactivated SARS-CoV-2 Vaccines on Symptomatic COVID-19 Infection in Adults: A Randomized Clinical Trial. JAMA. 2021;26:26. DOI: 10.1001/jama.2021.8565 10.1001/jama.2021.8565. ABSTRACT: Importance: Although effective vaccines against COVID-19 have been developed, additional vaccines are still needed. Objective: To evaluate the efficacy and adverse events of 2 inactivated COVID-19 vaccines. Design, Setting, and Participants: Prespecified interim analysis of an ongoing randomized, double-blind, phase 3 trial in the United Arab Emirates and Bahrain among adults 18 years and older without known history of COVID-19. Study enrollment began on July 16, 2020. Data sets used for the interim analysis of efficacy and adverse events were locked on December 20, 2020, and December 31, 2020, respectively. Interventions: Participants were randomized to receive 1 of 2 inactivated vaccines developed from SARS-CoV-2 WIV04 (5 microg/dose; n = 13 459) and HB02 (4 microg/dose; n = 13 465) strains or an aluminum hydroxide (alum)-only control (n = 13 458); they received 2 intramuscular injections 21 days apart. Main Outcomes and Measures: The primary outcome was efficacy against laboratory-confirmed symptomatic COVID-19 14 days following a second vaccine dose among participants who had no virologic evidence of SARS-CoV-2 infection at randomization. The secondary outcome was efficacy against severe COVID-19. Incidence of adverse events and reactions was collected among participants who received at least 1 dose. Results: Among 40 382 participants randomized to receive at least 1 dose of the 2 vaccines or alum- only control (mean age, 36.1 years; 32 261 [84.4%] men), 38 206 (94.6%) who received 2 doses, contributed at least 1 follow-up measure after day 14 following the second dose, and had negative reverse transcriptase- polymerase chain reaction test results at enrollment were included in the primary efficacy analysis. During a median (range) follow-up duration of 77 (1-121) days, symptomatic COVID-19 was identified in 26 participants in the WIV04 group (12.1 [95% CI, 8.3-17.8] per 1000 person-years), 21 in the HB02 group (9.8 [95% CI, 6.4-15.0] per 1000 person-years), and 95 in the alum-only group (44.7 [95% CI, 36.6-54.6] per 1000 person-years), resulting in a vaccine efficacy, compared with alum-only, of 72.8% (95% CI, 58.1%-82.4%) for WIV04 and 78.1% (95% CI, 64.8%- 86.3%) for HB02 (P < .001 for both). Two severe cases of COVID-19 occurred in the alum-only group and none occurred in the vaccine groups. Adverse reactions 7 days after each injection occurred in 41.7% to 46.5% of participants in the 3 groups; serious adverse events were rare and similar in the 3 groups (WIV04: 64 [0.5%]; HB02: 59 [0.4%]; alum-only: 78 [0.6%]). Conclusions and Relevance: In this prespecified interim analysis of a randomized clinical trial, treatment of adults with either of 2 inactivated SARS-CoV-2 vaccines significantly reduced the risk of symptomatic COVID-19, and serious adverse events were rare. Data collection for final analysis is pending. Trial Registration: ClinicalTrials.gov Identifier: NCT04510207; Chinese Clinical Trial Registry: ChiCTR2000034780. URL: https://www.ncbi.nlm.nih.gov/pubmed/34037666 DOI: 10.1001/jama.2021.8565 10.1001/jama.2021.8565.

10. Alismail S, Chipidza W. Accessibility Evaluation of COVID-19 Vaccine Registration Websites across the United States. J Am Med Inform Assoc. 2021;16:16. DOI: 10.1093/jamia/ocab105 10.1093/jamia/ocab105. ABSTRACT: This exploratory study investigated the web accessibility of 54 official COVID-19 vaccine registration websites in the US and their concordance with the WCAG 2.0 and 2.1 guidelines. We employed AChecker, WAVE, and SortSite web accessibility evaluation tools to conduct automated analyses of these websites. The results showed suboptimal compliance with WCAG 2.0 and 2.1 guidelines, as determined using the AChecker, WAVE, and SortSite tools. These shortcomings in compliance may pose difficulties to users with disabilities as they access information on the websites. Based on our findings, we offered recommendations for states and other authorities to improve the accessibility of their websites to ensure that users with disabilities can independently schedule vaccination appointments. URL: https://www.ncbi.nlm.nih.gov/pubmed/33993310 DOI: 10.1093/jamia/ocab105 10.1093/jamia/ocab105.

11. Aloweidi A, Bsisu I, Suleiman A, et al. Hesitancy towards COVID-19 Vaccines: An Analytical Cross–Sectional Study. Int J Environ Res Public Health. 2021;18(10). DOI: 10.3390/ijerph18105111 ABSTRACT: Vaccination is the most promising strategy to counter the spread of Coronavirus Disease 2019 (COVID- 19). Vaccine hesitancy is a serious global phenomenon, and therefore the aim of this cross-sectional study was to

Evidence Search Report: INF031801v5 ESR 9 explore the effect of educational background, work field, and social media on attitudes towards vaccination in Jordan. We compared between medical personnel who were in direct contact with patients and non-medical individuals at Jordan University Hospital in terms of demographics, knowledge about COVID-19 vaccines, rumors received via social media, their trust in these vaccines, and the encouraging factors for vaccination. 646 individuals were enrolled in this study, of which 287 (44.4%) were from medical field, and 359 (55.6%) from non-medical field. 226 (35%) were planning to take the vaccine once available, with a positive response from 131 (45.6%) medical field workers, compared to 94 (26.2%) non-medical individuals (p < 0.001). The social media rumor that was believed the most was the unsafety of these vaccines (n = 283; 43.8%). Only 163 (56.8%) of medical persons did not believe any of the circulated rumors, compared to 126 (35.1%) of non-medical persons (p <0.001). The effect of medical personnel advice (OR = 0.83; 95% CI = 0.70 to 0.98; p = 0.026) and social media (OR = 1.21; 95% CI = 1.04 to 1.41; p = 0.012) were significantly associated with the willingness to take COVID-19 vaccine once available. In conclusion, medical personnel and social media play a crucial role in increasing the society's inclination towards vaccination by providing the community with updated evidence-based information about COVID-19 vaccines as an efficient medical countermeasure and by correcting the previously spread misinformation. Copyright © 2021 by the authors. Licensee MDPI, Basel, Switzerland. URL: https://www.mdpi.com/1660- 4601/18/10/5111/pdfhttps://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=emexb&AN =2007147011https://libkey.io/libraries/843/openurl?output=full&sid=OVID:embase&id=pmid:&id=doi:10.3390%2 Fijerph18105111&issn=1661- 7827&isbn=&volume=18&issue=10&spage=5111&pages=&date=2021&title=International+Journal+of+Environmen tal+Research+and+Public+Health&atitle=Hesitancy+towards+covid-19+vaccines%3A+An+analytical+cross- sectional+study&aulast=Aloweidi&pid=%3Cauthor%3EAloweidi+A.%3BBsisu+I.%3BSuleiman+A.%3BAbu- Halaweh+S.%3BAlmustafa+M.%3BAqel+M.%3BAmro+A.%3BRadwan+N.%3BAssaf+D.%3BAbdullah+M.Z.%3BAlbata ineh+M.%3BMahasneh+A.%3BBadaineh+A.%3BObeidat+H.%3C%2Fauthor%3E%3CAN%3E2007147011%3C%2FAN %3E%3CDT%3EArticle%3C%2FDT%3E DOI: 10.3390/ijerph18105111

12. Alshogran OY, Altawalbeh SM, Al-Azzam SI, et al. Predictors of Covid-19 case fatality rate: An ecological study. Annals of medicine and surgery (2012). 2021;65(102319):102319. DOI: 10.1016/j.amsu.2021.102319 10.1016/j.amsu.2021.102319. Epub 2021 Apr 27. ABSTRACT: Background: The outbreak of novel coronavirus (Covid-19) has a significant burden on global health and could be associated with significant mortality. Limited information exists about determinants of its fatality worldwide. Thus, this ecological study examined the association of various predictors with Covid-19 fatality. Methods: International data bases of Covid-19 statistics and health metrics available primarily at WHO were reviewed to collect information for 113 countries. The dependent variable was Covid-19 case fatality rate. Independent variables were demographic, social, clinical, economic, heath care and child health factors. Results: Case fatality rate of Covid-19 varies across countries with an average of 4.2 +/- 3.8%, and about half of countries had fatality rate >3.2% (median). Significant relationships were observed between Covid-19 fatality rate and socio- economic, clinical, and health variables at the unadjusted regression analysis. At the multivariate adjusted model, percentage of population with age>60 years was positively associated with Covid-19 fatality (B = 0.032, p = 0.005), while Polio-3 immunization at 1-year old was inversely related (B = -0.057, p = 0.017). Conclusions: This ecological investigation highlights the higher risk of death among elderly with Covid-19 pandemic and suggests that Polio-3 immunization coverage among 1-year-olds may be associated with better survival. Future research is warranted to validate these findings. URL: https://www.ncbi.nlm.nih.gov/pubmed/33936591 DOI: 10.1016/j.amsu.2021.102319 10.1016/j.amsu.2021.102319. Epub 2021 Apr 27.

13. Althaus K, Moller P, Uzun G, et al. Antibody-mediated procoagulant platelets in SARS-CoV-2- vaccination associated immune thrombotic thrombocytopenia. Haematologica. 2021;20:20. DOI: 10.3324/haematol.2021.279000 10.3324/haematol.2021.279000.

Evidence Search Report: INF031801v5 ESR 10 ABSTRACT: The COVID-19 pandemic has resulted in significant morbidity and mortality worldwide. To prevent severe infection, mass COVID-19 vaccination campaigns with several vaccine types are currently underway. We report pathological and immunological findings in 8 patients who developed vaccine-induced immune thrombotic thrombocytopenia (VITT) after administration of SARS-CoV-2 vaccine ChAdOx1 nCoV-19. We analyzed patient material using enzyme immune assays, flow cytometry and heparin-induced platelet aggregation assay and performed autopsies on two fatal cases. Eight patients (5 female, 3 male) with a median age of 41.5 years (range, 24 to 53) were referred to us with suspected thrombotic complications 6 to 20 days after ChAdOx1 nCoV-19 vaccination. All patients had thrombocytopenia at admission. Patients had a median platelet count of 46.5 x109/L (range, 8 to 92). Three had a fatal outcome and 5 were successfully treated. Autopsies showed arterial and venous thromboses in various organs and the occlusion of glomerular capillaries by hyaline thrombi. Sera from VITT patients contain high titer antibodies against platelet factor 4 (PF4) (OD 2.59+/-0.64). PF4 antibodies in VITT patients induced significant increase in procoagulant markers (P-selectin and phosphatidylserine externalization) compared to healthy volunteers and healthy vaccinated volunteers. The generation of procoagulant platelets was PF4 and heparin dependent. We demonstrate the contribution of antibody-mediated platelet activation in the pathogenesis of VITT. URL: https://www.ncbi.nlm.nih.gov/pubmed/34011137 DOI: 10.3324/haematol.2021.279000 10.3324/haematol.2021.279000.

14. An QJ, Qin DA, Pei JX. Reactive arthritis after COVID-19 vaccination. Hum Vaccin Immunother. 2021:1-3. DOI: 10.1080/21645515.2021.1920274 10.1080/21645515.2021.1920274. ABSTRACT: The severe acute respiratory syndrome coronavirus 2-induced coronavirus disease 2019 (COVID-19) has had a global spread. Vaccines play an essential role in preventing the spread. However, almost all types of vaccines have been reported to be associated with adverse events. Reactive arthritis (ReA) after vaccination has been reported; however, ReA after COVID-19 vaccination has not been reported. We reported a 23-year-old woman who suffered from an acute ReA on her left knee joint after COVID-19 vaccination and discussed the etiology and preventive strategy. She presented with swollen, painful left knee joint for 18 d. She had been inoculated 0.5 ml CoronaVac vaccine on 0 d and the 14th day with deltoid intramuscular injection. Finally, she was diagnosed as ReA after CoronaVac vaccination and was administered a single intra-articular injection of 1 ml compound betamethasone. The swelling and pain nearly disappeared after 2 d. On 1month follow-up, her condition was normal. ReA after COVID-19 vaccination is rare. The benefits of vaccination far outweigh its potential risks and vaccination should be administered according to the current recommendations. Further attentions should be put to determine which individual is at higher risk for developing autoimmune diseases after COVID-19 vaccination. More versatile and safer vaccines should be explored. URL: https://www.ncbi.nlm.nih.gov/pubmed/34033732 DOI: 10.1080/21645515.2021.1920274 10.1080/21645515.2021.1920274.

15. Anand P, Stahel VP. Correction to: The safety of Covid-19 mRNA vaccines: a review. Patient Saf Surg. 2021;15(1):22. DOI: 10.1186/s13037-021-00296-4 10.1186/s13037-021-00296-4. URL: https://www.ncbi.nlm.nih.gov/pubmed/34006292 DOI: 10.1186/s13037-021-00296-4 10.1186/s13037-021-00296-4.

16. Anand S, Montez-Rath ME, Han J, et al. Antibody Response to COVID-19 vaccination in Patients Receiving Dialysis. medRxiv. 2021;12:12. DOI: 10.1101/2021.05.06.21256768 10.1101/2021.05.06.21256768. ABSTRACT: Background: Patients receiving dialysis may mount impaired responses to COVID19 vaccination. Methods: We report antibody response to vaccination from 1140 patients without, and 493 patients with pre- vaccination SARS-CoV-2 RBD antibody. We used commercially available assays (Siemens) to test remainder plasma monthly in association with vaccination date and type, and assess prevalence of absent total receptor binding

Evidence Search Report: INF031801v5 ESR 11 antibody, and absent or attenuated (index value < 10) semiquantitative receptor binding domain IgG index values. We used Poisson regression to evaluate risk factors for absent or attenuated response to vaccination. Results: Among patients who were seronegative versus seropositive before vaccination, 62% and 56% were >/=65 years old, 20% and 24% were Hispanic, and 22% and 23% were Black. Median IgG index values rose steadily over time, and were higher among the seropositive than in the seronegative patients after completing vaccination (150 [25 (th) , 75 (th) percentile 23.2, 150.0] versus 41.6 [11.3, 150.0]). Among 610 patients who completed vaccination (assessed >/=14 days later, median 29 days later), the prevalence of absent total RBD response, and absent and attenuated semiquantitative IgG response was 4.4% (95% CI 3.1, 6.4%), 3.4% (2.4, 5.2%), and 14.3% (11.7, 17.3%) respectively. Risk factors for absent or attenuated response included longer vintage of end-stage kidney disease, and lower pre-vaccination serum albumin. Conclusions: More than one in five patients receiving dialysis had evidence of an attenuated immune response to COVID19 vaccination. Significance statement: Patients receiving dialysis face high likelihood of severe COVID19; at the same time, vaccination may be less efficacious, as prior data indicate impaired immune responses to influenza and Hepatitis B vaccination. We found that 22% of patients receiving dialysis had suboptimal responses to vaccination, irrespective of whether or not they had evidence of prior SARS-CoV-2 infection. Poorer health status and longer duration of end-stage kidney disease increased likelihood of suboptimal response. Ongoing vigilance for COVID19 in dialysis facilities and studies of modified vaccination dosing schedules will be critical to protecting patients receiving dialysis. URL: https://www.ncbi.nlm.nih.gov/pubmed/34013281 DOI: 10.1101/2021.05.06.21256768 10.1101/2021.05.06.21256768.

17. Angel Y, Spitzer A, Henig O, et al. Association Between Vaccination With BNT162b2 and Incidence of Symptomatic and Asymptomatic SARS-CoV-2 Infections Among Health Care Workers. JAMA. 2021. DOI: 10.1001/jama.2021.7152 10.1001/jama.2021.7152. ABSTRACT: Importance: Randomized clinical trials have provided estimates of the effectiveness of the BNT162b2 vaccine against symptomatic SARS-CoV-2 infection, but its effect on asymptomatic infections remains unclear. Objective: To estimate the association of vaccination with the Pfizer-BioNTech BNT162b2 vaccine with symptomatic and asymptomatic SARS-CoV-2 infections among health care workers. Design, Setting, and Participants: This was a single-center, retrospective cohort study conducted at a tertiary medical center in Tel Aviv, Israel. Data were collected on symptomatic and asymptomatic SARS-CoV-2 infections confirmed via polymerase chain reaction (PCR) tests in health care workers undergoing regular screening with nasopharyngeal swabs between December 20, 2020, and February 25, 2021. Logistic regression was used to calculate incidence rate ratios (IRRs) comparing the incidence of infection between fully vaccinated and unvaccinated participants, controlling for demographics and the number of PCR tests performed. Exposures: Vaccination with the BNT162b2 vaccine vs unvaccinated status was ascertained from the employee health database. Full vaccination was defined as more than 7 days after receipt of the second vaccine dose. Main Outcomes and Measures: The primary outcome was the regression-adjusted IRR for symptomatic and asymptomatic SARS-CoV-2 infection of fully vaccinated vs unvaccinated health care workers. The secondary outcomes included IRRs for partially vaccinated health care workers (days 7-28 after first dose) and for those considered as late fully vaccinated (>21 days after second dose). Results: A total of 6710 health care workers (mean [SD] age, 44.3 [12.5] years; 4465 [66.5%] women) were followed up for a median period of 63 days; 5953 health care workers (88.7%) received at least 1 dose of the BNT162b2 vaccine, 5517 (82.2%) received 2 doses, and 757 (11.3%) were not vaccinated. Vaccination was associated with older age compared with those who were not vaccinated (mean age, 44.8 vs 40.7 years, respectively) and male sex (31.4% vs 17.7%). Symptomatic SARS-CoV-2 infection occurred in 8 fully vaccinated health care workers and 38 unvaccinated health care workers (incidence rate, 4.7 vs 149.8 per 100000 person- days, respectively, adjusted IRR, 0.03 [95% CI, 0.01-0.06]). Asymptomatic SARS-CoV-2 infection occurred in 19 fully vaccinated health care workers and 17 unvaccinated health care workers (incidence rate, 11.3 vs 67.0 per 100000 person-days, respectively, adjusted IRR, 0.14 [95% CI, 0.07-0.31]). The results were qualitatively unchanged by the propensity score sensitivity analysis. Conclusions and Relevance: Among health care workers at a single center in Tel Aviv, Israel, receipt of the BNT162b2 vaccine compared with no vaccine was associated with a significantly lower incidence of symptomatic and asymptomatic SARS-CoV-2 infection more than 7 days after the second dose. Findings are limited by the observational design.

Evidence Search Report: INF031801v5 ESR 12 URL: https://www.ncbi.nlm.nih.gov/pubmed/33956048 DOI: 10.1001/jama.2021.7152 10.1001/jama.2021.7152.

18. Aspatwar A, Gong W, Wang S, et al. Tuberculosis vaccine BCG: the magical effect of the old vaccine in the fight against the COVID-19 pandemic. Int Rev Immunol. 2021:1-14. DOI: 10.1080/08830185.2021.1922685 10.1080/08830185.2021.1922685. ABSTRACT: Bacillus Calmette-Guerin (BCG) is a live attenuated M. bovis vaccine that was developed about 100 years ago by Albert Calmette and Camille Guerin. Many countries have been using the vaccine for decades against tuberculosis (TB). The World Health Organization (WHO) recommends a single dose of BCG for infants in TB endemic as well as leprosy high risk countries, and globally almost 130 million infants are vaccinated yearly. The role of BCG is well known in reducing neonatal and childhood death rates. Epidemiological and retrospective cross- sectional studies demonstrated that the BCG vaccination protects the children against respiratory tract infections and lowers the risk of malaria in children. In addition, BCG enhances IFN-gamma and IL-10 levels, thus providing immunity against respiratory tract infection even in elderly people. The BCG is also known to provide nonspecific innate immunity against viruses and parasites, through an innate immune mechanism termed 'trained immunity' and is defined as the immunological recall of the innate immune system by epigenetic reprogramming. Based on these studies it is suggested that the BCG has the potential to act as a protective agent against COVID-19. Further proven safety records of BCG in humans, its adjuvant activity and low-cost manufacturing make it an attractive option to stop the pandemic and reduce the COVID-19 related mortality. In this review we discuss the heterologous effects of BCG, induction of trained immunity and its implication in development of a potential vaccine against COVID-19 pandemic. URL: https://www.ncbi.nlm.nih.gov/pubmed/33960271 DOI: 10.1080/08830185.2021.1922685 10.1080/08830185.2021.1922685.

19. Aygun D, Onal P, Apaydin G, et al. Coronavirus infections in childhood and vaccine studies. Turk Arch Pediatr. 2021;56(1):10-4. DOI: 10.5152/TurkArchPediatr.2020.20255 10.5152/TurkArchPediatr.2020.20255. eCollection 2021 Jan. ABSTRACT: In late December 2019, a new coronavirus (CoV) called the severe acute respiratory syndrome CoV 2 (SARS-CoV-2), which had not been detected in humans before, caused a worldwide pandemic. Owing to the highly infectious nature of this virus, it spread rapidly from person to person despite the warnings of the World Health Organization and all the measures taken by the governments. Although it has been reported that SARS-CoV-2 is more likely to infect the elderly, all age groups are susceptible to this virus, including newborns. CoV disease 2019 (COVID-19) symptoms seem to be less severe in children than in adults, but similar to the 2003 severe acute respiratory syndrome epidemic, in the COVID-19 pandemic, the number of cases and the risk of serious diseases increase as age increases. The treatment of COVID-19 is still challenging, especially in children, and the virus continues to cause death worldwide. The safest and most controlled way to effectively and sustainably prevent COVID-19 in a society is to have an effective and safe vaccine and to successfully vaccinate the majority of the population. It is possible that vaccines with safety and efficacy that have been proven in phase III tri als will be effective in handling COVID-19. URL: https://www.ncbi.nlm.nih.gov/pubmed/34013223 DOI: 10.5152/TurkArchPediatr.2020.20255 10.5152/TurkArchPediatr.2020.20255. eCollection 2021 Jan.

20. Bailly B, Guilpain L, Bouiller K, et al. BNT162b2 mRNA vaccination did not prevent an outbreak of SARS COV-2 variant 501Y.V2 in an elderly nursing home but reduced transmission and disease severity. Clin Infect Dis. 2021;16:16. DOI: 10.1093/cid/ciab446 10.1093/cid/ciab446. ABSTRACT: We report an outbreak of SARS-CoV-2 501Y.V2 in a nursing home. All non-vaccinated residents (5/5) versus half of those vaccinated with BNT162b2 (13/26) were infected. Two of 13 vaccinated versus 4 of 5 non- vaccinated residents presented severe disease. BNT162b2 did not prevent the outbreak, but reduced transmission and disease severity.

Evidence Search Report: INF031801v5 ESR 13 URL: https://www.ncbi.nlm.nih.gov/pubmed/33993228 DOI: 10.1093/cid/ciab446 10.1093/cid/ciab446.

21. Barda B, Cerny A. Safety of mRNA-Based Vaccines for SARS CoV-2. Chem Res Toxicol. 2021;19:19. DOI: 10.1021/acs.chemrestox.1c00129 10.1021/acs.chemrestox.1c00129. ABSTRACT: SARS-CoV-2 has infected more than 100 million people, causing 2 million deaths globally. Studies on the development of a vaccine ended up with different formulations. We herein discuss the safety record of the two approved vaccines. URL: https://www.ncbi.nlm.nih.gov/pubmed/34009959 DOI: 10.1021/acs.chemrestox.1c00129 10.1021/acs.chemrestox.1c00129.

22. Batty GD, Deary IJ, Altschul D. Pre-pandemic mental and physical health as predictors of COVID-19 vaccine hesitancy: evidence from a UK-wide cohort study. medRxiv. 2021;30:30. DOI: 10.1101/2021.04.27.21256185 10.1101/2021.04.27.21256185. ABSTRACT: Importance: Although several predictors of COVID-19 vaccine hesitancy have been identified, the role of physical health has not been well-examined, and the association with mental health is unknown. Objective: To examine the association of pre-pandemic mental health, physical health, and shielding with vaccine hesitancy after the announcement of the successful testing of the Oxford University/AstraZeneca vaccine. Design Setting and Participants: We used individual-level data from a pandemic-focused investigation (COVID Survey), a prospective cohort study nested within the UK Understanding Society (Main Survey) project. In the week immediately following the announcement of successful testing of the first efficacious (November/December 2020), data on vaccine intentionality were collected in 12,035 individuals aged 16-95 years. Pre-pandemic, study members had responded to enquiries about diagnoses of mental and physical health, completed the 12-item General Health Questionnaire for symptoms of psychological distress (anxiety and depression), and indicated whether they or someone in their household was shielding. Main outcome measures: Self-reported intention to take up a vaccination for COVID-19. To summarise our results, we computed odds ratios with accompanying 95% confidence intervals for indices of health and shielding adjusted for selected covariates. Results: In an analytical sample of 11,955 people (6741 women), 15.4% indicated that they were vaccine hesitant. Relative to their disease- free counterparts, shielding was associated with a 24% lower risk of being hesitant (odds ratio; 95% confidence interval: 0.76; 0.59, 0.96), after adjustment for a range of covariates which included age, education, and ethnicity. Corresponding results for cardiometabolic disease were 22% (0.78; 0.64, 0.95), and for respiratory disease were 26% (0.74; 0.59, 0.93). Having a pre-pandemic diagnosis of anxiety or depression, or a high score on the distress symptom scale, were all unrelated to the willingness to take up a vaccine. Conclusions and relevance: People who have been prioritised for COVID-19 vaccination owing to a physical condition are more likely to take it up. These effects were not apparent for indices of mental health. URL: https://www.ncbi.nlm.nih.gov/pubmed/34013297 DOI: 10.1101/2021.04.27.21256185 10.1101/2021.04.27.21256185.

23. Ber I, Lerman Y, Muhsen K. [the Need for Reducing Disparities in Sars-Cov-2 Immunization: The Ultraorthodox and Arab Populations in Israel]. Harefuah. 2021;160(5):285-90. ABSTRACT: INTRODUCTION: Immunization against coronavirus disease 2019 (COVID-19) in Israel began on December 2020, using the BNT162b2 mRNA vaccine. Individuals aged 60 years or older and medical staff were prioritized in COVID-19 immunization, and currently individuals aged 16 years or older are eligible to receive the vaccine. To achieve levels of community immunity (herd immunity) immunization of 60-70% of the population is required. As of mid-February 2021, about 42% of the population in Israel received the first vaccine dose, and the coverage exceeded 70% in individuals aged 50 years or older. Despite this success, the rates of COVID-19 immunization are lower in the ultraorthodox and Arab populations compared to the general Jewish population. We reviewed factors that might affect acceptance of COVID-19 vaccines. Factors that might influence the individual's willingness to be vaccinated against COVID-19 include concerns about the safety of the vaccine,

Evidence Search Report: INF031801v5 ESR 14 recommendations by employers and treating physicians. Moreover, differences were found in the willingness to be vaccinated according to socio-demographic characteristics, such as employment, age and gender groups, and even political affiliation. Minority populations are vulnerable to misinformation about vaccines. The Arab and the ultraorthodox populations are the main minority groups in Israel, and characterized by lifestyle, and low socio- economic status, which increased, among other factors, the incidence of COVID-19 in these populations. To improve vaccine uptake in the ultraorthodox and Arab populations, there is an urgent need for better tailored solutions to the unique needs of these minority populations, which comprise main risk groups for misinformation related to COVID-19 vaccines. Moreover, a better understanding of the reasons for low uptake of COVID-19 vaccine in these populations is warranted. These activities should be undertaken in parallel to continuous efforts towards reducing socio-economic disparities between sub-population groups. URL: https://www.ncbi.nlm.nih.gov/pubmed/34028219

24. Bermingham WH, Ardern-Jones MR, Huissoon AP, et al. Forewarned is Forearmed: chronic spontaneous urticaria as a potential risk to effective SARS-COV-2 vaccine uptake and global public health. Br J Dermatol. 2021;20:20. DOI: 10.1111/bjd.20495 10.1111/bjd.20495. ABSTRACT: Chronic spontaneous urticaria and angioedema (CSU/A) is a common condition with an estimated global point prevalence of 0.7% (95% C.I, 0.2-1.4)(1), higher in non-White populations. Symptoms present as an 'allergy mimic' but are underpinned by non-specific, non-IgE-mediated mast cell histamine release. The combination of common population prevalence and likelihood of vaccines precipitating symptoms in those with CSU/A presents an immediate risk to the SARS-COV-2 global vaccine program. URL: https://www.ncbi.nlm.nih.gov/pubmed/34013621 DOI: 10.1111/bjd.20495 10.1111/bjd.20495.

25. Birhane M, Bressler S, Chang G, et al. COVID-19 Vaccine Breakthrough Infections Reported to CDC — United States, January 1–April 30, 2021. MMWR Morbidity and Mortality Weekly Report. 2021;70(21):792-3. DOI: 10.15585/mmwr.mm7021e3 DOI: 10.15585/mmwr.mm7021e3

26. Blanchard-Rohner G, Caprettini B, Rohner D, et al. Impact of COVID-19 and ICU capacity on vaccination support: Evidence from a two-leg representative survey in the UK. J Virus Erad. 2021:100044. DOI: 10.1016/j.jve.2021.100044 10.1016/j.jve.2021.100044. ABSTRACT: Background: Overcoming coronavirus disease (COVID-19) will likely require mass vaccination. With vaccination scepticism rising in many countries, assessing the willingness to vaccinate against COVID-19 is of crucial global health importance. Objective: The goal of this study was to examine how personal and family COVID-19 risk and ICU (intensive care unit) availability just before the influence the acceptance of future COVID-19 vaccines. Methods: A two-leg survey was carried out for comparing vaccination attitudes pre-and post-COVID-19. UK residents were surveyed in October 2019 about their vaccination attitudes, and again in a follow-up survey in April 2020, containing the previous questions and further ones related to COVID-19 exposure and COVID-19 vaccine attitudes. The study combined survey results with local COVID-19 incidence and pre-COVID-19 measures of ICU capacity and occupancy. Regression analysis of the impact of individual and public health factors on attitudes towards COVID-19 vaccination was performed. Results: The October 2019 survey included a nationally representative sample of 1,653 UK residents. All of them were invited for the follow-up survey in April 2020, and 1,194 (72%) participated. The April 2020 sample remained nationally representative. Overall, 85% of respondents (and 55% of vaccine sceptics) would be willing to be vaccinated against COVID-19. Higher personal and family risk for COVID-19 was associated with stronger COVID-19 vaccination willingness, whereas low pre-COVID-19 ICU availability was associated with lower trust in medical experts and lower COVID-19 vaccine support. Further, general vaccination support has risen during the COVID-19 pandemic. Conclusion: Support for COVID-19 vaccination is high amongst all groups, even vaccine sceptics, boding well for future vaccination take-up rates. Vaccination willingness is correlated with health care availability during the COVID-19 crisis, suggesting a powerful

Evidence Search Report: INF031801v5 ESR 15 synergy between health care system performance during crisis and the general population's trust in the medical profession - as reflected in vaccination support. URL: https://www.ncbi.nlm.nih.gov/pubmed/34026244 DOI: 10.1016/j.jve.2021.100044 10.1016/j.jve.2021.100044.

27. Boehm E, Kronig I, Neher RA, et al. Novel SARS-CoV-2 variants: the pandemics within the pandemic. Clin Microbiol Infect. 2021;17:17. DOI: 10.1016/j.cmi.2021.05.022 10.1016/j.cmi.2021.05.022. ABSTRACT: BACKGROUND: Many new variants of SARS-CoV-2 have been termed Variants of Concern/Interest (VOC/I) because of their greater risk due to possibly: enhanced transmissibility and/or severity, immune escape, diagnostic and/or treatment failure, and reduced vaccine efficacy. OBJECTIVES: We sought to review current knowledge of emerging SARS-CoV-2 variants, particularly those deemed VOC/Is: B.1.351, B.1.1.7, and P.1. SOURCES: MEDLINE and BioRxiv databases, as well as the grey literature were searched for reports of SARS-CoV-2 variants since November 2020. Relevant articles and their references were screened. CONTENT: Mutations on the spike protein in particular may affect both affinity for the SARS-CoV-2 cell receptor ACEII or antibody binding. These VOC/Is often share similar mutation sets. The N501Y mutation is shared by the main three VOCs: B.1.1.7, first identified in the United Kingdom; P.1, originating from ; and B.1.351, first described in South Africa. This mutation likely increases transmissibility, by increasing affinity for ACEII. The B.1.351 and P.1 variants also display the E484K mutation, which decreases binding of neutralizing antibodies, leading to partial immune escape, favoring reinfections, and decreased in vitro efficacy of some antibody therapies or vaccines. Those mutations may also have phenotypical repercussions of higher severity. Furthermore, the accumulation of mutations poses a diagnostic risk (lowered when using multiplex assays), as seen for some assays targeting the S-gene. With ongoing surveillance, many new VOC/Is have been identified. The emergence of the E484K mutation independently in different parts of the globe may reflect adaptation of SARS-CoV-2 to humans in a background of increasing immunity. IMPLICATIONS: These VOC/Is are increasing in frequency globally and pose challenges to any herd immunity approach of managing the pandemic. While vaccination is ongoing, vaccine updates may be prudent. The virus continues to adapt to transmission in humans, and further divergence from the initial Wuhan sequences is expected. URL: https://www.ncbi.nlm.nih.gov/pubmed/34015535 DOI: 10.1016/j.cmi.2021.05.022 10.1016/j.cmi.2021.05.022.

28. Bormann M, van de Sand L, Witzke O, et al. Recent Antiviral Treatment and Vaccination Strategies Against SARS-CoV-2. Klin Monbl Augenheilkd. 2021;238(5):569-78. DOI: 10.1055/a-1423-8961 10.1055/a-1423-8961. Epub 2021 May 21. ABSTRACT: Since the end of 2019, the novel severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) has been spreading worldwide and has caused severe health and economic issues on a global scale. By the end of February 2021, more than 100 million SARS-CoV-2 cases had been reported worldwide. SARS-CoV-2 causes the coronavirus disease 2019 (COVID-19) that can be divided into three phases: An early phase with fever and cough (phase I), a pulmonary vascular disease (phase II) and a hyperinflammatory syndrome (phase III). Since viral replication plays a particularly important role in the early stage of the disease and the patient's immune system in the later course of infection, different therapeutic options arise depending on the stage of the disease. The antiviral nucleoside analogue remdesivir is the only antiviral compound with conditional approval in the European Union. Treatment with remdesivir should be initiated early (within the first seven days of symptom onset) in patients receiving supplemental oxygen without invasive ventilation. In turn, the anti-inflammatory corticosteroid should be administered later in the course of disease in patients receiving oxygen therapy. Since autopsies indicate an increased frequency of thromboembolic events due to COVID-19, additional treatment with anticoagulants is recommended. Since the development of novel antivirals may take years, the application of convalescent plasma from patients who recovered from a SARS-CoV-2 infection for the treatment of COVID-19 is reasonable. However, large-scale studies indicated low efficacy of convalescent plasma. Furthermore, vaccination of the population is essential to control the pandemic. Currently, the mRNA vaccine Tozinameran from BioNTech and Pfizer, the mRNA-1273 vaccine from Moderna as well as the vector vaccine AZD1222 from AstraZeneca are

Evidence Search Report: INF031801v5 ESR 16 licensed in the European Union. All three vaccines have demonstrated high efficacy in large clinical trials. In addition to these licensed vaccines, many others are being tested in clinical trials. In the present article, an overview of therapeutic options for COVID-19 as well as vaccines for protection against SARS-CoV-2 is provided. URL: https://www.ncbi.nlm.nih.gov/pubmed/34020485 DOI: 10.1055/a-1423-8961 10.1055/a-1423-8961. Epub 2021 May 21.

29. Brillo E, Tosto V, Gerli S, et al. COVID-19 vaccination in pregnancy and postpartum. J Matern Fetal Neonatal Med. 2021:1-20. DOI: 10.1080/14767058.2021.1920916 10.1080/14767058.2021.1920916. ABSTRACT: AIM: To identify whether COVID-19 vaccines should be administered in pregnant and breastfeeding women by reviewing the guidance and other evidence. METHODS: We reviewed the COVID-19 vaccination guidance for pregnant and breastfeeding women published to date and evidence from preclinical experimental and observational clinical studies, and discuss their implications. RESULTS: Pregnant women were excluded from the initial phase 3 clinical trials of COVID-19 vaccines resulting in limited data on their efficacy and safety during pregnancy and postpartum. As a result, since December 2020, there has been conflicting advice from public health, governmental, and professional authorities on this matter. From the end of 2020 up to now, some consensus guidance has been published with a prevalent precautionary approach on the administration of vaccines in pregnant women, in breastfeeding ones, or for those who are planning a pregnancy (either spontaneously or with assisted technologies). After the first few months of vaccine administration in some countries, more permissiveness seems to prevail, although with inconsistencies. At the moment, the results obtained by preclinical experimental and observational clinical studies suggest that the risks of the maternal COVID-19 outweigh the undocumented and hypothetical risks of the COVID-19 vaccines in pregnancy. Also, until two viral vector COVID-19 vaccines were associated with very rare thromboembolic events, all guidance had agreed that all approved COVID- 19 vaccines could be administered in pregnancy. Actually, some concern has been expressed. CONCLUSION: COVID-19 vaccines administered in pregnancy can reduce the risk of severe COVID-19 and their serious consequences for mothers and their offspring. However, many aspects remain to be clarified. URL: https://www.ncbi.nlm.nih.gov/pubmed/33998379 DOI: 10.1080/14767058.2021.1920916 10.1080/14767058.2021.1920916.

30. Buttery JP. Developing standard safety outcomes for COVID-19 vaccines. Vaccine. 2021;39(22):3025-7. DOI: 10.1016/j.vaccine.2021.03.004 10.1016/j.vaccine.2021.03.004. Epub 2021 Mar 12. URL: https://www.ncbi.nlm.nih.gov/pubmed/33888324 DOI: 10.1016/j.vaccine.2021.03.004 10.1016/j.vaccine.2021.03.004. Epub 2021 Mar 12.

31. Caldera F, Balzora S, Hayney MS, et al. Ensuring High and Equitable COVID-19 Vaccine Uptake Among Patients With IBD. Inflamm Bowel Dis. 2021;20:20. DOI: 10.1093/ibd/izab114 10.1093/ibd/izab114. ABSTRACT: The recent emergency use authorization of a third COVID-19 vaccine means that most patients with inflammatory bowel disease (IBD) will soon be eligible to be vaccinated. Gastroenterology clinicians should be prepared to address patients' concerns regarding safety and efficacy of vaccines. They should also strongly recommend that all their patients be vaccinated with a COVID-19 vaccine. Additionally, they should be prepared to educate patients about logistics that will result in successful vaccination completion. All these measures will be crucial to ensure high uptake among their patients with IBD. URL: https://www.ncbi.nlm.nih.gov/pubmed/34013958 DOI: 10.1093/ibd/izab114 10.1093/ibd/izab114.

32. Callow MA, Callow DD. Older Adults' Behavior Intentions Once a COVID-19 Vaccine Becomes Available. J Appl Gerontol. 2021:7334648211019205. DOI: 10.1177/07334648211019205

Evidence Search Report: INF031801v5 ESR 17 10.1177/07334648211019205. ABSTRACT: BACKGROUND: The purpose of this study was to examine the impact of antecedent variables on older adults' intention to get a CORONAVIRUS DISEASE-2019 vaccine. Older adults are at higher risk of severe illness from the disease and face an increasingly ageist general population who misrepresent the pandemic as an older adult problem. We use the Theory of Planned Behavior framework to examine vaccine behavior intention. METHOD: A convenience sample (n = 583) of adults aged 60 and older in the United States participated in an online survey using vignettes. Hierarchical regression and analysis of covariance were used to test our model. RESULTS: Results suggest that perceived risk of the pandemic, general vaccine beliefs, and political affiliation influence respondents' attitude toward the vaccine. Respondents' attitudes toward the vaccine and their physician's recommendation help shape vaccine intention. CONCLUSION: The results provide partial support to the proposed model in shaping vaccine intention among older adults. URL: https://www.ncbi.nlm.nih.gov/pubmed/34036821 DOI: 10.1177/07334648211019205 10.1177/07334648211019205.

33. Calzetta L, Ritondo BL, Coppola A, et al. Factors Influencing the Efficacy of COVID-19 Vaccines: A Quantitative Synthesis of Phase III Trials. Vaccines. 2021;9(4):341. DOI: 10.3390/vaccines9040341 ABSTRACT: To date, there is still a paucity of data from Phase III trials concerning the efficacy of vaccines against COVID-19. Furthermore, no studies investigated the variables that may modulate the efficacy of vaccination. The aim of this analysis was to assess whether there are modifying factors that may potentially influence the clinical efficacy of COVID-19 vaccines. A quantitative synthesis of data from Phase III trials was performed via pairwise and network meta-analyses, along with meta-regression analysis. Data from Phase III trials are currently available only for AZD1222, BNT162b2, mRNA-1237, and Sputnik V. Vaccination resulted to be generally effective (90.0%, 95%CI 72.6-96.4; p < 0.001), although the efficacy of AZD1222 (62.1%) introduced a significant level of heterogeneity in the meta-analysis (I(2) 92.17%, p < 0.001). No significant modifying factors resulted from the meta-regression analysis. However, considering the mRNA-based vaccines, a trend toward significance (p = 0.081) resulted for age. The network meta-analysis provided the following rank of effectiveness: BNT162b2 ≃ mRNA-1273 > Sputnik V >> AZD1222. In conclusion, no modifying factors seem to modulate the efficacy of vaccines against COVID-19. This quantitative synthesis will need to be updated as soon as further clinical results on the efficacy profile are available from Phase III trials for further licensed COVID-19 vaccines. URL: https://pubmed.ncbi.nlm.nih.gov/33916222 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8065664/ DOI: 10.3390/vaccines9040341

34. Campbell J, Hobbs M, O'Hara L, et al. Equity in vaccine trials for higher weight people? Protocol for a rapid review of inclusion and exclusion criteria for higher weight people in clinical trials for COVID-19. BMJ Open. 2021;11(5):e050114. DOI: 10.1136/bmjopen-2021-050114 10.1136/bmjopen-2021-050114. ABSTRACT: INTRODUCTION: Vaccination is a public health strategy that aims to reduce the burden of viral illness, especially important for populations known or likely to be at increased risk for inequitable outcomes due to the disease itself or disparities in care accessed and received. The role of weight status in COVID-19 susceptibility and disease burden remains unclear. Despite this, higher weight is frequently described as a definitive risk factor for both susceptibility and disease severity. Therefore, COVID-19 vaccine trials should recruit a study group representative of the full weight spectrum, and undertake appropriate subgroup analysis by weight status to evaluate response and titrate dose regimes where indicated to ensure equitable outcomes for higher weight people. METHODS AND ANALYSIS: We aim to review inclusion and exclusion criteria of clinical trial protocols registered with ClinicalTrials.gov, ISRCTN Register, the WHO official register, and 'The COVID-19 Vaccine Tracker'. To determine the number of trials including higher weight (body mass index >30 kg/m(2)) individuals and the number of trials conducting efficacy subgroup analyses by weight status. Screening, data extraction and quality appraisal of trial protocols will be completed independently by a minimum of two reviewers. Clinical trials will be assessed for risk of bias using the Risk of Bias-2 tool. We will conduct a descriptive analysis of extracted data. The following subsets are proposed: participation of higher weight people in COVID-19 vaccine trials by trial phase, country and vaccine platform. ETHICS AND DISSEMINATION: Ethical approval was not required

Evidence Search Report: INF031801v5 ESR 18 for this review. The results of this rapid review will be presented at appropriate conferences and published in a suitable peer reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42020226573. URL: https://www.ncbi.nlm.nih.gov/pubmed/34035111 DOI: 10.1136/bmjopen-2021-050114 10.1136/bmjopen-2021-050114.

35. Campos-Outcalt D. ACIP recommendations for COVID-19 vaccines-and more. J Fam Pract. 2021;70(2):86;9;92. DOI: 10.12788/jfp.0153 10.12788/jfp.0153. ABSTRACT: Prioritized immunization is advised with the 2 COVID-19 vaccines. A third meningococcal ACWY vaccine is now the only one approved for those > 55 years. URL: https://www.ncbi.nlm.nih.gov/pubmed/33760898 DOI: 10.12788/jfp.0153 10.12788/jfp.0153.

36. Carneiro DC, Sousa JD, Monteiro-Cunha JP. The COVID-19 vaccine development: A pandemic paradigm. Virus Res. 2021;301:198454. DOI: 10.1016/j.virusres.2021.198454 10.1016/j.virusres.2021.198454. ABSTRACT: COVID-19 pandemic has resulted in millions of deaths and a social-economic crisis. A worldwide effort was made to develop efficient vaccines for this disease. A vaccine should produce immune responses with specific and neutralizing antibodies, and without harmful effects such as the antibody-dependent enhancement that may be associated with severe acute respiratory syndrome. Vaccine design involves the selection of platforms that includes viral, viral-vector, protein, nucleic acid, or trained immunity-based strategies. Its development initiates at a pre-clinical stage, followed by clinical trials when successful. Only if clinical trials show no significant evidence of safety concerns, vaccines can be manufactured, stored, and distributed to immunize the population. So far, regulatory authorities from many countries have approved nine vaccines with phase 3 results. In the current pandemic, a paradigm for the COVID-19 vaccine development has arisen, as many challenges must be overcome. Mass-production and cold-chain storage to immunize large human populations should be feasible and fast, and a combination of different vaccines may boost logistics and immunization. In silico trials is an emerging and innovative field that can be applied to predict and simulate immune, molecular, clinical, and epidemiological outcomes of vaccines to refine, reduce, and partially replace steps in vaccine development. Vaccine-resistant variants of SARS-CoV-2 might emerge, leading to the necessity of updates. A globally fair vaccine distribution system must prevail over vaccine nationalism for the world to return to its pre-pandemic status. URL: https://www.ncbi.nlm.nih.gov/pubmed/34015363 DOI: 10.1016/j.virusres.2021.198454 10.1016/j.virusres.2021.198454.

