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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 changes. Effectiveness against P1 variant. Booster doses for variants.

Does not include willingness/acceptance (to be run as a separate search)

Review Code: INF031801v2 ESR Complete Date: April 14, 2021

Cite As: Miller, L., Howell-Spooner, B. How effective are COVID-19 vaccines? 2021 Apr 14, Document no.: INF031801v2 ESR. In: COVID-19 Rapid Evidence Reviews [Internet]. SK: SK COVID Evidence Support Team, c2021. 69 p. (CEST rapid review report).

Librarian Notes & Comments

Greetings,

We received 181 new references re: vaccine safety/efficacy since the last search was conducted on March 17 2021 from MEDLINE. We have also included news & grey literature when applicable.

Sincerely,

Lukas & Brianna

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 limitations 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 search re sults 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.

Search Results: Guidelines, Summaries & Other Grey Literature

Government Health Canada  Extended dose intervals for COVID-19 vaccines to optimize early vaccine rollout and population protection in Canada in the context of limited vaccine supply. April 9, 2021. https://www.canada.ca/en/public-health/services//national-advisory-committee- on-immunization-naci/extended-dose-intervals-covid-19-vaccines-early-rollout-population- protection.html  Archived 5: NACI rapid response: Extended dose intervals for COVID-19 vaccines to optimize early vaccine rollout and population protection in Canada [2021-03-03]. March 3, 2021. https://www.canada.ca/en/public-health/services/immunization/national-advisory-committee- on-immunization-naci/rapid-response-extended-dose-intervals-covid-19-vaccines-early-rollout- population-protection.html

BCCDC  Monitoring vaccine uptake, safety and effectiveness. April 13, 2021. http://www.bccdc.ca/health-info/diseases-conditions/covid-19/covid-19-vaccine/monitoring- vaccine-uptake-safety-and-effectiveness

CDC / FDA  Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine https://www.cdc.gov/media/releases/2021/s0413-JJ-vaccine.html

National Immunization Technical Advisory Groups (Germany)  2nd STIKO update of the COVID-19 recommendation and the associated scientific Reason. 2021. https://www.nitag-resource.org/media-center/2nd-stiko-update-covid-19- vaccination-recommendation-and-associated-scientific-reason

STIKO  Decision of the STIKO for the recommendation of the COVID-19 vaccination and the corresponding scientific rationale (2nd update). February 4, 2021. https://www.rki.de/EN/Content/infections/Vaccination/recommandations/COVID-19-2nd- update.pdf?__blob=publicationFile#:~:text=In%20regard%20to%20the%20licensing,of%209%20 to%2012%20weeks.

Agency for Clinical Innovation and New South Wales Government  What evidence is emerging regarding the effectiveness of the AstraZeneca vaccine, particularly regarding hospitalizations in the (UK)?. March 14, 2021. https://aci.health.nsw.gov.au/__data/assets/pdf_file/0003/637464/Evidence-Check- AstraZeneca-and-rollout.pdf

WHO  Interim statement of the COVID-19 subcommittee of the WHO Global Advisory Committee on Vaccine Safety on AstraZeneca COVID-19 vaccine. April 7, 2021.

Evidence Search Report: INF031801v2 ESR 2 https://www.who.int/news/item/07-04-2021-interim-statement-of-the-covid-19- subcommittee-of-the-who-global-advisory-committee-on-vaccine-safety  Evaluation of COVID-19 vaccine effectiveness: interim guidance. March 17, 2021. https://apps.who.int/iris/handle/10665/340301

European Centre for Disease Prevention and Control  Risk of SARS-CoV-2 transmission from newly-infected individuals with documented previous or vaccination. March 29, 2021. https://www.ecdc.europa.eu/en/publications- data/sars-cov-2-transmission-newly-infected-individuals-previous-infection

Wisconsin Department of Health Services  COVID-19: Vaccine Safety and Efficacy. April 13, 2021. https://www.dhs.wisconsin.gov/covid- 19/vaccine-safety.htm

Clinical Trials Clinical Trials.gov  A Study to Evaluate Safety and Effectiveness of mRNA-1237 Vaccine in Healthy Children Between 6 Months of Age and Less Than 12 Years of Age. April 13, 2021. https://clinicaltrials.gov/ct2/show/NCT04796896  A Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2. S in Healthy Adults and Adolescents. April 12, 2021. https://clinicaltrials.gov/ct2/show/NCT04535453