37. Caron B, Neuville E, Peyrin-Biroulet L. Inflammatory Bowel Disease and COVID-19 Vaccination: A Patients' Survey. Dig Dis Sci. 2021. DOI: 10.1007/s10620-021-07040-z 10.1007/s10620-021-07040-z. ABSTRACT: BACKGROUND: Vaccination against COVID-19 is a major public health challenge, including the community of patients with inflammatory bowel disease. Vaccination coverage is suboptimal in inflammatory bowel disease population. It is of paramount importance to ensure an effective and rapid vaccination program with the adherence of the largest number of well-informed patients. AIMS: We assessed the acceptance of COVID- 19 vaccination among inflammatory bowel disease patients. METHODS: We performed a survey as part of routine practice, between January 8th and February 22nd, 2021. All consecutive adult patients followed at Nancy University Hospital for inflammatory bowel disease were included. Patients completed a self-administered, structured, paper-based questionnaire. Demographic data, medical history, knowledge, and perceptions of COVID- 19 vaccination were collected. RESULTS: Among the 104 patients who responded to the survey, 57 patients (54.8%) had intent to receive the COVID-19 vaccine. Vaccine efficacy, social responsibility, herd immunity, and desire to return to normal life were associated with self-reported willingness to receive a vaccine (20.2%, 20.2%, 11.5%, and 15.4%, respectively). Unknown long-term safety, risk of adverse reaction to vaccine and concern that the vaccine is being developed too quickly were the most commonly reported reasons for non-uptake (27.9%,

Evidence Search Report: INF031801v5 ESR 19 15.4%, and 12.5%, respectively). CONCLUSION: Half of the patients with inflammatory bowel disease would like to be vaccinated against SARS-CoV-2. This rate is similar to that reported in the French general population. Despite some concerns, patients with inflammatory bowel disease understood the necessity to be vaccinated against COVID-19. URL: https://www.ncbi.nlm.nih.gov/pubmed/33977419 DOI: 10.1007/s10620-021-07040-z 10.1007/s10620-021-07040-z.

38. Castro Dopico X, Muschiol S, Christian M, et al. Seropositivity in blood donors and pregnant women during the first year of SARS-CoV-2 transmission in Stockholm, Sweden. J Intern Med. 2021;18:18. DOI: 10.1111/joim.13304 10.1111/joim.13304. ABSTRACT: BACKGROUND: In Sweden, social restrictions to contain SARS-CoV-2 have primarily relied upon voluntary adherence to a set of recommendations. Strict lockdowns have not been enforced, potentially affecting viral dissemination. To understand the levels of past SARS-CoV-2 infection in the Stockholm population before the start of mass vaccinations, healthy blood donors and pregnant women (n = 5,100) were sampled at random between 14 March 2020 and 28 February 2021. METHODS: In this cross-sectional prospective study, otherwise- healthy blood donors (n = 2,600) and pregnant women (n = 2,500) were sampled for consecutive weeks (at four intervals) throughout the study period. Sera from all participants and a cohort of historical (negative) controls (n = 595) were screened for IgG responses against stabilized trimers of the SARS-CoV-2 spike (S) glycoprotein and the smaller receptor-binding domain (RBD). As a complement to standard analytical approaches, a probabilistic (cut- off independent) Bayesian framework that assigns likelihood of past infection was used to analyse data over time. SETTING: Healthy participant samples were randomly selected from their respective pools through Karolinska University Hospital. The study was carried out in accordance with Swedish Ethical Review Authority: registration number 2020-01807. PARTICIPANTS: No participants were symptomatic at sampling, and blood donors were all over the age of 18. No additional metadata were available from the participants. RESULTS: Blood donors and pregnant women showed a similar seroprevalence. After a steep rise at the start of the pandemic, the seroprevalence trajectory increased steadily in approach to the winter second wave of infections, approaching 15% of all individuals surveyed by 13 December 2020. By the end of February 2021, 19% of the population tested seropositive. Notably, 96% of seropositive healthy donors screened (n = 56) developed neutralizing antibody responses at titres comparable to or higher than those observed in clinical trials of SARS-CoV-2 spike mRNA vaccination, supporting that mild infection engenders a competent B-cell response. CONCLUSIONS: These data indicate that in the first year since the start of community transmission, seropositivity levels in metropolitan in Stockholm had reached approximately one in five persons, providing important baseline seroprevalence information prior to the start of vaccination. URL: https://www.ncbi.nlm.nih.gov/pubmed/34008203 DOI: 10.1111/joim.13304 10.1111/joim.13304.

39. Chakraborty K, Chakraborty N, Mitra RN, et al. The Impact of Covid-19 Pandemic Lockdown on Hypertensive Individuals with Comorbidities of a Longitudinal Cohort in India. J Hypertens. 2021;39(Supplement 1):e413. DOI: 10.1097/01.hjh.0000749404.82797.77 ABSTRACT: Objective: The study objectives are to assess the challenges faced, individual awareness of pandemic, attitudes, and compliance of guidelines during lockdown. Design and method: This telephonic survey of 404 adult individuals were administered among hypertensive population with and without comorbidities of a longitudinal cohort in Barrackpore, West Bengal, India in Aug-Sept'2020. Comorbidities comprised with cardiovascular diseases, diabetes, asthma, OSA, BMI, epilepsy, stroke, arthritis, and cancer. Convenience sampling was considered to outline socio-demographics; chronic illness status; knowledge, attitude and practices; mood changes; and difficulties faced during lockdown. Association between variables have been conformed through multivariate logistic regression. Result(s): A total of 404 respondents, lone hypertensive 6.4%, hypertensive with other comorbidities 93.6%. Overall mean score of knowledge was 18.4+/-5.2 (Range 1-23), practices 6.1+/-1.1 (Range 2- 8). Direct impacts on income 25.7%. Compliance of prescribed handwashing 93.3%, frequently hand sanitization 82.9%, using mask appropriately 91.1%, physical distancing 95.1%. Awareness of pandemic being contagious

Evidence Search Report: INF031801v5 ESR 20 respiratory virus infection 97.8%, dispersion from human-to-human close contact 97.2%, curable 13.6%, could be fatal 4.5%, regarding symptoms 94.6%. Adverse impact due to the non-availability of medicine at home 4.5%, in pharmacy 2.2%; absence of doctors 9.4%; procured medicine at higher cost 6.2%; inaccessibility of transport 2.7%. On 3 or more drugs 33.2%, stored drugs 34.7%. Required and received medical advice due to polypharmacy 2.5%. Inadequate knowledge regarding 14-days isolation 4.5%; isolation and treatment reduce spread 2.7%; Lockdown was not an effective measure 11.4%; unconcerned regarding family members protection 34.2%; vaccine available in market 12.4%; and non-compliance of personal hygiene 6.2%. Pandemic still uncontrolled 14.4%. Multiple physical and sedentary activities less among hypertensive with comorbidities compared to lone hypertensives (AOR=0.96, CI: 0.95, 0.97, p<.0001). Hypertensives with comorbidities expressed better knowledge and practices compared to lone hypertensives. Conclusion(s): Short term impact during lockdown on hypertensive with or without comorbidities individuals was not significant. For effective control of the pandemic each and every individual of the cohort needs fully to comply with the prescribed isolation regime, personal protective measures and physical distancing beside real understanding of preventive function of safe-effective vaccine for everyone when available. URL: https://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=emedx&AN=634886170https://lib key.io/libraries/843/openurl?output=full&sid=OVID:embase&id=pmid:&id=doi:10.1097%2F01.hjh.0000749404.82 797.77&issn=1473- 5598&isbn=&volume=39&issue=SUPPL+1&spage=e413&pages=e413&date=2021&title=Journal+of+Hypertension& atitle=The+impact+of+COVID- 19+pandemic+lockdown+on+hypertensive+individuals+with+comorbidities+of+a+longitudinal+cohort+in+India&au last=Chakraborty&pid=%3Cauthor%3EChakraborty+K.%3BChakraborty+N.%3BMitra+R.N.%3BMitra+D.%3C%2Faut hor%3E%3CAN%3E634886170%3C%2FAN%3E%3CDT%3EConference+Abstract%3C%2FDT%3E DOI: 10.1097/01.hjh.0000749404.82797.77

40. Charlton C, Kanji J, Tran V, et al. Practical guidance for clinical laboratories for SARS-CoV-2 serology testing. Can Commun Dis Rep. 2021;47(4):171-83. DOI: 10.14745/ccdr.v47i04a01 10.14745/ccdr.v47i04a01. eCollection 2021 May 7. ABSTRACT: The landscape of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) diagnostic testing is rapidly evolving. While serology testing has limited diagnostic capacity for acute infection, its role in providing population-based information on positivity rates and informing evidence-based decision making for public health recommendations is increasing. With the global availability of vaccines, there is increasing pressure on clinical laboratories to provide antibody screening and result interpretation for vaccinated and non-vaccinated individuals. Here we present the most up-to-date data on SARS-CoV-2 antibody timelines, including the longevity of antibodies, and the production and detection of neutralizing antibodies. Additionally, we provide practical guidance for clinical microbiology laboratories to both verify commercial serology assays and choose appropriate testing algorithms for their local populations. URL: https://www.ncbi.nlm.nih.gov/pubmed/34035663 DOI: 10.14745/ccdr.v47i04a01 10.14745/ccdr.v47i04a01. eCollection 2021 May 7.

41. Chiozzini C, Manfredi F, Ferrantelli F, et al. The C-Terminal Domain of Nef(mut) Is Dispensable for the CD8(+) T Cell Immunogenicity of In Vivo Engineered Extracellular Vesicles. Vaccines (Basel). 2021;9(4). DOI: 10.3390/vaccines9040373 10.3390/vaccines9040373. ABSTRACT: Intramuscular injection of DNA vectors expressing the extracellular vesicle (EV)-anchoring protein Nef(mut) fused at its C-terminus to viral and tumor elicit a potent, effective, and anti-tolerogenic CD8(+) T cell immunity against the heterologous . The immune response is induced through the production of EVs incorporating Nef(mut)-derivatives released by muscle cells. In the perspective of a possible translation into the clinic of the Nef(mut)-based vaccine platform, we aimed at increasing its safety profile by identifying the minimal part of Nef(mut) retaining the EV-anchoring protein property. We found that a C-terminal deletion of 29-amino acids did not affect the ability of Nef(mut) to associate with EVs. The EV-anchoring function was also preserved when antigens from both HPV16 (i.e., E6 and E7) and SARS-CoV-2 (i.e., S1 and S2) were fused to its C-terminus.

Evidence Search Report: INF031801v5 ESR 21 Most important, the Nef(mut) C-terminal deletion did not affect levels, quality, and diffusion at distal sites of the antigen-specific CD8(+) T immunity. We concluded that the C-terminal Nef(mut) truncation does not influence stability, EV-anchoring, and CD8(+) T cell immunogenicity of the fused antigen. Hence, the C-terminal deleted Nef(mut) may represent a safer alternative to the full-length isoform for vaccines in humans. URL: https://www.ncbi.nlm.nih.gov/pubmed/33921215 DOI: 10.3390/vaccines9040373 10.3390/vaccines9040373.

42. Chodick G, Tene L, Rotem RS, et al. The effectiveness of the TWO-DOSE BNT162b2 vaccine: analysis of real- world data. Clin Infect Dis. 2021;17:17. DOI: 10.1093/cid/ciab438 10.1093/cid/ciab438. ABSTRACT: BACKGROUND: COVID-19 mRNA vaccines were shown to be highly efficacious in preventing the disease in randomized controlled trials; nonetheless, evidence on the real-world effectiveness of this vaccine is limited. Study objective was to evaluate the effectiveness of BNT162b2 vaccine in preventing SARS-CoV-2 infection and COVID-19-related hospitalization and mortality. METHODS: This historical cohort study included members of a large health provider in Israel that were vaccinated with at least one dose of BNT162b2. The primary outcome was incidence rate of a SARS-CoV-2 infection confirmed with rt-PCR, between 7 to 27 days after second dose (protection-period), as compared to days 1 to 7 after the first dose, where no protection by the vaccine is assumed (reference-period). RESULTS: Data of 1,178,597 individuals vaccinated with BNT162b2 were analyzed (mean age 47.7 years [SD=18.1], 48.4% males) of whom 872,454 (74.0%) reached the protection period. Overall, 4514 infections occurred during the reference period compared to 728 during the protection period, yielding a weighted mean daily incidence of 54.8 per 100,000 (95%CI: 26.1-115.0 per 100,000) and 5.4 per 100,000 (95%CI: 3.5-8.4 per 100,000), respectively. The vaccine effectiveness in preventing infection was 90% (95%CI:79%- 95%) and 94% (95%CI:88%-97%) against COVID-19. Among immunosuppressed patients, vaccine effectiveness against infection was 71% (95%CI:37%-87%). The adjusted hazard ratios for hospitalization in those infected were 0.82 (95%CI:0.36- 1.88), 0.45 (95%CI:0.23-0.90), and 0.56 (95%CI:0.36-0.89) in the age groups 16-44, 45-64 and 75 and above, respectively. CONCLUSIONS: The effectiveness of the BNT162b2 vaccine is comparable to the one reported in the phase III clinical trial. URL: https://www.ncbi.nlm.nih.gov/pubmed/33999127 DOI: 10.1093/cid/ciab438 10.1093/cid/ciab438.

43. Choudhury NJ, Riely GJ, Sabbatini PJ, et al. Translating inspiration from COVID-19 vaccine trials to innovations in clinical cancer research. Cancer Cell. 2021;07:07. DOI: 10.1016/j.ccell.2021.05.001 10.1016/j.ccell.2021.05.001. URL: https://www.ncbi.nlm.nih.gov/pubmed/34004186 DOI: 10.1016/j.ccell.2021.05.001 10.1016/j.ccell.2021.05.001.

44. Civelek B, Yazici O, Ozdemir N, et al. Attitudes of physicians towards COVID-19 vaccines and reasons of vaccine hesitancy in Turkey. Int J Clin Pract. 2021:e14399. DOI: 10.1111/ijcp.14399 10.1111/ijcp.14399. ABSTRACT: AIM: The development of safe and effective vaccines against SARS-CoV-2 and successful implementation of a global vaccination programme are prerequisites for a return to normal living conditions. Despite these intensive research efforts, vaccine hesitancy and misinformation in many countries present substantial obstacles to achieving sufficient coverage and community immunity. Here, we report the findings of a survey regarding the likelihood of COVID-19 vaccine acceptance in a sample of physicians in Turkey. MATERIALS AND METHODS: An anonymous web-based survey was prepared and sent to medical doctors randomly selected from seven parts of Turkey via a text message sent to their mobile phones. Demographic data were collected, including sex (male or female), medical specialty, age, professional experience, COVID-19 history, knowledge of COVID-19 vaccines and behaviours related to vaccines against COVID-19 and other diseases. The survey was conducted over a 1-week period in December 2020. RESULTS: A total of 1,557 medical doctors responded to the survey. A total of 1,065 (68.4%) respondents were considering COVID-19 vaccination, 374 (24%) were undecided

Evidence Search Report: INF031801v5 ESR 22 and 118 (7.6%) did not want to be vaccinated. As a result of multivariate analysis, the male gender, absence of history of COVID-19 infection, and having sufficient information about the vaccine were determined as predictive factors for willingness to vaccination. CONCLUSION: Although trials tend to focus on the efficacy of vaccines, the results of this study indicated that the most important factor affecting the preference for a given vaccine among Turkish physicians is safety. URL: https://www.ncbi.nlm.nih.gov/pubmed/34037294 DOI: 10.1111/ijcp.14399 10.1111/ijcp.14399.

45. Coe AB, Elliott MH, Gatewood SBS, et al. Perceptions and predictors of intention to receive the COVID-19 vaccine. Res Social Adm Pharm. 2021;01:01. DOI: 10.1016/j.sapharm.2021.04.023 10.1016/j.sapharm.2021.04.023. ABSTRACT: BACKGROUND: The control of the Coronavirus Disease 2019 (COVID-19) pandemic may be dependent on widespread receipt of an effective vaccine. It is important to understand patient health-related behaviors and perceptions to guide public health vaccination strategies. OBJECTIVES: To examine perceptions of COVID-19 and vaccination beliefs, and identify predictors of intention to receive the COVID-19 vaccine in the US. METHODS: A cross-sectional, web-based survey guided by the Health Belief Model was conducted using a web-based Qualtrics survey panel of US adults. The main outcome was the intention to receive the COVID-19 vaccine if offered. Additional measures included: demographics, perceptions of COVID-19 severity, risk and susceptibility, views of a potential COVID-19 vaccine, virus and vaccine information sources, vaccine beliefs and behaviors, and seasonal flu vaccine history. RESULTS: A total of 1047 complete responses were included. Females had lower odds of intending to receive the COVID-19 vaccine than males (AOR = 0.54, 95% CI: 0.36-0.80). Those with a two-year degree/some college had lower odds of intending to receive the COVID-19 vaccine compared to those with a high school degree/GED (AOR = 0.59, 95% CI: 0.36-0.97). Respondents who perceived the severity of the virus to be higher, perceived a greater COVID-19 vaccine benefit, and perceived greater general vaccine benefits had higher odds of intending to receive a COVID-19 vaccine (AOR = 1.44, 95% CI: 1.09-1.91; AOR = 2.82, 95% CI: 2.24-3.56; AOR = 1.77, 95% CI 1.41-2.21, respectively). CONCLUSIONS: In this study, intention to receive the COVID-19 vaccine varied across demographics, perceived virus severity, COVID-19 vaccine and general vaccine beliefs. Successful implementation of a COVID-19 immunization strategy by healthcare providers and public health officials will need to incorporate diverse COVID-19 vaccination education strategies tailored to patients' health beliefs. URL: https://www.ncbi.nlm.nih.gov/pubmed/33994325 DOI: 10.1016/j.sapharm.2021.04.023 10.1016/j.sapharm.2021.04.023.

46. Cohen R, Ashman M, Taha MK, et al. Pediatric Infectious Disease Group (GPIP) position paper on the immune debt of the COVID-19 pandemic in childhood, how can we fill the immunity gap? Infect Dis Now. 2021;12:12. DOI: 10.1016/j.idnow.2021.05.004 10.1016/j.idnow.2021.05.004. ABSTRACT: Since the beginning of the COVID-19 pandemic, reduced incidence of many viral and bacterial infections has been reported in children: bronchiolitis, varicella, measles, pertussis, pneumococcal and meningococcal invasive diseases. The purpose of this opinion paper is to discuss various situations that could lead to larger epidemics when the non-pharmaceutical interventions (NPI) imposed by the SARS-CoV-2 epidemic will no longer be necessary. While NPIs limited the transmission of SARS-CoV-2, they also reduced the spread of other pathogens during and after lockdown periods, despite the re-opening of schools since June 2020 in France. This positive collateral effect in the short term is welcome as it prevents additional overload of the healthcare system. The lack of immune stimulation due to the reduced circulation of microbial agents and to the related reduced vaccine uptake induced an "immunity debt" which could have negative consequences when the pandemic is under control and NPIs are lifted. The longer these periods of "viral or bacterial low-exposure" are, the greater the likelihood of future epidemics. This is due to a growing proportion of "susceptible" people and a declined herd immunity in the population. The observed delay in vaccination program without effective catch-up and the decrease in viral and bacterial exposures lead to a rebound risk of vaccine-preventable diseases. With a that does not include vaccines against rotavirus, varicella, and serogroup B and ACYW Neisseria meningitidis, France could become more vulnerable to some of these rebound effects.

Evidence Search Report: INF031801v5 ESR 23 URL: https://www.ncbi.nlm.nih.gov/pubmed/33991720 DOI: 10.1016/j.idnow.2021.05.004 10.1016/j.idnow.2021.05.004.

47. Corey L. Behind the Scenes Heroes: the COVID-19 Vaccine Data and Safety Monitoring Board. J Infect Dis. 2021;19:19. DOI: 10.1093/infdis/jiab267 10.1093/infdis/jiab267. URL: https://www.ncbi.nlm.nih.gov/pubmed/34007981 DOI: 10.1093/infdis/jiab267 10.1093/infdis/jiab267.

48. Crosby S, Schuh MJ, Caldera F, et al. Vaccination of Patients With Inflammatory Bowel Disease During the COVID-19 Pandemic. Gastroenterol Hepatol (N Y). 2021;17(1):18-30. ABSTRACT: Inflammatory bowel disease and the subsequent immunosuppressive regimens used to treat this condition increase the risk for acquiring viral and bacterial infections. Ensuring that patients are up-to-date with their may help prevent the development of several of these vaccine-preventable diseases. Therefore, it is imperative that gastroenterology providers offer vaccinations to patients or direct vaccination guidance to primary care providers to minimize the risk for vaccine-preventable diseases. To decrease the risk for co-infection in the setting of the coronavirus disease 2019 pandemic and avoid placing any further burden on the health care system, the call to immunize is more important than ever. URL: https://www.ncbi.nlm.nih.gov/pubmed/34035759

49. Cucunawangsih C, Wijaya RS, Lugito NPH, et al. Post-vaccination COVID-19 cases among healthcare workers at Siloam Teaching Hospital, Indonesia. Int J Infect Dis. 2021;13:13. DOI: 10.1016/j.ijid.2021.05.020 10.1016/j.ijid.2021.05.020. ABSTRACT: BACKGROUND: Healthcare workers (HCWs) compared to the general population are at an increased risk of exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that causes coronavirus disease- 19 (COVID-19). Therefore, they are given priority for the COVID-19 vaccine in the national COVID-19 vaccination campaign in Indonesia. However, when the daily new COVID-19 cases are still high, and the data regarding the vaccine's efficacy in healthcare settings remains unavailable, the vaccinated HCWs still likely to get COVID-19 infection and at risk for further transmission. OBJECTIVE: To identify COVID-19 cases among vaccinated HCWs at Siloam Teaching Hospital, Indonesia, via active and passive surveillance conducted by the hospital's COVID-19 infection prevention and control unit RESULTS: Among 1,040 HCWs who have received the first and second vaccination, 13 (1.25%) HCWs were positive for SARS-CoV-2 RNA detection by reverse-transcriptase polymerase chain reaction (RT-PCR) from 2-11 days (median five days) after the second vaccination. CONCLUSION: The early laboratory-confirmed COVID-19 among post-vaccinated HCWs indicates that HCWs are still at risk to acquire COVID-19 disease during the vaccination campaign. Therefore, the presence of symptoms after vaccination cannot be considered as vaccine-related symptoms, and regular COVID-19 testing should be conducted among HCWs. URL: https://www.ncbi.nlm.nih.gov/pubmed/33992761 DOI: 10.1016/j.ijid.2021.05.020 10.1016/j.ijid.2021.05.020.

50. D'Agostino V, Caranci F, Negro A, et al. A Rare Case of Cerebral Venous Thrombosis and Disseminated Intravascular Coagulation Temporally Associated to the COVID-19 Vaccine Administration. J Pers Med. 2021;11(4). DOI: 10.3390/jpm11040285 10.3390/jpm11040285. ABSTRACT: Globally, at the time of writing (20 March 2021), 121.759.109 confirmed COVID-19 cases have been reported to the WHO, including 2.690.731 deaths. Globally, on 18 March 2021, a total of 364.184.603 vaccine doses have been administered. In Italy, 3.306.711 confirmed COVID-19 cases with 103.855 deaths have been reported to WHO. In Italy, on 9 March 2021, a total of 6.634.450 vaccine doses have been administered. On 15 March 2021, Italian Medicines Agency (AIFA) decided to temporarily suspend the use of the AstraZeneca COVID-19 vaccine throughout the country as a precaution, pending the rulings of the European Medicines Agency (EMA). This decision was taken in line with similar measures adopted by other European countries due to the death of

Evidence Search Report: INF031801v5 ESR 24 vaccinated people. On 18 March 2021, EMA's safety committee concluded its preliminary review about thromboembolic events in people vaccinated with COVID-19 Vaccine AstraZeneca at its extraordinary meeting, confirming the benefits of the vaccine continue to outweigh the risk of side effects, however, the vaccine may be associated with very rare cases of blood clots associated with thrombocytopenia, i.e., low levels of blood platelets with or without bleeding, including rare cases of cerebral venous thrombosis (CVT). We report the case of a 54- year-old woman who developed disseminated intravascular coagulation (DIC) with multi-district thrombosis 12 days after the AstraZeneca COVID-19 vaccine administration. A brain computed tomography (CT) scan showed multiple subacute intra-axial hemorrhages in atypical locations, including the right frontal and the temporal lobes. A plain old balloon angioplasty (POBA) of the right coronary artery was performed, without stent implantation, with restoration of distal flow, but with persistence of extensive thrombosis of the vessel. A successive thorax angio-CT added the findings of multiple contrast filling defects with multi-vessel involvement: at the level of the left upper lobe segmental branches, of left interlobar artery, of the right middle lobe segmental branches and of the right interlobar artery. A brain magnetic resonance imaging (MRI) in the same day showed the presence of an acute basilar thrombosis associated with the superior sagittal sinus thrombosis. An abdomen angio-CT showed filling defects at the level of left portal branch and at the level of right suprahepatic vein. Bilaterally, it was adrenal hemorrhage and blood in the pelvis. An evaluation of coagulation factors did not show genetic alterations so as the nasopharyngeal swab ruled out a COVID-19 infection. The patient died after 5 days of hospitalization in intensive care. URL: https://www.ncbi.nlm.nih.gov/pubmed/33917902 DOI: 10.3390/jpm11040285 10.3390/jpm11040285.

51. Dal-Re R, Bekker LG, Gluud C, et al. Ongoing and future COVID-19 vaccine clinical trials: challenges and opportunities. Lancet Infect Dis. 2021;18:18. DOI: 10.1016/S1473-3099(21)00263-2 10.1016/S1473-3099(21)00263-2. ABSTRACT: Large-scale deployment of COVID-19 vaccines will seriously affect the ongoing phases 2 and 3 randomised placebo-controlled trials assessing SARS-CoV-2 vaccine candidates. The effect will be particularly acute in high-income countries where the entire adult or older population could be vaccinated by late 2021. Regrettably, only a small proportion of the population in many low-income and middle-income countries will have access to available vaccines. Sponsors of COVID-19 vaccine candidates currently in phase 2 or initiating phase 3 trials in 2021 should consider continuing the research in countries with limited affordability and availability of COVID-19 vaccines. Several ethical principles must be implemented to ensure the equitable, non-exploitative, and respectful conduct of trials in resource-poor settings. Once sufficient knowledge on the immunogenicity response to COVID- 19 vaccines is acquired, non-inferiority immunogenicity trials-comparing the immune response of a vaccine candidate to that of an authorised vaccine-would probably be the most common trial design. Until then, placebo- controlled, double-blind, crossover trials will continue to play a role in the development of new vaccine candidates. WHO or the Council for International Organizations of Medical Sciences should define an ethical framework for the requirements and benefits for trial participants and host communities in resource-poor settings that should require commitment from all vaccine candidate sponsors from high-income countries. URL: https://www.ncbi.nlm.nih.gov/pubmed/34019801 DOI: 10.1016/S1473-3099(21)00263-2 10.1016/S1473-3099(21)00263-2.

52. David Batty G, Deary IJ, Fawns-Ritchie C, et al. Pre-pandemic Cognitive Function and COVID-19 Vaccine Hesitancy: Cohort Study. Brain Behav Immun. 2021;19:19. DOI: 10.1016/j.bbi.2021.05.016 10.1016/j.bbi.2021.05.016. ABSTRACT: BACKGROUND: Whereas several predictors of COVID-19 vaccine hesitancy have been examined, the role of cognitive function following the widely publicised development of an inoculation is unknown. Accordingly, our objective was to test the association between scores from an array of cognitive function tests and self- reported vaccine hesitancy after the announcement of the successful testing of the Oxford University/AstraZeneca vaccine. METHODS: We used individual-level data from a pandemic-focused study (COVID Survey), a prospective cohort study nested within United Kingdom Understanding Society (Main Survey). In the week immediately following the announcement of successful testing of the first efficacious inoculation (November/December 2020),

Evidence Search Report: INF031801v5 ESR 25 data on vaccine intentionality were collected in 11740 individuals (6702 women) aged 16-95. Pre-pandemic scores on general cognitive function, ascertained from a battery of six tests, were captured in 2011/12 wave of the Main Survey. Study members self-reported their intention to take up a vaccination for COVID-19. RESULTS: Of the study sample, 17.2% (N=1842) indicated they were hesitant about having the vaccine. After adjustment for age, sex, and ethnicity, study members with a lower baseline cognition score were markedly more likely to be vaccine hesitant (odds ratio per standard deviation lower score in cognition; 95% confidence interval: 1.76; 1.62, 1.90). Adjustment for mental and physical health plus household shielding status had no impact on these results, whereas controlling for educational attainment led to partial attenuation but the probability of hesitancy was still elevated (1.52; 1.37, 1.67). There was a linear association for vaccine hesitancy across the full range of cognition scores (p for trend: p<0.0001). CONCLUSIONS: Erroneous social media reports might have complicated personal decision-making, leading to people with lower cognitive ability test scores being vaccine-hesitant. With people with lower cognition also experiencing higher rates of COVID-19 in studies conducted prior to vaccine distribution, these new findings are suggestive of a potential additional disease burden. URL: https://www.ncbi.nlm.nih.gov/pubmed/34022372 DOI: 10.1016/j.bbi.2021.05.016 10.1016/j.bbi.2021.05.016.

53. de la Fuente J, Armas O, Sanchez-Rodriguez L, et al. Citizen science initiative points at childhood BCG vaccination as a risk factor for COVID-19. Transbound Emerg Dis. 2021. DOI: 10.1111/tbed.14097 10.1111/tbed.14097. ABSTRACT: Current results do not provide conclusive evidence on the effect of BCG vaccination on COVID-19 alone or in combination with other factors. To address this limitation, in this study we used a citizen science initiative on the COVID-19 pandemic to collect data worldwide during 2 October 2020-30 October 2020 (1,233 individuals) in a structured way for analysing factors and characteristics of affected individuals in relation to BCG vaccination. For the first time, the results of our study suggested that vaccination with BCG may increase the risk for COVID-19 at certain age, particularly in individuals vaccinated at childhood. Childhood BCG vaccination increased the likelihood of being diagnosed with COVID-19 fivefold in COVID-19 low-incidence countries and threefold in high-incidence countries. A reasonable explanation for this effect is the activation of certain innate immunity mechanisms associated with inflammatory reactions. These factors should be considered when analysing the risks associated with this global pandemic. URL: https://www.ncbi.nlm.nih.gov/pubmed/33825348 DOI: 10.1111/tbed.14097 10.1111/tbed.14097.

54. de Miguel Beriain I, Rueda J. Vaccination certificates, immunity passports, and test-based travel licences: Ethical, legal, and public health issues. Travel Med Infect Dis. 2021;42(102079):102079. DOI: 10.1016/j.tmaid.2021.102079 10.1016/j.tmaid.2021.102079. URL: https://www.ncbi.nlm.nih.gov/pubmed/33971334 DOI: 10.1016/j.tmaid.2021.102079 10.1016/j.tmaid.2021.102079.

55. Di Gennaro F, Murri R, Segala FV, et al. Attitudes towards Anti-SARS-CoV2 Vaccination among Healthcare Workers: Results from a National Survey in Italy. Viruses. 2021;13(3). DOI: 10.3390/v13030371 10.3390/v13030371. ABSTRACT: Coronavirus disease 2019 (COVID-19) has afflicted tens of millions of people, fostering and unprecedent effort in vaccine development and distribution. Healthcare workers (HCW) play a key role in vaccine promotion and patient guidance, and it is likely that hesitancy among this population will have a major impact on the adoption of a successful immunization policy. To investigate HCW attitudes towards anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccination, we developed an anonymous online cross-sectional survey. 1723 Italian HCW responded. Overall, 1155 (67%) intended to be vaccinated, while 443 (26%) were not sure and 125 (7%) declared refusal. In multivariate analysis, factors associated with hesitancy were using Facebook as the main information source and being a non-physician HCW, while predictors of acceptance included younger

Evidence Search Report: INF031801v5 ESR 26 age, being in close contact with high-risk groups and having received flu vaccination during the 2019-2020 season. Reasons for hesitancy included lack of trust in vaccine safety (85%) and receiving little (78%) or conflicting (69%) information about vaccines. According to our results, adequate investment in vaccine education for healthcare personnel appears to be urgently needed, prioritizing non-physicians and information quality spread through social media. We hope that our data could help governments and policy-makers to target communication in the ongoing COVID-19 vaccination campaign. URL: https://www.ncbi.nlm.nih.gov/pubmed/33652829 DOI: 10.3390/v13030371 10.3390/v13030371.

56. Dias S, Queiroz K, Araujo A. Controlling epidemic diseases based only on social distancing level: General case. ISA Trans. 2021;08:08. DOI: 10.1016/j.isatra.2021.05.004 10.1016/j.isatra.2021.05.004. ABSTRACT: The COVID-19 outbreak is an epidemic disease caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). When a new virus emerges, generally, little is known about it, and no vaccines or other pharmaceutical interventions are available. In the case of a person-to-person transmission virus with no vaccines or other pharmaceutical interventions, the only way to control the virus outbreak is by keeping a sustained physical distancing between the individuals. However, to adjust the level of the physical distancing accurately can be so complicated. Any level above the necessary can compromise the economic activity, and any level below can collapse the health care system. This work proposes a controller to keep the number of hospitalized individuals below a limit, and a new group-structured model to describe the COVID-19 outbreak. The proposed controller is robust to the uncertainties in the parameters of the model and keeps the number of infected individuals controlled only by adjusting the social distancing level. Numerical simulations, to show the behavior of the proposed controller and model, are done. URL: https://www.ncbi.nlm.nih.gov/pubmed/34016439 DOI: 10.1016/j.isatra.2021.05.004 10.1016/j.isatra.2021.05.004.

57. Dosanjh A. Pediatric Vaccine Hesitancy and the Utilization of Antibody Measurements: A Novel Strategy with Implications for COVID 19. J Asthma Allergy. 2021;14:427-31. DOI: 10.2147/JAA.S303309 10.2147/JAA.S303309. eCollection 2021. ABSTRACT: Vaccine hesitancy is a well researched area with implications for both public health and the health of children and their families The factors leading to vaccine hesitancy are often complex and involve fear of the healthcare system and the process of vaccine development, cultural viewpoints and experiences. Pediatric patients often rely on parental guidance and decision making, and this may result in a lack of immunization for some children. The availability of the COVID 19 vaccine has been widely anticipated, yet not all individuals will seek the vaccine. Once vaccines are available for children under the age of 16 years, this long-standing pediatric management issue may again emerge and impact public health. The clinical trial efficacy and safety data for children and adolescents less than 16 years of age are not yet available. A traditional approach is to discuss the concerns of the parent in relationship to presentation and review of American Association of Pediatrics (AAP) and CDC guidelines in the framework of medical and scientific explanations. This includes the presentation of efficacy and safety data. Therefore, the use of lab-based antibody testing adds scientific evidence and emphasizes the need for vaccination against SARS CoV-2 and other pathogens. The purpose of this commentary is to propose lab-based testing as a potential adjunctive strategy in addressing this public health concern. Further study of a pediatric population is required to assess the impact of the selective use of lab-based testing in improving vaccination rates among a pediatric population. URL: https://www.ncbi.nlm.nih.gov/pubmed/33935504 DOI: 10.2147/JAA.S303309 10.2147/JAA.S303309. eCollection 2021.

58. Dotan A, Shoenfeld Y. Perspectives on vaccine induced thrombotic thrombocytopenia. J Autoimmun. 2021;121:102663. DOI: 10.1016/j.jaut.2021.102663 10.1016/j.jaut.2021.102663.

Evidence Search Report: INF031801v5 ESR 27 ABSTRACT: As the novel SARS-CoV-2 continues to infect numerous individuals worldwide, one of the leading approaches in dealing with the global health crisis is vaccination against the COVID-19. Due to recent reports, vaccination with ChAdOx1 nCov-19 (developed by Oxford and AstraZeneca) may result in a vaccine-induced catastrophic thrombotic thrombocytopenia disorder. Thus, as of March 16 of 2021, vaccination programs in 18 countries had been suspended until further examination, including Sweden, Germany and France. This disorder presents as extensive thrombosis in atypical sites, primarily in the cerebral venous, alongside thrombocytopenia and the production of autoantibody against platelet-factor 4 (PF4). PF4 autoantibody has the ability to binds the human FcRgammaIIA receptor of platelets and contribute to their aggregation. This rare adverse effect extremely resembles the clinical presentation of the classical immune-mediated HIT disorder, which occurs following exposure to heparin. Surprisingly, none of these patients had been pre-exposed to heparin before disease onset, leading to the hypothesis that a viral antigen from the vaccine had triggered the response. Importantly, COVID-19 had been associated with numerous autoimmune manifestations, including the production of pathogenic autoantibodies, new onset of autoimmune diseases and disorders. As the ChAdOx1 nCov-19 vaccination leads to the synthesis of specific SARS-CoV-2-proteins, they may trigger a production of PF4 autoantibody though molecular mimicry phenomena, while vaccination compounds lead to a rigorous bystander activation of immune cells. If existing, removing such homological sequences from the vaccine may eliminate this phenomenon. In contrast, it needs to be emphasized that the ChAdOx1 nCoV-19 vaccine was found to be safe and efficacious against symptomatic COVID-19 in randomized controlled trials, which included 23,848 participants from the UK, Brazil and South Africa. URL: https://www.ncbi.nlm.nih.gov/pubmed/34020254 DOI: 10.1016/j.jaut.2021.102663 10.1016/j.jaut.2021.102663.

59. Douxfils J, Favresse J, Dogne JM, et al. Hypotheses behind the very rare cases of thrombosis with thrombocytopenia syndrome after SARS-CoV-2 vaccination. Thromb Res. 2021;203:163-71. DOI: 10.1016/j.thromres.2021.05.010 10.1016/j.thromres.2021.05.010. ABSTRACT: As of 4 April 2021, a total of 169 cases of cerebral venous sinus thrombosis (CVST) and 53 cases of splanchnic vein thrombosis were reported to EudraVigilance among around 34 million people vaccinated in the European Economic Area and United Kingdom with COVID-19 Vaccine AstraZeneca, a chimpanzee adenoviral vector (ChAdOx1) encoding the spike protein antigen of the SARS-CoV-2 virus. The first report of the European Medicines Agency gathering data on 20 million people vaccinated with Vaxzevria(R) in the UK and the EEA concluded that the number of post-vaccination cases with thromboembolic events as a whole reported to EudraVigilance in relation to the number of people vaccinated was lower than the estimated rate of such events in the general population. However, the EMA's Pharmacovigilance Risk Assessment Committee concluded that unusual thromboses with low blood platelets should be listed as very rare side effects of Vaxzevria(R), pointing to a possible link. The same issue was identified with the COVID-19 Vaccine Janssen (Ad26.COV2.S). Currently, there is still a sharp contrast between the clinical or experimental data reported in the literature on COVID-19 and the scarcity of data on the unusual thrombotic events observed after the vaccination with these vaccines. Different hypotheses might support these observations and should trigger further in vitro and ex vivo investigations. Specialized studies were needed to fully understand the potential relationship between vaccination and possible risk factors in order to implement risk minimization strategies. URL: https://www.ncbi.nlm.nih.gov/pubmed/34029848 DOI: 10.1016/j.thromres.2021.05.010 10.1016/j.thromres.2021.05.010.

60. El-Elimat T, AbuAlSamen MM, Almomani BA, et al. Acceptance and attitudes toward COVID-19 vaccines: A cross-sectional study from Jordan. PLoS One. 2021;16(4):e0250555. DOI: 10.1371/journal.pone.0250555 10.1371/journal.pone.0250555. eCollection 2021. ABSTRACT: Vaccines are effective interventions that can reduce the high burden of diseases globally. However, public vaccine hesitancy is a pressing problem for public health authorities. With the availability of COVID-19 vaccines, little information is available on the public acceptability and attitudes towards the COVID-19 vaccines in Jordan. This study aimed to investigate the acceptability of COVID-19 vaccines and its predictors in addition to the

Evidence Search Report: INF031801v5 ESR 28 attitudes towards these vaccines among public in Jordan. An online, cross-sectional, and self-administered questionnaire was instrumentalized to survey adult participants from Jordan on the acceptability of COVID-19 vaccines. Logistic regression analysis was used to find the predictors of COVID-19 vaccines' acceptability. A total of 3,100 participants completed the survey. The public acceptability of COVID-19 vaccines was fairly low (37.4%) in Jordan. Males (OR = 2.488, 95CI% = 1.834-3.375, p < .001) and those who took the seasonal influenza vaccine (OR = 2.036, 95CI% = 1.306-3.174, p = .002) were more likely to accept COVID-19 vaccines. Similarly, participants who believed that vaccines are generally safe (OR = 9.258, 95CI% = 6.020-14.237, p < .001) and those who were willing to pay for vaccines (OR = 19.223, 95CI% = 13.665-27.042, p < .001), once available, were more likely to accept the COVID-19 vaccines. However, those above 35 years old (OR = 0.376, 95CI% = 0.233-0.607, p < .001) and employed participants (OR = 0.542, 95CI% = 0.405-0.725, p < .001) were less likely to accept the COVID-19 vaccines. Moreover, participants who believed that there was a conspiracy behind COVID-19 (OR = 0.502, 95CI% = 0.356- 0.709, p < .001) and those who do not trust any source of information on COVID-19 vaccines (OR = 0.271, 95CI% = 0.183-0.400, p < .001), were less likely to have acceptance towards them. The most trusted sources of information on COVID-19 vaccines were healthcare providers. Systematic interventions are required by public health authorities to reduce the levels of vaccines' hesitancy and improve their acceptance. We believe these results and specifically the low rate of acceptability is alarming to Jordanian health authorities and should stir further studies on the root causes and the need of awareness campaigns. These interventions should take the form of reviving the trust in national health authorities and structured awareness campaigns that offer transparent information about the safety and efficacy of the vaccines and the technology that was utilized in their production. URL: https://www.ncbi.nlm.nih.gov/pubmed/33891660 DOI: 10.1371/journal.pone.0250555 10.1371/journal.pone.0250555. eCollection 2021.

61. Esther CR, Kimura KS, Mikami Y, et al. Pharmacokinetic-based failure of a detergent virucidal for SARS-COV-2 nasal infections. Res Sq. 2021;14:14. DOI: 10.21203/rs.3.rs-500168/v1 10.21203/rs.3.rs-500168/v1. ABSTRACT: The nose is the portal for SARS-CoV-2 infection, suggesting the nose as a target for topical antiviral therapies. Because detergents are virucidal, Johnson and Johnson's Baby Shampoo (J&J) was tested as a topical virucidal agent in SARS-CoV-2 infected subjects. Twice daily irrigation of J&J in hypertonic saline, hypertonic saline alone, or no intervention were compared (n = 24/group). Despite demonstrated safety and robust efficacy in in vitro virucidal assays, J&J irrigations had no impact on viral titers or symptom scores in treated subjects relative to controls. Similar findings were observed administering J&J to infected cultured human airway epithelia using protocols mimicking the clinical trial regimen. Additional studies of cultured human nasal epithelia demonstrated that lack of efficacy reflected pharmacokinetic failure, with the most virucidal J&J detergent components rapidly absorbed from nasal surfaces. This study emphasizes the need to assess the pharmacokinetic characteristics of virucidal agents on airway surfaces to guide clinical trials. URL: https://www.ncbi.nlm.nih.gov/pubmed/34013253 DOI: 10.21203/rs.3.rs-500168/v1 10.21203/rs.3.rs-500168/v1.

62. Etemadifar M, Sigari AA, Sedaghat N, et al. Acute relapse and poor immunization following COVID-19 vaccination in a rituximab-treated multiple sclerosis patient. Hum Vaccin Immunother. 2021:1-3. DOI: 10.1080/21645515.2021.1928463 10.1080/21645515.2021.1928463. ABSTRACT: With the progress of COVID-19 vaccination programs worldwide, some new adverse events associated with the available vaccines may unfold, especially in subpopulations, representatives of whom were not included in phase I, II, and III clinical trials of these vaccines, such as patients with autoimmune diseases, including multiple sclerosis (MS). A 34-year-old woman presented with severe right hemiplegia and ataxia. She was diagnosed with relapsing-remitting MS (RRMS) 13 years ago and treated with rituximab (an anti-CD20 ) during the last 15 months. She had received her first dose of adenovirus-vectored COVID-19 vaccine Gam-COVID- Vac (Sputnik V) three months after her last infusion of rituximab and three days before experiencing her latest MS relapse episode, preceded by mild symptoms (fatigue, myalgia, generalized weakness, etc.). Magnetic resonance imaging revealed several new periventricular, juxtacortical, brainstem, and cerebellar peduncle lesions. She

Evidence Search Report: INF031801v5 ESR 29 received corticosteroid therapy for five consecutive days, and her neurological deficits slightly improved. Twenty- one days after receiving the first dose of the vaccine, her anti-SARS-CoV-2 antibodies were below the lower detection limit. However, a decision was made to adhere to the vaccination schedule and not risk the patient's safety against an unfortunate COVID-19 contraction, and thus, she was advised to receive the second Gam-COVID- Vac dose after discontinuation of oral steroid taper. The safety of adenovirus-based vaccines in patients with autoimmune diseases requires further investigation. Meanwhile, clinicians should raise awareness among their patients regarding the potentially limited efficacy of COVID-19 vaccination in those treated with anti-CD20 treatments. After careful, individualized risk-benefit assessments, planning a delay/pause in such treatments to create a time window for patients to receive the vaccine and develop anti-SARS-CoV-2 immunity may be recommended. URL: https://www.ncbi.nlm.nih.gov/pubmed/34015240 DOI: 10.1080/21645515.2021.1928463 10.1080/21645515.2021.1928463.

63. Ewer KJ, Barrett JR, Belij-Rammerstorfer S, et al. Author Correction: T cell and antibody responses induced by a single dose of ChAdOx1 nCoV-19 (AZD1222) vaccine in a phase 1/2 clinical trial. Nat Med. 2021;21:21. DOI: 10.1038/s41591-021-01363-0 10.1038/s41591-021-01363-0. URL: https://www.ncbi.nlm.nih.gov/pubmed/34021278 DOI: 10.1038/s41591-021-01363-0 10.1038/s41591-021-01363-0.

64. Eyal N, Gerhard T, Strom BL. Strengthening and accelerating SARS-CoV-2 vaccine safety surveillance through registered pre-approval rollout after challenge tests. Vaccine. 2021;30:30. DOI: 10.1016/j.vaccine.2021.04.056 10.1016/j.vaccine.2021.04.056. URL: https://www.ncbi.nlm.nih.gov/pubmed/34023137 DOI: 10.1016/j.vaccine.2021.04.056 10.1016/j.vaccine.2021.04.056.

65. Farshidfar N, Jafarpour D, Hamedani S, et al. Proposal for Tier-Based Resumption of Dental Practice Determined by COVID-19 Rate, Testing and COVID-19 Vaccination: A Narrative Perspective. Journal of Clinical Medicine. 2021;10(10). DOI: 10.3390/jcm10102116 ABSTRACT: Since the emergence of the new coronavirus disease (COVID-19), profound alterations in general and specialist dental practice have been imposed to provide safe dental care. The guidelines introduced in response to the COVID-19 pandemic to mitigate healthcare disruption are inconsistent regarding the dental practice re- installation, particularly during a transitional time. Despite the successful mass vaccination campaigns rolled out in 2021, the presence of more than 80 genotypes of COVID-19, rapid neutralisation of antibodies within a short period of seropositivity, and the likelihood of recurrent infection raise some doubts on whether vaccination alone will provide longterm immunity against COVID-19 and its variants. Here, from this perspective, we aim to provide an initial proposal for dental services reinstallation, easily applicable in various care settings. We discuss the potential options for the transition of dental services, as well as challenges and opportunities to adapt to new circumstances after mass COVID-19 vaccination. The proposal of the universal three-tier system of dental services resumption, determined by regional COVID-19 rates, testing accessibility, and vaccination rollout has been presented. Following herd COVID-19 immunity enhancement, it would be prudent to confer various preventative measures until virus spread naturally diminishes or becomes less virulent. Based on modelling data, dental practices may not return to normal, routine operation even after global vaccination as there would still be a significant risk of outbreaks of infection. Variable, multi-level measures will still be required, depending on the local COVID-19 cases rate, to secure safe dental care provision, despite predicted success of vaccination agendas. This approach can be implemented by achievable, practical means as a part of risk assessment, altered work pattern, and re-arrange of dental surgery facilities. The adequate standard operating procedure, with the support of rapid point-of-care testing at workplace, would vastly intensify the uninterrupted recovery of the dental care sector. Copyright © 2021 by the authors. Licensee MDPI, Basel, Switzerland.

Evidence Search Report: INF031801v5 ESR 30 URL: https://www.mdpi.com/2077- 0383/10/10/2116/pdfhttps://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=emexb&AN =2007161666https://libkey.io/libraries/843/openurl?output=full&sid=OVID:embase&id=pmid:&id=doi:10.3390%2 Fjcm10102116&issn=2077- 0383&isbn=&volume=10&issue=10&spage=2116&pages=&date=2021&title=Journal+of+Clinical+Medicine&atitle= Proposal+for+tier-based+resumption+of+dental+practice+determined+by+covid-19+rate%2C+testing+and+covid- 19+vaccination%3A+A+narrative+perspective&aulast=Farshidfar&pid=%3Cauthor%3EFarshidfar+N.%3BJafarpour+ D.%3BHamedani+S.%3BDziedzic+A.%3BTanasiewicz+M.%3C%2Fauthor%3E%3CAN%3E2007161666%3C%2FAN%3E %3CDT%3EArticle%3C%2FDT%3E DOI: 10.3390/jcm10102116

66. Ferretti F, Cannatelli R, Benucci M, et al. How to Manage COVID-19 Vaccination in Immune-Mediated Inflammatory Diseases: An Expert Opinion by IMIDs Study Group. Front Immunol. 2021;12(656362):656362. DOI: 10.3389/fimmu.2021.656362 10.3389/fimmu.2021.656362. eCollection 2021. ABSTRACT: Since March 2020, the outbreak of Sars-CoV-2 pandemic has changed medical practice and daily routine around the world. Huge efforts from pharmacological industries have led to the development of COVID-19 vaccines. In particular two mRNA vaccines, namely the BNT162b2 (Pfizer-BioNTech) and the mRNA-1273 (Moderna), and a viral-vectored vaccine, i.e. ChAdOx1 nCoV-19 (AstraZeneca), have recently been approved in Europe. Clinical trials on these vaccines have been published on the general population showing a high efficacy with minor adverse events. However, specific data about the efficacy and safety of these vaccines in patients with immune-mediated inflammatory diseases (IMIDs) are still lacking. Moreover, the limited availability of these vaccines requires prioritizing some vulnerable categories of patients compared to others. In this position paper, we propose the point of view about the management of COVID-19 vaccination from Italian experts on IMIDs and the identification of high-risk groups according to the different diseases and their chronic therapy. URL: https://www.ncbi.nlm.nih.gov/pubmed/33936084 DOI: 10.3389/fimmu.2021.656362 10.3389/fimmu.2021.656362. eCollection 2021.

67. Ficarra V, Novara G, Giannarini G, et al. Urology practice during the COVID-19 vaccination campaign. Urologia. 2021:3915603211016321. DOI: 10.1177/03915603211016321 10.1177/03915603211016321. ABSTRACT: INTRODUCTION: The current scenario of the COVID-19 pandemic is significantly different from that of the first, emergency phase. Several countries in the world are experiencing a second, or even a third, wave of contagion, while awaiting the effects of mass vaccination campaigns. The aim of this report was to provide an update of previously released recommendations on prioritization and restructuring of urological activities. METHODS: A large group of Italian urologists directly involved in the reorganization of their urological wards during the first and second phase of the pandemic agreed on a set of updated recommendations for current urology practice. RESULTS: The updated recommendations included strategies for the prioritization of both surgical and outpatient activities, implementation of perioperative pathways for patients scheduled for elective surgery, management of urological conditions in infected patients. Future scenarios with possible implementation of telehealth and reshaping of clinical practice following the effects of vaccination are also discussed. CONCLUSION: The present update may be a valid tool to be used in the clinical practice, may provide useful recommendations for national and international urological societies, and may be a cornerstone for further discussion on the topic, also considering further evolution of the pandemic after the recently initiated mass vaccination campaigns. URL: https://www.ncbi.nlm.nih.gov/pubmed/33983086 DOI: 10.1177/03915603211016321 10.1177/03915603211016321.

68. Franchini M, Liumbruno GM, Pezzo M. COVID-19 Vaccine-associated Immune Thrombosis and Thrombocytopenia (VITT): diagnostic and therapeutic recommendations for a new syndrome. Eur J Haematol. 2021;13:13. DOI: 10.1111/ejh.13665 10.1111/ejh.13665.

Evidence Search Report: INF031801v5 ESR 31 ABSTRACT: Very rare cases of thrombosis associated with thrombocytopenia have occurred following the vaccination with AstraZeneca COVID-19 vaccine. The aim of this concise review is to summarize the current knowledge on the epidemiologic and pathogenic mechanisms of this syndrome named vaccine-associate immune thrombosis and thrombocytopenia (VITT). A practical patient management section will also be dealt with using information available from national and international scientific societies as well as expert panels. A literature search on the VITT syndrome was carried out in PubMed using appropriate MeSH headings. Overall, 40 VITT cases have been reported. Continuous pharmacovigilance monitoring is needed to collect more data on the real incidence and the pathogenesis of VITT syndrome. Such information will also help us to optimize the management this rare but often clinically severe thrombotic condition associated with COVID-19 vaccination. URL: https://www.ncbi.nlm.nih.gov/pubmed/33987882 DOI: 10.1111/ejh.13665 10.1111/ejh.13665.

69. Freeman D, Loe BS, Yu LM, et al. Effects of different types of written vaccination information on COVID-19 vaccine hesitancy in the UK (OCEANS-III): a single-blind, parallel-group, randomised controlled trial. Lancet Public Health. 2021;12:12. DOI: 10.1016/S2468-2667(21)00096-7 10.1016/S2468-2667(21)00096-7. ABSTRACT: BACKGROUND: The effectiveness of the COVID-19 vaccination programme depends on mass participation: the greater the number of people vaccinated, the less risk to the population. Concise, persuasive messaging is crucial, particularly given substantial levels of vaccine hesitancy in the UK. Our aim was to test which types of written information about COVID-19 vaccination, in addition to a statement of efficacy and safety, might increase vaccine acceptance. METHODS: For this single-blind, parallel-group, randomised controlled trial, we aimed to recruit 15 000 adults in the UK, who were quota sampled to be representative. Participants were randomly assigned equally across ten information conditions stratified by level of vaccine acceptance (willing, doubtful, or strongly hesitant). The control information condition comprised the safety and effectiveness statement taken from the UK National Health Service website; the remaining conditions addressed collective benefit, personal benefit, seriousness of the pandemic, and safety concerns. After online provision of vaccination information, participants completed the Oxford COVID-19 Vaccine Hesitancy Scale (outcome measure; score range 7-35) and the Oxford Vaccine Confidence and Complacency Scale (mediation measure). The primary outcome was willingness to be vaccinated. Participants were analysed in the groups they were allocated. p values were adjusted for multiple comparisons. The study was registered with ISRCTN, ISRCTN37254291. FINDINGS: From Jan 19 to Feb 5, 2021, 15 014 adults were recruited. Vaccine hesitancy had reduced from 26.9% the previous year to 16.9%, so recruitment was extended to Feb 18 to recruit 3841 additional vaccine-hesitant adults. 12 463 (66.1%) participants were classified as willing, 2932 (15.6%) as doubtful, and 3460 (18.4%) as strongly hesitant (ie, report that they will avoid being vaccinated for as long as possible or will never get vaccinated). Information conditions did not alter COVID-19 vaccine hesitancy in those willing or doubtful (adjusted p values >0.70). In those strongly hesitant, COVID-19 vaccine hesitancy was reduced, in comparison to the control condition, by personal benefit information (mean difference -1.49, 95% CI -2.16 to -0.82; adjusted p=0.0015), directly addressing safety concerns about speed of development (-0.91, -1.58 to -0.23; adjusted p=0.0261), and a combination of all information (-0.86, -1.53 to - 0.18; adjusted p=0.0313). In those strongly hesitant, provision of personal benefit information reduced hesitancy to a greater extent than provision of information on the collective benefit of not personally getting ill (-0.97, 95% CI -1.64 to -0.30; adjusted p=0.0165) or the collective benefit of not transmitting the virus (-1.01, -1.68 to -0.35; adjusted p=0.0150). Ethnicity and gender were found to moderate information condition outcomes. INTERPRETATION: In the approximately 10% of the population who are strongly hesitant about COVID-19 vaccines, provision of information on personal benefit reduces hesitancy to a greater extent than information on collective benefits. Where perception of risk from vaccines is most salient, decision making becomes centred on the personal. As such, messaging that stresses the counterbalancing personal benefits is likely to prove most effective. The messaging from this study could be used in public health communications. Going forwards, the study highlights the need for future health campaigns to engage with the public on the terrain that is most salient to them. FUNDING: National Institute for Health Research (NIHR) Oxford Biomedical Research Centre and NIHR Oxford Health Biomedical Research Centre. URL: https://www.ncbi.nlm.nih.gov/pubmed/33991482 DOI: 10.1016/S2468-2667(21)00096-7

Evidence Search Report: INF031801v5 ESR 32 10.1016/S2468-2667(21)00096-7.

70. Frenck RW, Jr., Klein NP, Kitchin N, et al. Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents. N Engl J Med. 2021. DOI: 10.1056/NEJMoa2107456 ABSTRACT: BACKGROUND: Until very recently, vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) had not been authorized for emergency use in persons younger than 16 years of age. Safe, effective vaccines are needed to protect this population, facilitate in-person learning and socialization, and contribute to herd immunity. METHODS: In this ongoing multinational, placebo-controlled, observer-blinded trial, we randomly assigned participants in a 1:1 ratio to receive two injections, 21 days apart, of 30 μg of BNT162b2 or placebo. Noninferiority of the immune response to BNT162b2 in 12-to-15-year-old participants as compared with that in 16- to-25-year-old participants was an immunogenicity objective. Safety ( and adverse events) and efficacy against confirmed coronavirus disease 2019 (Covid-19; onset, ≥7 days after dose 2) in the 12-to-15-year- old cohort were assessed. RESULTS: Overall, 2260 adolescents 12 to 15 years of age received injections; 1131 received BNT162b2, and 1129 received placebo. As has been found in other age groups, BNT162b2 had a favorable safety and side-effect profile, with mainly transient mild-to-moderate reactogenicity (predominantly injection-site pain [in 79 to 86% of participants], fatigue [in 60 to 66%], and headache [in 55 to 65%]); there were no vaccine- related serious adverse events and few overall severe adverse events. The geometric mean ratio of SARS-CoV-2 50% neutralizing titers after dose 2 in 12-to-15-year-old participants relative to 16-to-25-year-old participants was 1.76 (95% confidence interval [CI], 1.47 to 2.10), which met the noninferiority criterion of a lower boundary of the two-sided 95% confidence interval greater than 0.67 and indicated a greater response in the 12-to-15-year-old cohort. Among participants without evidence of previous SARS-CoV-2 infection, no Covid-19 cases with an onset of 7 or more days after dose 2 were noted among BNT162b2 recipients, and 16 cases occurred among placebo recipients. The observed vaccine efficacy was 100% (95% CI, 75.3 to 100). CONCLUSIONS: The BNT162b2 vaccine in 12-to-15-year-old recipients had a favorable safety profile, produced a greater immune response than in young adults, and was highly effective against Covid-19. (Funded by BioNTech and Pfizer; C4591001 ClinicalTrials.gov number, NCT04368728.). DOI: 10.1056/NEJMoa2107456

71. Fu Y, Jin H, Xiang H, et al. Optimal Lockdown Policy for Vaccination during COVID-19 Pandemic. Financ Res Lett. 2021:102123. DOI: 10.1016/j.frl.2021.102123 10.1016/j.frl.2021.102123. ABSTRACT: As the COVID-19 spreads across the world, many nations impose lockdown measures at the early stage of the pandemic to prevent the spread of the disease. Controversy surrounds the lockdown as it is a choice between economic freedom and public health. The ultimate solution to a pandemic is to vaccinate a massive population to achieve herd immunity. However, the whole vaccination programme is a long and complicated process. The virus and the vaccine will persist for quite a long time. How to gradually ease the lockdown based on vaccination progress is an important issue, as both economic and epidemiological issues are involved. In this paper, we extend the classic SIR model to find optimal decision making to balance between economy and public health in the process of vaccination rollout. The model provides an approach of vaccine value estimation. Our results provide scientific suggestion for policymakers to make important decisions about when to start the lockdown and how strong it should be over the entire vaccination cycle. URL: https://www.ncbi.nlm.nih.gov/pubmed/34007250 DOI: 10.1016/j.frl.2021.102123 10.1016/j.frl.2021.102123.

72. Funk CD, Laferriere C, Ardakani A. Target Product Profile Analysis of COVID-19 Vaccines in Phase III Clinical Trials and Beyond: An Early 2021 Perspective. Viruses. 2021;13(3). DOI: 10.3390/v13030418 10.3390/v13030418. ABSTRACT: The coronavirus SARS-CoV-2, which causes Coronavirus disease 2019 (COVID-19), has infected more than 100 million people globally and caused over 2.5 million deaths in just over one year since its discovery in Wuhan, in December 2019. The pandemic has evoked widespread collateral damage to societies and economies, and has destabilized mental health and well-being. Early in 2020, unprecedented efforts went into the development of vaccines that generate effective antibodies to the SARS-CoV-2 virus. Teams developing twelve

Evidence Search Report: INF031801v5 ESR 33 candidate vaccines, based on four platforms (messenger RNA, non-replicating viral vector, protein/virus-like particle, and inactivated virus) had initiated or announced the Phase III clinical trial stage by early November 2020, with several having received emergency use authorization in less than a year. Vaccine rollout has proceeded around the globe. Previously, we and others had proposed a target product profile (TPP) for ideal/optimal and acceptable/minimal COVID-19 vaccines. How well do these candidate vaccines stack up to a harmonized TPP? Here, we perform a comparative analysis in several categories of these candidate vaccines based on the latest available trial data and highlight the early successes as well as the hurdles and barriers yet to be overcome for ending the global COVID-19 pandemic. URL: https://www.ncbi.nlm.nih.gov/pubmed/33807839 DOI: 10.3390/v13030418 10.3390/v13030418.

73. Garcia-Prats AJ, McAdams RM, Matshaba M, et al. Mitigating the Impacts of COVID-19 on Global Child Health: a Call to Action. Curr Trop Med Rep. 2021:1-7. DOI: 10.1007/s40475-021-00241-6 10.1007/s40475-021-00241-6. ABSTRACT: Purpose of Review: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the cause of coronavirus disease 2019 (COVID-19), continues to affect individuals, communities, and health systems worldwide. Here, we highlight how COVID-19 threatens to jeopardize the tremendous gains made over the last few decades on improving children's health globally. Recent Findings: In contrast to adults, children with COVID-19 are less likely to develop severe disease requiring hospitalization or die as a direct result of infection. However, the pandemic will likely have other important health impacts disproportionately affecting vulnerable children globally. Possible effects include worsening of poverty and food insecurity; disruption of already strained routine child health services; damage to already imperiled healthcare workforces; a wave of mental health challenges; interruption of education; and increased risks of violence, abuse, exploitation, and neglect. These challenges notwithstanding, the response to COVID-19 may also provide opportunities, such as for health system strengthening, that could improve child health after the pandemic. Summary: The negative impacts of COVID-19 on global child health may be substantial. However, these are not foregone conclusions and much can be done to mitigate the worst outcomes. Child health providers should advocate for an equitable response to COVID-19 that prioritizes the health of vulnerable children and furthers the gains made in global child health. URL: https://www.ncbi.nlm.nih.gov/pubmed/33996382 DOI: 10.1007/s40475-021-00241-6 10.1007/s40475-021-00241-6.

74. Geoghegan S, Stephens LC, Feemster KA, et al. "This choice does not just affect me." Attitudes of pregnant women toward COVID-19 vaccines: a mixed-methods study. Hum Vaccin Immunother. 2021:1-6. DOI: 10.1080/21645515.2021.1924018 10.1080/21645515.2021.1924018. ABSTRACT: Public health experts agree that pregnant women who fall into priority groups may be offered a Coronavirus Disease 2019 (COVID-19) vaccine. However, little is known about attitudes of pregnant women toward COVID-19 vaccination. We surveyed 300 pregnant women during the roll out of the Pfizer-BioNTech vaccine in Ireland. Women rated likelihood of receipt of a vaccine during pregnancy, on a 1-10 scale (1 = very unlikely, 10 = very likely). One hundred and thirteen (38%) women responded with a score of >/=8, while a similar proportion (36%) selected a score of

Evidence Search Report: INF031801v5 ESR 34 75. Ghazy RM, Abd ElHafeez S, Shaaban R, et al. Determining the Cutoff Points of the 5C Scale for Assessment of COVID-19 Vaccines Psychological Antecedents among the Arab Population: A Multinational Study. J Prim Care Community Health. 2021;12:21501327211018568. DOI: 10.1177/21501327211018568 10.1177/21501327211018568. ABSTRACT: BACKGROUND: One of the newly faced challenges during the COVID-19 is vaccine hesitancy (VH). The validated 5C scale, that assesses 5 psychological antecedents of vaccination, could be effective in exploring COVID- 19 VH. This study aimed to determine a statistically valid cutoff points for the 5C sub-scales among the Arab population. METHODS: A cross-sectional study was conducted among 446 subjects from 3 Arab countries (Egypt, United Arab Emirates (UAE), and Jordan). Information regarding sociodemographics, clinical history, COVID-19 infection and vaccination history, and 5C scale were collected online. The 5C scores were analyzed to define the cutoff points using the receiver operating characteristic curve (ROC) and to verify the capability of the questionnaire to differentiate whether responders are hesitant or non-hesitant to accept vaccination. ROC curve analysis was conducted for previous vaccine administration as a response, with the predictors being the main 5 domains of the 5C questionnaire. The mean score of each sub-scale was compared with COVID-19 vaccine intake. RESULTS: The mean age of the studied population was 37 +/- 11, 42.9% were males, 44.8% from Egypt, 21.1% from Jordan, and 33.6% from the UAE. Statistically significant differences between vaccinated and unvaccinated participants, respectively, were detected in the median score of confidence [6.0(1.3) versus 4.7(2.0)], complacency [(2.7(2.0) versus 3.0(2.0)], constraints [1.7(1.7) versus 3.7(2.3)], and collective responsibility [6.7(1.7) versus 5.7(1.7)]. The area under the curve of the 5 scales was 0.72, 0.60, 0.76, 0.66, 0.66 for confidence, complacency, constraints, calculation, and collective responsibility at cutoff values of 5.7, 4.7, 6.0, 6.3, and 6.2, respectively. CONCLUSION: The Arabic validated version of the 5C scale has a good discriminatory power to predict COVID-19 vaccines antecedent. URL: https://www.ncbi.nlm.nih.gov/pubmed/34018891 DOI: 10.1177/21501327211018568 10.1177/21501327211018568.

76. Godeau D, Petit A, Richard I, et al. Return-to-work, disabilities and occupational health in the age of COVID- 19. Scand J Work Environ Health. 2021;18:18. DOI: 10.5271/sjweh.3960 10.5271/sjweh.3960. ABSTRACT: We have read with great interest the two editorials by Burdorf et al: "The COVID-19 pandemic: one year later - an occupational perspective" (1) and "The COVID-19 (Coronavirus) pandemic: consequences for occupational health" (2). The authors highlight the importance of the societal consequences of the outbreak and changes in the world of work to manage occupational health. The key points identified - such as individual socio- economic factors, psychological effects and occupations with highest risk of contamination - modify return-to-work approaches. It is estimated that around 800 million people of working age worldwide were living with disabilities before the SARS-CoV-2 pandemic. In early January 2021, the cumulative COVID-19 hospitalisation rate reached 207.4/100 000 (18-49-year-olds) and 505.7/100 000 (50-64-year-olds), respectively, in the United States (3). In France, the hospitalisation rate was 411.5/100 000 across all ages (4). A recent cohort study of working-age men who were hospitalised for COVID-19 highlighted the long-term health consequences of such a disease (5). The SARS-CoV-2 pandemic creates new challenges for occupational health, shifting attention away from return-to-work after health problems to resuming work during an outbreak, dealing with lockdown, and taking special account of workers with vulnerabilities (6, 7). We recommend considering three different aspects of occupational medicine during a pandemic. Firstly, for most workers at high-risk of severe COVID-19, the issues of work disability and resuming work had never occurred before the epidemic. Recommendations such as physical and social distancing and wearing a facemask are highly advisable to protect against infection but may not be enough to enable some individuals to resume work. Therefore, decision-making requires individual comprehensive assessments of the underlying medical condition, the SARS-CoV-2 contamination risk associated with either regular work or teleworking, and vaccination opportunities. The second situation concerns workers who have suffered from COVID-19. Preliminary studies suggest that long recovery duration is related to high severity (7), but this is still a matter of debate for patients suffering from "long COVID-19" (5, 8, 9), a condition for which the long-term effects remain unknown. Any long-running recovery must be considered to be a potential sign of long COVID-19. These long-lasting syndromes occur among patients with severe symptoms but have also been reported independently of acute phase severity, hospitalisation and receiving medical oxygen (8, 9). Researchers worldwide are currently

Evidence Search Report: INF031801v5 ESR 35 investigating such syndromes. Strategies promoting return to work for these workers will need to be implemented and could be similar to programmes developed for other chronic conditions. Moreover, numerous more serious sequelae following critical illness suggest the need for enhanced support by rehabilitation and occupational health specialists. Finally, the consequences of the epidemic must be evaluated over time for people who suffered from functional limitations before COVID-19 as their physical and mental condition may be modified by the epidemic and, specifically, the consequences of lockdown (10). In all of these situations, medical, social, financial and working contexts are key elements. In addition to a medical assessment, the use of scales such as the Work Ability Index (WAI) (11) or the Work Productivity and Activity Impairment (WPAI) (12) can help perform long-term follow- up and provide information about work capacity and workload. It also gives a "back to basics" perspective, urging politicians to move towards a `decent-work-for-all` policy, as advocated by the United Nation`s Sustainable Development Goal (SDG) 8, which the WHO has endorsed (13). References 1. Burdorf A, Porru F, Rugulies R. The COVID-19 pandemic: one year later - an occupational perspective. Scand J Work Environ Health - online first. https://doi.org/10.5271/sjweh.3956 2. Burdorf A, Porru F, Rugulies R. The COVID-19 (Coronavirus) pandemic: co sequences for occupational health. Scand J Work Environ Health. 2020;46(3):229-230. https://doi:org/10.5271/sjweh.3893. 3. COVID-19 Hospitalizations [Internet]. Available from: https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html 4. COVID-19 in France, vaccine and allergy management in occupational setting. Descatha A et al. Arch Mal Prof Environ 2021. Accepted for publication. 5. Huang C, Huang L, Wang Y, Li X, Ren L, Gu X, et al. 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study. Lancet 2021;397(10270):220-32 https://doi.org/10.1016/S0140-6736(20)32656-8 6. Shaw WS, Main CJ, Findley PA, Collie A, Kristman VL, Gross DP. Opening the Workplace After COVID-19: What Lessons Can be Learned from Return-to-Work Research? J Occup Rehabil. 2020;30(3):299-302. https://doi.org/10.1007/s10926-020-09908- 9 7. Taylor T, Das R, Mueller K, Pransky G, Christian J, Orford R, et al. Safely Returning America to Work: Part I: General Guidance for Employers. J Occup Environ Med. 2020;62(9):771-9. https://doi.org/10.1097/JOM.0000000000001984 8. Carfi A, Bernabei R, Landi F, Gemelli Against COVID-19 Post- Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020;324(6):603-5. https://doi.org/10.1001/jama.2020.12603 9. Tenforde MW, Kim SS, Lindsell CJ, Billig Rose E, Shapiro NI, Files DC, et al. Symptom Duration and Risk Factors for Delayed Return to Usual Health Among Outpatients with COVID-19 in a Multistate Health Care Systems Network - United States, March-June 2020. MMWR Morb Mortal Wkly. 2020;69(30):993-8. https://doi.org/10.15585/mmwr.mm6930e1 10. Chudasama YV, Gillies CL, Zaccardi F, Coles B, Davies MJ, Seidu S, et al. Impact of COVID-19 on routine care for chronic diseases: A global survey of views from healthcare professionals. Diabetes Metab Syndr. 2020;14(5):965-7. https://doi.org/10.1016/j.dsx.2020.06.042 11. Tuomi K. Eleven-year follow-up of aging workers. Scand J Work Environ Health. 1997;23(1):1-71. 12. Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. PharmacoEconomics. 1993;4(5):353-65. https://doi.org/10.2165/00019053-199304050-00006 13. Organization WH. Health in the 2030 agenda for sustainable development. Sixty-Ninth World Health Assembly. Document A. 2016, p69. URL: https://www.ncbi.nlm.nih.gov/pubmed/34003294 DOI: 10.5271/sjweh.3960 10.5271/sjweh.3960.

77. Haas EJ, Angulo FJ, McLaughlin JM, et al. Impact and effectiveness of mRNA BNT162b2 vaccine against SARS- CoV-2 infections and COVID-19 cases, hospitalisations, and deaths following a nationwide vaccination campaign in Israel: an observational study using national surveillance data. The Lancet. 2021;397(10287):1819-29. DOI: http://dx.doi.org/10.1016/S0140-6736%2821%2900947-8 ABSTRACT: Background: Following the emergency use authorisation of the Pfizer-BioNTech mRNA COVID-19 vaccine BNT162b2 (international non-proprietary name tozinameran) in Israel, the Ministry of Health (MoH) launched a campaign to immunise the 6.5 million residents of Israel aged 16 years and older. We estimated the real-world effectiveness of two doses of BNT162b2 against a range of SARS-CoV-2 outcomes and to evaluate the nationwide public-health impact following the widespread introduction of the vaccine. Method(s): We used national surveillance data from the first 4 months of the nationwide vaccination campaign to ascertain incident cases of laboratory-confirmed SARS-CoV-2 infections and outcomes, as well as vaccine uptake in residents of Israel aged 16 years and older. Vaccine effectiveness against SARS-CoV-2 outcomes (asymptomatic infection, symptomatic infection, and COVID-19-related hospitalisation, severe or critical hospitalisation, and death) was

Evidence Search Report: INF031801v5 ESR 36 calculated on the basis of incidence rates in fully vaccinated individuals (defined as those for whom 7 days had passed since receiving the second dose of vaccine) compared with rates in unvaccinated individuals (who had not received any doses of the vaccine), with use of a negative binomial regression model adjusted for age group (16- 24, 25-34, 35-44, 45-54, 55-64, 65-74, 75-84, and >=85 years), sex, and calendar week. The proportion of spike gene target failures on PCR test among a nationwide convenience-sample of SARS-CoV-2-positive specimens was used to estimate the prevelance of the B.1.1.7 variant. Finding(s): During the analysis period (Jan 24 to April 3, 2021), there were 232 268 SARS-CoV-2 infections, 7694 COVID-19 hospitalisations, 4481 severe or critical COVID- 19 hospitalisations, and 1113 COVID-19 deaths in people aged 16 years or older. By April 3, 2021, 4 714 932 (72.1%) of 6 538 911 people aged 16 years and older were fully vaccinated with two doses of BNT162b2. Adjusted estimates of vaccine effectiveness at 7 days or longer after the second dose were 95.3% (95% CI 94.9-95.7; incidence rate 91.5 per 100 000 person-days in unvaccinated vs 3.1 per 100 000 person-days in fully vaccinated individuals) against SARS-CoV-2 infection, 91.5% (90.7-92.2; 40.9 vs 1.8 per 100 000 person-days) against asymptomatic SARS-CoV-2 infection, 97.0% (96.7-97.2; 32.5 vs 0.8 per 100 000 person-days) against symptomatic COVID-19, 97.2% (96.8-97.5; 4.6 vs 0.3 per 100 000 person-days) against COVID-19-related hospitalisation, 97.5% (97.1-97.8; 2.7 vs 0.2 per 100 000 person-days) against severe or critical COVID-19-related hospitalisation, and 96.7% (96.0-97.3; 0.6 vs 0.1 per 100 000 person-days) against COVID-19-related death. In all age groups, as vaccine coverage increased, the incidence of SARS-CoV-2 outcomes declined. 8006 of 8472 samples tested showed a spike gene target failure, giving an estimated prevalence of the B.1.1.7 variant of 94.5% among SARS-CoV-2 infections. Interpretation(s): Two doses of BNT162b2 are highly effective across all age groups (>=16 years, including older adults aged >=85 years) in preventing symptomatic and asymptomatic SARS-CoV-2 infections and COVID-19- related hospitalisations, severe disease, and death, including those caused by the B.1.1.7 SARS-CoV-2 variant. There were marked and sustained declines in SARS-CoV-2 incidence corresponding to increasing vaccine coverage. These findings suggest that COVID-19 vaccination can help to control the pandemic. Funding(s): None. Copyright © 2021 Elsevier Ltd URL: http://www.journals.elsevier.com/the- lancet/https://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=emexb&AN=2012014857ht tps://libkey.io/libraries/843/openurl?output=full&sid=OVID:embase&id=pmid:33964222&id=doi:10.1016%2FS014 0-6736%252821%252900947-8&issn=0140-6736&isbn=&volume=397&issue=10287&spage=1819&pages=1819- 1829&date=2021&title=The+Lancet&atitle=Impact+and+effectiveness+of+mRNA+BNT162b2+vaccine+against+SAR S-CoV-2+infections+and+COVID- 19+cases%2C+hospitalisations%2C+and+deaths+following+a+nationwide+vaccination+campaign+in+Israel%3A+an +observational+study+using+national+surveillance+data&aulast=Haas&pid=%3Cauthor%3EHaas+E.J.%3BAngulo+F. J.%3BMcLaughlin+J.M.%3BAnis+E.%3BSinger+S.R.%3BKhan+F.%3BBrooks+N.%3BSmaja+M.%3BMircus+G.%3BPan+ K.%3BSouthern+J.%3BSwerdlow+D.L.%3BJodar+L.%3BLevy+Y.%3BAlroy- Preis+S.%3C%2Fauthor%3E%3CAN%3E2012014857%3C%2FAN%3E%3CDT%3EArticle%3C%2FDT%3E DOI: http://dx.doi.org/10.1016/S0140-6736%2821%2900947-8

78. Haghpanah F, Lin G, Levin SA, et al. Analysis of the potential impact of durability, timing, and transmission blocking of COVID-19 vaccine on morbidity and mortality. EClinicalMedicine. 2021;35(100863):100863. DOI: 10.1016/j.eclinm.2021.100863 10.1016/j.eclinm.2021.100863. Epub 2021 Apr 26. ABSTRACT: Background: COVID-19 vaccines have been approved and made available. While questions of vaccine allocation strategies have received significant attention, important questions remain regarding the potential impact of the vaccine given uncertainties regarding efficacy against transmission, availability, timing, and durability. Methods: We adapted a susceptible-exposed-infectious-recovered (SEIR) model to examine the potential impact on hospitalization and mortality assuming increasing rates of vaccine efficacy, coverage, and administration. We also evaluated the uncertainty of the vaccine to prevent infectiousness as well as the impact on outcomes based on the timing of distribution and the potential effects of waning immunity. Findings: Increased vaccine efficacy against disease reduces hospitalizations and deaths from COVID-19; however, the relative benefit of transmission blocking varied depending on the timing of vaccine distribution. Early in an outbreak, a vaccine that reduces transmission will be relatively more effective than one introduced later in the outbreak. In addition, earlier and accelerated implementation of a less effective vaccine is more impactful than later implementation of a more effective vaccine. These findings are magnified when considering the durability of the vaccine. Vaccination in

Evidence Search Report: INF031801v5 ESR 37 the spring will be less impactful when immunity is less durable. Interpretation: Policy choices regarding non- pharmaceutical interventions, such as social distancing and face mask use, will need to remain in place longer if the vaccine is less effective at reducing transmission or distributed slower. In addition, the stage of the local outbreak greatly impacts the overall effectiveness of the vaccine in a region and should be considered when allocating vaccines. Funding: Centers for Disease Control and Prevention (CDC) MInD-Healthcare Program (U01CK000589, 1U01CK000536), James S. McDonnell Foundation 21st Century Science Initiative Collaborative Award in Understanding Dynamic and Multiscale Systems, National Science Foundation (CNS-2027908), National Science Foundation Expeditions (CCF1917819), C3.ai Digital Transformation Institute (AWD1006615), and Google, LLC. URL: https://www.ncbi.nlm.nih.gov/pubmed/33937734 DOI: 10.1016/j.eclinm.2021.100863 10.1016/j.eclinm.2021.100863. Epub 2021 Apr 26.

79. Hakalehto E. Chicken IgY Antibodies Provide Mucosal Barrier against SARS-CoV-2 Virus and Other Pathogens. Isr Med Assoc J. 2021;23(4):208-11. ABSTRACT: BACKGROUND: This mini review includes two case descriptions. It introduces the use of chicken egg yolk antibody (IgY) solutions in the prevention and cure of viral and bacterial infections. Application for the protection against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), rotavirus, and influenza viruses, as well as for the eradication of Pseudomonas aeruginosa, caries, various enteric bacteria and other pathogens, and toxins have been developed. This approach is a fast, reliable, safe, and tested method for producing molecular shield and protection against emerging pathogens and epidemics. In the current pandemic situation caused by coronavirus disease-2019 (COVID-19), this method of passive immunization could be applied for rapid protection against modifiable agents. The specific IgY antibodies start to accumulate into egg yolks about 3 weeks after the immunization of the chicken. The product can be collected safely, as the antigen is not found in the eggs. This method for microbial safety uses natural means and commonly used food substances, which have been tested and could be produced for both blocking epidemics and applying personalized medicine. URL: https://www.ncbi.nlm.nih.gov/pubmed/33899350

80. Hashim JH, Adman MA, Hashim Z, et al. COVID-19 Epidemic in Malaysia: Epidemic Progression, Challenges, and Response. Front Public Health. 2021;9:560592. DOI: 10.3389/fpubh.2021.560592 10.3389/fpubh.2021.560592. eCollection 2021. ABSTRACT: COVID-19 pandemic is the greatest communicable disease outbreak to have hit Malaysia since the 1918 Spanish Flu which killed 34,644 people or 1% of the population of the then British Malaya. In 1999, the Nipah virus outbreak killed 105 Malaysians, while the SARS outbreak of 2003 claimed only 2 lives. The ongoing COVID-19 pandemic has so far claimed over 100 Malaysian lives. There were two waves of the COVID-19 cases in Malaysia. First wave of 22 cases occurred from January 25 to February 15 with no death and full recovery of all cases. The ongoing second wave, which commenced on February 27, presented cases in several clusters, the biggest of which was the Sri Petaling Tabligh cluster with an infection rate of 6.5%, and making up 47% of all cases in Malaysia. Subsequently, other clusters appeared from local mass gatherings and imported cases of Malaysians returning from overseas. Healthcare workers carry high risks of infection due to the daily exposure and management of COVID-19 in the hospitals. However, 70% of them were infected through community transmission and not while handling patients. In vulnerable groups, the incidence of COVID-19 cases was highest among the age group 55 to 64 years. In terms of fatalities, 63% were reported to be aged above 60 years, and 81% had chronic comorbidities such as diabetes, hypertension, and heart diseases. The predominant COVID-19 strain in Malaysia is strain B, which is found exclusively in East Asia. However, strain A, which is mostly found in the USA and Australia, and strain C in Europe were also present. To contain the epidemic, Malaysia implemented a Movement Control Order (MCO) beginning on March 18 in 4 phases over 2 months, ending on May 12. In terms of economic impacts, Malaysia lost RM2.4 billion a day during the MCO period, with an accumulated loss of RM63 billion up to the end of April. Since May 4, Malaysia has relaxed the MCO and opened up its economic sector to relieve its economic burden. Currently, the best approach to achieving herd immunity to COVID-19 is through vaccination rather than by acquiring it naturally. There are at least two candidate vaccines which have reached the final stage of human clinical trials. Malaysia's COVID-19 case fatality rate is lower than what it is globally; this is due to the successful implementation of early preparedness and planning, the public health and hospital system, comprehensive contact tracing, active case detection, and a strict enhanced MCO.

Evidence Search Report: INF031801v5 ESR 38 URL: https://www.ncbi.nlm.nih.gov/pubmed/34026696 DOI: 10.3389/fpubh.2021.560592 10.3389/fpubh.2021.560592. eCollection 2021.

81. Hazlewood GS, Pardo J, Barnabe C, et al. Canadian Rheumatology Association recommendation for the use of COVID-19 vaccination for patients with autoimmune rheumatic diseases. J Rheumatol. 2021;15:15. DOI: 10.3899/jrheum.210288 10.3899/jrheum.210288. ABSTRACT: OBJECTIVE: To develop guidance on the use of COVID-19 vaccines in patients with autoimmune rheumatic diseases (ARD). METHODS: The Canadian Rheumatology Association (CRA) formed a multidisciplinary panel including rheumatologists, researchers, methodologists, vaccine experts and patients. The panel used the GRADE approach. Outcomes were prioritized according to their importance for patients and clinicians. Evidence from the COVID-19 clinical trials was summarized. Indirect evidence for non-COVID-19 vaccines in ARD was also considered. The GRADE Evidence-to-Decision (EtD) framework was used to develop a recommendation for the use of the four COVID vaccines approved in Canada as of March 25, 2021 (BNT162b2, mRNA-1273, ChAdOx1 and Ad26.COV2.S) over four virtual panel meetings. RESULTS: The CRA guideline panel suggests using COVID-19 vaccination in persons with ARD. The panel unanimously agreed that for the majority of patients the potential health benefits of vaccination outweigh the potential harms in people with ARDs. The recommendation was graded as conditional because of low or very low certainty of the evidence about the effects in the population of interest primarily due to indirectness and imprecise effect estimates. The panel felt strongly that persons with autoimmune rheumatic diseases who meet local eligibility should not be required to take additional steps compared to people without autoimmune rheumatic diseases to obtain their vaccination. Guidance on medications, implementation, monitoring of vaccine uptake and research priorities are also provided. CONCLUSION: This recommendation will be updated over time as new evidence emerges, with the latest recommendation, evidence summaries and EtD available on the CRA website. URL: https://www.ncbi.nlm.nih.gov/pubmed/33993119 DOI: 10.3899/jrheum.210288 10.3899/jrheum.210288.

82. He Q, Mao Q, Zhang J, et al. COVID-19 Vaccines: Current Understanding on Immunogenicity, Safety, and Further Considerations. Front Immunol. 2021;12(669339):669339. DOI: 10.3389/fimmu.2021.669339 10.3389/fimmu.2021.669339. eCollection 2021. ABSTRACT: The world has entered the second wave of the COVID-19 pandemic, and its intensity is significantly higher than that of the first wave of early 2020. Many countries or regions have been forced to start the second round of lockdowns. To respond rapidly to this global pandemic, dozens of COVID-19 vaccine candidates have been developed and many are undergoing clinical testing. Evaluating and defining effective vaccine candidates for human use is crucial for prioritizing vaccination programs against COVID-19. In this review, we have summarized and analyzed the efficacy, immunogenicity and safety data from clinical reports on different COVID-19 vaccines. We discuss the various guidelines laid out for the development of vaccines and the importance of biological standards for comparing the performance of vaccines. Lastly, we highlight the key remaining challenges, possible strategies for addressing them and the expected improvements in the next generation of COVID-19 vaccines. URL: https://www.ncbi.nlm.nih.gov/pubmed/33912196 DOI: 10.3389/fimmu.2021.669339 10.3389/fimmu.2021.669339. eCollection 2021.

83. Hernandez RG, Hagen L, Walker K, et al. The COVID-19 vaccine social media infodemic: healthcare providers' missed dose in addressing misinformation and vaccine hesitancy. Hum Vaccin Immunother. 2021:1-3. DOI: 10.1080/21645515.2021.1912551 10.1080/21645515.2021.1912551. ABSTRACT: During the COVID-19 pandemic, antivaccination social media accounts are proliferating online, threatening to further escalate vaccine hesitancy related to the COVID-19 vaccine. This commentary seeks to alert and encourage the health care provider community, including health care professionals and academic organizations, to engage in social media to counter the mounting vaccine-related infodemic. To validate our

Evidence Search Report: INF031801v5 ESR 39 recommendation for engagement, the authors describe preliminary findings using a mixed methods approach of quantitative Twitter-based ranking algorithms of networks and users with qualitative content analysis of 1 million tweets related to COVID-19 vaccine conversations. Results show highly polarized and active antivaccine conversations that were primarily influenced by political and nonmedical Twitter users. In contrast, less than 10% of the tweets stemmed from the medical community, demonstrating a lack of active health care professional connectivity in addressing COVID-19 misinformation. The authors introduce the concept of Health Care Provider Social Media Hesitancy to refer to the public health threat of health care providers' nonaction in providing pro- vaccine and scientific information about the vaccine on social media. The authors conclude by describing multilevel strategies for encouraging health care providers and the medical community to effectively "Tweet up" to combat the mounting threat of vaccine misinformation and hesitancy. URL: https://www.ncbi.nlm.nih.gov/pubmed/33890838 DOI: 10.1080/21645515.2021.1912551 10.1080/21645515.2021.1912551.