Trial Scope  A COVID-19 vaccine study for children. n.d. https://connect.trialscope.com/studies/0e8fc8e6- 5782-46fd-8b03-0994a5ad8b41

White Papers Healthy Debate  Comparing vaccines: efficacy, safety and side effects. March 11, 2021. https://healthydebate.ca/2021/03/topic/comparing-vaccines/

Institute for Health Metrics and Evaluation, University of Washington  COVID-19 vaccine efficacy summary. March 4, 2021. http://www.healthdata.org/covid/covid-19- vaccine-efficacy-summary

Search Results: News, Blogs, & Social Media

News CBC  Experts encourage Sask. Residents to take AstraZeneca vaccine, affirm it’s safe. April 14, 2021. https://www.cbc.ca/news/canada/saskatchewan/experts-astrazeneca-myths-misinformation- 1.5986246

Evidence Search Report: INF031801v2 ESR 3  Why the U.S. recommended suspending Johnson & Johnson’s vaccine, and what it means for Canada. April 13, 2021. https://www.cbc.ca/news/health/johnson-johnson-vaccine-1.5986097  3 vaccinated hospitalized COVID patients ‘a bit surprising,’ says epidemiologist. April 13, 2021. https://www.cbc.ca/news/canada/new-brunswick/covid-19-vaccine-hospital-new-brunswick- epidemiologist-1.5983764  U.S. recommends ‘pause’ for Johnson & Johnson vaccine over clot reports. April 13, 2021. https://www.cbc.ca/news/world/johnson-and-johnson-vaccine-pause-1.5985110  Australia abandons COVID-19 vaccination targets after new advice on AstraZeneca shots. April 12, 2021. https://www.cbc.ca/news/health/australia-astrazeneca-vaccine-1.5983756  Top official admits China’s COVID-19 vaccines have low efficacy. April 11, 2021. https://www.cbc.ca/news/health/china-vaccines-covid-19-low-efficacy-1.5983594  Canada is losing the race between vaccines and variants as the 3rd wave worsens. April 8, 2021. https://www.cbc.ca/news/health/coronavirus-variants-canada-covid-19-vaccine-third-wave- 1.5978394  Study suggests vaccines may improve symptoms for some COVID-19 long-haulers. April 7, 2021. https://www.cbc.ca/news/health/covid-longhaulers-vaccines-1.5976738  Pfizer study suggests COVID-19 vaccine is safe, protective in younger teens. March 31, 2021. https://www.cbc.ca/news/health/pfizer-study-suggests-covid-19-vaccine-is-safe-protective-in- younger-teens-1.5970857  AstraZeneca-Oxford’s COVID-19 vaccine safety questions answered. March 31, 2021. https://www.cbc.ca/news/health/astrazeneca-oxford-vaccine-concerns-1.5951672  B.C. to open AstraZeneca COVID-19 vaccines for ages 55 to 65 in Lower Mainland. March 31, 2021. https://www.cbc.ca/news/canada/british-columbia/astrazeneca-vaccine-covid-19-update- mar-30-1.5969949  Pfizer study suggests COVID-19 vaccine is safe, protective in younger teens. March 31,2021. https://www.cbc.ca/news/health/pfizer-study-suggests-covid-19-vaccine-is-safe-protective-in- younger-teens-1.5970857  Here’s what we know so far about B.C.’s response to AstraZeneca vaccine concerns. March 30, 2021. https://www.cbc.ca/news/canada/british-columbia/bc-astrazeneca-covid-19-clots- 1.5969202  Doctors agree with pause of AstraZeneca-Oxford COVID-19 vaccine doses, but Manitobans have questions. March 30, 2021. https://www.cbc.ca/news/canada/manitoba/manitoba-covid-19- astrazeneca-vaccine-pause-1.5969235  Saskatchewan pauses AstraZeneca for people under 55. March 29, 2021. https://www.cbc.ca/news/canada/saskatoon/covid-19-saskatchewan-1.5968597  Manitoba pauses use of AstraZeneca COVID-19 vaccine on people under 55. March 29, 2021. https://www.cbc.ca/news/canada/manitoba/manitoba-vaccine-update-march29-2021- 1.5968335  Quebec suspends giving doses of AstraZeneca to those under 55, though no issues reported in Canada. March 29, 2021. https://www.cbc.ca/news/canada/montreal/astrazeneca-quebec- suspended-1.5968451  N.L. pausing use of AstraZeneca-Oxford vaccine on people under 55. March 29, 2021. https://www.cbc.ca/news/canada/newfoundland-labrador/nl-covid-march-29-2021-1.5963405  Ontario suspending use of AstraZeneca vaccine for people under 55 following NACI recommendations. March 29, 2021. https://www.cbc.ca/news/canada/toronto/covid-19- ontario-march-29-2021-vaccine-doses-1.5967888