84. Hetherington E, Edwards SA, MacDonald SE, et al. SARS-CoV-2 vaccination intentions among mothers of children aged 9 to 12 years: a survey of the All Our Families cohort. CMAJ Open. 2021;9(2):E548-E55. DOI: 10.9778/cmajo.20200302 10.9778/cmajo.20200302. Print 2021 Apr-Jun. ABSTRACT: BACKGROUND: Acceptance of a vaccine against SARS-CoV-2 is critical to achieving high levels of immunization. The objectives of this study were to understand mothers' SARS-CoV-2 vaccine intentions to explore reasons for and against SARS-CoV-2 vaccination. METHODS: Participants from the All Our Families pregnancy longitudinal cohort whose children had reached ages 9-12 years were invited in May-June 2020 to complete a survey on the impact of COVID-19. The survey covered topics about the impact of the pandemic and included 2 specific questions on mothers' intentions to vaccinate their child against SARS-CoV-2. Current responses were linked to previously collected data, including infant vaccine uptake. Multinomial regression models were run to estimate associations between demographic factors, past vaccination status and vaccination intention. Qualitative responses regarding factors affecting decision-making were analyzed thematically. RESULTS: The response rate was 53.8% (1321/2455). A minority of children of participants had partial or no vaccinations at age 2 (n = 200, 15.1%). A total of 60.4% of mothers (n = 798) intended to vaccinate their children with the SARS-CoV-2 vaccine, 8.6% (n = 113) did not intend to vaccinate and 31.0% (n = 410) were unsure. Lower education, lower income and incomplete vaccination history were inversely associated with intention to vaccinate. Thematic analysis of qualitative responses showed 10 themes, including safety and efficacy, long-term effects and a rushed process. INTERPRETATION: Within a cohort with historically high infant vaccination, a third of mothers remained unsure about vaccinating their children against SARS-CoV-2. Given the many uncertainties about future SARS-CoV-2 vaccines, clear communication regarding safety will be critical to ensuring vaccine uptake. URL: https://www.ncbi.nlm.nih.gov/pubmed/34021012 DOI: 10.9778/cmajo.20200302 10.9778/cmajo.20200302. Print 2021 Apr-Jun.

85. Hirsch JS, Ikizler TA, Sharma S, et al. Acute Kidney Injury and Advanced Kidney Disease in the COVID-19 Pandemic: Proceedings From a National Kidney Foundation Symposium. Kidney Med. 2021. DOI: 10.1016/j.xkme.2021.03.003 10.1016/j.xkme.2021.03.003. ABSTRACT: The coronavirus disease 2019 (COVID-19) pandemic is an unprecedented and historic public health crisis that continues to expand and evolve. The National Kidney Foundation (NKF) held a two-part CME live virtual symposium on July 16th and July 24(th) 2020 to address the multiple challenges of COVID-19 in the context of advanced chronic kidney disease (CKD). Faculty addressed the pathophysiology, impact, risks, and management of COVID-19 as it relates to advanced kidney disease. Testing, risk mitigation, and inpatient and outpatient management were also addressed. This concise review addresses major findings of the symposium along with certain updates regarding vaccinations since then. These findings include: 1) Severe COVID-19 has been associated with acute kidney injury (AKI); 2) It is essential to prevent and actively manage AKI to decrease mortality in these critically ill patients; 3) Management of patients with advanced kidney disease should be geared towards

Evidence Search Report: INF031801v5 ESR 40 minimizing their risk of exposure while making sure they are receiving adequate treatments. 4) Patients with kidney disease, especially ones in advanced stages, should be prioritized for vaccination. URL: https://www.ncbi.nlm.nih.gov/pubmed/33898966 DOI: 10.1016/j.xkme.2021.03.003 10.1016/j.xkme.2021.03.003.

86. Hoffman MC, Freedman R, Law AJ, et al. Maternal nutrients and effects of gestational COVID-19 infection on fetal brain development. Clin Nutr ESPEN. 2021;43:1-8. DOI: 10.1016/j.clnesp.2021.04.019 10.1016/j.clnesp.2021.04.019. Epub 2021 Apr 29. ABSTRACT: BACKGROUND & AIMS: Maternal gestational infection is a well-characterized risk factor for offsprings' development of mental disorders including schizophrenia, autism, and attention deficit disorder. The inflammatory response elicited by the infection is partly directed against the placenta and fetus and is the putative pathogenic mechanism for fetal brain developmental abnormalities. Fetal brain abnormalities are generally irreversible after birth and increase risk for later mental disorders. Maternal immune activation in animals models this pathophysiology. SARS-CoV-2 produces maternal inflammatory responses during pregnancy similar to previously studied common respiratory viruses. METHOD: Choline, folic acid, Vitamin D, and n-3 polyunsaturated fatty acids are among the nutrients that have been studied as possible mitigating factors for effects of maternal infection and inflammation on fetal development. Clinical and animal studies relevant to their use in pregnant women who have been infected are reviewed. RESULTS: Higher maternal choline levels have positive effects on the development of brain function for infants of mothers who experienced viral infections in early pregnancy. No other nutrient has been studied in the context of viral inflammation. Vitamin D reduces pro-inflammatory cytokines in some, but not all, studies. Active folic acid metabolites decrease anti-inflammatory cytokines. N-3 polyunsaturated fatty acids have no effect. CONCLUSIONS: Vitamin D and folic acid are already supplemented in food additives and in prenatal vitamins. Despite recommendations by several public health agencies and medical societies, choline intake is often inadequate in early gestation when the brain is forming. A public health initiative for choline supplements during the pandemic could be helpful for women planning or already pregnant who also become exposed or infected with SARS-CoV-2. URL: https://www.ncbi.nlm.nih.gov/pubmed/34024500 DOI: 10.1016/j.clnesp.2021.04.019 10.1016/j.clnesp.2021.04.019. Epub 2021 Apr 29.

87. Hogan AB, Winskill P, Watson OJ, et al. Within-country age-based prioritisation, global allocation, and public health impact of a vaccine against SARS-CoV-2: A mathematical modelling analysis. Vaccine. 2021;39(22):2995- 3006. DOI: 10.1016/j.vaccine.2021.04.002 10.1016/j.vaccine.2021.04.002. Epub 2021 Apr 8. ABSTRACT: The worldwide endeavour to develop safe and effective COVID-19 vaccines has been extraordinary, and vaccination is now underway in many countries. However, the doses available in 2021 are likely to be limited. We extend a mathematical model of SARS-CoV-2 transmission across different country settings to evaluate the public health impact of potential vaccines using WHO-developed target product profiles. We identify optimal vaccine allocation strategies within- and between-countries to maximise averted deaths under constraints on dose supply. We find that the health impact of SARS-CoV-2 vaccination depends on the cumulative population-level infection incidence when vaccination begins, the duration of natural immunity, the trajectory of the epidemic prior to vaccination, and the level of healthcare available to effectively treat those with disease. Within a country we find that for a limited supply (doses for < 20% of the population) the optimal strategy is to target the elderly. However, with a larger supply, if vaccination can occur while other interventions are maintained, the optimal strategy switches to targeting key transmitters to indirectly protect the vulnerable. As supply increases, vaccines that reduce or block infection have a greater impact than those that prevent disease alone due to the indirect protection provided to high-risk groups. Given a 2 billion global dose supply in 2021, we find that a strategy in which doses are allocated to countries proportional to population size is close to optimal in averting deaths and aligns with the ethical principles agreed in pandemic preparedness planning. URL: https://www.ncbi.nlm.nih.gov/pubmed/33933313 DOI: 10.1016/j.vaccine.2021.04.002 10.1016/j.vaccine.2021.04.002. Epub 2021 Apr 8.

Evidence Search Report: INF031801v5 ESR 41

88. Hotez P. Preventing the next pandemic and tackling antiscience: an interview with Peter Hotez. Future Microbiol. 2021;16:539-41. DOI: 10.2217/fmb-2021-0088 10.2217/fmb-2021-0088. Epub 2021 May 17. ABSTRACT: This interview was conducted by Atiya Henry, Commissioning Editor of Future Microbiology. Peter J Hotez, MD, PhD is Dean of the National School of Tropical Medicine and Professor of Pediatrics and Molecular Virology & Microbiology at Baylor College of Medicine. He is an internationally recognized physician-scientist in neglected tropical diseases and vaccine development. As head of the Texas Children's Center for Vaccine Development, he leads a team and product development partnership for developing new vaccines for infection, , leishmaniasis, Chagas disease and SARS/MERS/SARS-2 coronavirus. Dr Hotez has authored more than 500 original papers and is the author of four single-author books. Most recently as both a vaccine scientist and autism parent, he has led national efforts to defend vaccines and to serve as an ardent champion of vaccines going up against a growing national 'antivax' threat. URL: https://www.ncbi.nlm.nih.gov/pubmed/33998265 DOI: 10.2217/fmb-2021-0088 10.2217/fmb-2021-0088. Epub 2021 May 17.

89. Huang H, Zhang C, Yang S, et al. The investigation of mRNA vaccines formulated in liposomes administrated in multiple routes against SARS-CoV-2. J Control Release. 2021;21:21. DOI: 10.1016/j.jconrel.2021.05.024 10.1016/j.jconrel.2021.05.024. ABSTRACT: COVID-19 pandemic has resulted in an unprecedented global public health crisis. It is obvious that SARS-CoV-2 vaccine is needed to control the global COVID-19 public health crisis. Since obvious advantages including fast manufacturing speed, potent immunogenicity and good safety profile, six mRNA vaccines have been used to prevent SARS-CoV-2 infections in clinic with lipid nanoparticles (LNP) formulation via intramuscular injection. In this work, we first constructed RBD-encoding mRNA (RBD-mRNA) formulated in liposomes (LPX/RBD- mRNA) and investigated the influence of administration routes on the immunogenicity. LPX/RBD-mRNA can express RBD in vivo and successfully induced SARS-CoV-2 RBD specific antibodies in the vaccinated mice, which efficiently neutralized SARS-CoV-2 pseudotyped virus. Moreover, the administration routes were found to affect the virus neutralizing capacity of sera derived from the immunized mice and the types (Th1-type and Th2-type) of cellular immune responses. This study indicated that liposome-based RBD-mRNA vaccine with optimal administration route might be a potential candidate against SARS-CoV-2 infection with good efficacy and safety. URL: https://www.ncbi.nlm.nih.gov/pubmed/34029632 DOI: 10.1016/j.jconrel.2021.05.024 10.1016/j.jconrel.2021.05.024.

90. Huang Z, Jiang Q, Wang Y, et al. SARS-CoV-2 (Vero cells) shows good safety in repeated administration toxicity test of Sprague Dawley rats. Food Chem Toxicol. 2021;152(112239):112239. DOI: 10.1016/j.fct.2021.112239 10.1016/j.fct.2021.112239. Epub 2021 Apr 24. ABSTRACT: The outbreak of COVID-19 has posed a serious threat to global public health. Vaccination may be the most effective way to prevent and control the spread of the virus. The safety of vaccines is the focus of preclinical research, and the repeated dose toxicity test is the key safety test to evaluate the vaccine before clinical tri als. The purpose of this study was (i) to observe the toxicity and severity of an inactivated SARS-CoV-2 vaccine (Vero cells) in rodent Sprague Dawley rats after multiple intramuscular injections under the premise of Good Laboratory Practice principles and (ii) to provide a basis for the formulation of a clinical trial scheme. The results showed that all animals in the experimental group were in good condition, no regular changes related to the vaccine were found in the detection of various toxicological indexes, and no noticeable stimulating reaction related to the vaccine was found in the injected local tissues. The neutralizing antibodies in the low- and high-dose vaccine groups began to appear 14 days after the last administration. In the negative control group, no neutralizing antibodies were observed from the administration period to the recovery period. Therefore, the repeated administration toxicity test of the inactivated SARS-CoV-2 vaccine (Vero cells) in Sprague Dawley rats showed no obvious toxic reaction. It was preliminarily confirmed that the vaccine can stimulate production of neutralizing antibodies and is safe in Sprague Dawley rats.

Evidence Search Report: INF031801v5 ESR 42 URL: https://www.ncbi.nlm.nih.gov/pubmed/33901607 DOI: 10.1016/j.fct.2021.112239 10.1016/j.fct.2021.112239. Epub 2021 Apr 24.

91. Huynh G, Nguyen TV, Nguyen DD, et al. Knowledge About COVID-19, Beliefs and Vaccination Acceptance Against COVID-19 Among High-Risk People in Ho Chi Minh City, Vietnam. Infect Drug Resist. 2021;14:1773-80. DOI: 10.2147/IDR.S308446 10.2147/IDR.S308446. eCollection 2021. ABSTRACT: Background: Vaccination is one of the best ways to control a pandemic such as COVID-19. However, identifying community apprehensions towards vaccination needs to be understood in detail. This study aims to determine the factors that can predict the acceptance of the COVID-19 vaccine. Methods: A cross-sectional study was considered by systematic random sampling of 425 adults with chronic illnesses in Ho Chi Minh City. Data were collected between December 2020 and January 2021 via a self-administered, structured questionnaire. The main outcome was the acceptance of future COVID-19 vaccinations. Results: A total of 425 eligible adults responded to the survey, whose mean age was 52.9+/-15.6 years; 67.8% of them were women, more than a half of them had high school education level or higher (57.4%) and received COVID-19 information mainly via television and social media accounted for 82.4% and 58.1%, respectively. Overall, knowledge of COVID-19 was reported as relatively good, with a mean score of 7.11 +/- 1.77 (0-9). Determinants of vaccination acceptance were knowledge and cues to action. Accordingly, there was a 1.2-fold increase in the odds of acceptance of COVID-19 vaccination for a 1-unit increase in "the total knowledge score" (AOR 1.2, 95% CI: 1.1-1.3, p<0.05), and there was a 3.2-fold increase in the odds of vaccination acceptance for a 1-unit increase in "cues to action" (AOR 3.2, 95% CI: 1.7-5.8, p<0.001). Conclusion: Determinants that influence the intention to have the COVID-19 vaccination are identified, which can be applied to future health education interventions that should focus on enhanced knowledge towards COVID-19 via mass media messages and cues to action from healthcare workers' recommendations to promote vaccine acceptance. URL: https://www.ncbi.nlm.nih.gov/pubmed/34012276 DOI: 10.2147/IDR.S308446 10.2147/IDR.S308446. eCollection 2021.

92. Jahn B, Sroczynski G, Bicher M, et al. Targeted COVID-19 Vaccination (TAV-COVID) Considering Limited Vaccination Capacities-An Agent-Based Modeling Evaluation. Vaccines (Basel). 2021;9(5). DOI: 10.3390/vaccines9050434 10.3390/vaccines9050434. ABSTRACT: (1) Background: The Austrian supply of COVID-19 vaccine is limited for now. We aim to provide evidence-based guidance to the authorities in order to minimize COVID-19-related hospitalizations and deaths in Austria. (2) Methods: We used a dynamic agent-based population model to compare different vaccination strategies targeted to the elderly (65 >/= years), middle aged (45-64 years), younger (15-44 years), vulnerable (risk of severe disease due to comorbidities), and healthcare workers (HCW). First, outcomes were optimized for an initially available vaccine batch for 200,000 individuals. Second, stepwise optimization was performed deriving a prioritization sequence for 2.45 million individuals, maximizing the reduction in total hospitalizations and deaths compared to no vaccination. We considered sterilizing and non-sterilizing immunity, assuming a 70% effectiveness. (3) Results: Maximum reduction of hospitalizations and deaths was achieved by starting vaccination with the elderly and vulnerable followed by middle-aged, HCW, and younger individuals. Optimizations for vaccinating 2.45 million individuals yielded the same prioritization and avoided approximately one third of deaths and hospitalizations. Starting vaccination with HCW leads to slightly smaller reductions but maximizes occupational safety. (4) Conclusion: To minimize COVID-19-related hospitalizations and deaths, our study shows that elderly and vulnerable persons should be prioritized for vaccination until further vaccines are available. URL: https://www.ncbi.nlm.nih.gov/pubmed/33925650 DOI: 10.3390/vaccines9050434 10.3390/vaccines9050434.

93. Jain VK, Iyengar K, Garg R, et al. Elucidating reasons of COVID-19 re-infection and its management strategies. Diabetes Metab Syndr. 2021;15(3):1001-6. DOI: 10.1016/j.dsx.2021.05.008

Evidence Search Report: INF031801v5 ESR 43 10.1016/j.dsx.2021.05.008. ABSTRACT: BACKGROUND AND AIMS: Reinfection is gradually being recognised after symptomatic or asymptomatic COVID-19 infection. We try to elucidate various explanations behind COVID-19 reinfection and suggest possible strategies to counteract this threat. METHODS: We carried out a comprehensive review of the literature using suitable keywords such as 'COVID-19', 'Pandemics', 'Reinfection', 'Vaccines' and 'India' on the search engines of PubMed, SCOPUS, Google Scholar and Research Gate in March 2021 and first half of April 2021 during the current COVID-19 pandemic. , risk factors and trends of reinfection were assessed. RESULTS: A multitude of factors have been associated with rising incidence of COVID-19 reinfection in India and across the world. Emergence of 'Variants of Concern (VOC)', pandemic fatigue and disregard of infection prevention strategies appear to be the most obvious reasons. CONCLUSIONS: COVID-19 reinfection is an emerging concern amongst the worldwide population with newer mutant strains demonstrating increasing transmissibility and responsible for continuing waves of the pandemic. COVID Appropriate Behaviour (CAB), improvised vaccines and enhanced vaccination drives are necessary to mitigate global threat. URL: https://www.ncbi.nlm.nih.gov/pubmed/33989898 DOI: 10.1016/j.dsx.2021.05.008 10.1016/j.dsx.2021.05.008.

94. Joffe S, Babiker A, Ellenberg SS, et al. Data and Safety Monitoring of COVID-19 Vaccine Clinical Trials. J Infect Dis. 2021;19:19. DOI: 10.1093/infdis/jiab263 10.1093/infdis/jiab263. ABSTRACT: To speed the development of vaccines against SARS-CoV-2, the United States federal government has funded multiple phase 3 trials of candidate vaccines. A single 11-member data and safety monitoring board (DSMB) monitors all government-funded trials to ensure coordinated oversight, promote harmonized designs, and allow shared insights related to safety across trials. DSMB reviews encompass 3 domains: 1) the conduct of trials, including overall and subgroup accrual and data quality and completeness; 2) safety, including individual events of concern and comparisons by randomized group; and 3) interim analyses of efficacy when event-driven milestones are met. Challenges have included the scale and pace of the trials, the frequency of safety events related to the combined enrollment of over 100,000 participants, many of whom are older adults or have comorbid conditions that place them at independent risk of serious health events, and the politicized environment in which the trials have taken place. URL: https://www.ncbi.nlm.nih.gov/pubmed/34008027 DOI: 10.1093/infdis/jiab263 10.1093/infdis/jiab263.

95. Kaakati R, Khokhar D, Akin C. Safety of COVID-19 Vaccination in Patients with Mastocytosis and Monoclonal Mast Cell Activation Syndrome. J Allergy Clin Immunol Pract. 2021;22:22. DOI: 10.1016/j.jaip.2021.05.010 10.1016/j.jaip.2021.05.010. URL: https://www.ncbi.nlm.nih.gov/pubmed/34033981 DOI: 10.1016/j.jaip.2021.05.010 10.1016/j.jaip.2021.05.010.

96. Kanno AI, Barbosa MMF, Moraes L, et al. SARS-CoV-2 vaccine development and how Brazil is contributing. Genet Mol Biol. 2021;44(1 Suppl 1):e20200320. DOI: 10.1590/1678-4685-GMB-2020-0320 10.1590/1678-4685-GMB-2020-0320. eCollection 2021. ABSTRACT: The SARS-CoV-2 coronavirus pandemic calls for coordinated efforts by the scientific community for the development of vaccines. The most advanced strategies have focused on modifications of technologies that were already under development for other viruses, such as SARS, MERS, and even Influenza. Classic and new technologies, such as inactivated and attenuated viruses (non-replicative and replicative), DNA and mRNA vaccines, and nanoparticles containing SARS-CoV-2 antigens, are some of the strategies currently investigated. Although there is a very high expectation for the effectiveness of the most advanced vaccine candidates, there are still no established correlates of protection. Previous experience in vaccine development for other pathogens shows that differences in vaccine formulation can result in diverse immune responses and consequently, different protective properties. Therefore the importance of continuing investigations on a broad range of strategies.

Evidence Search Report: INF031801v5 ESR 44 Expertise in vaccine development in Brazil was refocused to the new coronavirus. Impressive collaboration between institutions will support further developments until we have available a safe, effective, and economically viable vaccine. Established competence and collaborations will allow preparedness for future challenges and can also be used to address local issues as neglected infectious diseases. URL: https://www.ncbi.nlm.nih.gov/pubmed/33818582 DOI: 10.1590/1678-4685-GMB-2020-0320 10.1590/1678-4685-GMB-2020-0320. eCollection 2021.

97. Kanyike AM, Olum R, Kajjimu J, et al. Acceptance of the coronavirus disease-2019 vaccine among medical students in Uganda. Trop Med Health. 2021;49(1):37. DOI: 10.1186/s41182-021-00331-1 10.1186/s41182-021-00331-1. ABSTRACT: BACKGROUND: COVID-19 is still a major global threat for which vaccination remains the ultimate solution. Uganda reported 40,751 cases and 335 deaths as of 9 April 2021 and started its vaccination program among priority groups like health workers, teachers, those with chronic diseases among others in early March 2021. Unanimous uptake of the COVID-19 vaccine is required to subsequently avert its spread; therefore, we assessed COVID-19 vaccine acceptability, hesitancy, and associated factors among medical students in Uganda. METHODS: This study employed an online descriptive cross-sectional survey among medical students across 10 medical schools in Uganda. A structured questionnaire via Google Form was conveniently sent to eligible participants via WhatsApp. Each medical school had a coordinator who consistently shared the data tool in the WhatsApp groups. Chi-square or Fisher's exact test, and logistic regression were used to assess the association between vaccine acceptability with demographics, COVID-19 risk perception, and vaccine hesitancy. RESULTS: We surveyed 600 medical students, 377 (62.8%) were male. COVID-19 vaccine acceptability was 37.3% and vaccine hesitancy 30.7%. Factors associated with vaccine acceptability were being male (adjusted odds ratio (aOR) = 1.9, 95% CI 1.3-2.9, p=0.001) and being single (aOR= 2.1, 95% CI 1.1-3.9, p=0.022). Very high (aOR= 3.5, 95% CI 1.7-6.9, p<0.001) or moderate (aOR =2.2, 95% CI 1.2-4.1, p=0.008) perceived risk of getting COVID-19 in the future, receiving any vaccine in the past 5 years (aOR= 1.6, 95% CI 1.1-2.5, p=0.017), and COVID-19 vaccine hesitancy (aOR 0.6, 95% CI 0.4-0.9, p=0.036). CONCLUSIONS: This study revealed low levels of acceptance towards the COVID-19 vaccine among medical students, low self-perceived risks of COVID-19, and many had relied on social media that provided them with negative information. This poses an evident risk on the battle towards COVID-19 in the future especially when these future health professions are expected to be influencing decisions of the general public towards the same. URL: https://www.ncbi.nlm.nih.gov/pubmed/33985592 DOI: 10.1186/s41182-021-00331-1 10.1186/s41182-021-00331-1.

98. Kelly H, Sokola B, Abboud H. Safety and efficacy of COVID-19 vaccines in multiple sclerosis patients. J Neuroimmunol. 2021;356:577599. DOI: 10.1016/j.jneuroim.2021.577599 10.1016/j.jneuroim.2021.577599. ABSTRACT: COVID-19 vaccination is recommended for multiple sclerosis patients. Disease-modifying therapies can influence the safety and efficacy of COVID-19 vaccines. RNA, DNA, protein, and inactivated vaccines are likely safe for multiple sclerosis patients. A few incidences of central demyelination were reported with viral vector vaccines, but their benefits likely outweigh their risks if alternatives are unavailable. Live-attenuated vaccines should be avoided whenever possible in treated patients. Interferon-beta, glatiramer acetate, teriflunomide, fumarates, and natalizumab are not expected to impact vaccine efficacy, while cell-depleting agents (ocrelizumab, rituximab, ofatumumab, alemtuzumab, and cladribine) and sphingosine-1-phosphate modulators will likely attenuate vaccine responses. Coordinating vaccine timing with dosing regimens for some therapies may optimize vaccine efficacy. URL: https://www.ncbi.nlm.nih.gov/pubmed/34000472 DOI: 10.1016/j.jneuroim.2021.577599 10.1016/j.jneuroim.2021.577599.

99. Kerr JR, Freeman ALJ, Marteau TM, et al. Effect of Information about COVID-19 Vaccine Effectiveness and Side Effects on Behavioural Intentions: Two Online Experiments. Vaccines (Basel). 2021;9(4). DOI: 10.3390/vaccines9040379

Evidence Search Report: INF031801v5 ESR 45 10.3390/vaccines9040379. ABSTRACT: The success of mass COVID-19 vaccination campaigns rests on widespread uptake. However, although vaccinations provide good protection, they do not offer full immunity and while they likely reduce transmission of the virus to others, the extent of this remains uncertain. This produces a dilemma for communicators who wish to be transparent about benefits and harms and encourage continued caution in vaccinated individuals but not undermine confidence in an important public health measure. In two large pre-registered experimental studies on quota-sampled UK public participants we investigate the effects of providing transparent communication-including uncertainty-about vaccination effectiveness on decision-making. In Study 1 (n = 2097) we report that detailed information about COVID-19 vaccines, including results of clinical trials, does not have a significant impact on beliefs about the efficacy of such vaccines, concerns over side effects, or intentions to receive a vaccine. Study 2 (n = 2217) addressed concerns that highlighting the need to maintain protective behaviours (e.g., social distancing) post-vaccination may lower perceptions of vaccine efficacy and willingness to receive a vaccine. We do not find evidence of this: transparent messages did not significantly reduce perceptions of vaccine efficacy, and in some cases increased perceptions of efficacy. We again report no main effect of messages on intentions to receive a vaccine. The results of both studies suggest that transparently informing people of the limitations of vaccinations does not reduce intentions to be vaccinated but neither does it increase intentions to engage in protective behaviours post-vaccination. URL: https://www.ncbi.nlm.nih.gov/pubmed/33924542 DOI: 10.3390/vaccines9040379 10.3390/vaccines9040379.

100. Khan A, Khan S, Saleem S, et al. Immunogenomics guided design of immunomodulatory multi-epitope against the SARS-CoV-2 new variants, and its validation through in silico cloning and immune simulation. Comput Biol Med. 2021;133(104420):104420. DOI: 10.1016/j.compbiomed.2021.104420 10.1016/j.compbiomed.2021.104420. ABSTRACT: Reports of the novel and more contagious strains of SARS-CoV-2 originating in different countries have further aggravated the pandemic situation. The recent substitutions in spike protein may be critical for the virus to evade the host's immune system and therapeutics that have already been developed. Thus, this study has employed an immunoinformatics pipeline to target the spike protein of this novel strain to construct an immunogenic epitope (CTL, HTL, and B cell) vaccine against the new variant. Our investigation revealed that 12 different epitopes imparted a critical role in immune response induction. This was validated by an exploration of physiochemical properties and experimental feasibility. In silico and host immune simulation confirmed the expression and induction of both primary and secondary immune factors such as IL, cytokines, and antibodies. The current study warrants further lab experiments to demonstrate its efficacy and safety. URL: https://www.ncbi.nlm.nih.gov/pubmed/33930764 DOI: 10.1016/j.compbiomed.2021.104420 10.1016/j.compbiomed.2021.104420.

101. Kharmoum S, El M'Rabet FZ. [COVID-19 vaccines and cancer patients: State of the art and guidelines summary]. Bull Cancer. 2021;108(5):553-5. DOI: 10.1016/j.bulcan.2021.03.008 10.1016/j.bulcan.2021.03.008. Epub 2021 Apr 8. URL: https://www.ncbi.nlm.nih.gov/pubmed/33902920 DOI: 10.1016/j.bulcan.2021.03.008 10.1016/j.bulcan.2021.03.008. Epub 2021 Apr 8.

102. Khubchandani J, Macias Y. COVID-19 Vaccination Hesitancy in Hispanics and African-Americans: A Review and Recommendations for Practice. Brain Behav Immun Health. 2021:100277. DOI: 10.1016/j.bbih.2021.100277 10.1016/j.bbih.2021.100277. ABSTRACT: COVID-19 vaccines were approved for use in the general American public by late 2020 and early 2021. Media reports started highlighting COVID-19 vaccination hesitancy in racial and ethnic minorities. However, little is known about the extent of COVID-19 vaccination hesitancy in racial and ethnic minorities and whether there are unique sociodemographic and cognitive correlates associated with vaccine hesitancy. Thus, the purpose of this study was to review all nationwide studies on COVID-19 vaccine hesitancy among African-Americans and Hispanics

Evidence Search Report: INF031801v5 ESR 46 (the largest minority groups in the U.S.). A comprehensive review of the published literature was conducted to search for national studies and a final pool of 13 studies (n=107,841 participants) was included in this review. The overall pooled prevalence rate of COVID-19 vaccination hesitancy for adult Americans across all studies was 26.3% (95%Ci=17.3-36.4). In contrast, the overall pooled prevalence rate of COVID-19 vaccination hesitancy for African- Americans was 41.6% (95%Ci=34.4-48.9) and for Hispanics, it was 30.2% (95%Ci=23.2-37.7). The major predictors of vaccine hesitancy in African-Americans and Hispanics were: sociodemographic characteristics (e.g., age, gender, income, education, and household size); medical mistrust and history of racial discrimination; exposure to myths and misinformation, perceived risk of getting infected with COVID-19; beliefs about vaccines and past vaccine compliance, and concerns about the safety, efficacy, and side effects from the COVID-19 vaccines. Given the high COVID-19 vaccine hesitancy rates in racial/ethnic minorities and the unique factors associated with vaccine hesitancy in African-Americans and Hispanics, several clinic-based and community-oriented practice recommendations have been included in this article. URL: https://www.ncbi.nlm.nih.gov/pubmed/34036287 DOI: 10.1016/j.bbih.2021.100277 10.1016/j.bbih.2021.100277.

103. Kiran Misra S, Pathak K, Pathak D, et al. Current Updates on Covid-19 Vaccines. Asian Journal of Pharmaceutical and Clinical Research. 2021;14(5):17-23. DOI: 10.22159/ajpcr.2021.v14i5.41061 ABSTRACT: Objective: COVID-19 caused the world to shut down and made us to critically look out at our advanced healthcare systems that are well prepared for heart diseases, cancers, organ transplantation but not for attack of a tiny virus. WHO and other authorized bodies are continuously issuing advisory on preventive measurements, tracking the outbreak and distributing vital medical kits. Scientific community and vaccine experts have developed and started to distribute safe and effective immunization worldwide. The paper outlines several developed and developing immunization vehicles for the management of COVID -19 that will hit global market in year 2021. Method(s): Non clinical and clinical data are collected from authentic sources of World Health Organization portal and press release provided by COVID-19 vaccine developers. Result(s): Different platforms including mRNA, DNA, Viral vectors, Synthetic peptides etc. have been conversed that are globally involved for elimination of SARS-CoV-2, a causative virus of COVID-19. Conclusion(s): Numerous academic institutions and companies of worldwide have developed and evaluated their inoculums after extremely compressed clinical trial agendas. Worldwide eminent developers such as Pfizer and BioNTech, Moderna, AstraZenaca and Bharat Biotech are ready with their esteemed products for the management of pandemic COVID-19. They explored pharmaceutical technologies reliant on genetics, nanoengineering and biotechnology for successful development of these anti SARS-CoV-2 inoculums. Taking account on conditions of more vulnerable community including immunocompromised, geriatrics and comorbidities patients the safety and efficacy of vaccine are yet to be monitored.. Copyright © 2021 Innovare Academics Sciences Pvt. Ltd. All rights reserved. URL: https://innovareacademics.in/journals/index.php/ajpcr/article/view/41061https://ovidsp.ovid.com/ovidweb.cgi?T =JS&CSC=Y&NEWS=N&PAGE=fulltext&D=emexb&AN=2012042525https://libkey.io/libraries/843/openurl?output= full&sid=OVID:embase&id=pmid:&id=doi:10.22159%2Fajpcr.2021.v14i5.41061&issn=0974- 2441&isbn=&volume=14&issue=5&spage=17&pages=17- 23&date=2021&title=Asian+Journal+of+Pharmaceutical+and+Clinical+Research&atitle=Current+updates+on+COVI D- 19+vaccines&aulast=Misra&pid=%3Cauthor%3EMisra+S.K.%3BPathak+K.%3BPathak+D.%3BYadav+R.%3C%2Fauth or%3E%3CAN%3E2012042525%3C%2FAN%3E%3CDT%3EReview%3C%2FDT%3E DOI: 10.22159/ajpcr.2021.v14i5.41061

104. Koch T, Fathi A, Addo MM. The COVID-19 Vaccine Landscape. Adv Exp Med Biol. 2021;1318:549-73. DOI: 10.1007/978-3-030-63761-3_31 10.1007/978-3-030-63761-3_31. ABSTRACT: The history of vaccine development spans centuries. At first, whole pathogens were used as vaccine agents, either inactivated or attenuated, to reduce virulence in humans. Safety and tolerability were increased by including only specific proteins as antigens and using cell culture methods, while novel vaccine strategies, like nucleic acid- or vector-based vaccines, hold high promise for the future. Vaccines have generally not been

Evidence Search Report: INF031801v5 ESR 47 employed as the primary tools in outbreak response, but this might change since advances in medical technology in the last decades have made the concept of developing vaccines against novel pathogens a realistic strategy. Wandering the uncharted territory of a novel pathogen, severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2), we can learn from other human Betacoronaviridae that emerged in the last decades, SARS-CoV-1 and MERS-CoV. We can identify the most likely target structures of immunity, establish animal models that emulate human disease and immunity as closely as possible, and learn about complex mechanisms of immune interaction such as cross-reactivity or antibody-dependent enhancement (ADE). However, significant knowledge gaps remain. What are the correlates of protection? How do we best induce immunity in vulnerable populations like the elderly? Will the immunity induced by vaccination (or by natural infection) wane over time? To date, at least 149 vaccine candidates against SARS-CoV-2 are under development. At the time of writing, at least 17 candidates have already progressed past preclinical studies (in vitro models and in vivo animal experiments) into clinical development. This chapter will provide an overview of this rapidly developing field. URL: https://www.ncbi.nlm.nih.gov/pubmed/33973199 DOI: 10.1007/978-3-030-63761-3_31 10.1007/978-3-030-63761-3_31.

105. Kohmer N, Rühl C, Ciesek S, et al. Utility of Different Surrogate Enzyme-Linked Immunosorbent Assays (sELISAs) for Detection of SARS-CoV-2 Neutralizing Antibodies. Journal of Clinical Medicine. 2021;10(10). DOI: 10.3390/jcm10102128 ABSTRACT: The plaque reduction neutralization test (PRNT) is a preferred method for the detection of functional, SARS-CoV-2 specific neutralizing antibodies from serum samples. Alternatively, surrogate enzyme-linked immunosorbent assays (ELISAs) using ACE2 as the target structure for the detection of neutralization-competent antibodies have been developed. They are capable of high throughput, have a short turnaround time, and can be performed under standard laboratory safety conditions. However, there are very limited data on their clinical performance and how they compare to the PRNT. We evaluated three surrogate immunoassays (GenScript SARS- CoV-2 Surrogate Virus Neutralization Test Kit (GenScript Biotech, Piscataway Township, NJ, USA), the TECO SARS- CoV-2 Neutralization Antibody Assay (TECOmedical AG, Sissach, Switzerland), and the Leinco COVID-19 ImmunoRankTM Neutralization MICRO-ELISA (Leinco Technologies, Fenton, MO, USA)) and one automated quantitative SARS-CoV-2 Spike protein-based IgG antibody assay (Abbott GmbH, Wiesbaden, Germany) by testing 78 clinical samples, including several follow-up samples of six BNT162b2 (BioNTech/Pfizer, Mainz, Germany/New York, NY, USA) vaccinated individuals. Using the PRNT as a reference method, the overall sensitivity of the examined assays ranged from 93.8 to 100% and specificity ranged from 73.9 to 91.3%. Weighted kappa demonstrated a substantial to almost perfect agreement. The findings of our study allow these assays to be considered when a PRNT is not available. However, the latter still should be the preferred choice. For optimal clinical performance, the cut-off value of the TECO assay should be individually adapted. Copyright © 2021 by the authors. Licensee MDPI, Basel, Switzerland. URL: https://www.mdpi.com/2077- 0383/10/10/2128/pdfhttps://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=emexb&AN =2007161654https://libkey.io/libraries/843/openurl?output=full&sid=OVID:embase&id=pmid:&id=doi:10.3390%2 Fjcm10102128&issn=2077- 0383&isbn=&volume=10&issue=10&spage=2128&pages=&date=2021&title=Journal+of+Clinical+Medicine&atitle= Utility+of+different+surrogate+enzyme-linked+immunosorbent+assays+%28Selisas%29+for+detection+of+sars- cov- 2+neutralizing+antibodies&aulast=Kohmer&pid=%3Cauthor%3EKohmer+N.%3BRuhl+C.%3BCiesek+S.%3BRabenau +H.F.%3C%2Fauthor%3E%3CAN%3E2007161654%3C%2FAN%3E%3CDT%3EArticle%3C%2FDT%3E DOI: 10.3390/jcm10102128

106. Kumari A, Ranjan P, Chopra S, et al. Development and validation of a questionnaire to assess knowledge, attitude, practices, and concerns regarding COVID-19 vaccination among the general population. Diabetes Metab Syndr. 2021;15(3):919-25. DOI: 10.1016/j.dsx.2021.04.004 10.1016/j.dsx.2021.04.004. ABSTRACT: BACKGROUND AND AIMS: There seems to be hesitation in the general population in accepting COVID 19 vaccine because of associated myths and/or misinformation. This study is dedicated to devel op and validate a

Evidence Search Report: INF031801v5 ESR 48 tool to interpret vaccine acceptance and/or hesitancy by assessing the knowledge, attitude, practices, and concerns regarding the COVID vaccine. MATERIAL AND METHODS: Mixed methods study design was used. In phase 1, the questionnaire was developed through literature review, focus group discussion, expert evaluation, and pre- testing. In phase 2, the validity of the questionnaire was obtained by conducting a cross-sectional survey on 201 participants. The construct validity was established via principal component analysis. Cronbach's alpha value was used to assess the reliability of the questionnaire. RESULTS: The 39-item questionnaire to assess the knowledge, attitude, practices, and concerns regarding the COVID-19 vaccine was developed. The Cronbach's alpha value of the questionnaire was 0.86 suggesting a good internal consistency. CONCLUSION: The developed tool is valid to assess the knowledge, attitude, practices and concerns regarding the COVID-19 vaccine acceptance and/or hesitancy. It has the potential utility for healthcare workers and government authorities to further build vaccine literacy. URL: https://www.ncbi.nlm.nih.gov/pubmed/33930855 DOI: 10.1016/j.dsx.2021.04.004 10.1016/j.dsx.2021.04.004.

107. Kuppalli K, Brett-Major DM, Smith TC. COVID-19 Vaccine Acceptance: We Need to Start Now. Open Forum Infect Dis. 2021;8(2):ofaa658. DOI: 10.1093/ofid/ofaa658 10.1093/ofid/ofaa658. eCollection 2021 Feb. ABSTRACT: In this perspective, we discuss the importance of developing a vaccine to help curb transmission of severe acute respiratory syndrome coronavirus 2. The question remains: Once a safe and effective vaccine is developed, will the public be willing to get it? We present information from one of the first tracking polls to assess public attitudes and perceptions toward a possible coronavirus disease 2019 vaccine that suggests public hesitancy over a potential vaccine, concern regarding accelerating clinical trials, and unease over the vaccine approval process. Public health experts, government officials, advocates, and others in the scientific community should respect the signals of hesitancy and communicate sensitivity, applying lessons not only to how we message, but also in how we build this urgently needed vaccine if we are to have successful uptake once available. URL: https://www.ncbi.nlm.nih.gov/pubmed/33623802 DOI: 10.1093/ofid/ofaa658 10.1093/ofid/ofaa658. eCollection 2021 Feb.

108. Lee ACK, Morling J. COVID-19: viral origins, vaccine fears and risk perceptions. Public Health. 2021;27:27. DOI: 10.1016/j.puhe.2021.04.013 10.1016/j.puhe.2021.04.013. URL: https://www.ncbi.nlm.nih.gov/pubmed/34034901 DOI: 10.1016/j.puhe.2021.04.013 10.1016/j.puhe.2021.04.013.

109. Lefebvre M, Vignier N, Pitard B, et al. COVID-19 vaccines: Frequently asked questions and updated answers. Infect Dis Now. 2021;51(4):319-33. DOI: 10.1016/j.idnow.2021.02.007 10.1016/j.idnow.2021.02.007. Epub 2021 Feb 27. ABSTRACT: At the end of December 2019, China notified the World Health Organization about a viral pneumonia epidemic soon to be named COVID-19, of which the infectious agent, SARS-CoV-2, was rapidly identified. Less than one year later, published phase 3 clinical trials underlined the effectiveness of vaccines utilizing hitherto unusual technology consisting in injection of the messenger RNA (m-RNA) of a viral protein. In the meantime, numerous clinical trials had failed to identify a maximally effective antiviral treatment, and mass vaccination came to be considered as the strategy most likely to put an end to the pandemic. The objective of this text is to address and hopefully answer the questions being put forward by healthcare professionals on the different anti-SARS-CoV-2 vaccines as regards their development, their modes of action, their effectiveness, their limits, and their utilization in different situations; we are proposing a report on both today's state of knowledge, and the 14 February 2021 recommendations of the French health authorities. URL: https://www.ncbi.nlm.nih.gov/pubmed/33681861 DOI: 10.1016/j.idnow.2021.02.007 10.1016/j.idnow.2021.02.007. Epub 2021 Feb 27.

Evidence Search Report: INF031801v5 ESR 49

110. Leung C. Guillain-Barre syndrome should be monitored upon mass vaccination against SARS-CoV-2. Hum Vaccin Immunother. 2021:1-2. DOI: 10.1080/21645515.2021.1922061 10.1080/21645515.2021.1922061. ABSTRACT: In response to the recent pandemic, vaccines have been developed for large-scale immunization. Despite safety and efficacy verified by health authorities, Guillain-Barre syndrome (GBS) remains a risk of unexpected adverse reactions. Since COVID-19-related GBS cases have largely been reported in Europe, vaccines involving viral genetic materials can potentially trigger GBS, as demonstrated in clinical trials in the Americas. Therefore, medical professionals should be aware of GBS as a potential adverse reaction in SARS-CoV-2 vaccination. Consultation with a neurologist may be needed. Nevertheless, this is not to say that the use of vaccines against SARS-CoV-2 should be suspended and that the association between GBS and the vaccine is confirmed or excluded. The benefits of vaccine still outweigh potential adverse effects. URL: https://www.ncbi.nlm.nih.gov/pubmed/34032555 DOI: 10.1080/21645515.2021.1922061 10.1080/21645515.2021.1922061.

111. Lewnard JA, Patel MM, Jewell NP, et al. Theoretical framework for retrospective studies of the effectiveness of SARS-CoV-2 vaccines. Epidemiology. 2021;13:13. DOI: 10.1097/EDE.0000000000001366 10.1097/EDE.0000000000001366. ABSTRACT: Observational studies of the effectiveness of vaccines to prevent COVID-19 are needed to inform real- world use. Such studies are now underway amid the ongoing rollout of SARS-CoV-2 vaccines globally. While traditional case-control and test-negative design studies feature prominently among strategies used to assess vaccine effectiveness, such studies may encounter important threats to validity. Here we review the theoretical basis for estimation of vaccine direct effects under traditional case-control and test-negative design frameworks, addressing specific natural history parameters of SARS-CoV-2 infection and COVID-19 relevant to these designs. Bias may be introduced by misclassification of cases and controls, particularly when clinical case criteria include common, non-specific indicators of COVID-19. When using diagnostic assays with high analytical sensitivity for SARS-CoV-2 detection, individuals testing positive may be counted as cases even if their symptoms are due to other causes. The traditional case-control design may be particularly prone to confounding due to associations of vaccination with healthcare-seeking behavior or risk of infection. The test-negative design reduces but may not eliminate this confounding, for instance if individuals who receive vaccination seek care or testing for less-severe illness. These circumstances indicate the two study designs cannot be applied naively to datasets gathered through public health surveillance or administrative sources. We suggest practical strategies to reduce bias in vaccine effectiveness estimates at the study design and analysis stages. URL: https://www.ncbi.nlm.nih.gov/pubmed/34001753 DOI: 10.1097/EDE.0000000000001366 10.1097/EDE.0000000000001366.

112. Limper U, Defosse J, Schildgen O, et al. Perioperative risk evaluation in patients scheduled for elective surgery in close relation to their SARS-CoV-2 vaccination. Br J Anaesth. 2021;126(6):e225-e6. DOI: 10.1016/j.bja.2021.03.007 10.1016/j.bja.2021.03.007. Epub 2021 Mar 20. URL: https://www.ncbi.nlm.nih.gov/pubmed/33863474 DOI: 10.1016/j.bja.2021.03.007 10.1016/j.bja.2021.03.007. Epub 2021 Mar 20.

113. Lin A, Liu J, Ma X, et al. Heterologous vaccination strategy for containing COVID-19 pandemic. medRxiv; 2021. ABSTRACT: <h4>Summary</h4> An unequitable vaccine allocation and continuously emerging SARS- CoV-2 variants pose challenges to contain the pandemic, which underscores the need for licensing more vaccine candidates, increasing manufacturing capacity and implementing better immunization strategy. Here, we report data from a proof-of-concept investigation in two healthy individuals who received two doses of inactivated whole-virus COVID-19 vaccines, followed by a single heterologous boost vaccination after 7 months with an mRNA

Evidence Search Report: INF031801v5 ESR 50 vaccine candidate (LPP-Spike-mRNA) developed by Stemirna Therapeutics. Following the boost, Spike-specific antibody (Ab), memory B cell and T cell responses were significantly increased. These findings indicate that a heterologous immunization strategy combining inactivated and mRNA vaccines can generate robust vaccine responses and therefore provide a rational and effective vaccination regimen. URL: http://europepmc.org/abstract/PPR/PPR344565https://doi.org/10.1101/2021.05.17.21257134 DOI: 10.1101/2021.05.17.21257134

114. Lipsitch M, Kahn R. Interpreting vaccine efficacy trial results for infection and transmission. medRxiv. 2021:2021.02.25.21252415. DOI: 10.1101/2021.02.25.21252415 10.1101/2021.02.25.21252415. ABSTRACT: Randomized controlled trials (RCTs) have shown high efficacy of multiple vaccines against SARS-CoV-2 disease (COVID-19), but evidence remains scarce about vaccines' efficacy against infection with, and ability to transmit, the virus. We describe an approach to estimate these vaccines' effects on viral positivity, a prevalence measure which under reasonable assumptions forms a lower bound on efficacy against transmission. Specifically, we recommend separate analysis of positive tests triggered by symptoms (usually the primary outcome) and cross- sectional prevalence of positive tests obtained regardless of symptoms. The odds ratio of carriage for vaccine vs. placebo provides an unbiased estimate of vaccine effectiveness against viral positivity, under certain assumptions, and we show through simulations that likely departures from these assumptions will only modestly bias this estimate. Applying this approach to published data from the RCT of the Moderna vaccine, we estimate that one dose of vaccine reduces the potential for transmission by at least 61%, possibly considerably more. We describe how these approaches can be translated into observational studies of vaccine effectiveness. Highlights: SARS-CoV- 2 vaccine trials did not directly estimate vaccine efficacy against transmission.We describe an approach to estimate a lower bound of vaccine efficacy against transmission.We estimate one dose of the Moderna vaccine reduces the potential for transmission by at least 61%.We recommend approaches for analyzing data from trials and observational studies. URL: https://www.ncbi.nlm.nih.gov/pubmed/33655276 DOI: 10.1101/2021.02.25.21252415 10.1101/2021.02.25.21252415.

115. Lopez Bernal J, Andrews N, Gower C, et al. Effectiveness of the Pfizer-BioNTech and Oxford-AstraZeneca vaccines on covid-19 related symptoms, hospital admissions, and mortality in older adults in England: test negative case-control study. BMJ. 2021;373:n1088. DOI: 10.1136/bmj.n1088 10.1136/bmj.n1088. ABSTRACT: OBJECTIVE: To estimate the real world effectiveness of the Pfizer-BioNTech BNT162b2 and Oxford- AstraZeneca ChAdOx1-S vaccines against confirmed covid-19 symptoms (including the UK B.1.1.7), admissions to hospital, and deaths. DESIGN: Test negative case-control study. SETTING: Community testing for covid-19 in England. PARTICIPANTS: 156 930 adults aged 70 years and older who reported symptoms of covid-19 between 8 December 2020 and 19 February 2021 and were successfully linked to vaccination data in the National Immunisation Management System. INTERVENTIONS: Vaccination with BNT162b2 or ChAdOx1-S. MAIN OUTCOME MEASURES: Primary outcomes were polymerase chain reaction confirmed symptomatic SARS-CoV-2 infections, admissions to hospital for covid-19, and deaths with covid-19. RESULTS: Participants aged 80 years and older vaccinated with BNT162b2 before 4 January 2021 had a higher odds of testing positive for covid-19 in the first nine days after vaccination (odds ratio up to 1.48, 95% confidence interval 1.23 to 1.77), indicating that those initially targeted had a higher underlying risk of infection. Vaccine effectiveness was therefore compared with the baseline post-vaccination period. Vaccine effects were noted 10 to 13 days after vaccination, reaching a vaccine effectiveness of 70% (95% confidence interval 59% to 78%), then plateauing. From 14 days after the second dose a vaccination effectiveness of 89% (85% to 93%) was found compared with the increased baseline risk. Participants aged 70 years and older vaccinated from 4 January (when ChAdOx1-S delivery commenced) had a similar underlying risk of covid-19 to unvaccinated individuals. With BNT162b2, vaccine effectiveness reached 61% (51% to 69%) from 28 to 34 days after vaccination, then plateaued. With ChAdOx1-S, effects were seen from 14 to 20 days after vaccination, reaching an effectiveness of 60% (41% to 73%) from 28 to 34 days, increasing to 73% (27% to 90%) from day 35 onwards. On top of the protection against symptomatic disease, a further 43% (33% to 52%) reduced risk of emergency hospital admission and 51% (37% to 62%) reduced risk of death was observed in those

Evidence Search Report: INF031801v5 ESR 51 who had received one dose of BNT162b2. Participants who had received one dose of ChAdOx1-S had a further 37% (3% to 59%) reduced risk of emergency hospital admission. Follow-up was insufficient to assess the effect of ChAdOx1-S on mortality. Combined with the effect against symptomatic disease, a single dose of either vaccine was about 80% effective at preventing admission to hospital with covid-19 and a single dose of BNT162b2 was 85% effective at preventing death with covid-19. CONCLUSION: Vaccination with either one dose of BNT162b2 or ChAdOx1-S was associated with a significant reduction in symptomatic covid-19 in older adults, and with further protection against severe disease. Both vaccines showed similar effects. Protection was maintained for the duration of follow-up (>6 weeks). A second dose of BNT162b2 was associated with further protection against symptomatic disease. A clear effect of the vaccines against the B.1.1.7 variant was found. URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8116636/ DOI: 10.1136/bmj.n1088 10.1136/bmj.n1088.

116. Lu J, Wen X, Guo Q, et al. Sensitivity to COVID-19 Vaccine Effectiveness and Safety in Shanghai, China. Vaccines. 2021;9(5). DOI: 10.3390/vaccines9050472 ABSTRACT: Several COVID-19 vaccines have been on the market since early 2021 and may vary in their effectiveness and safety. This study characterizes hesitancy about accepting COVID-19 vaccines among parents in Shanghai, China, and identifies how sensitive they are to changes in vaccine safety and effectiveness profiles. Schools in each township of Minhang District, Shanghai, were sampled, and parents in the WeChat group of each school were asked to participate in this cross-sectional Internet-based survey. Parents responded to questions about hesitancy and were given information about five different COVID-19 vaccine candidates, the effectiveness of which varied between 50 and 95% and which had a risk of fever as a side effect between 5 and 20%. Overall, 3673 parents responded to the survey. Almost 90% would accept a vaccine for themselves (89.7%), for their child (87.5%) or for an elderly parent (88.5%) with the most ideal attributes (95% effectiveness with 5% risk of fever). But with the least ideal attributes (50% effectiveness and a 20% risk of fever) these numbers dropped to 33.5%, 31.3%, and 31.8%, respectively. Vaccine hesitancy, age at first child's birth, and relative income were all significantly related to sensitivity to vaccine safety and effectiveness. Parents showed a substantial shift in attitudes towards a vaccine based on its safety and effectiveness profile. These findings indicate that COVID-19 vaccine acceptance may be heavily influenced by how effective the vaccine actually is and could be impeded or enhanced based on vaccines already on the market. Copyright © 2021 by the authors. Licensee MDPI, Basel, Switzerland. URL: https://www.mdpi.com/2076- 393X/9/5/472/pdfhttps://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=emedx&AN=20 07173427https://libkey.io/libraries/843/openurl?output=full&sid=OVID:embase&id=pmid:&id=doi:10.3390%2Fvac cines9050472&issn=2076- 393X&isbn=&volume=9&issue=5&spage=472&pages=&date=2021&title=Vaccines&atitle=Sensitivity+to+covid- 19+vaccine+effectiveness+and+safety+in+shanghai%2C+china&aulast=Lu&pid=%3Cauthor%3ELu+J.%3BWen+X.%3 BGuo+Q.%3BJi+M.%3BZhang+F.%3BWagner+A.L.%3BLu+Y.%3C%2Fauthor%3E%3CAN%3E2007173427%3C%2FAN %3E%3CDT%3EArticle%3C%2FDT%3E DOI: 10.3390/vaccines9050472

117. Lu L, Xiong W, Mu J, et al. Neurological side effects of COVID-19 vaccines are rare. Acta Neurol Scand. 2021;17:17. DOI: 10.1111/ane.13444 10.1111/ane.13444. URL: https://www.ncbi.nlm.nih.gov/pubmed/34002386 DOI: 10.1111/ane.13444 10.1111/ane.13444.

118. Lundstrom K. Viral Vectors for COVID-19 Vaccine Development. Viruses. 2021;13(2). DOI: 10.3390/v13020317 10.3390/v13020317. ABSTRACT: Vaccine development against SARS-CoV-2 has been fierce due to the devastating COVID-19 pandemic and has included all potential approaches for providing the global community with safe and efficient vaccine

Evidence Search Report: INF031801v5 ESR 52 candidates in the shortest possible timeframe. Viral vectors have played a central role especially using adenovirus- based vectors. Additionally, other viral vectors based on vaccinia viruses, measles viruses, rhabdoviruses, influenza viruses and lentiviruses have been subjected to vaccine development. Self-amplifying RNA virus vectors have been utilized for lipid nanoparticle-based delivery of RNA as COVID-19 vaccines. Several adenovirus-based vaccine candidates have elicited strong immune responses in immunized animals and protection against challenges in mice and primates has been achieved. Moreover, adenovirus-based vaccine candidates have been subjected to phase I to III clinical trials. Recently, the simian adenovirus-based ChAdOx1 vector expressing the SARS-CoV-2 S spike protein was approved for use in humans in the UK. URL: https://www.ncbi.nlm.nih.gov/pubmed/33669550 DOI: 10.3390/v13020317 10.3390/v13020317.

119. Machanick P. Revisiting early-stage COVID-19 strategy options. F1000Research. 2021;9(327). DOI: 10.12688/f1000research.23524.3 ABSTRACT: Background: Early-stage interventions in a potential pandemic are important to understand as they can make the difference between runaway exponential growth that is hard to turn back and stopping the spread before it gets that far. COVID19 is an interesting case study because there have been very different outcomes in different localities. These variations are best studied after the fact if precision is the goal; while a pandemic is still unfolding less precise analysis is of value in attempting to guide localities to learn lessons of those that preceded them. Method(s): I examine two factors that could differentiate strategy: asymptomatic spread and the risks of basing strategy on untested claims, such as potential protective value of the Bacillus Calmette-Guerin (BCG) tuberculosis vaccine. Result(s): Differences in disease progression as well as the possibility of alternative strategies to prevent COVID-19 from entering the runaway phase or damping it down later can be elucidated by a study of asymptomatic infection. An early study to demonstrate not only what fraction are asymptomatic but how contagious they are would have informed policy on nonpharmaceutical interventions but could still be of value to understand containment during vaccine roll out. Conclusion(s): When a COVID-19 outbreak is at a level that makes accurate trace-and test possible, investigation of asymptomatic transmission is viable and should be attempted to enhance understanding of spread and variability in the disease as well as policy options for slowing the spread. Understanding mild cases could shed light on the disease in the longer term, including whether vaccines prevent contagiousness. Copyright © 2021 Machanick P. URL: http://f1000research.com/articles?tab=ALL&articleType=&subjectArea=&subtopic=&show=50https://ovidsp.ovid. com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=emexb&AN=634995733https://libkey.io/libraries/843 /openurl?output=full&sid=OVID:embase&id=pmid:&id=doi:10.12688%2Ff1000research.23524.3&issn=2046- 1402&isbn=&volume=9&issue=&spage=327&pages=&date=2021&title=F1000Research&atitle=Revisiting+early- stage+COVID- 19+strategy+options&aulast=Machanick&pid=%3Cauthor%3EMachanick+P.%3C%2Fauthor%3E%3CAN%3E634995 733%3C%2FAN%3E%3CDT%3EArticle%3C%2FDT%3E DOI: 10.12688/f1000research.23524.3

120. Majeed A, Papaluca M, Molokhia M. Assessing the long-term safety and efficacy of COVID-19 vaccines. J R Soc Med. 2021:1410768211013437. DOI: 10.1177/01410768211013437 10.1177/01410768211013437. URL: https://www.ncbi.nlm.nih.gov/pubmed/33945346 DOI: 10.1177/01410768211013437 10.1177/01410768211013437.

121. Malinowski AK, Whittle W, Murphy K, et al. Expecto Patronum! Leveraging the positive force of COVID-19 Vaccines for Pregnant and Lactating Individuals. J Obstet Gynaecol Can. 2021;14:14. DOI: 10.1016/j.jogc.2021.04.015 10.1016/j.jogc.2021.04.015. ABSTRACT: For over a year, the world has been gripped by the coronavirus disease 2019 (COVID-19) pandemic, which has had far-reaching effects on society. The integrity of national health care systems has also been

Evidence Search Report: INF031801v5 ESR 53 challenged, owing to shifts in guidance and misinformation. While initial reports suggested that pregnant people were not at increased risk of severe COVID-19 disease, current data arising from the "third wave" paint a much more concerning picture. Additionally, pregnant and lactating people were excluded from vaccine trials, which has hindered the ability of health care professionals to provide evidence-based counselling regarding the safety and efficacy of the available vaccines in these populations. This commentary reviews the current data on the safety of COVID-19 vaccines in pregnancy. The evidence is clear that the risks of hospitalization and severe maternal and potentially fetal morbidity from COVID-19 in pregnancy far outweigh the very minimal risks of COVID-19 vaccination in pregnancy. URL: https://www.ncbi.nlm.nih.gov/pubmed/34000442 DOI: 10.1016/j.jogc.2021.04.015 10.1016/j.jogc.2021.04.015.

122. Mallavarpu Ambrose J, Priya Veeraraghavan V, Kullappan M, et al. Comparison of Immunological Profiles of SARS-CoV-2 Variants in the COVID-19 Pandemic Trends: An Immunoinformatics Approach. Antibiotics. 2021;10(5). DOI: 10.3390/antibiotics10050535 ABSTRACT: The current dynamics of the COVID-19 pandemic have become a serious concern with the emergence of a series of mutant variants of the SARS-CoV-2 virus. Unlike the previous strain, it is reported that the descendants are associated with increased risk of transmission yet causing less impact in terms of hospital admission, the severity of illness, or mortality. Moreover, the vaccine efficacy is also not believed to vary among the population depending on the variants of the virus and ethnicity. It has been determined that the mutations recorded in the spike gene and protein of the newly evolved viruses are specificallyresponsible for this transformation in the behavior of the virus and its disease condition. Hence, this study aimed to compare the immunogenic profiles of the spike protein from the latest variants of the SARS-CoV-2 virus concerning the probability of COVID-19 severity. Genome sequences of the latest SARS-CoV-2 variants were obtained from GISAID and NCBI repositories. The translated protein sequences were run against T-cell and B-cell epitope prediction tools. Subsequently, antigenicity, immunogenicity, allergenicity, toxicity, and conservancy of the identified epitopes were ascertained using various prediction servers. Only the non-allergic and non-toxic potential epitopes were matched for population relevance by using the Human Leucocyte Antigen population registry in IEDB. Finally, the selected epitopes were validated by docking and simulation studies. The evaluated immunological parameters would concurrently reveal the severity of COVID-19, determining the infection rate of the pathogen. Our immunoinformatics approach disclosed that spike protein of the five variants was capable of forming potential T and B-cell epitopes with varying immune responses. Although the Wuhan strain showed a high number of epitope/HLA combinations, relatively less antigenicity and higher immunogenicity results in poor neutralizing capacity, which could be associated with increased disease severity. Our data demonstrate that increased viral antigenicity with moderate to high immunogenicity, and several potential epitope/HLA combinations in England strain, the USA, India, and South Africa variants, could possess a high neutralizing ability. Therefore, our findings reinforce that the newly circulating variants of SARS-CoV-2 might be associated with more infectiousness and less severe disease condition despite their greater viremia, as reported in the recent COVID-19 cases, whichconsequently determine their increased epidemiological fitness. Copyright © 2021 by the authors. Licensee MDPI, Basel, Switzerland. URL: https://www.mdpi.com/2079- 6382/10/5/535/pdfhttps://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=emexb&AN=2 007161888https://libkey.io/libraries/843/openurl?output=full&sid=OVID:embase&id=pmid:&id=doi:10.3390%2Fa ntibiotics10050535&issn=2079- 6382&isbn=&volume=10&issue=5&spage=535&pages=&date=2021&title=Antibiotics&atitle=Comparison+of+imm unological+profiles+of+sars-cov-2+variants+in+the+covid- 19+pandemic+trends%3A+An+immunoinformatics+approach&aulast=Ambrose&pid=%3Cauthor%3EAmbrose+J.M. %3BVeeraraghavan+V.P.%3BKullappan+M.%3BChellapandiyan+P.%3BMohan+S.K.%3BManivel+V.A.%3C%2Fauthor %3E%3CAN%3E2007161888%3C%2FAN%3E%3CDT%3EArticle%3C%2FDT%3E DOI: 10.3390/antibiotics10050535

123. Manansala M, Chopra A, Baughman RP, et al. COVID-19 and Sarcoidosis, Readiness for Vaccination: Challenges and Opportunities. Front Med (Lausanne). 2021;8:672028. DOI: 10.3389/fmed.2021.672028

Evidence Search Report: INF031801v5 ESR 54 10.3389/fmed.2021.672028. eCollection 2021. ABSTRACT: Sarcoidosis is an immune mediated chronic inflammatory disorder that is best characterized by non- caseating granulomas found in one or more affected organs. The COVID-19 pandemic poses a challenge for clinicians caring for sarcoidosis patients who may be at increased risk of infection compared to the general population. With the recent availability of COVID-19 vaccines, it is expected that clinicians raise questions regarding efficacy and safety in sarcoidosis. However, studies examining safety and efficacy of vaccines in sarcoidosis are lacking. In this review, we examine the current literature regarding vaccination in immunocompromised populations and apply them to sarcoidosis patients. The available literature suggests that vaccines are safe and effective in patients with autoimmune disorders and in those taking immunosuppressive medications. We strongly recommend the administration of COVID-19 vaccines in patients with sarcoidosis. We also present a clinical decision algorithm to provide guidance on vaccination of sarcoidosis patients against COVID- 19. URL: https://www.ncbi.nlm.nih.gov/pubmed/33996868 DOI: 10.3389/fmed.2021.672028 10.3389/fmed.2021.672028. eCollection 2021.

124. Manna S, Mal M, Bhowmik M, et al. Therapeutic Agents for COVID-19: an Overview. Curr Drug Ther. 2021;16(1):22-44. DOI: 10.2174/1574885515999201111201713 ABSTRACT: Background: The pathological agent of Coronavirus disease 2019 (COVID-19) is a novel coronavirus termed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COVID-19 has its origin in Wuhan, China, and spread to other provinces of China and subsequently to other countries resulting in a pandemic worldwide. The virus is extremely contagious and causes pneumonia and respiratory failure. Since its emergence, researchers around the world are trying to develop vaccines and find suitable drugs for the treatment of COVID-19. Objective(s): To give an overview of the various therapeutic agents for COVID-19 such as vaccines and drugs that are in preclinical stage or under different stages of clinical trials. Result(s): As per World Health Organization (WHO), there are 137 vaccines under development to date, out of which few vaccines have successfully completed preclinical studies and reached clinical trials. According to the present scenario, only one coronavirus vaccine (sputnik-V) has been approved by the Ministry of Health of the Russian Federation. Till date, there are no United States Food and Drug Administration (USFDA) approved drugs to treat COVID-19 patients. However, depending on patient's condition, different drugs such as antiviral agents like Remdesivir, antimalarial drugs like Hy- droxychloroquine, antibiotics like Azithromycin and corticosteroids like Dexamethasone are being applied and some of them have proved to be effective up to a certain extent. Conclusion(s): Although several vaccines for COVID-19 are under development and various drugs have been tried for its treatment, an ideal drug candidate or a vaccine is still lacking. Almost all the big pharmaceutical companies are associated with one or more research initiatives in order to develop vaccines and drugs. Many of them are going through clinical stages, expecting a positive outcome by the end of 2020. Copyright © 2021 Bentham Science Publishers. URL: https://www.eurekaselect.com/187883/articlehttps://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE =fulltext&D=emedx&AN=2007238331https://libkey.io/libraries/843/openurl?output=full&sid=OVID:embase&id=p mid:&id=doi:10.2174%2F1574885515999201111201713&issn=1574- 8855&isbn=&volume=16&issue=1&spage=22&pages=22- 44&date=2021&title=Current+Drug+Therapy&atitle=Therapeutic+agents+for+covid- 19%3A+An+overview&aulast=Manna&pid=%3Cauthor%3EManna+S.%3BMal+M.%3BBhowmik+M.%3BMandal+D. %3C%2Fauthor%3E%3CAN%3E2007238331%3C%2FAN%3E%3CDT%3EReview%3C%2FDT%3E DOI: 10.2174/1574885515999201111201713

125. Marion O, Del Bello A, Abravanel F, et al. Safety and Immunogenicity of Anti-SARS-CoV-2 Messenger RNA Vaccines in Recipients of Solid Organ Transplants. Ann Intern Med. 2021;25:25. DOI: 10.7326/M21-1341 10.7326/M21-1341. URL: https://www.ncbi.nlm.nih.gov/pubmed/34029487 DOI: 10.7326/M21-1341 10.7326/M21-1341.

Evidence Search Report: INF031801v5 ESR 55 126. Martins I, Louwen F, Ayres-de-Campos D, et al. EBCOG position statement on COVID-19 vaccination for pregnant and breastfeeding women. Eur J Obstet Gynecol Reprod Biol. 2021;14:14. DOI: 10.1016/j.ejogrb.2021.05.021 10.1016/j.ejogrb.2021.05.021. ABSTRACT: Covid 19 pandemic has led to significant mortality and long term morbidity globally. Pregnant women are at increased risk of severe illness from COVID 19 infection. There is an urgent need for all health authorities and Governments to offer vaccination to all pregnant women especially those with high risk pregnancy. URL: https://www.ncbi.nlm.nih.gov/pubmed/34020833 DOI: 10.1016/j.ejogrb.2021.05.021 10.1016/j.ejogrb.2021.05.021.

127. McGovern AP, Thomas NJ, Vollmer SJ, et al. Basic and clinical science posters: Actions, metabolism and therapy. Diabet Med. 2021;38(S1):12-3. DOI: 10.1111/dme.14556 ABSTRACT: Aim: Diabetes has consistently been shown to increase the risk of poor covid-19 outcomes. Rather than a simple additive effect of diabetes and age-related risk, recent studies suggest a disproportionately higher relative mortality risk in younger people. Better understanding the interaction between age and diabetes could help inform complex prioritisation decisions around covid-19 vaccination. Method(s): We triangulate evidence on heterogeneity of diabetes effect by age on covid-19 mortality from large UK studies. Two population-based studies (OpenSAFELY [n = 17,278,392, 8.8% diabetes] and QCOVID [n = 6,083,102, 7.0% diabetes]), report age-specific hazard ratios (HR) associated with diabetes for covid-19 mortality. We also examine age-specific HRs in severe covid-19 (n = 19,256 critical care patients in England, 18.3% diabetes). To aid interpretability, we translate risk estimates into covid-age; the additional years of covid-19 mortality risk added to an individual's chronological age if diabetes is present. Result(s): Additional covid-19 mortality risk associated with diabetes is markedly higher in younger than older people across all studies. This reflects the higher relative risk associated with diabetes in younger age groups (HRs for diabetes >5 in ages <50 in OpenSAFELY and QCOVID). For a person aged 40 with diabetes, additional mortality risk is equivalent to 20 years of chronological age, meaning risk is similar to that of a person without diabetes aged 60. For a person aged 70 with diabetes, additional mortality risk from diabetes is equivalent to an additional 5 years, so their covid age is 75. Conclusion(s): The disproportionate covid-19 mortality risk in younger people with diabetes should be considered to ensure they are appropriately prioritised for vaccination. URL: https://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=emexb&AN=635024824https://lib key.io/libraries/843/openurl?output=full&sid=OVID:embase&id=pmid:&id=doi:10.1111%2Fdme.14556&issn=1464 -5491&isbn=&volume=38&issue=SUPPL+1&spage=12&pages=12- 13&date=2021&title=Diabetic+Medicine&atitle=In+younger+people+with+diabetes+the+disproportionate+additio nal+covid-19+mortality+risk+of+covid- 19+warrants+vaccination+prioritisation&aulast=McGovern&pid=%3Cauthor%3EMcGovern+A.P.%3BThomas+N.J.% 3BVollmer+S.J.%3BHattersley+A.T.%3BMateen+B.A.%3BDennis+J.M.%3C%2Fauthor%3E%3CAN%3E635024824%3C %2FAN%3E%3CDT%3EConference+Abstract%3C%2FDT%3E DOI: 10.1111/dme.14556

128. Meyers LM, Gutierrez AH, Boyle CM, et al. Highly conserved, non-human-like, and cross-reactive SARS-CoV- 2 T cell epitopes for COVID-19 vaccine design and validation. NPJ Vaccines. 2021;6(1):71. DOI: 10.1038/s41541- 021-00331-6 10.1038/s41541-021-00331-6. ABSTRACT: Natural and vaccine-induced SARS-CoV-2 immunity in humans has been described but correlates of protection are not yet defined. T cells support the SARS-CoV-2 antibody response, clear virus-infected cells, and may be required to block transmission. In this study, we identified peptide epitopes associated with SARS-CoV-2 T- cell immunity. Using immunoinformatic methods, T-cell epitopes from spike, membrane, and envelope were selected for maximal HLA-binding potential, coverage of HLA diversity, coverage of circulating virus, and minimal potential cross-reactivity with self. Direct restimulation of PBMCs collected from SARS-CoV-2 convalescents confirmed 66% of predicted epitopes, whereas only 9% were confirmed in naive individuals. However, following a brief period of epitope-specific T-cell expansion, both cohorts demonstrated robust T-cell responses to 97% of

Evidence Search Report: INF031801v5 ESR 56 epitopes. HLA-DR3 transgenic mouse immunization with peptides co-formulated with poly-ICLC generated a potent Th1-skewed, epitope-specific memory response, alleviating safety concerns of enhanced respiratory disease associated with Th2 induction. Taken together, these epitopes may be used to improve our understanding of natural and vaccine-induced immunity, and to facilitate the development of T-cell-targeted vaccines that harness pre-existing SARS-CoV-2 immunity. URL: https://www.ncbi.nlm.nih.gov/pubmed/33986292 DOI: 10.1038/s41541-021-00331-6 10.1038/s41541-021-00331-6.

129. Mezencev R, Klement C, Dluholucky S. Potential problem of the co-occurrence of pandemic covid-19 and seasonal influenza. [Czech]. Epidemiol Mikrobiol Imunol. 2021;70(1):67-71. ABSTRACT: In times of COVID-19 pandemics, the upcoming period of the year when influenza activity usually increases in the Northern Hemisphere brings new medical and public health challenges. These challenges include the risk of mixed infections and/or a possible collision of the two epidemics ("twindemia") with a potentially serious impact on individual health and public health. In this report, we discuss the results of the published studies and conclude that the catastrophic collision of the seasonal influenza and COVID-19 epidemics is unlikely when efficient non-pharmaceutical public health measures are applied to control or mitigate the spread of the COVID-19 epidemic. This conclusion is supported by several lines of evidence, including the extremely low seasonal influenza activity registered in the Southern Hemisphere in 2020. On the other hand, the existence of mixed SARS-CoV-2 and influenza virus infections has been demonstrated in humans. The continuing uncertainty about the occurrence and potential severity of these mixed infections emphasizes the importance of seasonal influenza vaccination in the current epidemiological situation and raises the need to: (i) ensure vaccine availability, (ii) facilitate access to safe seasonal influenza vaccination under the conditions of the ongoing COVID-19 epidemic, and (iii) promote the vaccine to the public. Copyright © 2021, Czech Medical Association J.E. Purkyne. All rights reserved. URL: https://www.prolekare.cz/casopisy/epidemiologie/2021-1-19/potencialny-problem-spolocneho-vyskytu- pandemickeho-covidu-19-a-sezonnej-chripky- 126637/download?hl=cshttps://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=emedx& AN=2007146970https://libkey.io/libraries/843/openurl?output=full&sid=OVID:embase&id=pmid:33853340&id=do i:&issn=1210-7913&isbn=&volume=70&issue=1&spage=67&pages=67- 71&date=2021&title=Epidemiologie%2C+Mikrobiologie%2C+Imunologie&atitle=Potencialny+problem+spolocneho +vyskytu+pandemickeho+covidu- 19+a+sezonnej+chripky&aulast=Mezencev&pid=%3Cauthor%3EMezencev+R.%3BKlement+C.%3BDluholucky+S.%3 C%2Fauthor%3E%3CAN%3E2007146970%3C%2FAN%3E%3CDT%3EArticle%3C%2FDT%3E

130. Michael E, Newcomb K, Mubayi A, et al. Recovery from the COVID-19 pandemic by mass vaccination: emergent lessons from the United States and India. medRxiv. 2021:2021.05.26.21257847. DOI: 10.1101/2021.05.26.21257847 ABSTRACT: The advent of vaccinations has heightened global optimism that the end of the SARS-CoV-2 pandemic could be in sight. However, concerns, including the impact of variations in the rates of vaccination between countries, raise questions about the use of mass vaccination for accomplishing a quick recovery from the contagion. Here, we used a SEIR-based model calibrated to data on the pandemic and vaccinations reported for the United States (US) and India to gain strategic insights into using mass vaccinations for ending COVID-19. We estimate that while up to 65% of the US population is already immune to the virus due to the recent rapid mass vaccinations carried out, only 13% of the Indian population may be immune currently owing to a slow rate of vaccination and the effect of a stricter lockdown imposed to curb the first wave of the pandemic. We project that due to the higher immune to susceptible ratio already achieved in the US, the pandemic will only decline if the present rates of vaccinations and social mitigations are continued and remain effective. By contrast, the recent loosening of social measures coupled with a slow rate of vaccination is the chief reason for the virus resurgence in India, with only immediate lockdowns coupled with ramping up of vaccinations providing the means to control the present wave. These results highlight that using mass vaccination to achieve a speedy recovery from the SARS-CoV- 2 pandemic will depend crucially on the ability to carry out national vaccinations as rapidly as possible.Competing Interest StatementThe authors have declared no competing interest.Funding StatementNo external funding was received for this work.Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any

Evidence Search Report: INF031801v5 ESR 57 necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:This is a modelling study of publically reported data, so no approval or exemption required.All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesThe computation system, data and model parameters are available at: https://github.com/EdwinMichaelLab/COVID-SEIR- Indiahttps://github.com/EdwinMichaelLab/COVID-SEIR-India URL: http://medrxiv.org/content/early/2021/05/27/2021.05.26.21257847.abstract DOI: 10.1101/2021.05.26.21257847

131. Mir HH, Parveen S, Mullick NH, et al. Using structural equation modeling to predict Indian people's attitudes and intentions towards COVID-19 vaccination. Diabetes Metab Syndr. 2021;15(3):1017-22. DOI: 10.1016/j.dsx.2021.05.006 10.1016/j.dsx.2021.05.006. ABSTRACT: BACKGROUND AND AIM: Understanding people's attitudes towards Covid-19 vaccination is crucial to the successful implementation of a vaccination program. Hence this research study seeks to identify critical factors influencing Indian people's attitudes and intentions to take up Covid-19 vaccinations. METHODS: An online questionnaire was administered to a sample (n = 254) drawn from Indian population, to assess the impact of perceived benefits, risk perceptions, social media exposure, social norms, and trust associated with Covid-19 vaccines on people's attitudes towards Covid-19 vaccines and their intentions to take up the Covid-19 vaccinations. RESULTS: The findings showed that the perceived benefits, social norms, and trust correlated significantly with people's attitudes towards Covid-19 vaccinations. In contrast, risk perceptions and social media exposure showed an insignificant influence on people's attitudes towards Covid-19 vaccinations. Social norms, trust, and people's attitudes towards the Covid-19 vaccinations are significantly correlated with their intentions to take up Covid-19 vaccinations. On the contrary, social media exposure was found to have an insignificant influence on people's intentions to take up Covid-19 vaccinations. CONCLUSION: Participants' intentions to take up Covid-19 vaccinations was influenced mainly by their attitudes and perceptions of Covid-19 vaccines in general, which strongly confirms the importance of various dimensions (perceived benefits, trust, social norms) of Covid-19 vaccines in cultivating Covid-19 vaccination acceptance among participants'. URL: https://www.ncbi.nlm.nih.gov/pubmed/34000711 DOI: 10.1016/j.dsx.2021.05.006 10.1016/j.dsx.2021.05.006.

132. Nazy I, Sachs UJ, Arnold DM, et al. Recommendations for the clinical and laboratory diagnosis of VITT against COVID-19: Communication from the ISTH SSC Subcommittee on Platelet Immunology. J Thromb Haemost. 2021;22:22. DOI: 10.1111/jth.15341 10.1111/jth.15341. ABSTRACT: Vaccine administration is under way worldwide to combat the current COVID-19 pandemic. The newly developed vaccines are highly effective with minimal adverse effects. Recently, the AstraZeneca ChadOx1 nCov-19 vaccine has raised public alarm with concerns regarding the rare, but serious, development of thrombotic events, now known as vaccine-induced immune thrombotic thrombocytopenia (VITT). These thrombotic events appear similar to heparin-induced thrombocytopenia, both clinically and pathologically. In this manuscript, the ISTH SSC Subcommittee on Platelet Immunology outlines guidelines on how to recognize, diagnose and manage patients with VITT. URL: https://www.ncbi.nlm.nih.gov/pubmed/34018298 DOI: 10.1111/jth.15341 10.1111/jth.15341.

Evidence Search Report: INF031801v5 ESR 58 133. Neufeld M, Alves da Costa F, Ferreira-Borges C. Prisons need to be included in global and national vaccinations effort against COVID-19. Lancet Reg Health Eur. 2021;4:100088. DOI: 10.1016/j.lanepe.2021.100088 10.1016/j.lanepe.2021.100088. Epub 2021 Mar 21. URL: https://www.ncbi.nlm.nih.gov/pubmed/33997833 DOI: 10.1016/j.lanepe.2021.100088 10.1016/j.lanepe.2021.100088. Epub 2021 Mar 21.

134. Nguyen LC, Bakerlee CW, McKelvey TG, et al. Evaluating Use Cases for Human Challenge Trials in Accelerating SARS-CoV-2 Vaccine Development. Clin Infect Dis. 2021;72(4):710-5. DOI: 10.1093/cid/ciaa935 10.1093/cid/ciaa935. ABSTRACT: Human challenge trials (HCTs) have been proposed as a means to accelerate SARS-CoV-2 vaccine development. We identify and discuss 3 potential use cases of HCTs in the current pandemic: evaluating efficacy, converging on correlates of protection, and improving understanding of pathogenesis and the human immune response. We outline the limitations of HCTs and find that HCTs are likely to be most useful for vaccine candidates currently in preclinical stages of development. We conclude that, while currently limited in their application, there are scenarios in which HCTs would be extremely beneficial. Therefore, the option of conducting HCTs to accelerate SARS-CoV-2 vaccine development should be preserved. As HCTs require many months of preparation, we recommend an immediate effort to (1) establish guidelines for HCTs for COVID-19; (2) take the first steps toward HCTs, including preparing challenge virus and making preliminary logistical arrangements; and (3) commit to periodically re-evaluating the utility of HCTs. URL: https://www.ncbi.nlm.nih.gov/pubmed/32628748 DOI: 10.1093/cid/ciaa935 10.1093/cid/ciaa935.

135. Nikolovski J, Koldijk M, Weverling GJ, et al. Factors indicating intention to vaccinate with a COVID-19 vaccine among older U.S. adults. PLoS One. 2021;16(5):e0251963. DOI: 10.1371/journal.pone.0251963 10.1371/journal.pone.0251963. eCollection 2021. ABSTRACT: BACKGROUND: The success of vaccination efforts to curb the COVID-19 pandemic will require broad public uptake of immunization and highlights the importance of understanding factors associated with willingness to receive a vaccine. METHODS: U.S. adults aged 65 and older enrolled in the HeartlineTM clinical study were invited to complete a COVID-19 vaccine assessment through the HeartlineTM mobile application between November 6-20, 2020. Factors associated with willingness to receive a COVID-19 vaccine were evaluated using an ordered logistic regression as well as a Random Forest classification algorithm. RESULTS: Among 9,106 study participants, 81.3% (n = 7402) responded and had available demographic data. The majority (91.3%) reported a willingness to be vaccinated. Factors most strongly associated with vaccine willingness were beliefs about the safety and efficacy of COVID-19 vaccines and vaccines in general. Women and Black or African American respondents reported lower willingness to vaccinate. Among those less willing to get vaccinated, 66.2% said that they would talk with their health provider before making a decision. During the study, positive results from the first COVID-19 vaccine outcome study were released; vaccine willingness increased after this report. CONCLUSIONS: Even among older adults at high-risk for COVID-19 complications who are participating in a longitudinal clinical study, 1 in 11 reported lack of willingness to receive COVID-19 vaccine in November 2020. Variability in vaccine willingness by gender, race, education, and income suggests the potential for uneven vaccine uptake. Education by health providers directed toward assuaging concerns about vaccine safety and efficacy can help improve vaccine acceptance among those less willing. TRIAL REGISTRATION: Clinicaltrials.gov NCT04276441. URL: https://www.ncbi.nlm.nih.gov/pubmed/34029345 DOI: 10.1371/journal.pone.0251963 10.1371/journal.pone.0251963. eCollection 2021.

136. Oduwole EO, Mahomed H, Ayele BT, et al. Estimating vaccine confidence levels among healthcare students and staff of a tertiary institution in South Africa: protocol of a cross-sectional survey. BMJ Open. 2021;11(5):e049877. DOI: 10.1136/bmjopen-2021-049877 10.1136/bmjopen-2021-049877.

Evidence Search Report: INF031801v5 ESR 59 ABSTRACT: INTRODUCTION: The outbreak of novel COVID-19 caught the world off guard in the first quarter of 2020. To stem the tide of this pandemic, there was acceleration of the development, testing and prelicensure approval for emergency use of some COVID-19 vaccine candidates. This led to raised public concern about their safety and efficacy, compounding the challenges of vaccine hesitancy. The onus of managing and administering these vaccines to a sceptical populace when they do become available rests mostly on the shoulders of healthcare workers (HCWs). Therefore, the vaccine confidence levels of HCWs become critical to the success of vaccination endeavours. This proposed study aims to estimate the level of vaccine confidence and the intention to receive a COVID-19 vaccine among future HCWs and their trainers at a specific university in Cape Town, South Africa, and to identify any vaccination concerns early for targeted intervention. METHODS AND ANALYSIS: This proposed study is a cross-sectional survey study. An online questionnaire will be distributed to all current staff and students of the Faculty of Medicine Health Sciences of Stellenbosch University in Cape Town, South Africa. No sampling strategy will be employed. The survey questionnaire will consist of demographic questions (consisting of six items) and vaccine confidence questions (comprising six items in Likert scale format). Log binomial models will be employed to identify factors associated with vaccine confidence and intention. The strength of association will be assessed using the OR and its 95% CI. Statistical significance will be defined at a p value <0.05. ETHICS AND DISSEMINATION: Ethics approval has been obtained for the study from Stellenbosch University (Human Research Ethics Committee reference number S19/01/014 (PhD)). The results will be shared with relevant health authorities, presented at conferences and published in a peer-reviewed journal. URL: https://www.ncbi.nlm.nih.gov/pubmed/33986069 DOI: 10.1136/bmjopen-2021-049877 10.1136/bmjopen-2021-049877.

137. Oku K, Hamijoyo L, Kasitanon N, et al. Prevention of infective complications in systemic lupus erythematosus: A systematic literature review for the APLAR consensus statements. Int J Rheum Dis. 2021;17:17. DOI: 10.1111/1756-185X.14125 10.1111/1756-185X.14125. ABSTRACT: Systemic lupus erythematosus (SLE) is a more common autoimmune rheumatic disease in the Asia- Pacific region. The prognosis of SLE remains unsatisfactory in some Asian countries because of delayed diagnosis, limited access to medications, increased complications and issues of tolerability and adherence to treatment. The Asia-Pacific League of Associations for Rheumatology SLE special interest group has recently published a set of consensus recommendations on the management of SLE for specialists, family physicians, specialty nurses, and other healthcare professionals in the Asia-Pacific region. This article reports a systematic literature review of the infective complications of SLE in Asia and evidence for prevention of these infections by pre-emptive antimicrobial therapy and vaccination. URL: https://www.ncbi.nlm.nih.gov/pubmed/33999518 DOI: 10.1111/1756-185X.14125 10.1111/1756-185X.14125.

138. Orvieto R, Noach-Hirsh M, Segev-Zahav A, et al. Does mRNA SARS-CoV-2 vaccine influence patients' performance during IVF-ET cycle? Reprod Biol Endocrinol. 2021;19(1):69. DOI: 10.1186/s12958-021-00757-6 10.1186/s12958-021-00757-6. ABSTRACT: OBJECTIVE: No information exists in the literature regarding the effect of mRNA SARS-CoV-2 vaccine on subsequent IVF cycle attempt. We therefore aim to assess the influence of mRNA SARS-CoV-2 vaccine on IVF treatments. DESIGN: An observational study. SETTING: A tertiary, university-affiliated medical center. PATIENTS AND METHODS: All couples undergoing consecutive ovarian stimulation cycles for IVF before and after receiving mRNA SARS-CoV-2 vaccine, and reached the ovum pick-up (OPU) stage. The stimulation characteristics and embryological variables of couples undergoing IVF treatments after receiving mRNA SARS-CoV-2 vaccine were assessed and compared to their IVF cycles prior to vaccination. MAIN OUTCOME MEASURES: Stimulation characteristics and embryological variables. RESULTS: Thirty-six couples resumed IVF treatment 7-85 days after receiving mRNA SARS-CoV-2 vaccine. No in-between cycles differences were observed in ovarian stimulation and embryological variables before and after receiving mRNA SARS-CoV-2 vaccination. CONCLUSIONS: mRNA SARS- CoV-2 vaccine did not affect patients' performance or ovarian reserve in their immediate subsequent IVF cycle. Future larger studies with longer follow-up will be needed to validate our observations.

Evidence Search Report: INF031801v5 ESR 60 URL: https://www.ncbi.nlm.nih.gov/pubmed/33985514 DOI: 10.1186/s12958-021-00757-6 10.1186/s12958-021-00757-6.

139. Pan HX, Liu JK, Huang BY, et al. Immunogenicity and safety of a SARS-CoV-2 inactivated vaccine in healthy adults: randomized, double-blind, and placebo-controlled phase 1 and phase 2 clinical trials. Chin Med J (Engl). 2021. DOI: 10.1097/cm9.0000000000001573 ABSTRACT: BACKGROUND: The significant morbidity and mortality resulted from the infection of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) call for urgent development of effective and safe vaccines. We report the immunogenicity and safety of an inactivated SARS-CoV-2 vaccine, KCONVAC, in healthy adults. METHODS: Phase 1 and phase 2 randomized, double-blind, and placebo-controlled trials of KCONVAC were conducted in healthy Chinese adults aged 18-59 years. The participants in the phase 1 trial were randomized to receive two doses, one each on Days 0 and 14, of either KCONVAC (5 μg/dose or 10 μg/dose) or placebo. The participants in the phase 2 trial were randomized to receive either KCONVAC (at 5 or 10 μg/dose) or placebo on Days 0 and 14 (0/14 regimen) or Days 0 and 28 (0/28 regimen). In the phase 1 trial, the primary safety endpoint was the proportion of participants experiencing adverse reactions/events within 28 days following the administration of each dose. In the phase 2 trial, the primary immunogenicity endpoints were neutralization antibody seroconversion and titer and anti-receptor-binding domain immunoglobulin G seroconversion at 28 days after the second dose. RESULTS: In the phase 1 trial, 60 participants were enrolled and received at least one dose of 5-μg vaccine (n = 24), 10-μg vaccine (n = 24), or placebo (n = 12). In the phase 2 trial, 500 participants were enrolled and received at least one dose of 5-μg vaccine (n = 100 for 0/14 or 0/28 regimens), 10-μg vaccine (n = 100 for each regimen), or placebo (n = 50 for each regimen). In the phase 1 trial, 13 (54%), 11 (46%), and 7 (58%) participants reported at least one adverse event (AE) after receiving 5-μg vaccine, 10-μg vaccine, or placebo, respectively. In the phase 2 trial, 16 (16%), 19 (19%), and 9 (18%) 0/14-regimen participants reported at least one AE after receiving 5-μg vaccine, 10-μg vaccine, or placebo, respectively. Similar AE incidences were observed in the three 0/28-regimen treatment groups. No AEs with an intensity of grade 3+ were reported, expect for one vaccine- unrelated serious AE (foot fracture) reported in the phase 1 trial. KCONVAC induced significant antibody responses; 0/28 regimen showed a higher immune responses than that did 0/14 regimen after receiving two vaccine doses. CONCLUSIONS: Both doses of KCONVAC are well tolerated and able to induce robust immune responses in healthy adults. These results support testing 5-μg vaccine in the 0/28 regimen in an upcoming phase 3 efficacy trial. TRIAL REGISTRATION: http://www.chictr.org.cn/index.aspx (No. ChiCTR2000038804, http://www.chictr.org.cn/showproj.aspx?proj=62350; No. ChiCTR2000039462, http://www.chictr.org.cn/showproj.aspx?proj=63353). DOI: 10.1097/cm9.0000000000001573

140. Panda DS, Giri RK, Nagarajappa AK, et al. Covid-19 vaccine, acceptance, and concern of safety from public perspective in the state of Odisha, India. Hum Vaccin Immunother. 2021:1-5. DOI: 10.1080/21645515.2021.1924017 10.1080/21645515.2021.1924017. ABSTRACT: Introduction: No medication or therapies were found to be effective in controlling the covid-19 pandemic. The fast-track development of covid-19 vaccine brought some hope among health practitioners globally. The major challenge seems to be safety, efficacy, and acceptance of the vaccine. A cross-sectional survey was conducted among the community of the state of Odisha, India, to find out the concerns of safety and acceptance for the vaccine.Methods: A self-administered multiple-choice questionnaire containing 23 items with three sections was prepared in Google form and deployed following snow ball sampling method. The participants recruited were above 18 years of age residing in Odisha. The participation in the survey was completely voluntary. The survey was conducted during February 2021.Results and discussion: In total, 359 members participated in the survey. Majority of the respondent strongly agree/agree that covid-19 vaccine is safe for adults and children. Significant variation among all the groups was found regarding acquisition of higher immunity following infection rather by vaccination, effectiveness in infection prevention, safety in children, provision of mandatory vaccination by government, and public health protection following government guidelines.Conclusion: The major barrier to the covid-19 vaccination was found to be safety and awareness. But there is well acceptance to covid-19 vaccine

Evidence Search Report: INF031801v5 ESR 61 among the community of Odisha, India, and further efforts to create awareness concerning safety and vaccination will be instrumental in the eradication of this infection. URL: https://www.ncbi.nlm.nih.gov/pubmed/34010097 DOI: 10.1080/21645515.2021.1924017 10.1080/21645515.2021.1924017.

141. Parry H, Bruton R, Stephens C, et al. Extended interval BNT162b2 vaccination enhances peak antibody generation in older people. medRxiv. 2021:2021.05.15.21257017. DOI: 10.1101/2021.05.15.21257017 ABSTRACT: Objectives To assess the relative immunogenicity of standard or extended interval BNT162b2 vaccination.Design Population based cohort study comparing immune responses 2 weeks after the second vaccine, with appropriate time-matched samples in participants who received standard or extended interval double vaccination.Setting Primary care networks, Birmingham, UK. December 2020 to April 2021.Participants 172 people aged over 80 years of age. All donors received the BNT162b2 Pfizer/BioNTech vaccination and were vaccinated with either a standard 3 week interval between doses or an extended interval schedule.Main outcome measures Peak quantitative spike-specific antibody and cellular immune responses.Results In donors without evidence of previous infection the peak antibody response was 3.5-fold higher in donors who had undergone delayed interval vaccination. Cellular immune responses were 3.6-fold lower.Conclusion Peak antibody responses after the second BNT162b2 vaccine are markedly enhanced in older people when this is delayed to 12 weeks although cellular responses are lower. Extended interval vaccination may therefore offer the potential to enhance and extend humoral immunity. Further follow up is now required to assess long term immunity and clinical protection.What is already known on this topic The BNT162b2 vaccine is highly effective against Covid-19 infection and was delivered with a 3-week time interval in registration studies. However, this interval has been extended in many countries in order to extend population coverage with a single vaccine. It is not known how immune responses after the second dose are influenced by delaying the second vaccine.What this study adds We provide the first assessment of immune responses in the first 14 weeks after standard or extended interval BNT162b2 vaccination and show that delaying the second dose acts to strongly boost the peak antibody response in older people. The extended interval vaccination may offer a longer period of clinical protection. This information will be of value in optimizing vaccine regimens and help guide guide vaccination policies.Competing Interest StatementThe authors have declared no competing interest.Funding StatementThis work was supported by the UK Coronavirus Immunology Consortium (UK-CIC) funded by DHSC/UKRI and the National Core Studies Immunity programme. Ethical Approval: The work was performed under the CIA UPH IRAS approval (REC 20\NW\0240) and conducted according to the Declaration of Helsinki and good clinical practice. Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:Ethical approval was obtained from North West Preston Research Ethics Committee with favourable outcome and approval (REC 20\NW\0240).All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesAuthors agree to share the anonymised raw data for this study once published. URL: http://medrxiv.org/content/early/2021/05/17/2021.05.15.21257017.abstract DOI: 10.1101/2021.05.15.21257017

142. Parums DV. Editorial: mRNA Vaccines and Future Epidemic, Pandemic, and Endemic Zoonotic Virus Infections. Med Sci Monit. 2021;27(e932915):e932915. DOI: 10.12659/MSM.932915 10.12659/MSM.932915. ABSTRACT: There have been rapid developments in safe and effective mRNA vaccines for zoonotic infections in the past year. Years of research have made these advances possible, leading to in vitro-transcribed (IVT) mRNA expressing therapeutic proteins. There are several advantages of mRNA vaccines that include their low-cost

Evidence Search Report: INF031801v5 ESR 62 manufacturing process, large-scale and rapid production, and the ability to modify the vaccines in response to emerging infections and viral variants. The COVID-19 pandemic and successful vaccination programs for SARS-CoV- 2 have highlighted the advantages of mRNA vaccines. Also, mRNA vaccines are in development for several other potential pandemic zoonotic infections, including virus, rabies virus, Zika virus, HIV-1, and influenza. There may also be hope for the control of pandemic by the combination of improved and rapid viral genotyping and the rapid development and mass production of mRNA vaccines. This Editorial aims to present a brief overview of how mRNA vaccines may help control and future epidemic, pandemic, and endemic zoonotic virus infections. URL: https://www.ncbi.nlm.nih.gov/pubmed/33942804 DOI: 10.12659/MSM.932915 10.12659/MSM.932915.

143. Pascolo S. Synthetic Messenger RNA-Based Vaccines: from Scorn to Hype. Viruses. 2021;13(2). DOI: 10.3390/v13020270 10.3390/v13020270. ABSTRACT: In the race for a vaccine against SARS-CoV-2, the synthetic mRNA format has been shown to be the fastest one and proved to be safe and highly efficient, even at the very low dose of a few microg per injection. The mRNA vaccines are not new: vaccines that are based on attenuated mRNA viruses, such as Mumps, Measles, and Rubella, immunize by delivering their mRNAs into the cells of the vaccinated individual, who produces the viral proteins that then prime the immune response. Synthetic mRNA in liposomes can be seen as a modern, more refined, and thereby a safer version of those live attenuated RNA viruses. The anti-COVID-19 mRNA vaccine (coding the SARS-CoV-2 spike protein) is the third synthetic RNA therapeutic being approved. It follows the aptamer Macugen((R)) (which neutralizes VEGF) and the siRNA Onpattro((R)) (which destroys the transthyretin- coding mRNA). Remarkably, the 30 microg of mRNA that are contained in the first approved anti-COVID-19 vaccine are sufficient for generating high levels of neutralizing antibodies against the virus in all injected volunteers (including participants over 65 years old). The efficacy and safety data are stunning. The distribution of these vaccines throughout the world will bring a halt to the coronavirus pandemic. URL: https://www.ncbi.nlm.nih.gov/pubmed/33572452 DOI: 10.3390/v13020270 10.3390/v13020270.

144. Pastorino R, Villani L, La Milia DI, et al. Influenza and pneumococcal vaccinations are not associated to COVID-19 outcomes among patients admitted to a university hospital. Vaccine. 2021;09:09. DOI: 10.1016/j.vaccine.2021.05.015 10.1016/j.vaccine.2021.05.015. ABSTRACT: In order to reduce the burden on healthcare systems and to support differential diagnosis with COVID- 19, influenza and pneumococcal vaccinations were strongly recommended during the COVID-19 pandemic, especially in vulnerable groups. However, no univocal and conclusive evidence on the relationship between influenza and pneumococcal vaccinations and COVID-19 outcomes exists. We evaluated the association between such vaccinations, COVID-19 hospitalization, intensive care unit admissions and deaths in a cohort (N = 741) of COVID-19 patients who had access to the emergency room of a large Italian University hospital between March 1, 2020 and June 1, 2020. Results show that influenza and pneumococcal vaccinations did not affect hospitalization, intensive care unit admission and deaths in COVID-19 patients in the overall sample and in those >/=65 years. The same pattern of results was confirmed considering timing of administration, vaccination type, and number of uptakes in the last five vaccination campaigns. In conclusion, our study does not support an impact of influenza and pneumococcal vaccinations on COVID-19 outcomes. URL: https://www.ncbi.nlm.nih.gov/pubmed/34020813 DOI: 10.1016/j.vaccine.2021.05.015 10.1016/j.vaccine.2021.05.015.

145. Patel SU, Khurram R, Lakhani A, et al. Guillain-Barre syndrome following the first dose of the chimpanzee adenovirus-vectored COVID-19 vaccine, ChAdOx1. BMJ Case Rep. 2021;14(4). DOI: 10.1136/bcr-2021-242956 10.1136/bcr-2021-242956.

Evidence Search Report: INF031801v5 ESR 63 ABSTRACT: Prevention strategies for COVID-19 transmission are at the forefront of healthcare paradigms worldwide, the main emphasis of which is vaccination. We present an interesting case of a 37-year-old man who, 3 weeks following his first dose of the chimpanzee adenovirus-vectored COVID-19 vaccine, ChAdOx1, presented to hospital with a rapidly progressive ascending muscle weakness and back pain in the absence of any other triggers. He also had a negative COVID-19 swab during admission. A diagnosis of Guillain-Barre syndrome was confirmed by correlating the clinical features with cerebrospinal fluid analysis, nerve conduction studies and MRI of the brain and whole spine. The patient received treatment with 5 days of intravenous immunoglobulin and did not require any respiratory support. He was also regularly reviewed by a multidisciplinary team consisting of neurologists, speech and language therapists, and physiotherapists and is on the course to a recovery. URL: https://www.ncbi.nlm.nih.gov/pubmed/33888484 DOI: 10.1136/bcr-2021-242956 10.1136/bcr-2021-242956.

146. Pavli A, Maltezou HC. COVID-19 vaccine passport for a safe resumption of travel. J Travel Med. 2021;18:18. DOI: 10.1093/jtm/taab079 10.1093/jtm/taab079. URL: https://www.ncbi.nlm.nih.gov/pubmed/34008004 DOI: 10.1093/jtm/taab079 10.1093/jtm/taab079.

147. Perera PY, Perera LP. Development of leading first-generation vaccines against SARS-CoV-2. Microbes Infect. 2021:104841. DOI: 10.1016/j.micinf.2021.104841 10.1016/j.micinf.2021.104841. ABSTRACT: SARS-CoV-2 has infected more than 152 million individuals globally. Highly effective and safe vaccines are required to accelerate the development of herd immunity to end the pandemic. This review focuses on vaccines that are being developed at unprecedented speed globally and are completing late phase clinical trials to meet this urgent need. URL: https://www.ncbi.nlm.nih.gov/pubmed/34022375 DOI: 10.1016/j.micinf.2021.104841 10.1016/j.micinf.2021.104841.

148. Pfaar O, Klimek L, Hamelmann E, et al. COVID-19 vaccination of patients with allergies and type-2 inflammation with concurrent antibody therapy (biologicals) - A Position Paper of the German Society of Allergology and Clinical Immunology (DGAKI) and the German Society for Applied Allergology (AeDA). Allergol Select. 2021;5(4):140-7. DOI: 10.5414/ALX02241E 10.5414/ALX02241E. eCollection 2021. ABSTRACT: BACKGROUND: After the beginning and during the worldwide pandemic caused by the severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2), patients with allergic and atopic diseases have felt and still feel insecure. Currently, four vaccines against SARS-CoV-2 have been approved by the Paul Ehrlich Institute in Germany, and vaccination campaigns have been started nationwide. In this respect, it is of utmost importance to give recommendations on possible immunological interactions and potential risks of immunomodulatory substances (monoclonal antibodies, biologicals) during concurrent vaccination with the approved vaccines. MATERIALS AND METHODS: This position paper provides specific recommendations on the use of immunomodulatory drugs in the context of concurrent SARS-CoV-2 vaccinations based on current literature. RESULTS: The recommendations are covering the following conditions in which biologicals are indicated and approved: 1) chronic inflammatory skin diseases (atopic dermatitis, chronic spontaneous urticaria), 2) bronchial asthma, and 3) chronic rhinosinusitis with nasal polyps (CRSwNP). Patients with atopic dermatitis or chronic spontaneous urticaria are not at increased risk for allergic reactions after COVID-19 vaccination. Nevertheless, vaccination may result in transient eczema exacerbation due to general immune stimulation. Vaccination in patients receiving systemic therapy with biologicals can be performed. Patients with severe asthma and concomitant treatment with biologicals also do not have an increased risk of allergic reaction following COVID-19 vaccination which is recommended in these patients. Patients with CRSwNP are also not known to be at increased risk for allergic vaccine reactions, and continuation or initiation of a treatment with biologicals is also

Evidence Search Report: INF031801v5 ESR 64 recommended with concurrent COVID-19 vaccination. In general, COVID-19 vaccination should be given within the interval between two applications of the respective biological, that is, with a time-lag of at least 1 week after the previous or at least 1 week before the next biological treatment planned. CONCLUSION: Biologicals for the treatment of atopic dermatitis, chronic spontaneous urticaria, bronchial asthma, and CRSwNP should be continued during the current COVID-19 vaccination campaigns. However, the intervals of biological treatment may need to be slightly adjusted (DGAKI/AeDA recommendations as of March 22, 2021). URL: https://www.ncbi.nlm.nih.gov/pubmed/33842829 DOI: 10.5414/ALX02241E 10.5414/ALX02241E. eCollection 2021.

149. Pfrepper C, Holstein K, Konigs C, et al. Consensus Recommendations for Intramuscular COVID-19 Vaccination in Patients with Hemophilia. Hamostaseologie. 2021. DOI: 10.1055/a-1401-2691 10.1055/a-1401-2691. ABSTRACT: BACKGROUND: Currently available coronavirus disease 2019 (COVID-19) vaccines are approved for intramuscular injection and efficacy may not be ensured when given subcutaneously. For years, subcutaneous vaccination was recommended in patients with hemophilia to avoid intramuscular bleeds. Therefore, recommendations for the application of COVID-19 vaccines are needed. METHODS: The Delphi methodology was used to develop consensus recommendations. An initial list of recommendations was prepared by a steering committee and evaluated by 39 hemophilia experts. Consensus was defined as >/=75% agreement and strong consensus as >/=95% agreement, and agreement as a score >/=7 on a scale of 1 to 9. After four rounds, a final list of statements was compiled. RECOMMENDATIONS: Consensus was achieved that COVID-19 vaccines licensed only for intramuscular injection should be administered intramuscularly in hemophilia patients. Prophylactic factor replacement, given on the day of vaccination with a maximum interval between prophylaxis and vaccination of 24 hours (factor VIII and conventional factor IX concentrates) or 48 hours (half-life extended factor IX), should be provided in patients with moderate or severe hemophilia. Strong consensus was achieved that patients with mild hemophilia and residual factor activity greater than 10% with mild bleeding phenotype or patients on emicizumab usually do not need factor replacement before vaccination. Swelling, erythema, and hyperthermia after vaccination are not always signs of bleeding but should prompt consultation of a hemophilia care center. In case of injection-site hematoma, patients should receive replacement therapy until symptoms disappear. CONCLUSIONS: Consensus was achieved on recommendations for intramuscular COVID-19 vaccination after replacement therapy for hemophilia patients depending on disease severity. URL: https://www.ncbi.nlm.nih.gov/pubmed/33860513 DOI: 10.1055/a-1401-2691 10.1055/a-1401-2691.

150. Pilishvili T, Fleming-Dutra KE, Farrar JL, et al. Interim Estimates of Vaccine Effectiveness of Pfizer-BioNTech and Moderna COVID-19 Vaccines Among Health Care Personnel - 33 U.S. Sites, January-March 2021. MMWR Morb Mortal Wkly Rep. 2021;70(20):753-8. DOI: 10.15585/mmwr.mm7020e2 10.15585/mmwr.mm7020e2. ABSTRACT: Throughout the COVID-19 pandemic, health care personnel (HCP) have been at high risk for exposure to SARS-CoV-2, the virus that causes COVID-19, through patient interactions and community exposure (1). The Advisory Committee on Immunization Practices recommended prioritization of HCP for COVID-19 vaccination to maintain provision of critical services and reduce spread of infection in health care settings (2). Early distribution of two mRNA COVID-19 vaccines (Pfizer-BioNTech and Moderna) to HCP allowed assessment of the effectiveness of these vaccines in a real-world setting. A test-negative case-control study is underway to evaluate mRNA COVID-19 vaccine effectiveness (VE) against symptomatic illness among HCP at 33 U.S. sites across 25 U.S. states. Interim analyses indicated that the VE of a single dose (measured 14 days after the first dose through 6 days after the second dose) was 82% (95% confidence interval [CI] = 74%-87%), adjusted for age, race/ethnicity, and underlying medical conditions. The adjusted VE of 2 doses (measured >/=7 days after the second dose) was 94% (95% CI = 87%-97%). VE of partial (1-dose) and complete (2-dose) vaccination in this population is comparable to that reported from clinical trials and recent observational studies, supporting the effectiveness of mRNA COVID-19 vaccines against symptomatic disease in adults, with strong 2-dose protection. URL: https://www.ncbi.nlm.nih.gov/pubmed/34014909

Evidence Search Report: INF031801v5 ESR 65 DOI: 10.15585/mmwr.mm7020e2 10.15585/mmwr.mm7020e2.

151. Pimpinelli F, Marchesi F, Piaggio G, et al. Fifth-week immunogenicity and safety of anti-SARS-CoV-2 BNT162b2 vaccine in patients with multiple myeloma and myeloproliferative malignancies on active treatment: preliminary data from a single institution. J Hematol Oncol. 2021;14(1):81. DOI: 10.1186/s13045-021-01090-6 10.1186/s13045-021-01090-6. ABSTRACT: BACKGROUND: Safety and immunogenicity of BNT162b2 mRNA vaccine are unknown in hematological patients; both were evaluated prospectively in 42 patients with multiple myeloma (MM) and 50 with myeloproliferative malignancies (MPM) (20 chronic myeloid leukemias and 30 myeloproliferative neoplasms), all of them on active anti-cancer treatment, in comparison with 36 elderly controls not suffering from cancer. Subjects serologically and/or molecularly (by nasal/throat swab) positives at basal for SARS-CoV-2 were excluded. Primary endpoint was to compare titers of neutralizing anti-SARS-CoV-2 IgG and seroprotection rates among the cohorts at 3 and 5 weeks from first dose. METHODS: Titration was done using LIAISON(R) SARS-CoV-2 S1/S2 IgG test, a quantitative chemiluminescent immunoassay approved by FDA on the basis of robust evidences of concordance (94.4%) between the test at cutoff of 15 AU/mL and the Plaque Reduction Neutralization Test 90% at 1:40 ratio. Cutoff of 15 AU/mL was assumed to discriminate responders to vaccination with a protective titer. Cohorts were compared using Fisher' exact test and the Mann-Whitney test as appropriated. Geometric mean concentrations (GMCs), geometric mean ratios and response rates after 1st and 2nd dose were compared in each cohort by Wilcoxon and McNemar tests, respectively. RESULTS: At 5 weeks, GMC of IgG in elderly controls was 353.3 AU/mL versus 106.7 in MM (p = 0.003) and 172.9 in MPM patients (p = 0.049). Seroprotection rate at cutoff of 15 AU/mL was 100% in controls compared to 78.6% in MM (p = 0.003) and 88% in MPM patients (p = 0.038). In terms of logarithm of IgG titer, in a generalized multivariate linear model, no gender effect was observed (p = 0.913), while there was a significant trend toward lower titers by increasing age (p < 0.001) and in disease cohorts with respect to controls (MM: p < 0.001 and MPM: p < 0.001). An ongoing treatment without daratumumab was associated with higher likelihood of response in MM patients (p = 0.003). No swabs resulted positive on each time point. No safety concerns were observed. CONCLUSIONS: BNT162b2 has demonstrated to be immunogenic at different extent among the cohorts. Response was 88% and robust in MPM patients. MM patients responded significantly less, particularly those on anti-CD38-based treatment. These latter patients should be advised to maintain masks and social distancing regardless of vaccination status, and their cohabiting family members need to be vaccinated in order to reduce the risk of contagion from the family. Additional boosters and titer monitoring could be considered. Trial registration Study was formally approved by the IRCCS Central Ethical Committee of Regione Lazio in January 2021 (Prot. N-1463/21). URL: https://www.ncbi.nlm.nih.gov/pubmed/34001183 DOI: 10.1186/s13045-021-01090-6 10.1186/s13045-021-01090-6.

152. Pinnawala NU, Thrastardottir TO, Constantinou C. Keeping a Balance During the Pandemic: a Narrative Review on the Important Role of Micronutrients in Preventing Infection and Reducing Complications of COVID- 19. Curr Nutr Rep. 2021. DOI: 10.1007/s13668-021-00356-2 10.1007/s13668-021-00356-2. ABSTRACT: PURPOSE OF REVIEW: The SARS-CoV-2 (COVID-19) outbreak has manifested into a major public health concern across the globe, affecting particularly the most vulnerable population groups. Currently, there are various clinical trials being conducted to develop effective treatments. It is estimated that it could take one or more years before these drugs pass all safety tests and concrete results with regard to their effectiveness become available. In addition, despite the recent development of vaccines (licensed for use under conditional licenses) and the commencement of COVID-19 vaccination programs in several countries, there is still a need for safe and novel strategies that may reduce the symptomatology and/or prevent the severe complications associated with COVID- 19. Natural compounds previously shown to have antiviral potential should be thoroughly considered and investigated for use in prophylactic treatment of COVID-19 due to their availability and safety. RECENT FINDINGS: The current narrative review investigates whether there is evidence in the literature that supplementation with dietary minerals and vitamins may have a role in preventing infection with SARS-CoV-2 or in reducing COVID-19 symptomatology and disease progression. The current evidence from the literature supports that zinc and vitamin

Evidence Search Report: INF031801v5 ESR 66 C have a potential in reducing the inflammatory response associated with SARS-CoV-2 while folate and vitamin D may have a role in antagonizing the entry of SARs-CoV-2 virus in host calls. Thus, further research should be conducted that could lead to the development of nutritional supplements involving natural and widely available compounds such as zinc, folate, vitamin C, and vitamin D. The latter could be an effective, safe, and inexpensive way to either prevent infection with SARS-CoV-2 and/or lessen the burden of COVID-19 disease. URL: https://www.ncbi.nlm.nih.gov/pubmed/33948913 DOI: 10.1007/s13668-021-00356-2 10.1007/s13668-021-00356-2.

153. Procter SR, Abbas K, Flasche S, et al. SARS-CoV-2 infection risk during delivery of childhood vaccination campaigns: a modelling study. medRxiv. 2021;19:19. DOI: 10.1101/2021.05.14.21257215 10.1101/2021.05.14.21257215. ABSTRACT: Background: The COVID-19 pandemic has disrupted delivery of immunisation services globally. Many countries have postponed vaccination campaigns out of concern about infection risks to staff delivering vaccination, the children being vaccinated and their families. The World Health Organization recommends considering both the benefit of preventive campaigns and the risk of SARS-CoV-2 transmission when making decisions about campaigns during COVID-19 outbreaks, but there has been little quantification of the risks. Methods: We modelled excess SARS-CoV-2 infection risk to vaccinators, vaccinees and their caregivers resulting from vaccination campaigns delivered during a COVID-19 epidemic. Our model used population age-structure and contact patterns from three exemplar countries (Burkina Faso, Ethiopia, and Chile). It combined an existing compartmental transmission model of an underlying COVID-19 epidemic with a Reed-Frost model of SARS-CoV-2 infection risk to vaccinators and vaccinees. We explored how excess risk depends on key parameters governing SARS-CoV-2 transmissibility, and aspects of campaign delivery such as campaign duration, number of vaccinations, and effectiveness of personal protective equipment (PPE) and symptomatic screening. Results: Infection risks differ considerably depending on the circumstances in which vaccination campaigns are conducted. A campaign conducted at the peak of a SARS-CoV-2 epidemic with high prevalence and without special infection mitigation measures could increase absolute infection risk by 32% to 58% for vaccinators, and 0.3% to 0.9% for vaccinees and caregivers. However, these risks could be reduced to 3.6% to 8.0% and 0.1% to 0.4% respectively by use of PPE that reduces transmission by 90% (as might be achieved with N95 respirators or high-quality surgical masks) and symptomatic screening. Conclusions: SARS-CoV-2 infection risks to vaccinators, vaccinees and caregivers during vaccination campaigns can be greatly reduced by adequate PPE, symptomatic screening, and appropriate campaign timing. Our results support the use of adequate risk mitigation measures for vaccination campaigns held during SARS-CoV-2 epidemics, rather than cancelling them entirely. URL: https://www.ncbi.nlm.nih.gov/pubmed/34031666 DOI: 10.1101/2021.05.14.21257215 10.1101/2021.05.14.21257215.

154. Ramaiah GB, Tegegne A, Melese B. Developments in Nano-materials and Analysing its role in Fighting COVID-19. Mater Today Proc. 2021;09:09. DOI: 10.1016/j.matpr.2021.05.020 10.1016/j.matpr.2021.05.020. ABSTRACT: Nanomaterials like silver, iron, ceramic, graphene carbon nanotubes, etc. These are used to develop and create multifunctional materials to fight the corona virus. This work focuses on analyzing and discussing the developments of Nano-materials and their effectiveness in fighting and preventing the spread of the corona virus. The paper also analyses the use of Nano-materials in the development of vaccines and anti-viral drugs. However, the use of carbon-based materials like carbon dots and other forms of carbon has not only helped in increasing the protection levels in human life but also provided greater security and freedom for people to carry out day-to-day activities without any fear of being infected by the virus. The application of graphene-based materials for making unique face masks and germ trap technologies is presented. Nano-compounds blended with hand sanitizers have played an active role in the control of coronavirus along with soap-based liquids that are used for handwashing. Some of the Nano-materials like gold nanoparticles are extensively used in the making of detection devices like RT- PCR, etc. The use of Nano-polymer coatings has created a safe environment for users by preventing the spread of coronavirus through surfaces. Different coating methods used for the application of nanomaterials are explained with suitable technical interpretations The anti-viral efficiency of different coatings is also discussed through

Evidence Search Report: INF031801v5 ESR 67 surfaces. Nano-materials and contributions from the synthetic biology area have helped to develop vaccines and anti-viral drugs which are presently used to cure and prevent the spread of coronavirus infected patients. The method followed in analyzing the Nano-materials and their applications mainly focused on tracing the development and applications of Nano-materials. This analysis proves and shows that Nano-materials are playing a vital role in fighting the corona virus. URL: https://www.ncbi.nlm.nih.gov/pubmed/33996513 DOI: 10.1016/j.matpr.2021.05.020 10.1016/j.matpr.2021.05.020.

155. Ramakrishnan S, Nicolau DV, Jr., Langford B, et al. Inhaled budesonide in the treatment of early COVID-19 (STOIC): a phase 2, open-label, randomised controlled trial. Lancet Respir Med. 2021. DOI: 10.1016/S2213- 2600(21)00160-0 10.1016/S2213-2600(21)00160-0. ABSTRACT: BACKGROUND: Multiple early reports of patients admitted to hospital with COVID-19 showed that patients with chronic respiratory disease were significantly under-represented in these cohorts. We hypothesised that the widespread use of inhaled glucocorticoids among these patients was responsible for this finding, and tested if inhaled glucocorticoids would be an effective treatment for early COVID-19. METHODS: We performed an open-label, parallel-group, phase 2, randomised controlled trial (Steroids in COVID-19; STOIC) of inhaled budesonide, compared with usual care, in adults within 7 days of the onset of mild COVID-19 symptoms. The trial was done in the community in Oxfordshire, UK. Participants were randomly assigned to inhaled budsonide or usual care stratified for age (40 years), sex (male or female), and number of comorbidities (/=2). Randomisation was done using random sequence generation in block randomisation in a 1:1 ratio. Budesonide dry powder was delivered using a turbohaler at a dose of 800 mug per actuation. Participants were asked to take two inhalations twice a day until symptom resolution. The primary endpoint was COVID-19-related urgent care visit, including emergency department assessment or hospitalisation, analysed for both the per- protocol and intention-to-treat (ITT) populations. The secondary outcomes were self-reported clinical recovery (symptom resolution), viral symptoms measured using the Common Cold Questionnare (CCQ) and the InFLUenza Patient Reported Outcome Questionnaire (FLUPro), body temperature, blood oxygen saturations, and SARS-CoV-2 viral load. The trial was stopped early after independent statistical review concluded that study outcome would not change with further participant enrolment. This trial is registered with ClinicalTrials.gov, NCT04416399. FINDINGS: From July 16 to Dec 9, 2020, 167 participants were recruited and assessed for eligibility. 21 did not meet eligibility criteria and were excluded. 146 participants were randomly assigned-73 to usual care and 73 to budesonide. For the per-protocol population (n=139), the primary outcome occurred in ten (14%) of 70 participants in the budesonide group and one (1%) of 69 participant in the usual care group (difference in proportions 0.131, 95% CI 0.043 to 0.218; p=0.004). For the ITT population, the primary outcome occurred in 11 (15%) participants in the usual care group and two (3%) participants in the budesonide group (difference in proportions 0.123, 95% CI 0.033 to 0.213; p=0.009). The number needed to treat with inhaled budesonide to reduce COVID-19 deterioration was eight. Clinical recovery was 1 day shorter in the budesonide group compared with the usual care group (median 7 days [95% CI 6 to 9] in the budesonide group vs 8 days [7 to 11] in the usual care group; log-rank test p=0.007). The mean proportion of days with a fever in the first 14 days was lower in the budesonide group (2%, SD 6) than the usual care group (8%, SD 18; Wilcoxon test p=0.051) and the proportion of participants with at least 1 day of fever was lower in the budesonide group when compared with the usual care group. As-needed antipyretic medication was required for fewer proportion of days in the budesonide group compared with the usual care group (27% [IQR 0-50] vs 50% [15-71]; p=0.025) Fewer participants randomly assigned to budesonide had persistent symptoms at days 14 and 28 compared with participants receiving usual care (difference in proportions 0.204, 95% CI 0.075 to 0.334; p=0.003). The mean total score change in the CCQ and FLUPro over 14 days was significantly better in the budesonide group compared with the usual care group (CCQ mean difference -0.12, 95% CI -0.21 to -0.02 [p=0.016]; FLUPro mean difference -0.10, 95% CI -0.21 to -0.00 [p=0.044]). Blood oxygen saturations and SARS-CoV-2 load, measured by cycle threshold, were not different between the groups. Budesonide was safe, with only five (7%) participants reporting self-limiting adverse events. INTERPRETATION: Early administration of inhaled budesonide educed the likelihood of needing urgent medical care and reduced time to recovery after early COVID-19. FUNDING: National Institute for Health Research Biomedical Research Centre and AstraZeneca.

Evidence Search Report: INF031801v5 ESR 68 URL: https://www.ncbi.nlm.nih.gov/pubmed/33844996 DOI: 10.1016/S2213-2600(21)00160-0 10.1016/S2213-2600(21)00160-0.

156. Ramirez GA, Della-Torre E, Moroni L, et al. Correspondence on 'Immunogenicity and safety of anti-SARS- CoV-2 mRNA vaccines in patients with chronic inflammatory conditions and immunosuppressive therapy in a monocentric cohort'. Ann Rheum Dis. 2021;24:24. DOI: 10.1136/annrheumdis-2021-220539 10.1136/annrheumdis-2021-220539. URL: https://www.ncbi.nlm.nih.gov/pubmed/34031031 DOI: 10.1136/annrheumdis-2021-220539 10.1136/annrheumdis-2021-220539.

157. Rammensee HG, Gouttefangeas C, Heidu S, et al. Designing a SARS-CoV-2 T-Cell-Inducing Vaccine for High- Risk Patient Groups. Vaccines (Basel). 2021;9(5). DOI: 10.3390/vaccines9050428 10.3390/vaccines9050428. ABSTRACT: We describe the results of two vaccinations of a self-experimenting healthy volunteer with SARS-CoV- 2-derived peptides performed in March and April 2020, respectively. The first set of peptides contained eight peptides predicted to bind to the individual's HLA molecules. The second set consisted of ten peptides predicted to bind promiscuously to several HLA-DR allotypes. The vaccine formulation contained the new TLR 1/2 agonist XS15 and was administered as an emulsion in Montanide as a single subcutaneous injection. Peripheral blood mononuclear cells isolated from blood drawn before and after vaccinations were assessed using Interferon-gamma ELISpot assays and intracellular cytokine staining. We detected vaccine-induced CD4 T cell responses against six out of 11 peptides predicted to bind to HLA-DR after 19 days, following vaccination, for one peptide already at day 12. We used these results to support the design of a T-cell-inducing vaccine for application in high-risk patients, with weakened lymphocyte performance. Meanwhile, an according vaccine, incorporating T cell epitopes predominant in convalescents, is undergoing clinical trial testing. URL: https://www.ncbi.nlm.nih.gov/pubmed/33923363 DOI: 10.3390/vaccines9050428 10.3390/vaccines9050428.

158. Reddy KP, Fitzmaurice KP, Scott JA, et al. Clinical outcomes and cost-effectiveness of COVID-19 vaccination in South Africa. medRxiv. 2021;12:12. DOI: 10.1101/2021.05.07.21256852 10.1101/2021.05.07.21256852. ABSTRACT: Low- and middle-income countries are implementing COVID-19 vaccination strategies in light of varying and uncertain vaccine efficacies and costs, supply shortages, and resource constraints. We used a microsimulation model to evaluate clinical outcomes and cost-effectiveness of a COVID-19 vaccination program in South Africa. We varied vaccination coverage, pace, acceptance, effectiveness, and cost as well as epidemic dynamics. Providing vaccine to at least 40% of the population and prioritizing accelerated vaccine rollout prevented >9 million infections and >73,000 deaths and reduced costs due to fewer hospitalizations. Further, the vaccination program was cost-saving even at the lowest examined levels of acceptance (50%), effectiveness against infection (20%), effectiveness against symptomatic disease (30%), and effectiveness against severe/critical disease requiring hospitalization (40%), and with vaccination costs of up to USD25/person. In summary, a COVID- 19 vaccination program would reduce both deaths and health care costs in South Africa across a wide range of assumptions. Vaccination program implementation factors, including prompt procurement, distribution, and rollout, are likely more influential than characteristics of the vaccine itself in maximizing public health benefits and economic efficiency. URL: https://www.ncbi.nlm.nih.gov/pubmed/34013291 DOI: 10.1101/2021.05.07.21256852 10.1101/2021.05.07.21256852.

159. Remmel A. 'It's a minefield': COVID vaccine safety poses unique communication challenge. Nature. 2021;593(7860):488-9. DOI: 10.1038/d41586-021-01257-8 10.1038/d41586-021-01257-8.

Evidence Search Report: INF031801v5 ESR 69 URL: https://www.ncbi.nlm.nih.gov/pubmed/34021288 DOI: 10.1038/d41586-021-01257-8 10.1038/d41586-021-01257-8.

160. Risma KA, Edwards KM, Hummell DS, et al. Potential mechanisms of anaphylaxis to COVID-19 mRNA vaccines. J Allergy Clin Immunol. 2021. DOI: 10.1016/j.jaci.2021.04.002 10.1016/j.jaci.2021.04.002. ABSTRACT: Anaphylaxis to vaccines is historically a rare event. The coronavirus disease 2019 pandemic drove the need for rapid vaccine production applying a novel antigen delivery system: messenger RNA vaccines packaged in lipid nanoparticles. Unexpectedly, public vaccine administration led to a small number of severe allergic reactions, with resultant substantial public concern, especially within atopic individuals. We reviewed the constituents of the messenger RNA lipid nanoparticle vaccine and considered several contributors to these reactions: (1) contact system activation by nucleic acid, (2) complement recognition of the vaccine-activating allergic effector cells, (3) preexisting antibody recognition of polyethylene glycol, a lipid nanoparticle surface hydrophilic polymer, and (4) direct mast cell activation, coupled with potential genetic or environmental predispositions to hypersensitivity. Unfortunately, measurement of anti-polyethylene glycol antibodies in vitro is not clinically available, and the predictive value of skin testing to polyethylene glycol components as a coronavirus disease 2019 messenger RNA vaccine-specific anaphylaxis marker is unknown. Even less is known regarding the applicability of vaccine use for testing (in vitro/vivo) to ascertain pathogenesis or predict reactivity risk. Expedient and thorough research-based evaluation of patients who have suffered anaphylactic vaccine reactions and prospective clinical trials in putative at-risk individuals are needed to address these concerns during a public health crisis. URL: https://www.ncbi.nlm.nih.gov/pubmed/33857566 DOI: 10.1016/j.jaci.2021.04.002 10.1016/j.jaci.2021.04.002.

161. Rodríguez-Blanco N, Montero-Navarro S, Botella-Rico JM, et al. Willingness to Be Vaccinated against COVID- 19 in Spain before the Start of Vaccination: A Cross-Sectional Study. Int J Environ Res Public Health. 2021;18(10). DOI: 10.3390/ijerph18105272 ABSTRACT: Vaccine hesitancy has increased in the past few years, influenced by the socio-cultural differences, political populism, or concerns related to the effectiveness and safety of some vaccines, resulting a feeling of distrust. This feeling can become a barrier against the achievement of the immunity necessary to stop the expansion of COVID-19. The aim of this study was to evaluate the acceptance of the vaccine against COVID-19 in Spain, as well as to identify the factors that have an influence on the concerns and attitudes of people against accepting the vaccine in the months prior to the start of vaccination on December 2020. An online questionnaire was created to obtain information about (1) sociodemographic characteristics; (2) concerns and sources of information about vaccines; and (3) attitudes about vaccination and state of health. A multivariate logistic regression was performed to identify the influencing factors. Of the 2501 participants, 1207 (48.3%) would accept the COVID-19 vaccine, 623 (24.9%) were hesitant, and 671 (26.8%) would reject it. The logistic regression showed that being male, older than 60, married, retired, with a high level of education, or with a leftist political inclination, could increase the probability of accepting the COVID-19 vac-cine. Disinformation and the lack of political consensus were the main sources of distrust. The patients with hypertension, immunodepression, hypercholesterolemia, or respiratory disease, or were overweight, showed a greater acceptance to the vaccine, while those with cancer took the longest to accept it. A low acceptance of the vaccine against COVID-19 was observed among the Spanish population in the phase prior to its availability, and the main fears of the population were identified. It is necessary to offer correct and transparent information about these vaccines to reduce the concerns and increase the trust of the population, to thereby guarantee the success of the vaccination cam-paigns. Copyright © 2021 by the authors. Licensee MDPI, Basel, Switzerland. URL: https://www.mdpi.com/1660- 4601/18/10/5272/pdfhttps://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=emexb&AN =2007162327https://libkey.io/libraries/843/openurl?output=full&sid=OVID:embase&id=pmid:&id=doi:10.3390%2 Fijerph18105272&issn=1661- 7827&isbn=&volume=18&issue=10&spage=5272&pages=&date=2021&title=International+Journal+of+Environmen tal+Research+and+Public+Health&atitle=Willingness+to+be+vaccinated+against+covid-

Evidence Search Report: INF031801v5 ESR 70 19+in+spain+before+the+start+of+vaccination%3A+A+cross-sectional+study&aulast=Rodriguez- Blanco&pid=%3Cauthor%3ERodriguez-Blanco+N.%3BMontero-Navarro+S.%3BBotella-Rico+J.M.%3BFelipe- Gomez+A.J.%3BSanchez- Mas+J.%3BTuells+J.%3C%2Fauthor%3E%3CAN%3E2007162327%3C%2FAN%3E%3CDT%3EArticle%3C%2FDT%3E DOI: 10.3390/ijerph18105272

162. Romero-Brufau S, Chopra A, Ryu AJ, et al. Public health impact of delaying second dose of BNT162b2 or mRNA-1273 covid-19 vaccine: simulation agent based modeling study. BMJ. 2021;373(n1087):n1087. DOI: 10.1136/bmj.n1087 10.1136/bmj.n1087. ABSTRACT: OBJECTIVE: To estimate population health outcomes with delayed second dose versus standard schedule of SARS-CoV-2 mRNA vaccination. DESIGN: Simulation agent based modeling study. SETTING: Simulated population based on real world US county. PARTICIPANTS: The simulation included 100 000 agents, with a representative distribution of demographics and occupations. Networks of contacts were established to simulate potentially infectious interactions though occupation, household, and random interactions. INTERVENTIONS: Simulation of standard covid-19 vaccination versus delayed second dose vaccination prioritizing the first dose. The simulation runs were replicated 10 times. Sensitivity analyses included first dose vaccine efficacy of 50%, 60%, 70%, 80%, and 90% after day 12 post-vaccination; vaccination rate of 0.1%, 0.3%, and 1% of population per day; assuming the vaccine prevents only symptoms but not asymptomatic spread (that is, non-sterilizing vaccine); and an alternative vaccination strategy that implements delayed second dose for people under 65 years of age, but not until all those above this age have been vaccinated. MAIN OUTCOME MEASURES: Cumulative covid-19 mortality, cumulative SARS-CoV-2 infections, and cumulative hospital admissions due to covid-19 over 180 days. RESULTS: Over all simulation replications, the median cumulative mortality per 100 000 for standard dosing versus delayed second dose was 226 v 179, 233 v 207, and 235 v 236 for 90%, 80%, and 70% first dose efficacy, respectively. The delayed second dose strategy was optimal for vaccine efficacies at or above 80% and vaccination rates at or below 0.3% of the population per day, under both sterilizing and non-sterilizing vaccine assumptions, resulting in absolute cumulative mortality reductions between 26 and 47 per 100 000. The delayed second dose strategy for people under 65 performed consistently well under all vaccination rates tested. CONCLUSIONS: A delayed second dose vaccination strategy, at least for people aged under 65, could result in reduced cumulative mortality under certain conditions. URL: https://www.ncbi.nlm.nih.gov/pubmed/33980718 DOI: 10.1136/bmj.n1087 10.1136/bmj.n1087.

163. Roth M, Holtmann C, Tillmann A, et al. [Assessment of subjective risk of infection and willingness to vaccinate against SARS-CoV-2 among German ophthalmologists : Results of a survey by DOG and BVA]. Ophthalmologe. 2021;21:21. DOI: 10.1007/s00347-021-01425-1 10.1007/s00347-021-01425-1. ABSTRACT: BACKGROUND AND OBJECTIVE: After approval of the first COVID-19 vaccines in Germany, vaccination prioritization and vaccination preparedness are central topics in the discussion on strategies to end the pandemic. How ophthalmologists evaluate their risk of infection and whether they are willing to be vaccinated has not been investigated so far. The aim of this project was to assess the subjective rating of the risk of infection and the willingness to be vaccinated among German ophthalmologists. METHODS: Data were collected by an anonymous online survey conducted by the Professional Association of Ophthalmologists in Germany (BVA) and the German Ophthalmological Society (DOG) under the auspices of the University Eye Hospital Dusseldorf. The questionnaire was open for participation from 22 January to 12 February 2021. The survey was addressed to all colleagues in ophthalmology. RESULTS: A total of 1162 completed questionnaires were analyzed. On average, survey respondents rated their risk of infection as 7.5+/- 1.9 (scale of 1-10; 1= very low risk, 10= very high risk). Of the respondents 971 (83.6%) rated their risk of infection as higher compared to other disciplines and 92.9% (n= 1079) indicated they would be willing to be vaccinated. CONCLUSION: The ophthalmologists interviewed consider their professional group to be exposed to an above-average risk of SARS-COV2 infection compared to other disciplines. They frequently criticized the prioritization ranking of the German Ministry of Health (BMG), which deviated from

Evidence Search Report: INF031801v5 ESR 71 the suggestions of the Standing Vaccination Committee of Germany (STIKO). The willingness to be vaccinated was very high among the surveyed German ophthalmologists. URL: https://www.ncbi.nlm.nih.gov/pubmed/34019126 DOI: 10.1007/s00347-021-01425-1 10.1007/s00347-021-01425-1.

164. Ruddy JA, Boyarsky BJ, Werbel WA, et al. Safety and antibody response to the first dose of SARS-CoV-2 messenger RNA vaccine in persons with HIV. AIDS. 2021;14:14. DOI: 10.1097/QAD.0000000000002945 10.1097/QAD.0000000000002945. ABSTRACT: In this study of 12 people with HIV who received the first dose of SARS-CoV-2 mRNA vaccination, anti- SARS-CoV-2 receptor binding domain antibodies were detectable in all participants; lower antibody levels were seen in those with lower CD4 counts, and vaccine reactions were generally mild. URL: https://www.ncbi.nlm.nih.gov/pubmed/33993131 DOI: 10.1097/QAD.0000000000002945 10.1097/QAD.0000000000002945.

165. Rutkowski K, Mirakian R, Till S, et al. Adverse reactions to COVID-19 vaccines: A practical approach. Clin Exp Allergy. 2021;51(6):770-7. DOI: 10.1111/cea.13880 10.1111/cea.13880. Epub 2021 Apr 14. ABSTRACT: COVID-19-related mortality in high-risk individuals is substantial and current treatment options are limited. There is convincing evidence that the COVID-19 vaccines reduce the severity of infection and prevent deaths. Three COVID-19 vaccines are approved in the United Kingdom with many more in development. There are limited data on the triggers and mechanisms of anaphylaxis to these vaccines. We review the potential allergenic compounds in the COVID-19 vaccines and describe an innovative allergy support model for the vaccination hubs that allows most patients with severe allergy be immunized. Finally, we propose a practical algorithm for the investigations of anaphylaxis to these vaccines. URL: https://www.ncbi.nlm.nih.gov/pubmed/33813758 DOI: 10.1111/cea.13880 10.1111/cea.13880. Epub 2021 Apr 14.

166. Rzymski P, Zeyland J, Poniedzialek B, et al. The Perception and Attitudes toward COVID-19 Vaccines: A Cross-Sectional Study in Poland. Vaccines (Basel). 2021;9(4). DOI: 10.3390/vaccines9040382 10.3390/vaccines9040382. ABSTRACT: Vaccine hesitancy is a major threat to the success of COVID-19 vaccination programs. The present cross-sectional online survey of adult Poles (n = 1020) expressing a willingness to receive the COVID-19 vaccine was conducted between February and March 2021 and aimed to assess (i) the general trust in different types of vaccines, (ii) the level of acceptance of the COVID-19 vaccines already in use in Poland (BNT162b2 by BioNTech/Pfizer, mRNA-1273 by Moderna and AZD1222 by Oxford/AstraZeneca) as well as eight vaccines approved outside European Union (EU) or in advanced stages of clinical trials, (iii) level of fear of vaccination against COVID-19, and (iv) main sources of information on COVID-19 vaccination. Among all major vaccine technology, the highest level of trust was observed for the mRNA platform, with a considerable number of surveyed (>20%) not aware of the existence of vaccines produced using the traditional approach (inactivated and live attenuated vaccines). The age of participants was the main factor differentiating the level of trust in a particular vaccine type. Both BNT162b and mRNA-1273 received a high level of acceptance, contrary to AZD1222. From eight vaccines unauthorized in the EU at the moment of study, the CVnCoV (mRNA; CureVac) was met with the highest level of trust, followed by Ad26.COV2.S (vector; Janssen/Johnson&Johnson) and NVX-CoV2373 (protein; Novavax). Sputnik V (vector; Gamaleya Research Institute) was decidedly the least trusted vaccine. The median level of fear (measured by the 10-point Likert-type scale) in the studied group was 4.0, mostly related to the risk of serious allergic reactions, other severe adverse events and unknown long-term effects of vaccination. Female, individuals with a lower level of education and those not seeking any information on the COVID-19 vaccines revealed a higher fear of vaccination. Experts' materials were the major source of information on COVID- 19 vaccines in the studied group. The study shows the level of trust in COVID-19 vaccines can vary much across the producers while the mRNA vaccines are received with a high level of acceptance. It also emphasizes the need for

Evidence Search Report: INF031801v5 ESR 72 effective and continuous science communication when fighting the pandemic as it may be an ideal time to increase the general awareness of vaccines. URL: https://www.ncbi.nlm.nih.gov/pubmed/33919672 DOI: 10.3390/vaccines9040382 10.3390/vaccines9040382.

167. Sadoff J, Le Gars M, Shukarev G, et al. Interim Results of a Phase 1-2a Trial of Ad26.COV2.S Covid-19 Vaccine. N Engl J Med. 2021;384(19):1824-35. DOI: 10.1056/NEJMoa2034201 10.1056/NEJMoa2034201. Epub 2021 Jan 13. ABSTRACT: BACKGROUND: Efficacious vaccines are urgently needed to contain the ongoing coronavirus disease 2019 (Covid-19) pandemic of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). A candidate vaccine, Ad26.COV2.S, is a recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike protein. METHODS: In this multicenter, placebo-controlled, phase 1-2a trial, we randomly assigned healthy adults between the ages of 18 and 55 years (cohort 1) and those 65 years of age or older (cohort 3) to receive the Ad26.COV2.S vaccine at a dose of 5x10(10) viral particles (low dose) or 1x10(11) viral particles (high dose) per milliliter or placebo in a single-dose or two-dose schedule. Longer-term data comparing a single-dose regimen with a two-dose regimen are being collected in cohort 2; those results are not reported here. The primary end points were the safety and reactogenicity of each dose schedule. RESULTS: After the administration of the first vaccine dose in 805 participants in cohorts 1 and 3 and after the second dose in cohort 1, the most frequent solicited adverse events were fatigue, headache, myalgia, and injection-site pain. The most frequent systemic adverse event was fever. Systemic adverse events were less common in cohort 3 than in cohort 1 and in those who received the low vaccine dose than in those who received the high dose. Reactogenicity was lower after the second dose. Neutralizing-antibody titers against wild-type virus were detected in 90% or more of all participants on day 29 after the first vaccine dose (geometric mean titer [GMT], 212 to 354), regardless of vaccine dose or age group, and reached 96% by day 57 with a further increase in titers (GMT, 288 to 488) in cohort 1a. Titers remained stable until at least day 71. A second dose provided an increase in the titer by a factor of 2.6 to 2.9 (GMT, 827 to 1266). Spike-binding antibody responses were similar to neutralizing-antibody responses. On day 15, CD4+ T-cell responses were detected in 76 to 83% of the participants in cohort 1 and in 60 to 67% of those in cohort 3, with a clear skewing toward type 1 helper T cells. CD8+ T-cell responses were robust overall but lower in cohort 3. CONCLUSIONS: The safety and immunogenicity profiles of Ad26.COV2.S support further development of this vaccine candidate. (Funded by Johnson & Johnson and the Biomedical Advanced Research and Development Authority of the Department of Health and Human Services; COV1001 ClinicalTrials.gov number, NCT04436276.). URL: https://www.ncbi.nlm.nih.gov/pubmed/33440088 DOI: 10.1056/NEJMoa2034201 10.1056/NEJMoa2034201. Epub 2021 Jan 13.

168. Saibene AM, Allevi F, Ayad T, et al. Appropriateness for SARS-CoV-2 vaccination for otolaryngologist and head and neck surgeons in case of pregnancy, breastfeeding, or childbearing potential: Yo-IFOS and CEORL-HNS joint clinical consensus statement. Eur Arch Otorhinolaryngol. 2021. DOI: 10.1007/s00405-021-06794-6 10.1007/s00405-021-06794-6. ABSTRACT: PURPOSE: SARS-CoV-2 vaccines are a key step in fighting the pandemic. Nevertheless, their rapid development did not allow for testing among specific population subgroups such as pregnant and breastfeeding women, or elaborating specific guidelines for healthcare personnel working in high infection risk specialties, such as otolaryngology (ORL). This clinical consensus statement (CCS) aims to offer guidance for SARS-CoV-2 vaccination to this high-risk population based on the best evidence available. METHODS: A multidisciplinary international panel of 33 specialists judged statements through a two-round modified Delphi method survey. Statements were designed to encompass the following topics: risk of SARS-Cov-2 infection and use of protective equipment in ORL; SARS-Cov-2 infection and vaccines and respective risks for the mother/child dyad; and counseling for SARS-CoV-2 vaccination in pregnant, breastfeeding, or fertile healthcare workers (PBFHW). All ORL PBFHW were considered as the target audience. RESULTS: Of the 13 statements, 7 reached consensus or strong consensus, 2 reached no consensus, and 2 reached near-consensus. According to the statements with strong consensus otorhinolaryngologists-head and neck surgeons who are pregnant, breastfeeding, or with childbearing potential

Evidence Search Report: INF031801v5 ESR 73 should have the opportunity to receive SARS-Cov-2 vaccination. Moreover, personal protective equipment (PPE) should still be used even after the vaccination. CONCLUSION: Until prospective evaluations on these topics are available, ORL-HNS must be considered a high infection risk specialty. While the use of PPE remains pivotal, ORL PBFHW should be allowed access to SARS-CoV-2 vaccination provided they receive up-to-date information. URL: https://www.ncbi.nlm.nih.gov/pubmed/33855628 DOI: 10.1007/s00405-021-06794-6 10.1007/s00405-021-06794-6.

169. Sakakibara S, Jinma K, Haneda H. Evaluation of Within-farm Transmission Dynamics of Bovine Coronavirus Disease Using a Mathematical Model. Journal of the Japan Veterinary Medical Association. 2021;74(3):175-80. DOI: 10.12935/jvma.74.175 ABSTRACT: We analyzed the within-farm transmission dynamics of bovine coronavirus disease (BCoVD) using a mathematical model and evaluated the vaccination coverage (VC) and outbreak prevention effect of isolation of symptomatic cattle. The estimated basic reproduction number (R0) were 8.00 (3.15-16.0) and VC values were 0.875 (0.682-0.937). The stochastic simulation predicted that isolating all symptomatic cattle, including mild symptomatic cattle, within 12 hours of onset prevents BCoVD outbreaks. In contrast, the stochastic simulation predicted that when mild symptomatic cattle were not isolated, BCoVD outbreaks could not be successfully controlled. Copyright © 2021, Japan Veterinary Medical Association. All rights reserved. URL: https://www.jstage.jst.go.jp/article/jvma/74/3/74_175/_pdf/- char/enhttps://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=emexb&AN=2007146997h ttps://libkey.io/libraries/843/openurl?output=full&sid=OVID:embase&id=pmid:&id=doi:10.12935%2Fjvma.74.175 &issn=0446-6454&isbn=&volume=74&issue=3&spage=175&pages=175- 180&date=2021&title=Journal+of+the+Japan+Veterinary+Medical+Association&atitle=Evaluation+of+within- farm+transmission+dynamics+of+bovine+coronavirus+disease+using+a+mathematical+model&aulast=Sakakibara& pid=%3Cauthor%3ESakakibara+S.%3BJinma+K.%3BHaneda+H.%3C%2Fauthor%3E%3CAN%3E2007146997%3C%2F AN%3E%3CDT%3EArticle%3C%2FDT%3E DOI: 10.12935/jvma.74.175

170. Salles C, Freitas MCS, Meira ECM. Comorbid insomnia and sleep apnea (COMISA) as an additional risk factor for reduced response to the COVID-19 vaccination? Sleep Med. 2021;83:159. DOI: 10.1016/j.sleep.2021.04.018 10.1016/j.sleep.2021.04.018. URL: https://www.ncbi.nlm.nih.gov/pubmed/34022491 DOI: 10.1016/j.sleep.2021.04.018 10.1016/j.sleep.2021.04.018.

171. Samaranayake LP, Seneviratne CJ, Fakhruddin KS. Coronavirus Disease 2019 (COVID-19) Vaccines: A Concise Review. Oral Dis. 2021;15:15. DOI: 10.1111/odi.13916 10.1111/odi.13916. ABSTRACT: The development of a successful vaccine against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the agent of coronavirus disease 2019 (COVID-19), in an unmatched period of ten months, is a tribute to human ingenuity in the face of a vicious pandemic. A return to pre-pandemic `normalcy` depends on the successful delivery of the vaccine to a majority (~70%) so as to develop herd immunity critical to arrest the community spread of infection. Vaccination against COVID-19 is particularly important for dentistry as the dental team works in an environment replete with aerosol-generating procedures (AGP) that facilitate virus spread. Hence, a COVID-19 vaccine is likely to be an obligatory requirement for the dental practice, and the latest addition to the extensive list of vaccines required for dental professionals for the safe delivery of dental care. Here, we review the currently available major candidate vaccines against SARS-CoV-2 and their benefits and risks. These include the vaccines developed on next-generation platforms (mRNA, DNA, and viral vector vaccines), and the classic platforms (the live-attenuated virus, and the protein subunit vaccines) The review concludes with a summary of impending issues and challenges facing the provision of COVID-19 vaccines for all stakeholders in dentistry. URL: https://www.ncbi.nlm.nih.gov/pubmed/33991381 DOI: 10.1111/odi.13916

Evidence Search Report: INF031801v5 ESR 74 10.1111/odi.13916.

172. Santosa A, Xu C, Arkachaisri T, et al. Recommendations for COVID-19 vaccination in people with rheumatic disease: Developed by the Singapore Chapter of Rheumatologists. Int J Rheum Dis. 2021. DOI: 10.1111/1756- 185X.14107 10.1111/1756-185X.14107. ABSTRACT: AIM: People with rheumatic diseases (PRD) remain vulnerable in the era of the COVID-19 pandemic. We formulated recommendations to meet the urgent need for a consensus for vaccination against SARS-CoV-2 in PRD. METHODS: Systematic literature reviews were performed to evaluate: (a) outcomes in PRD with COVID-19; (b) efficacy, immunogenicity and safety of COVID-19 vaccination; and (c) published guidelines/recommendations for non-live, non-COVID-19 vaccinations in PRD. Recommendations were formulated based on the evidence and expert opinion according to the Grading of Recommendations Assessment, Development and Evaluation methodology. RESULTS: The consensus comprises 2 overarching principles and 7 recommendations. Vaccination against SARS-CoV-2 in PRD should be aligned with prevailing national policy and should be individualized through shared decision between the healthcare provider and patient. We strongly recommend that eligible PRD and household contacts be vaccinated against SARS-CoV-2. We conditionally recommended that the COVID-19 vaccine be administered during quiescent disease if possible. Immunomodulatory drugs, other than rituximab, can be continued alongside vaccination. We conditionally recommend that the COVID-19 vaccine be administered prior to commencing rituximab if possible. For patients on rituximab, the vaccine should be administered a minimum of 6 months after the last dose and/or 4 weeks prior to the next dose of rituximab. Post-vaccination antibody titers against SARS-CoV-2 need not be measured. Any of the approved COVID-19 vaccines may be used, with no particular preference. CONCLUSION: These recommendations provide guidance for COVID-19 vaccination in PRD. Most recommendations in this consensus are conditional, reflecting a lack of evidence or low-level evidence. URL: https://www.ncbi.nlm.nih.gov/pubmed/33973379 DOI: 10.1111/1756-185X.14107 10.1111/1756-185X.14107.

173. Selby LM, Hewlett AL, Cawcutt KA, et al. Effect of severe acute respiratory coronavirus virus 2 (SARS-CoV-2) mRNA vaccination in healthcare workers with high-risk coronavirus disease 2019 (COVID-19) exposure. Infect Control Hosp Epidemiol. 2021:1-2. DOI: 10.1017/ice.2021.193 10.1017/ice.2021.193. ABSTRACT: Appropriate precautions for fully vaccinated healthcare providers following high risk household SARS CoV-2 exposure remains unknown. Herein, we report initial results from our employee health protocol for such situations. Copyright © 2021 by The Society for Healthcare Epidemiology of America. All rights reserved. URL: https://www.ncbi.nlm.nih.gov/pubmed/33934742 DOI: 10.1017/ice.2021.193 10.1017/ice.2021.193.

174. Shaker M, Phillips E, Blumenthal KG, et al. The Importance of a Timely Second Dose of the 2021 COVID-19 mRNA Vaccine Depends on the Protection Afforded by a First Dose and Subsequent Risk of Anaphylaxis. J Allergy Clin Immunol Pract. 2021. DOI: 10.1016/j.jaip.2021.04.015 10.1016/j.jaip.2021.04.015. ABSTRACT: Vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) represents our greatest hope to combat the devastating coronavirus disease 2019 (COVID-19) pandemic. Amid ongoing global vaccination efforts, rare cases of severe allergic reactions to COVID-19 mRNA vaccines have received significant attention. Although the exact nature of these reactions may be heterogeneous, various approaches exist to engage with patients, communities, public health departments, primary care providers, and other clinicians in a multidisciplinary approach to advance population health. Whereas it is optimal for patients to receive COVID-19 vaccination as outlined in emergency use authorizations, second-dose deferral of mRNA vaccines may be a consideration within a shared decision-making paradigm of care in select circumstances characterized by high durable first-vaccine-dose protection and significant elevations of vaccine anaphylaxis risk. Still, the durability of protection afforded by a single dose of a COVID-19 mRNA vaccine is uncertain, and alternative approaches to complete vaccination, including precautionary use of a COVID-19 , also remain patient-

Evidence Search Report: INF031801v5 ESR 75 preference-sensitive options. There is an urgent need to define correlates of COVID-19 immunity and the level of longer-term protection afforded by COVID-19 vaccination. URL: https://www.ncbi.nlm.nih.gov/pubmed/33892171 DOI: 10.1016/j.jaip.2021.04.015 10.1016/j.jaip.2021.04.015.

175. She R, Chen X, Li L, et al. Factors associated with behavioral intention of free and self-paid COVID-19 vaccination based on the social cognitive theory among nurses and doctors in China. Infect Control Hosp Epidemiol. 2021:1-25. DOI: 10.1017/ice.2021.201 10.1017/ice.2021.201. ABSTRACT: OBJECTIVE: To examine the associations between factors based on the Social Cognitive Theory (SCT) and behavioral intention of free and self-paid (600 RMB or 91 USD) COVID-19 vaccination of 80% effectiveness and rare mild side effects among doctors and nurses in China. DESIGN: Cross-sectional study. SETTING: Public hospitals. PARTICIPANTS: 362 doctors and 1702 nurses in major departments of five hospitals of three Chinese provinces. METHODS: An anonymous online survey was conducted from October to November 2020, facilitated by hospital administrators through online WeChat/QQ working groups. Data on outcome expectations, self-efficacy, norms, and COVID-19-related work experiences were collected. Multivariate logistic regression models were used for data analysis. RESULTS: The logistic regression analysis showed that physical (e.g., protective effect of vaccination) and self-evaluative outcome expectations (e.g., anticipated regret), self-efficacy, norms (e.g., descriptive norm, subjective norm, professional norm, and moral norm), and job satisfaction were significantly and positively associated with the free and self-paid COVID-19 vaccination intention outcomes among doctors and nurses, adjusted for background variables. Doctors who had engaged in COVID-19-related work reported higher self-paid vaccination intention. CONCLUSIONS: Health promotion is needed to improve the uptake of COVID-19 vaccination among healthcare workers. Such interventions may consider modifying the identified factors of vaccination intention, including strengthening perceived efficacy, positive feelings about vaccination, the need to avoid future regret, self-efficacy, and social norms. Future studies should examine the actual behavior patterns of COVID-19 vaccination and testing the efficacy of promotion intervention through randomized controlled studies. URL: https://www.ncbi.nlm.nih.gov/pubmed/33938413 DOI: 10.1017/ice.2021.201 10.1017/ice.2021.201.

176. Simon B, Rubey H, Treipl A, et al. Haemodialysis patients show a highly diminished antibody response after COVID-19 mRNA vaccination compared to healthy controls. Nephrol Dial Transplant. 2021;17:17. DOI: 10.1093/ndt/gfab179 10.1093/ndt/gfab179. ABSTRACT: BACKGROUND: Haemodialysis (HD) patients are exposed to a high risk due to the SARS-CoV-2 pandemic. They are prone to acquiring the infection and are threatened by high mortality rates in case of infection. However, HD patients were not included in the efficacy trials of the SARS-CoV-2 vaccines. Such efficacy data would have been critical because HD patients show decreased responses against various other vaccines and this could translate to the SARS-CoV-2 vaccines as well. METHODS: We conducted a prospective cohort study that contained a group of 81 HD patients and 80 healthy controls. All of them had been vaccinated with the BioNTech/Pfizer mRNA vaccine (two doses, as per the manufacturer's recommendation). The anti-SARS-CoV-2 S antibody response was measured for all participants 21 days after the second dose. The groups were compared using univariate quantile regressions and a multivariate analysis. The adverse events (AEs) of the vaccination were assessed via a questionnaire. Finally, a correlation between the HBs-Antibody response and the SARS-CoV-2 antibody response in the HD patients was established. RESULTS: The HD patients had significantly lower Anti -SARS-CoV-2 S antibody titres than the control patients 21 days after vaccination (median was 171 U/ml for dialysis patients and 2,500 U/ml for the controls). Further, the HD group presented less AEs than the control group. No correlation was found between the antibody response to previous Hepatitis B vaccination and that of the SARS-CoV-2 vaccine. CONCLUSIONS: HD patients present highly diminished SARS-CoV-2 S antibody titres compared to a cohort of controls. Therefore, they could be much less protected by SARS-CoV-2 mRNA vaccinations than expected. Further studies to test alternative vaccination schemes should be considered. URL: https://www.ncbi.nlm.nih.gov/pubmed/33999200

Evidence Search Report: INF031801v5 ESR 76 DOI: 10.1093/ndt/gfab179 10.1093/ndt/gfab179.

177. Skowronski DM, De Serres G. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2021;384(16):1576-7. DOI: 10.1056/NEJMc2036242 10.1056/NEJMc2036242. Epub 2021 Feb 17. URL: https://www.ncbi.nlm.nih.gov/pubmed/33596348 DOI: 10.1056/NEJMc2036242 10.1056/NEJMc2036242. Epub 2021 Feb 17.

178. Soeiro T, Salvo F, Pariente A, et al. Type I interferons as the potential mechanism linking mRNA COVID-19 vaccines to Bell's palsy. Therapie. 2021. DOI: 10.1016/j.therap.2021.03.005 10.1016/j.therap.2021.03.005. URL: https://www.ncbi.nlm.nih.gov/pubmed/33858693 DOI: 10.1016/j.therap.2021.03.005 10.1016/j.therap.2021.03.005.

179. Sonderskov KM, Dinesen PT, Ostergaard SD. Sustained COVID-19 vaccine willingness after safety concerns over the Oxford-AstraZeneca vaccine. Dan Med J. 2021;68(5). ABSTRACT: INTRODUCTION Prompted by reports of thromboembolic events - some with fatal outcomes - among people who had received the ChAdOx1 nCoV-19 (AZD1222) vaccine from Oxford-AstraZeneca against COVID-19, a number of European countries paused vaccination with this vaccine in early and mid-March 2021. Prior studies have suggested that vaccine willingness is highly dependent on public trust in the s afety of vaccines. We therefore investigated whether vaccine willingness dropped in the wake of the reported cases of thromboembolic events in relation to the Oxford-AstraZeneca COVID-19 vaccine. METHODS Using longitudinal survey data from Denmark, we compared vaccine willingness shortly before and after the reported cases of thromboembolic events, as well as the perceived safety of the two most widely used COVID-19 vaccines in Denmark - those from Pfizer-BioNTech and Oxford-AstraZeneca - in the wake of these events. RESULTS We found sustained vaccine willingness after the reported cases of thromboembolic events (89% both before and after). However, the safety of the Oxford- AstraZeneca COVID-19 vaccine was perceived to be significantly and substantially lower than the safety of the vaccine from Pfizer-BioNTech, and this difference was particularly pronounced among those who were vaccine- hesitant. CONCLUSIONS The vaccine willingness of Danes does not seem to have been affected by the reports of thromboembolic events in relation to the Oxford-AstraZeneca COVID-19 vaccine. FUNDING The study was funded by a grant from the Novo Nordisk Foundation (grant number: NNF20SA0062874). TRIAL REGISTRATION not relevant. URL: https://www.ncbi.nlm.nih.gov/pubmed/33870886

180. Spagnolo F, Boutros A, Croce E, et al. Influenza vaccination in cancer patients receiving immune checkpoint inhibitors: A systematic review. Eur J Clin Invest. 2021:e13604. DOI: 10.1111/eci.13604 10.1111/eci.13604. ABSTRACT: BACKGROUND: There is a concern that influenza vaccination may increase the incidence of immune- related adverse events in patients receiving immune checkpoint inhibitors. The aim of this systematic review was to summarize the available data on the safety and efficacy of influenza vaccination in cancer patients receiving immune checkpoint inhibitors. METHODS: Studies reporting safety and efficacy outcomes of influenza vaccination in cancer patients receiving immune checkpoint inhibitors were included. Only descriptive statistics were conducted to obtain a pooled rate of immune-related adverse events in vaccinated patients. RESULTS: Ten studies assessing the safety and eight assessing the efficacy of influenza vaccination in cancer patients receiving immune checkpoint inhibitors were identified, for a total of 1,124 and 986 vaccinated patients, respectively. Most patients had melanoma or lung cancer and received a single agent anti-PD-1, but also other tumor types and immunotherapy combinations were represented. No severe vaccination-related toxicities were reported. The pooled incidence of any grade immune checkpoint inhibitor-related adverse events was 28.9%. In the 6 studies specifying the incidence of grade 3-4 toxicities, the pooled incidence was 7.5%. No grade 5 toxicities were reported. No pooled descriptive analysis was conducted in studies reporting efficacy outcomes due to the

Evidence Search Report: INF031801v5 ESR 77 heterogeneity of endpoints and data reporting. Nevertheless, among the eight studies included, seven reported positive efficacy outcomes of influenza vaccination. CONCLUSION: The results of this systematic review support the safety and efficacy of influenza vaccination in cancer patients receiving immune checkpoint inhibitors. These results are particularly relevant in the context of the SARS-Cov-2 pandemic. URL: https://www.ncbi.nlm.nih.gov/pubmed/34021591 DOI: 10.1111/eci.13604 10.1111/eci.13604.

181. Stapelberg NJC, Smoll NR, Randall M, et al. A Discrete-Event, Simulated Social Agent-Based Network Transmission (DESSABNeT) model for communicable diseases: Method and validation using SARS-CoV-2 data in three large Australian cities. PLoS One. 2021;16(5):e0251737. DOI: 10.1371/journal.pone.0251737 10.1371/journal.pone.0251737. eCollection 2021. ABSTRACT: IMPORTANCE: During pandemics Agent Based Models (ABMs) can model complex, fine-grained behavioural interactions occurring in social networks, that contribute to disease transmission by novel viruses such as SARS-CoV-2. OBJECTIVE: We present a new agent-based model (ABM) called the Discrete-Event, Simulated Social Agent based Network Transmission model (DESSABNeT) and demonstrate its ability to model the spread of COVID-19 in large cities like Sydney, Melbourne and Gold Coast. Our aim was to validate the model with its disease dynamics and underlying social network. DESIGN: DESSABNeT relies on disease transmission within simulated social networks. It employs an epidemiological SEIRD+M (Susceptible, exposed, infected, recovered, died and managed) structure. One hundred simulations were run for each city, with simulated social restrictions closely modelling real restrictions imposed in each location. MAIN OUTCOME(S) AND MEASURE(S): The mean predicted daily incidence of COVID-19 cases were compared to real case incidence data for each city. Reff and health service utilisation outputs were compared to the literature, or for the Gold Coast with daily incidence of hospitalisation. RESULTS: DESSABNeT modelled multiple physical distancing restrictions and predicted epidemiological outcomes of Sydney, Melbourne and the Gold Coast, validating this model for future simulation work. CONCLUSIONS AND RELEVANCE: DESSABNeT is a valid platform to model the spread of COVID-19 in large cities in Australia and potentially internationally. The platform is suitable to model different combinations of social restrictions, or to model contact tracing, predict, and plan for, the impact on hospital and ICU admissions, and deaths; and also the rollout of COVID-19 vaccines and optimal social restrictions during vaccination. URL: https://www.ncbi.nlm.nih.gov/pubmed/34019561 DOI: 10.1371/journal.pone.0251737 10.1371/journal.pone.0251737. eCollection 2021.

182. Sultan S, Siddique SM, Singh S, et al. AGA Rapid Review and Guideline for SARS-CoV2 Testing and Endoscopy Post-Vaccination: 2021 Update. Gastroenterology. 2021;21:21. DOI: 10.1053/j.gastro.2021.05.039 10.1053/j.gastro.2021.05.039. ABSTRACT: This guideline provides updated recommendations on the role of pre-procedure testing for SARS-CoV2 in individuals undergoing endoscopy in the post-vaccination period and replaces the prior guideline from the American Gastroenterological Association (released July 29, 2020). Since the start of the pandemic, our increased understanding of transmission has facilitated the implementation of practices to promote patient and healthcare worker (HCW) safety. Simultaneously, there has been increasing recognition of the potential harm associated with delays in patient care as well as inefficiency of endoscopy units. With widespread vaccination of HCWs and the general population, a re-evaluation of AGA's prior recommendations was warranted. In order to update the role of pre-procedure testing for SARS-CoV2, the AGA guideline panel reviewed the evidence on (1) prevalence of asymptomatic SARS-CoV2 infections in individuals undergoing endoscopy, (2) patient and HCW risk of infections that may be acquired immediately before, during, or after endoscopy, (3) effectiveness of COVID-19 vaccine in reducing risk of infections and transmission, (4) patient and HCW anxiety, (5) patient delays in care and potential impact on cancer burden, and (6) endoscopy volumes. The panel considered the certainty of the evidence, weighed the benefits and harms of routine pre-procedure testing, and considered burden, equity, and cost using the GRADE framework. Based on very low certainty evidence, the panel made a conditional recommendation against routine pre-procedure testing for SARS-CoV2 in patients scheduled to undergo endoscopy. The panel placed a high value on minimizing additional delays in patient care, acknowledging the reduced endoscopy volumes, downstream impact on delayed cancer diagnoses and burden of testing on patients.

Evidence Search Report: INF031801v5 ESR 78 URL: https://www.ncbi.nlm.nih.gov/pubmed/34029569 DOI: 10.1053/j.gastro.2021.05.039 10.1053/j.gastro.2021.05.039.

183. SÜMbÜL AT, YalÇIn Ş, ÖZet A, et al. Turkish Society of Medical Oncology COVID-19 Pandemic Advisory Board Updated Recommendations for Medical Oncologists: Included Vaccination. Journal of Oncological Sciences. 2021;7(1):1-6. DOI: 10.37047/jos.2021-81962 URL: http://www.journalofoncology.org/current-issue/get- pdf/169/119331003862315.pdfhttps://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=e mexb&AN=2006972187https://libkey.io/libraries/843/openurl?output=full&sid=OVID:embase&id=pmid:&id=doi:1 0.37047%2Fjos.2021-81962&issn=2452-3364&isbn=&volume=7&issue=1&spage=1&pages=1- 6&date=2021&title=Journal+of+Oncological+Science&atitle=Turkish+society+of+medical+oncology+covid- 19+pandemic+advisory+board+updated+recommendations+for+medical+oncologists%3A+Included+vaccination&a ulast=Sumbul&pid=%3Cauthor%3ESumbul+A.T.%3BYalcin+S.%3BOzet+A.%3BUnal+S.%3BDizdar+O.%3BAkbulut+H. %3BKaraoglu+A.%3BKaradurmus+N.%3BSendur+M.A.N.%3BCilbir+E.%3BYildiz+F.%3BTufan+G.%3BUysal+Sonmez+ O.%3BTurhal+N.S.%3C%2Fauthor%3E%3CAN%3E2006972187%3C%2FAN%3E%3CDT%3EEditorial%3C%2FDT%3E DOI: 10.37047/jos.2021-81962

184. Taborska P, Strizova Z, Stakheev D, et al. CD4(+) T Cells of Prostate Cancer Patients Have Decreased Immune Responses to Antigens Derived From SARS-CoV-2 Spike Glycoprotein. Front Immunol. 2021;12:629102. DOI: 10.3389/fimmu.2021.629102 10.3389/fimmu.2021.629102. eCollection 2021. ABSTRACT: The adaptive immune response to severe acute respiratory coronavirus 2 (SARS-CoV-2) is important for vaccine development and in the recovery from coronavirus disease 2019 (COVID-19). Men and cancer patients have been reported to be at higher risks of contracting the virus and developing the more severe forms of COVID- 19. Prostate cancer (PCa) may be associated with both of these risks. We show that CD4(+) T cells of SARS-CoV-2- unexposed patients with hormone-refractory (HR) metastatic PCa had decreased CD4(+) T cell immune responses to antigens from SARS-CoV-2 spike glycoprotein but not from the spiked glycoprotein of the 'common cold'- associated human coronavirus 229E (HCoV-229E) as compared with healthy male volunteers who responded comparably to both HCoV-229E- and SARS-CoV-2-derived antigens. Moreover, the HCoV-229E spike glycoprotein antigen-elicited CD4(+) T cell immune responses cross-reacted with the SARS-CoV-2 spiked glycoprotein antigens. PCa patients may have impaired responses to the vaccination, and the cross-reactivity can mediate antibody- dependent enhancement (ADE) of COVID-19. These findings highlight the potential for increased vulnerability of PCa patients to COVID-19. URL: https://www.ncbi.nlm.nih.gov/pubmed/34012431 DOI: 10.3389/fimmu.2021.629102 10.3389/fimmu.2021.629102. eCollection 2021.

185. Tan CS, Hamzah ND, Ismail ZHF, et al. Self-sampling in Human Papillomavirus screening during and post- COVID-19 pandemic. Med J Malaysia. 2021;76(3):298-303. ABSTRACT: INTRODUCTION: Cervical cancer is the third most common cancer among Malaysian women. Sarawak, the largest state in Malaysia has consistently recorded the highest cervical cancer rate in the country where nearly half of its population still live in the rural areas and is at increased risk of the disease due to inequitable access to healthcare. The countrywide lockdown due to the COVID-19 pandemic had halted the accessibility to cervical cancer screening programme. The aim of the study is to determine the feasibility of providing primary HPV DNA test using the selfsampling method to the hard-to-reach population in the interior of Sarawak during the COVID-19 pandemic. MATERIALS AND METHODS: This is a cross-sectional study where women aged between 20-80 years were recruited via convenient sampling from villages in Long Banga, Sarawak over a five-day outreach programme. Cervicovaginal selfsamples were obtained and screened for the presence of high-risk human papillomavirus DNA (HR-HPV) using the careHPVTM Test. A self-administered questionnaire was also administered to determine the sociodemographic and perception towards the self-sampling method. RESULTS: The 55 women recruited consist of ethnic backgrounds of Penan (58.18%), Kenyah (25.45%), Iban (5.45%), Saban (3.64%), Kelabit (3.64%), Malay (1.82%) and Chinese (1.82%). The prevalence of HR-HPV was 1.85% (n=1/55). Nearly 80% of the women were

Evidence Search Report: INF031801v5 ESR 79 unemployed, and more than half have had attended primary education. Nine (16.4%) have heard about HPV, and seven (13%) knew HPV infection could cause cervical cancer. Three of them had HPV vaccination, and only one (1.85%) knew the brand of the HPV vaccine. Although 40% preferred self-sampling over clinician-collection, only ten (18.2%) women have completed the self-collection perception questionnaire. CONCLUSION: Primary HPV DNA screening using the selfsampling method can be carried out in the remote areas during the COVID-19 pandemic without compromising mobility restriction. URL: https://www.ncbi.nlm.nih.gov/pubmed/34031326

186. Thiel N, Selwyn C, Murphy G, et al. Recommendations for acceleration of vaccine development and emergency use filings for COVID-19 leveraging lessons from the novel oral . NPJ Vaccines. 2021;6(1):63. DOI: 10.1038/s41541-021-00325-4 10.1038/s41541-021-00325-4. ABSTRACT: A new oral polio vaccine, nOPV2, has become the first vaccine to pursue a WHO Emergency Use Listing. Many lessons were learned as part of the accelerated development plan and submission, which have been categorized under the following sections: regulatory, clinical development, chemistry manufacturing and controls, and post-deployment monitoring. Efforts were made to adapt findings from these studies to COVID-19 vaccine candidates. Specific concepts for accelerating COVID-19 vaccine development across multiple functional domains were also included. The goals of this effort were twofold: (1) to help familiarize vaccine developers with the EUL process; and (2) to provide general guidance for faster development and preparations for launch during the COVID-19 pandemic. URL: https://www.ncbi.nlm.nih.gov/pubmed/33888722 DOI: 10.1038/s41541-021-00325-4 10.1038/s41541-021-00325-4.

187. Tobaiqy M, Elkout H, MacLure K. Analysis of Thrombotic Adverse Reactions of COVID-19 AstraZeneca Vaccine Reported to EudraVigilance Database. Vaccines (Basel). 2021;9(4). DOI: 10.3390/vaccines9040393 10.3390/vaccines9040393. ABSTRACT: The development of safe, effective, affordable vaccines against COVID-19 remains the cornerstone to mitigating this pandemic. Early in December 2020, multiple research groups had designed potential vaccines. From 11 March 2021, several European countries temporarily suspended the use of the Oxford-AstraZeneca vaccine amid reports of blood clot events and the death of a vaccinated person, despite the European Medicines Agency (EMA) and the World Health Organization's assurance that there was no indication that vaccination was linked. This study aimed to identify and analyse the thrombotic adverse reactions associated with the Oxford-AstraZeneca vaccine. This was a retrospective descriptive study using spontaneous reports submitted to the EudraVigilance database in the period from 17 February to 12 March 2021. There were 54,571 adverse reaction reports, of which 28 were associated with thrombotic adverse reactions. Three fatalities were related to pulmonary embolism; one fatality to thrombosis. With 17 million people having had the AstraZeneca vaccine, these are extremely rare events The EMA's Pharmacovigilance Risk Assessment Committee (18 March 2021) concluded that the vaccine was safe, effective and the benefits outweighed the risks. Conducting further analyses based on more detailed thrombotic adverse event reports, including patients' characteristics and comorbidities, may enable assessment of the causality with higher specificity. URL: https://www.ncbi.nlm.nih.gov/pubmed/33923530 DOI: 10.3390/vaccines9040393 10.3390/vaccines9040393.

188. Tougeron D, Hentzien M, Seitz-Polski B, et al. Severe acute respiratory syndrome coronavirus 2 vaccination for patients with solid cancer: Review and point of view of a French oncology intergroup (GCO, TNCD, UNICANCER). Eur J Cancer. 2021;150:232-9. DOI: 10.1016/j.ejca.2021.03.030 10.1016/j.ejca.2021.03.030. Epub 2021 Apr 1. ABSTRACT: The impacts of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic on cancer care are multiple, entailing a high risk of death from coronavirus disease 2019 (COVID-19) in patients with cancer treated by chemotherapy. SARS-CoV-2 vaccines represent an opportunity to decrease the rate of severe COVID-19 cases in patients with cancer and also to restore normal cancer care. Patients with cancer to be targeted for

Evidence Search Report: INF031801v5 ESR 80 vaccination are difficult to define owing to the limited contribution of these patients in the phase III trials testing the different vaccines. It seems appropriate to vaccinate not only patients with cancer with ongoing treatment or with a treatment having been completed less than 3 years ago but also household and close contacts. High-risk patients with cancer who are candidates for priority access to vaccination are those treated by chemotherapy. The very high-priority population includes patients with curative treatment and palliative first- or second-line chemotherapy, as well as patients requiring surgery or radiotherapy involving a large volume of lung, lymph node and/or haematopoietic tissue. When possible, vaccination should be carried out before cancer treatment begins. SARS-CoV-2 vaccination can be performed during chemotherapy while avoiding periods of neutropenia and lymphopenia. For organisational reasons, vaccination should be performed in cancer care centres with messenger RNA vaccines (or non-replicating adenoviral vaccines in non-immunocompromised patients). Considering the current state of knowledge, the benefit-risk ratio strongly favours SARS-CoV-2 vaccination of all patients with cancer. To obtain more data concerning the safety and effectiveness of vaccines, it is necessary to implement cohorts of vaccinated patients with cancer. URL: https://www.ncbi.nlm.nih.gov/pubmed/33934060 DOI: 10.1016/j.ejca.2021.03.030 10.1016/j.ejca.2021.03.030. Epub 2021 Apr 1.

189. Tre-Hardy M, Cupaiolo R, Papleux E, et al. Reactogenicity, safety and antibody response, after one and two doses of mRNA-1273 in seronegative and seropositive healthcare workers. J Infect. 2021. DOI: 10.1016/j.jinf.2021.03.025 10.1016/j.jinf.2021.03.025. URL: https://www.ncbi.nlm.nih.gov/pubmed/33811939 DOI: 10.1016/j.jinf.2021.03.025 10.1016/j.jinf.2021.03.025.

190. Tsalouchos A, Rossolini GM, Magg L, et al. COVID-19 in a kidney transplant recipient after mRNA-based SARS-CoV-2 vaccination. Transpl Infect Dis. 2021:e13649. DOI: 10.1111/tid.13649 10.1111/tid.13649. ABSTRACT: Immunocompromised patients, including solid organ transplant recipients (SOTRs), were not included in the two large trials of Pfizer/BioNTech and Moderna mRNA vaccines, and therefore, safety and effi cacy data are lacking in this population. Recently, immunogenicity, at a median of 29 days, after dose 2 of the mRNA SARS-CoV-2 vaccines have been studied among 658 SOTRs. 46% of participants did not mount anti spike antibody responses suggesting that such patients may remain at high risk for COVID-19 despite vaccination. URL: https://www.ncbi.nlm.nih.gov/pubmed/34032340 DOI: 10.1111/tid.13649 10.1111/tid.13649.

191. Vilches TN, Nourbakhsh S, Zhang K, et al. Multifaceted strategies for the control of COVID-19 outbreaks in long-term care facilities in Ontario, Canada. Prev Med. 2021;148(106564):106564. DOI: 10.1016/j.ypmed.2021.106564 10.1016/j.ypmed.2021.106564. Epub 2021 Apr 18. ABSTRACT: The novel coronavirus disease 2019 (COVID-19) has caused severe outbreaks in Canadian long-term care facilities (LTCFs). In Canada, over 80% of COVID-19 deaths during the first pandemic wave occurred in LTCFs. We sought to evaluate the effect of mitigation measures in LTCFs including frequent testing of staff, and vaccination of staff and residents. We developed an agent-based transmission model and parameterized it with disease-specific estimates, temporal sensitivity of nasopharyngeal and saliva testing, results of vaccine efficacy trials, and data from initial COVID-19 outbreaks in LTCFs in Ontario, Canada. Characteristics of staff and residents, including contact patterns, were integrated into the model with age-dependent risk of hospitalization and death. Estimates of infection and outcomes were obtained and 95% credible intervals were generated using a bias- corrected and accelerated bootstrap method. Weekly routine testing of staff with 2-day turnaround time reduced infections among residents by at least 25.9% (95% CrI: 23.3%-28.3%), compared to baseline measures of mask- wearing, symptom screening, and staff cohorting alone. A similar reduction of hospitalizations and deaths was achieved in residents. Vaccination averted 2-4 times more infections in both staff and residents as compared to

Evidence Search Report: INF031801v5 ESR 81 routine testing, and markedly reduced hospitalizations and deaths among residents by 95.9% (95% CrI: 95.4%- 96.3%) and 95.8% (95% CrI: 95.5%-96.1%), respectively, over 200 days from the start of vaccination. Vaccination could have a substantial impact on mitigating disease burden among residents, but may not eliminate the need for other measures before population-level control of COVID-19 is achieved. URL: https://www.ncbi.nlm.nih.gov/pubmed/33878351 DOI: 10.1016/j.ypmed.2021.106564 10.1016/j.ypmed.2021.106564. Epub 2021 Apr 18.

192. von Lilienfeld-Toal M, Rieger C, Giesen N, et al. [Vaccination against SARS-CoV-2 in cancer patients]. Onkologe (Berl). 2021:1-6. DOI: 10.1007/s00761-021-00972-1 10.1007/s00761-021-00972-1. ABSTRACT: Patients with cancer are at an increased risk to suffer severe coronavirus disease 2019 (COVID-19). Therefore, specific preventative measures including COVID-19 vaccines are especially important. Both anticancer therapies and the underlying malignancy itself can lead to significant immunosuppression posing a particular challenge for vaccination strategies in these patients. At the moment, four COVID-19 vaccines are European Medicines Agency (EMA) approved in Germany: two mRNA and two viral vector-based vaccines. All four vaccines show excellent protection against severe COVID-19. Their mechanism of action relies on the induction of the production of virus-specific proteins by human cells and the following activation of a specific adaptive immune response. Vaccination against COVID-19 has been prioritized for cancer patients and medical personnel in Germany. Regarding timing of vaccination, vaccination prior to initiation of anticancer therapy seems ideal in newly diagnosed disease. However, due to the significant risk of severe COVID-19 in cancer patients, vaccination is also strongly recommended for patients already undergoing anticancer therapy. In these patients, immune response might be reduced. In two particular patient cohorts, namely stem cell transplant recipients and patients treated with Bcell depleting agents, an interval of several months following therapy is recommended because otherwise the response to vaccination will most likely be severely reduced. Preliminary data suggest only low rates of seroconversion following a single shot of vaccine in cancer patients. Therefore, on the long run, repeat vaccination regimens might be preferable in cancer patients. URL: https://www.ncbi.nlm.nih.gov/pubmed/34025046 DOI: 10.1007/s00761-021-00972-1 10.1007/s00761-021-00972-1.

193. Wadei HM, Gonwa TA, Leoni JC, et al. COVID-19 infection in solid organ transplant recipients after SARS- CoV-2 vaccination. Am J Transplant. 2021. DOI: 10.1111/ajt.16618 10.1111/ajt.16618. URL: https://www.ncbi.nlm.nih.gov/pubmed/33890410 DOI: 10.1111/ajt.16618 10.1111/ajt.16618.

194. Wagner AL, Sheinfeld Gorin S, Boulton ML, et al. Effect of vaccine effectiveness and safety on COVID-19 vaccine acceptance in Detroit, Michigan, July 2020. Hum Vaccin Immunother. 2021:1-6. DOI: 10.1080/21645515.2021.1917233 10.1080/21645515.2021.1917233. ABSTRACT: This study examined whether future COVID-19 vaccine acceptance differed based on an experimental manipulation of the vaccine safety and effectiveness profile. Data come from the Detroit Metro Area Community Study, a population-based study conducted July 15-20, 2020. Participants were asked whether they would get a new COVID-19 vaccine after being randomly assigned information about the vaccine's effectiveness (50% or 95%) and chance of fever (5% or 20%). Among 1,117 Detroiters, 51.3% would accept a COVID-19 vaccine that is 50% effective and 77.1% would accept a vaccine that is 95% effective. Women and adults >/=65 were more accepting of a vaccine; Black Detroiters were less accepting. Believing vaccines to be important, effective, and safe was associated with higher acceptance. Uptake of a COVID-19 may be limited, depending on perceived vaccine effectiveness and general attitudes toward vaccines. Public health approaches to modifying these attitudes will be especially important in the Black community. URL: https://www.ncbi.nlm.nih.gov/pubmed/33998949

Evidence Search Report: INF031801v5 ESR 82 DOI: 10.1080/21645515.2021.1917233 10.1080/21645515.2021.1917233.

195. Wallace M, Woodworth KR, Gargano JW, et al. The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Adolescents Aged 12-15 Years - United States, May 2021. MMWR Morb Mortal Wkly Rep. 2021;70(20):749-52. DOI: 10.15585/mmwr.mm7020e1 10.15585/mmwr.mm7020e1. ABSTRACT: The Pfizer-BioNTech COVID-19 (BNT162b2) vaccine is a lipid nanoparticle-formulated, nucleoside- modified mRNA vaccine encoding the prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. Vaccination with the Pfizer-BioNTech COVID-19 vaccine consists of 2 intramuscular doses (30 mug, 0.3 mL each) administered 3 weeks apart. On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for use of the Pfizer-BioNTech COVID-19 vaccine (Pfizer, Inc; Philadelphia, Pennsylvania) in persons aged >/=16 years (1); on December 12, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of the vaccine in the same age group (2). As of May 12, 2021, approximately 141.6 million doses of the Pfizer-BioNTech COVID-19 vaccine had been administered to persons aged >/=16 years.* On May 10, 2021, FDA expanded the EUA for the Pfizer-BioNTech COVID-19 vaccine to include adolescents aged 12-15 years (1). On May 12, 2021, ACIP issued an interim recommendation(dagger) for use of the Pfizer-BioNTech COVID-19 vaccine in adolescents aged 12-15 years for the prevention of COVID-19. To guide its deliberations regarding the vaccine, ACIP used the Evidence to Recommendation (EtR) Framework,( section sign) using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.( paragraph sign) The ACIP recommendation for the use of the Pfizer-BioNTech COVID-19 vaccine in persons aged >/=12 years under an EUA is interim and will be updated as additional information becomes available. URL: https://www.ncbi.nlm.nih.gov/pubmed/34014913 DOI: 10.15585/mmwr.mm7020e1 10.15585/mmwr.mm7020e1.

196. Wang G, Zhu L, Zhu Y, et al. Safety survey by clinical pharmacists on COVID-19 vaccination from a single center in China. Hum Vaccin Immunother. 2021:1-5. DOI: 10.1080/21645515.2021.1913964 10.1080/21645515.2021.1913964. ABSTRACT: This study explored the safety of COVID-19 vaccine (Aikewei) and the role of clinical pharmacists in the implementation of COVID-19 vaccination. A total of 2305 hospital employees in Children's Hospital of Fudan University in Shanghai, China received the COVID-19 vaccine. The whole process of vaccination was monitored by clinical pharmacists, and the occurrence, types, severity of adverse reactions were recorded in detail. Through the investigation and analysis on the safety of COVID-19 vaccination of the 2305 people, the important role and value of clinical pharmacists in the vaccination process was elaborated. Common adverse reactions included local pain, dizziness and fatigue, with the incidence rates of 2.09%, 0.67% and 0.49%, respectively. Others such as headache, nausea, skin itching, cough, palpitation, dry mouth, hand anesthesia, local induration, muscle soreness, local rash, and chill had incidence rates of less than 0.30%. Three cases of serious adverse events that occurred in this vaccination returned to normal after treatment, with no subsequent discomfort. Clinical pharmacists played an important role in the safety monitoring of COVID-19 vaccination. The safety of the inactivated COVID-19 vaccine is good. Most of the common adverse reactions were mild and tolerable, with generally low incidence. The work of clinical pharmacists is important and can be expanded in the future to ensure the safety of vaccination and to provide better health care service. URL: https://www.ncbi.nlm.nih.gov/pubmed/33886411 DOI: 10.1080/21645515.2021.1913964 10.1080/21645515.2021.1913964.

197. Wang L, Xu Y, Zhang L, et al. [COVID-19 Vaccination for Cancer Patients: Progress and Preliminary Recommendations]. Zhongguo Fei Ai Za Zhi. 2021;24:24. DOI: 10.3779/j.issn.1009-3419.2021.101.18 10.3779/j.issn.1009-3419.2021.101.18. ABSTRACT: The pandemic of coronavirus disease 2019 (COVID-19) has had a serious impact on global health. COVID-19 vaccines may be one of the most effective measure to end the pandemic. High infection risk and higher serious incident and mortality rates have been shown in cancer patients with COVID-19. Therefore, cancer patients

Evidence Search Report: INF031801v5 ESR 83 should be the priority group for COVID-19 prevention. Until now, data of COVID-19 vaccination for cancer patients is lacking. We review the interim data of safety and immune-efficacy of COVID-19 vaccination in cancer patients based on the latest studies. Due to the complicated immune systems of cancer patients caused by the malignancy and anticancer treatments, we proposed preliminary specific COVID-19 vaccination recommendations for cancer patients with different anticancer treatments and at different stages of the disease. Preventing COVID-19 with vaccinations for cancer patients is crucial, and we call for more large-scale clinical trials and real-world studies, for further COVID-19 vaccination recommendations development.. URL: https://www.ncbi.nlm.nih.gov/pubmed/34024060 DOI: 10.3779/j.issn.1009-3419.2021.101.18 10.3779/j.issn.1009-3419.2021.101.18.

198. Wang X, Lam JY, Chen L, et al. Mining of linear B cell epitopes of SARS-CoV-2 ORF8 protein from COVID-19 patients. Emerg Microbes Infect. 2021:1-19. DOI: 10.1080/22221751.2021.1931465 10.1080/22221751.2021.1931465. ABSTRACT: Given the ongoing SARS-CoV-2 pandemic, identification of immunogenic targets against the viral protein will provide crucial advances towards the development of sensitive diagnostic tools and vaccination strategies. Our previous study has found that ORF8 protein of SARS-CoV-2 is highly immunogenic and shows high sensitivity in identifying COVID-19 disease. In this study, by employing overlapping linear peptides, we characterized the IgG immunodominant regions on SARS-CoV-2 ORF8 protein that are seropositive in the sera from SARS-CoV-2-infected patients. The major immunogenic epitopes are localised at 1) N- termini alpha helix, 2) the resides spanning beta 2 and 3 sheets, and 3) the loop between beta 4 and 5 sheets. Additionally, hamster model infected by SARS-CoV-2 further validate the seropositivity of the linear epitopes in-vivo, demonstrating a potential application of the linear peptide-based immunization strategy. Taken together, identification and validation of these B-cell linear epitopes will provide insights towards the design of serological diagnostics and peptide-based vaccination approach against this pandemic virus of high priority. URL: https://www.ncbi.nlm.nih.gov/pubmed/34003073 DOI: 10.1080/22221751.2021.1931465 10.1080/22221751.2021.1931465.

199. Ward BJ, Gobeil P, Seguin A, et al. Phase 1 randomized trial of a plant-derived virus-like particle vaccine for COVID-19. Nat Med. 2021;18:18. DOI: 10.1038/s41591-021-01370-1 10.1038/s41591-021-01370-1. ABSTRACT: Several severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines are being deployed, but the global need greatly exceeds the supply, and different formulations might be required for specific populations. Here we report Day 42 interim safety and immunogenicity data from an observer-blinded, dose escalation, randomized controlled study of a virus-like particle vaccine candidate produced in plants that displays the SARS-CoV-2 spike glycoprotein (CoVLP: NCT04450004 ). The co-primary outcomes were the short-term tolerability/safety and immunogenicity of CoVLP formulations assessed by neutralizing antibody (NAb) and cellular responses. Secondary outcomes in this ongoing study include safety and immunogenicity assessments up to 12 months after vaccination. Adults (18-55 years, n = 180) were randomized at two sites in Quebec, Canada, to receive two intramuscular doses of CoVLP (3.75 mug, 7.5 mug, and 15 mug) 21 d apart, alone or adjuvanted with AS03 or CpG1018. All formulations were well tolerated, and adverse events after vaccination were generally mild to moderate, transient and highest in the adjuvanted groups. There was no CoVLP dose effect on serum NAbs, but titers increased significantly with both adjuvants. After the second dose, NAbs in the CoVLP + AS03 groups were more than tenfold higher than titers in Coronavirus 2019 convalescent sera. Both spike protein-specific interferon- gamma and interleukin-4 cellular responses were also induced. This pre-specified interim analysis supports further evaluation of the CoVLP vaccine candidate. URL: https://www.ncbi.nlm.nih.gov/pubmed/34007070 DOI: 10.1038/s41591-021-01370-1 10.1038/s41591-021-01370-1.

Evidence Search Report: INF031801v5 ESR 84 200. Watad A, De Marco G, Mahajna H, et al. Immune-Mediated Disease Flares or New-Onset Disease in 27 Subjects Following mRNA/DNA SARS-CoV-2 Vaccination. Vaccines (Basel). 2021;9(5). DOI: 10.3390/vaccines9050435 10.3390/vaccines9050435. ABSTRACT: BACKGROUND: Infectious diseases and vaccines can occasionally cause new-onset or flare of immune- mediated diseases (IMDs). The adjuvanticity of the available SARS-CoV-2 vaccines is based on either TLR-7/8 or TLR-9 agonism, which is distinct from previous vaccines and is a common pathogenic mechanism in IMDs. METHODS: We evaluated IMD flares or new disease onset within 28-days of SARS-CoV-2 vaccination at five large tertiary centres in countries with early vaccination adoption, three in Israel, one in UK, and one in USA. We assessed the pattern of disease expression in terms of autoimmune, autoinflammatory, or mixed disease phenotype and organ system affected. We also evaluated outcomes. FINDINGS: 27 cases included 17 flares and 10 new onset IMDs. 23/27 received the BNT - 162b2 vaccine, 2/27 the mRNA-1273 and 2/27 the ChAdOx1 vaccines. The mean age was 54.4 +/- 19.2 years and 55% of cases were female. Among the 27 cases, 21 (78%) had at least one underlying autoimmune/rheumatic disease prior the vaccination. Among those patients with a flare or activation, four episodes occurred after receiving the second-dose and in one patient they occurred both after the first and the second-dose. In those patients with a new onset disease, two occurred after the second-dose and in one patient occurred both after the first (new onset) and second-dose (flare). For either dose, IMDs occurred on average 4 days later. Of the cases, 20/27 (75%) were mild to moderate in severity. Over 80% of cases had excellent resolution of inflammatory features, mostly with the use of corticosteroid therapy. Other immune-mediated conditions included idiopathic pericarditis (n = 2), neurosarcoidosis with small fiber neuropathy (n = 1), demyelination (n = 1), and myasthenia gravis (n = 2). In 22 cases (81.5%), the insurgence of Adverse event following immunization (AEFI)/IMD could not be explained based on the drug received by the patient. In 23 cases (85.2%), AEFI development could not be explained based on the underlying disease/co-morbidities. Only in one case (3.7%), the timing window of the insurgence of the side effect was considered not compatible with the time from vaccine to flare. INTERPRETATION: Despite the high population exposure in the regions served by these centers, IMDs flares or onset temporally-associated with SARS-CoV-2 vaccination appear rare. Most are moderate in severity and responsive to therapy although some severe flares occurred. FUNDING: none. URL: https://www.ncbi.nlm.nih.gov/pubmed/33946748 DOI: 10.3390/vaccines9050435 10.3390/vaccines9050435.

201. Watson SI, Lilford RJ. Global COVID-19 vaccine roll-out: time to randomise vaccine allocation? Lancet. 2021;397(10287):1804-5. DOI: 10.1016/S0140-6736(21)00895-3 10.1016/S0140-6736(21)00895-3. URL: https://www.ncbi.nlm.nih.gov/pubmed/33992138 DOI: 10.1016/S0140-6736(21)00895-3 10.1016/S0140-6736(21)00895-3.

202. Wherry EJ, Jaffee EM, Warren N, et al. How Did We Get a COVID-19 Vaccine in Less Than 1 Year? Clin Cancer Res. 2021;27(8):2136-8. DOI: 10.1158/1078-0432.CCR-21-0079 10.1158/1078-0432.CCR-21-0079. Epub 2021 Feb 4. ABSTRACT: The successful development of COVID-19 vaccines within an unprecedented short time needs to be followed by rapid vaccine uptake, in particular, in high-risk populations such as patients with cancer. It is important for the scientific research community and cancer physicians to convey the knowledge behind the COVID-19 vaccine development and contribute to build the required trust on their use. URL: https://www.ncbi.nlm.nih.gov/pubmed/33542081 DOI: 10.1158/1078-0432.CCR-21-0079 10.1158/1078-0432.CCR-21-0079. Epub 2021 Feb 4.

203. Wilson E, Girotto J, Passerrello N, et al. Importance of Pediatric Studies in SARS-CoV-2 Vaccine Development. J Pediatr Pharmacol Ther. 2021;26(4):418-21. DOI: 10.5863/1551-6776-26.4.418 10.5863/1551-6776-26.4.418. Epub 2021 May 19.

Evidence Search Report: INF031801v5 ESR 85 ABSTRACT: Vaccination efforts against COVID-19 must include the pediatric population, not only to protect children and their families from the virus, but also to support a safe return to in-person schooling. Given the novel methodologies and targets used in the COVID-19 vaccines and the potential for multisystem inflammatory syndrome-children, it is insufficient to extrapolate safety and efficacy data between different vaccine candidates or from adult studies. Adequate enrollment in pediatric studies for COVID-19 vaccines is crucial. The Pediatric Pharmacy Association supports continued research, surveillance, and transparency for COVID-19 vaccines in the pediatric population, including those younger than 12 years of age. URL: https://www.ncbi.nlm.nih.gov/pubmed/34035689 DOI: 10.5863/1551-6776-26.4.418 10.5863/1551-6776-26.4.418. Epub 2021 May 19.

204. Wingert A, Pillay J, Gates M, et al. Risk factors for severity of COVID-19: a rapid review to inform vaccine prioritisation in Canada. BMJ Open. 2021;11(5):e044684. DOI: 10.1136/bmjopen-2020-044684 10.1136/bmjopen-2020-044684. ABSTRACT: OBJECTIVES: Rapid review to determine the magnitude of association between potential risk factors and severity of COVID-19, to inform vaccine prioritisation in Canada. SETTING: Ovid MEDLINE(R) ALL, Epistemonikos COVID-19 in L.OVE Platform, McMaster COVID-19 Evidence Alerts and websites were searched to 15 June 2020. Eligible studies were conducted in high-income countries and used multivariate analyses. PARTICIPANTS: After piloting, screening, data extraction and quality appraisal were performed by a single experienced reviewer. Of 3740 unique records identified, 34 were included that reported on median 596 (range 44-418 794) participants, aged 42-84 years. 19/34 (56%) were good quality. OUTCOMES: Hospitalisation, intensive care unit admission, length of stay in hospital or intensive care unit, , severe disease, mortality. RESULTS: Authors synthesised findings narratively and appraised the certainty of the evidence for each risk factor-outcome association. There was low or moderate certainty evidence for a large (>/=2-fold) magnitude of association between hospitalisation in people with COVID-19, and: obesity class III, heart failure, diabetes, chronic kidney disease, dementia, age >45 years, male gender, black race/ethnicity (vs non-Hispanic white), homelessness and low income. Age >60 and >70 years may be associated with large increases in mechanical ventilation and severe disease, respectively. For mortality, a large magnitude of association may exist with liver disease, Bangladeshi ethnicity (vs British white), age >45 years, age >80 years (vs 65-69 years) and male gender among 20-64 years (but not older). Associations with hospitalisation and mortality may be very large (>/=5-fold) for those aged >/=60 years. CONCLUSIONS: Increasing age (especially >60 years) may be the most important risk factor for severe outcomes. High-quality primary research accounting for multiple confounders is needed to better understand the magnitude of associations for severity of COVID-19 with several other factors. PROSPERO REGISTRATION NUMBER: CRD42020198001. URL: https://www.ncbi.nlm.nih.gov/pubmed/33986052 DOI: 10.1136/bmjopen-2020-044684 10.1136/bmjopen-2020-044684.

205. Woodfield MC, Pergam SA, Shah PD. against COVID-19: The argument for vaccinating caregivers of patients with cancer. Cancer. 2021. DOI: 10.1002/cncr.33598 10.1002/cncr.33598. URL: https://www.ncbi.nlm.nih.gov/pubmed/33891713 DOI: 10.1002/cncr.33598 10.1002/cncr.33598.

206. Wyller TB, Kittang BR, Ranhoff AH, et al. Nursing home deaths after COVID-19 vaccination. Tidsskr Nor Laegeforen. 2021;141. DOI: 10.4045/tidsskr.21.0383 ABSTRACT: BACKGROUND: In the period 27 December 2020 to 15 February 2021, about 29 400 of Norway's roughly 35 000 nursing home patients were vaccinated with the mRNA vaccine BNT162b2. During the same period, the Norwegian Medicines Agency received 100 reports of suspected fatal adverse reactions to the vaccine. An expert group has examined the reports and assessed the extent of a causal link between vaccination and death. MATERIAL AND METHOD: The expert group worked in two pairs, each of which examined 50 anonymised reports. Each member first examined the reports alone and classified the causality as unlikely, possible, probable, certain or

Evidence Search Report: INF031801v5 ESR 86 unclassifiable. Each pair then discussed their results until they reached a consensus. All four experts assessed a random sample of 20 reports. The degree of agreement was assessed using weighted kappa and McNemar's test of symmetry. RESULTS: The mean age of the patients was 87.7 years (range 61-103 years). Among 100 reported deaths, a causal link to the vaccine was considered probable in 10 cases, possible in 26 and unlikely in 59. Five were unclassifiable. Weighted kappa was 0.40 and 0.38 in the two expert pairs, respectively. INTERPRETATION: Most nursing home patients have a short remaining life expectancy, but vaccination may, in a few cases, have accelerated a process of dying that had already begun. Nursing home patients should still be given priority for vaccination, but the benefits versus risk must be carefully weighed up for the frailest patients. DOI: 10.4045/tidsskr.21.0383

207. Xing K, Tu XY, Liu M, et al. Efficacy and safety of COVID-19 vaccines: a systematic review. Zhongguo Dang Dai Er Ke Za Zhi. 2021;23(3):221-8. DOI: http://dx.doi.org/10.7499/j.issn.1008-8830.2101133 ABSTRACT: OBJECTIVE: To evaluate systematically the efficacy and safety of COVID-19 vaccines. METHODS: PubMed, Embase, Cochrane Library, Clinicaltrial.gov, CNKI, Wanfang Data, China Biomedical Literature Service System, and China Clinical Trial Registry were searched for randomized controlled trials of COVID-19 vaccines published up to December 31, 2020. The Cochrane bias risk assessment tool was used to assess the quality of studies. A qualitative analysis was performed on the results of clinical trials. RESULTS: Thirteen randomized, blinded, controlled trials, which involved the safety and efficacy of 11 COVID-19 vaccines, were included. In 10 studies, the 28-day seroconversion rate of subjects exceeded 80%. In two 10 000-scale clinical trials, the vaccines were effective in 95% and 70.4% of the subjects, respectively. The seroconversion rate was lower than 60% in only one study. In six studies, the proportion of subjects who had an adverse reaction within 28 days after vaccination was lower than 30%. This proportion was 30%-50% in two studies and > 50% in the other two studies. Most of the adverse reactions were mild to moderate and resolved within 24 hours after vaccination. The most common local adverse reaction was pain or tenderness at the injection site, and the most common systemic adverse reaction was fatigue, fever, or bodily pain. The immune response and incidence of adverse reactions to the vaccines were positively correlated with the dose given to the subjects. The immune response to the vaccines was worse in the elderly than in the younger population. In 6 studies that compared single-dose and double-dose vaccination, 4 studies showed that double-dose vaccination produced a stronger immune response than single-dose vaccination. CONCLUSIONS: Most of the COVID-19 vaccines appear to be effective and safe. Double-dose vaccination is recommended. However, more research is needed to investigate the long-term efficacy and safety of the vaccines and the influence of dose, age, and production process on the protective efficacy. URL: https://www.ncbi.nlm.nih.gov/pubmed/33691913 DOI: http://dx.doi.org/10.7499/j.issn.1008-8830.2101133

208. Yadav R, Bajpai PK, Srivastava DK, et al. Epidemiological characteristics, reinfection possibilities and vaccine development of SARS CoV2: A global review. J Family Med Prim Care. 2021;10(3):1095-101. DOI: 10.4103/jfmpc.jfmpc_2151_20 ABSTRACT: According to the World Health Organization (WHO), there are 37,704,153 cases and 10,79,029 deaths due to COVID-19 till the 13th October 2020 in the world. Day by day, rise in the number of COVID-19 deaths has created great pressure on health facilities, governmental bodies, and health workers. There is a need for knowledge regarding lifecycle, transmission, and different strains of SARSCoV2, so that countries can stop the disease as early as possible. The present study was conducted to review various epidemiological aspects along with measures used in the containment and prevention of this new pandemic. The scientific literature database was searched using the terms: coronavirus, 2019-nCoV, SARSCoV2, and COVID-19. Articles with appropriate topics fulfilling the objective of the present work were included. The epidemiological characteristics regarding life-cycle, intermediate hosts, viability on various surfaces, strains, case fatality rate, and their implication to reduce the transmission of SARSCoV2 have been identified. According to Centers for Disease Control and Prevention, Atlanta (updated till October 05, 2020) people with recurrent or persistent positive COVID-19 tests in South Korea and USA did not show to have live virus in their bodies. As per WHO web-page information till 15 October 2020, there were 42 candidate vaccines in clinical evaluation and 156 vaccines are in preclinical evaluation phase. As the virus can easily be transmitted to the people either via droplets, fomites, and may be via the fecal-oral route, knowledge regarding the above-mentioned areas is needed for time to be prepared for the next waves of the COVID-19 pandemic.

Evidence Search Report: INF031801v5 ESR 87 DOI: 10.4103/jfmpc.jfmpc_2151_20

209. Yang LJ, Chen RH, Hamdoun S, et al. Corilagin prevents SARS-CoV-2 infection by targeting RBD-ACE2 binding. Phytomedicine. 2021;87:153591. DOI: 10.1016/j.phymed.2021.153591 10.1016/j.phymed.2021.153591. ABSTRACT: BACKGROUND: The outbreak of coronavirus (SARS-CoV-2) disease caused more than 100,000,000 people get infected and over 2,200,000 people being killed worldwide. However, the current developed vaccines or drugs may be not effective in preventing the pandemic of COVID-19 due to the mutations of coronavirus and the severe side effects of the newly developed vaccines. Chinese herbal medicines and their active components play important antiviral activities. Corilagin exhibited antiviral effect on human immunodeficiency virus (HIV), hepatitis C virus (HCV) and Epstein-Barr virus (EBV). However, whether it blocks the interaction between SARS- CoV-2 RBD and hACE2 has not been elucidated. PURPOSE: To characterize an active compound, corilagin derived from Phyllanthus urinaria as potential SARS-CoV-2 entry inhibitors for its possible preventive application in daily anti-virus hygienic products. METHODS: Computational docking coupled with bio-layer interferometry, BLI were adopted to screen more than 1800 natural compounds for the identification of SARS-CoV-2 spike-RBD inhibitors. Corilagin was confirmed to have a strong binding affinity with SARS-CoV-2-RBD or human ACE2 (hACE2) protein by the BLI, ELISA and immunocytochemistry (ICC) assay. Furthermore, the inhibitory effect of viral infection of corilagin was assessed by in vitro pseudovirus system. Finally, the toxicity of corilagin was examined by using MTT assay and maximal tolerated dose (MTD) studies in C57BL/6 mice. RESULTS: Corilagin preferentially binds to a pocket that contains residues Cys 336 to Phe 374 of spike-RBD with a relatively low binding energy of -9.4 kcal/mol. BLI assay further confirmed that corilagin exhibits a relatively strong binding affinity to SARS-CoV-2-RBD and hACE2 protein. In addition, corilagin dose-dependently blocks SARS-CoV-2-RBD binding and abolishes the infectious property of RBD-pseudotyped lentivirus in hACE2 overexpressing HEK293 cells, which mimicked the entry of SARS-CoV-2 virus in human host cells. Finally, in vivo studies revealed that up to 300 mg/kg/day of corilagin was safe in C57BL/6 mice. Our findings suggest that corilagin could be a safe and potential antiviral agent against the COVID-19 acting through the blockade of the fusion of SARS-CoV-2 spike-RBD to hACE2 receptors. CONCLUSION: Corilagin could be considered as a safe and environmental friendly anti-SARS-CoV-2 agent for its potential preventive application in daily anti-virus hygienic products. URL: https://www.ncbi.nlm.nih.gov/pubmed/34029937 DOI: 10.1016/j.phymed.2021.153591 10.1016/j.phymed.2021.153591.

210. Young B, Kotzur M, Gatting L, et al. The impact of theory-based messages on COVID-19 vaccination intentions: a structured summary of a study protocol for a randomised controlled trial. Trials. 2021;22(1):311. DOI: 10.1186/s13063-021-05277-7 10.1186/s13063-021-05277-7. ABSTRACT: OBJECTIVES: Uptake of vaccination against COVID-19 is key to controlling the pandemic. However, a significant proportion of people report that they do not intend to have a vaccine, often because of concerns they have about vaccine side effects or safety. This study will assess the impact of theory-based messages on COVID-19 vaccination intention, drawing on the Necessity-Concerns framework to address previously reported beliefs and concerns about COVID-19 vaccination, and assess whether hypothesised variables (illness coherence, perceived necessity and concerns) mediate change in vaccination intention. TRIAL DESIGN: Prospective, parallel two-arm, individually randomised (1:1) trial. PARTICIPANTS: Adults aged over 18 years, living in Scotland and not vaccinated for COVID-19. A quota sampling approach will be used with the aim of achieving a nationally representative sample on gender, region and ethnic group, with oversampling of individuals with no educational qualifications or with only school-level qualifications. INTERVENTION AND COMPARATOR: Intervention: Brief exposure to online text and image-based messages addressing necessity beliefs and concerns about COVID-19 vaccination. Comparator: Brief exposure to online text and image-based messages containing general information about COVID-19 and COVID-19 vaccination. MAIN OUTCOMES: Primary outcome: Self-reported intention to receive a vaccine for COVID-19 if invited, immediately post-intervention. SECONDARY OUTCOMES: Self-reported COVID-19 illness coherence, perceived necessity of a COVID-19 vaccine and concerns about a COVID-19 vaccine, immediately post-intervention. RANDOMISATION: Quasi-randomisation performed automatically by online survey software, by creating a variable derived from the number of seconds in the minute that the participant initiates the survey. Participants starting

Evidence Search Report: INF031801v5 ESR 88 the survey at 0-14 or 30-44 seconds in the minute are allocated to the intervention and 15-29 or 45-59 seconds to the comparator. BLINDING (MASKING): Participants will not be blinded to group assignment but will not be informed of the purpose of the study until they have completed the follow-up survey. Investigators will be blinded to allocation as all procedures will be undertaken digitally and remotely without any investigator contact with participants. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total of 1,094 will be randomised 1:1 into two groups with 547 individuals in each. TRIAL STATUS: Protocol version number 1.0, 26(th) February 2021. Recruitment status: Not yet recruiting, set to start April 2021 and end April 2021. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04813770 , 24(th) March 2021. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. URL: https://www.ncbi.nlm.nih.gov/pubmed/33926540 DOI: 10.1186/s13063-021-05277-7 10.1186/s13063-021-05277-7.

211. Yu Y, Lau JTF, She R, et al. Prevalence and associated factors of intention of COVID-19 vaccination among healthcare workers in China: application of the Health Belief Model. Hum Vaccin Immunother. 2021:1-9. DOI: 10.1080/21645515.2021.1909327 10.1080/21645515.2021.1909327. ABSTRACT: Healthcare workers (HCWs) are at an increased risk of coronavirus disease 2019 (COVID-19) and warrant COVID-19 vaccination to reduce nosocomial infections. This study investigated: (1) the prevalence of behavioral intention of COVID-19 vaccination (BICV) under eight scenarios combining vaccines' effectiveness/safety/cost, plus two general scenarios of free/self-paid vaccination given governmental/hospital recommendations, (2) perceptions involving preferred timing of COVID-19 vaccination and impacts of various attributes on BICV, and (3) factors of BICV based on the Health Belief Model. An anonymous online cross-sectional survey was conducted among 2,254 full-time doctors/nurses in three Chinese provinces during 10/2020-11/2020. The prevalence of BICV was 75.1%/68.0% among nurses/doctors under the most opti mum scenario of this study (free/80% effectiveness/rare mild side effects); it dropped to 64.6%/56.5% if it costed 600 Yuan (USD90). Similar prevalence was obtained (72.7%/71.2%) if the vaccination was recommended by the government/hospitals but dropped to <50% if effectiveness was 50% or mild side effects were common; 13.0% preferred to take up COVID- 19 vaccination at the soonest (81.8% would wait and see). Scientific proof (completion of phase III clinical trials and approval from health authorities) was rated the highest in its impacts on vaccination decision, followed by vaccines' performance, and then logistics. Multivariable logistic regression analyses showed that perceived severity, perceived barriers, cues to action, and self-efficacy (but neither perceived susceptibility nor perceived barriers) were significantly associated with the two BICV outcomes. The coverage of COVID-19 vaccination would be high only if the vaccines perform well. Health promotion may take the findings into account. URL: https://www.ncbi.nlm.nih.gov/pubmed/33877955 DOI: 10.1080/21645515.2021.1909327 10.1080/21645515.2021.1909327.

212. Jensen S, Twitty C, Paustian C, et al. 480 Preliminary evaluation of a novel coronavirus vaccine (CORVax) using electroporation of plasmid DNA encoding a stabilized prefusion SARS-CoV-2 spike protein alone or with transfection of plasmid IL-12. Journal for ImmunoTherapy of Cancer. 2020;8(Suppl 3):A514-A. DOI: 10.1136/jitc- 2020-SITC2020.0480 ABSTRACT: Background SARS-CoV-2 (CoV2) has precipitated a global pandemic and the effectiveness of standard vaccine strategies to induce potent and persistent immunity to CoV2 is in question, particularly for the elderly. This problem is not dissimilar to what we have struggled with in our quest to induce immunity to cancer antigens, where vaccine-induced anti-cancer immune responses can be weak. Here, we describe a novel vaccine approach which leverages electroporation (EP) of a plasmid encoding a prefusion stabilized CoV2 spike protein (CORVax). As IL-12 has been shown to augment the efficacy of immunotherapy in aged mice,1 we have initiated studies to evaluate if plasmid IL-12 (TAVOTM) can similarly augment anti-CoV2 immune responses in young mice and have planned studies in aged animals. Methods A prefusion stabilized CoV2 spike plasmid expression vector was constructed, a master cell bank generated and clinical- grade plasmid manufactured. C57BL/6 and BALB/c were

Evidence Search Report: INF031801v5 ESR 89 vaccinated via intramuscular (IM) and/or intradermal (ID) injection followed immediately by EP of plasmids encoding the CoV2 spike protein with or without plasmid-encoded murine IL-12 on days 1 and 14 or 21. Mice were followed for >120 days to assess safety. Splenocytes and serum were harvested at different time points to interrogate virus-specific cellular responses as well anti-spike IgG1/IgG2 antibody titers. A surrogate viral neutralization test (sVNT) assessed serum blockade of soluble hACE2R binding to immobilized CoV2 spike. Results Preliminary data shows that EP of CORVax alone or combined with IL-12 was safe. EP of CORVax was able to elicit anti-Spike IgG antibodies (IC50 = 1/2112), as well as IgG antibodies targeting the receptor binding domain of the Spike protein (IC50 = 1/965) approximately 40 days after the booster vaccination. In 2 of 2 experiments, CORVax combined with IL-12 significantly (P<0.0001) increased the sVNT titers at 2 months, but this benefit was lost by 3 months. Conclusions Early preclinical data shows that EP of CORVax can induce IgG responses to CoV2 Spike and the receptor binding domain (RBD) as well as apparent viral neutralizing activity. The addition of IL-12, at least transiently, increased sVNT titer. We plan to investigate alternate vaccine boosting strategies while extending these studies into aged animals and initiate a clinical trial in the near future. URL: https://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=emexb&AN=635024243https://lib key.io/libraries/843/openurl?output=full&sid=OVID:embase&id=pmid:&id=doi:10.1136%2Fjitc-2020- SITC2020.0480&issn=2051- 1426&isbn=&volume=8&issue=SUPPL+3&spage=A296&pages=A296&date=2020&title=Journal+for+ImmunoThera py+of+Cancer&atitle=Preliminary+evaluation+of+a+novel+coronavirus+vaccine+%28CORVAX%29+using+electropo ration+of+plasmid+DNA+encoding+a+stabilized+prefusion+SARS-COV- 2+spike+protein+alone+or+with+transfection+of+plasmid+IL- 12&aulast=Jensen&pid=%3Cauthor%3EJensen+S.%3BTwitty+C.%3BPaustian+C.%3BLaws+M.%3BMcDonnell+G.%3 BWegmann+K.%3BMoudgil+T.%3BAfentoulis+M.%3BHan+M.%3BFoerter+K.M.%3BCanton+D.%3BLee+J.%3BNguye n+B.%3BRodriguez+J.%3BJaffe+K.%3BPiening+B.%3BBifulco+C.%3BO%27Connor+D.%3BUrba+W.%3BLeidner+R.%3 BHilton+T.%3BHu+H.- M.%3BFox+B.%3C%2Fauthor%3E%3CAN%3E635024243%3C%2FAN%3E%3CDT%3EConference+Abstract%3C%2FDT %3E DOI: 10.1136/jitc-2020-SITC2020.0480

213. Joly E. Confronting Covid-19 by exploring the possibility of vaccinating with live SARS-CoV-2 virus itself, via a route that would reduce the incidence of pulmonary complications. F1000Res. 2020;9:309. DOI: 10.12688/f1000research.23480.1 10.12688/f1000research.23480.1. eCollection 2020. ABSTRACT: This article proposes that one should explore whether the pulmonary complications of Covid-19 can be reduced or avoided by bypassing the airway entry of the SARS-CoV-2 virus. This could possibly be achieved by injecting live SARS-CoV-2 virus intradermal (ID), subcutaneous, intra-muscular (IM) or intra-peritoneal (IP), or by targeting the virus to the digestive tract. The effectiveness and innocuity of using those various routes could be tested very rapidly in animal models, such as Macaques, Hamsters, Ferrets or Cats. The hope is that these experiments will reveal a route of inoculation that can reliably lead to bona-fide infections, resulting in strong immune responses, with both cellular and serological components, but with much less viral replication in the lungs. This would not only hopefully reduce the incidence of pulmonary complications in the infected subjects, but would also probably reduce the amount of virus released by them via aerosols, and thus reduce the vector of contagiosity that is hardest to control, and that probably leads most effectively to viral replication in the lungs. If those experiments in animal models reveal that one or several routes can be used effectively to reduce pulmonary pathology, a clinical trial could be conducted in human volunteers with very low risk profiles. The ID route should probably be considered as a priority, since it could double-up as a skin test to reveal the immune status of the recipients towards the SARS-CoV-2 virus. The course of action proposed here may possibly provide a way of taking a step ahead of the virus, and if it works as hoped, could help to end the need for confinement within a matter of months, if not weeks. URL: https://www.ncbi.nlm.nih.gov/pubmed/34035902 DOI: 10.12688/f1000research.23480.1 10.12688/f1000research.23480.1. eCollection 2020.

Evidence Search Report: INF031801v5 ESR 90 214. Stoye E. Daily briefing: Hope and caution greet coronavirus vaccine trial results. Nature. 2020;20:20. DOI: 10.1038/d41586-020-01534-y 10.1038/d41586-020-01534-y. URL: https://www.ncbi.nlm.nih.gov/pubmed/34012121 DOI: 10.1038/d41586-020-01534-y 10.1038/d41586-020-01534-y.

215. Tumban E. Lead SARS-CoV-2 Candidate Vaccines: Expectations from Phase III Trials and Recommendations Post-Vaccine Approval. Viruses. 2020;13(1). DOI: 10.3390/v13010054 10.3390/v13010054. ABSTRACT: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is transmitted primarily through respiratory droplets/aerosols and it causes COVID-19. The virus infects epithelial cells by using the spike protein on its surface to bind to angiotensin-converting enzyme 2 receptor on the cells. Thus, candidate vaccines targeting the spike protein are currently being developed to prevent against infections. Approximately 44 SARS-CoV-2 candidate vaccines are in clinical trials (phase I-III) and an additional 164 candidates are in preclinical stages. The efficacy data from phase I/II trials of lead candidate vaccines look very promising with virus-neutralizing geometric mean antibody titers in the range of 16.6-3906. Most recently, two SARS-CoV-2 candidate vaccines, BNT162b2 and mRNA-1273, have been granted the first emergency use authorization (EUA) in the U.S.; BNT162b2 has also been granted an EUA in the United Kingdom, Canada, and in the European Union. This review assesses whether SARS- CoV-2 candidate vaccines (with approved EUA or in phase III trials) meet the criteria for an ideal SARS-CoV-2 vaccine. The review concludes with expectations from phase III trials and recommendations for phase IV studies (post-vaccine approval). URL: https://www.ncbi.nlm.nih.gov/pubmed/33396343 DOI: 10.3390/v13010054 10.3390/v13010054.

216. Anonymous. Covid-19 Vaccines. National Institute of Diabetes and Digestive and Kidney Diseases. 2012. ABSTRACT: The Severe Acute Respiratory Syndrome Coronavirus type 2 (SARS-CoV-2) is the cause of the pandemic of coronavirus disease (COVID-19) that was first detected in December 2019 in Wuhan, China and subsequently spread globally. By March 2020, COVID-19 was declared a global pandemic and within a year it accounted for more than 100 million cases and 2 million deaths. Also, within a year of its detection, vaccines against SARS-CoV-2 were developed using several methodologies including mRNA-, adenoviral vector- and recombinant DNA-technology. Several of these vaccines have been evaluated in large, placebo-controlled trials and found to be both safe and effective. Adverse events have been mild-to-moderate local reactions and transient systemic symptoms such as fatigue, nausea and headache. No hepatic specific adverse events have been described, although rare reports of thrombotic thrombocytopenia have occurred with the adenoviral based vaccines that sometimes involve portal or hepatic vein thromboses and some degree of liver dysfunction. URL: https://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=medp&AN=34014629https://libke y.io/libraries/843/openurl?output=full&sid=OVID:medline&id=pmid:34014629&id=doi:&issn=&isbn=&volume=&is sue=&spage=&pages=&date=2012&title=&atitle=Covid- 19+Vaccines.&aulast=&pid=%3Cauthor%3Eanonymous%3C%2Fauthor%3E%3CAN%3E34014629%3C%2FAN%3E%3 CDT%3EReview%3C%2FDT%3E

Appendix 1: Evidence Search Details

Evidence Search Report: INF031801v5 ESR 91 Filters, Limits English only & Exclusions: May 14 – 28, 2021

Sources  Agency for Clinical Innovation  Globe and Mail Searched: and New South Wales  Library and Knowledge Services Government (England)  CBC  Medline  CDC  National Collaborating Centre for  Center for Infectious Disease Methods and Tools Research and Policy (CIDRAP)  National Health Library &  Centre for Evidence-Based Knowledge Service (Ireland) Medicine, University of Oxford  Public Health Ontario  COVID-19 Best Evidence Front  Pubmed Door, University of Michigan  Science Table (Ontario)  COVID Immunity Task Force  Strategy for Patient-Oriented  Embase Research  European Centres for Disease  Veteran Affairs Evidence Synthesis Prevention and Control Program, COVID-19 Evidence  Evidence Synthesis Network Reviews (Ontario)

Librarian(s): Lukas Miller, Clinical Librarian, Saskatchewan Health Authority Brianna Howell-Spooner, Clinical Librarian, Saskatchewan Health Authority

Appendix 2: Search Strategies

Ovid MEDLINE(R) ALL <1946 to May 26, 2021> # Searches Results 1 (nCoV* or 2019nCoV or 19nCoV or COVID19* or COVID or SARS-COV-2 or SARSCOV-2 or 137328 SARSCOV2 or Severe Acute Respiratory Syndrome Coronavirus 2 or Severe Acute Respiratory Syndrome Corona Virus 2 or coronavirus*).ti,kf,nm,ox,rx,px. 2 ((new or novel or "19" or "2019" or Wuhan or Hubei or China or Chinese) adj3 13986 (coronavirus* or corona virus* or betacoronavirus* or CoV or HCoV)).ti,kf. 3 ((coronavirus* or corona virus* or betacoronavirus*) adj3 (pandemic* or epidemic* or 2532 outbreak* or crisis)).ti,kf. 4 or/1-3 137430

5 (vaccinat* or vaccine? or inoculat* or immunization? or immunize? or 342216 immunogenicity).ti,kf. or (vaccinat* or vaccine? or inoculat* or immunization? or immunize? or immunogenicity).ab. /freq=2

6 4 and 5 7456 7 (moderna? or mrna-1273 or mrna1273).mp. 1235

8 (pfizer* or biontech* or tozinameran or BNT162b2).mp. 3477 9 (astrazeneca or astra zeneca or "ChAdOx1-S" or ChAdOx1* or COVISHIELD or (oxford adj3 1479

Evidence Search Report: INF031801v5 ESR 92 astrazeneca)).mp. 10 (janssen? or "ad26.cov2.s" or ad26cov2s or ad26cov2* or (johnson adj2 johnson)).mp. 16356

11 or/7-10 22077 12 4 and 11 708 13 (safe* or risk? or harm* or unsafe* or effect* of efficacy or viability or viable or success* 1735176 or valid* or evidence-based? or outcome? or guidance or best practice? or guideline? or

recommendation? or advisor* or standard*).ti,kf. 14 (safe* or risk? or harm* or unsafe* or effect* of efficacy or viability or viable or success* 3361377 or valid* or evidence-based? or outcome? or guidance or best practice? or guideline? or

recommendation? or advisor* or standard*).ab. /freq=2 15 (random* or placebo or clinical trial? or control* trial? or trial?).ti,kf. 436242

16 (random* or placebo or clinical trial? or control* trial?).ab. /freq=2 589126 17 ((prevent* or control* or reduce?) adj2 (infect* or re-infect* or reinfect* or spread* or 28364 outbreak* or epidemic or pandemic or illness* or critical or hospitaliz* or intubat* or death* or fatal* or morbid* or severe* or severity)).ti,kf. 18 ((prevent* or control* or reduce?) adj2 (infect* or re-infect* or reinfect* or spread* or 20048 outbreak* or epidemic or pandemic or illness* or critical or hospitaliz* or intubat* or death* or fatal* or morbid* or severe* or severity)).ab. /freq=2 19 or/13-18 4581042

20 (6 or 12) and 19 2073 21 limit 20 to dt=20210514-20210527 119

Embase <1974 to 2021 May 26> # Searches Results 1 (nCoV* or 2019nCoV or 19nCoV or COVID19* or COVID or SARS-COV-2 or SARSCOV-2 132040 or SARSCOV2 or Severe Acute Respiratory Syndrome Coronavirus 2 or Severe Acute

Respiratory Syndrome Corona Virus 2 or coronavirus*).ti,kw. 2 ((new or novel or "19" or "2019" or Wuhan or Hubei or China or Chinese) adj3 13551 (coronavirus* or corona virus* or betacoronavirus* or CoV or HCoV)).ti,kw. 3 ((coronavirus* or corona virus* or betacoronavirus*) adj3 (pandemic* or epidemic* or 2482 outbreak* or crisis)).ti,kw.

4 or/1-3 132163 5 (vaccinat* or vaccine? or inoculat* or immunization? or immunize? or 377802 immunogenicity).ti,kw. or (vaccinat* or vaccine? or inoculat* or immunization? or immunize? or immunogenicity).ab. /freq=2 6 4 and 5 6445

7 (moderna? or mrna-1273 or mrna1273).mp. 997 8 (pfizer* or biontech* or tozinameran or BNT162b2).mp. 52604 9 (astrazeneca or astra zeneca or "ChAdOx1-S" or ChAdOx1* or COVISHIELD or (oxford 22511 adj3 astrazeneca)).mp.

Evidence Search Report: INF031801v5 ESR 93 10 (janssen? or "ad26.cov2.s" or ad26cov2s or ad26cov2* or (johnson adj2 johnson)).mp. 57709 11 or/7-10 121855

12 4 and 11 937 13 (safe* or risk? or harm* or unsafe* or effect* of efficacy or viability or viable or 2473591 success* or valid* or evidence-based? or outcome? or guidance or best practice? or guideline? or recommendation? or advisor* or standard*).ti,kw. 14 (safe* or risk? or harm* or unsafe* or effect* of efficacy or viability or viable or 4981813 success* or valid* or evidence-based? or outcome? or guidance or best practice? or guideline? or recommendation? or advisor* or standard*).ab. /freq=2

15 (random* or placebo or clinical trial? or control* trial? or trial?).ti,kw. 600152 16 (random* or placebo or clinical trial? or control* trial?).ab. /freq=2 831958

17 ((prevent* or control* or reduce?) adj2 (infect* or re-infect* or reinfect* or spread* 32222 or outbreak* or epidemic or pandemic or illness* or critical or hospitaliz* or intubat* or death* or fatal* or morbid* or severe* or severity)).ti,kw. 18 ((prevent* or control* or reduce?) adj2 (infect* or re-infect* or reinfect* or spread* 27296 or outbreak* or epidemic or pandemic or illness* or critical or hospitaliz* or intubat* or death* or fatal* or morbid* or severe* or severity)).ab. /freq=2

19 or/13-18 6558664 20 (6 or 12) and 19 1898

21 limit 20 to dd=20210514-20210527 155 22 limit 21 to medline 50 23 21 not 22 105

Other sources Vaccin* Immuniz*

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Evidence Search Report: INF031801v5 ESR 94