Evidence Search Report: INF031801v2 ESR 4  Alberta temporarily pauses AstraZeneca vaccine for people under 55. March 29, 2021. https://www.cbc.ca/news/canada/edmonton/deena-hinshaw-alberta-covid-1.5968291  Why Canada is suspending use of AstraZeneca vaccine in people under 55. March 29, 2021. https://www.cbc.ca/news/health/canada-suspends-astrazeneca-vaccine-covid-19-1.5968657  Pfizer, Moderna COVID-19 vaccines highly effective after 1st shot in real-world, U.S. study suggests. March 29, 2021. https://www.cbc.ca/news/health/mrna-covid-19-vaccines-cdc- effectiveness-1.5968376  Suspend AstraZeneca use for people under 55, vaccine committee recommends. March 29, 2021. https://www.cbc.ca/news/politics/astrazeneca-under-55-1.5968128  PEI suspends AstraZeneca vaccine program. March 29, 2021. https://www.cbc.ca/news/canada/prince-edward-island/pei-astrazeneca-suspended-1.5968090  Pfizer begins COVID-19 for children under 12. March 25, 2021. https://www.cbc.ca/news/health/pfizer-vaccine-trial-children-1.5963854  AstraZeneca says COVID-19 vaccine shows 76% efficacy in updated analysis of U.S. trial. March 25, 2021. https://www.cbc.ca/news/world/astrazeneca-trial-efficacy-1.5963123  Do we know how effective vaccines are against the variants? Your COVID-19 questions answered. March 24, 2021. https://www.cbc.ca/news/health/covid-19-vaccine-variant- audience-q-1.5923227  Health Canada says AstraZeneca shot is safe as U.S. questions vaccine’s data. March 23, 2021. https://www.cbc.ca/news/politics/health-canada-astra-zeneca-us-questions- 1.5960612  AstraZeneca trial results may have included ‘outdated’ information, U.S. health officials say. March 23, 2021. https://www.cbc.ca/news/health/astrazeneca-us-trial-covid19-outdated- 1.5960112  AstraZeneca says U.S. trial data shows 79% efficacy against COVID-19. March 22, 2021. https://www.cbc.ca/news/world/astrazeneca-oxford-trial-efficacy-1.5958717  EU drug regulator backs AstraZeneca-Oxford COVID-19 vaccine after safety investigation. March 18, 2021. https://www.cbc.ca/news/world/ema-astrazeneca-oxford-vaccine-safety-1.5954427  New outbreak of COVID-19 in B.C. care home where 82% of residents were already vaccinated. March 9, 2021. https://www.cbc.ca/news/canada/british-columbia/with-vaccinations-about-to- roll-out-b-c-health-officials-provide-update-on-covid-19-1.5941508

CIDRAP  US to distribute less J&J COVID vaccine next week. April 8, 2021. https://www.cidrap.umn.edu/news-perspective/2021/04/us-distribute-less-jj-covid-vaccine- next-week  Groups find possible link between AstraZeneca COVID vaccine, blood clots. April 7, 2021. https://www.cidrap.umn.edu/news-perspective/2021/04/groups-find-possible-link-between- astrazeneca-covid-vaccine-blood-clots  More global reports of blood clots after AstraZeneca COVID vaccination. April 2, 2021. https://www.cidrap.umn.edu/news-perspective/2021/04/more-global-reports-blood-clots- after-astrazeneca-covid-vaccination  Pfizer COVID vaccine 91% effective for at least 6 months. April 1, 2021. https://www.cidrap.umn.edu/news-perspective/2021/04/pfizer-covid-vaccine-91-effective- least-6-months

Evidence Search Report: INF031801v2 ESR 5  Pfizer, BioNTech: COVID vaccine effective in teens. March 31, 2021. https://www.cidrap.umn.edu/news-perspective/2021/03/pfizer-biontech-covid-vaccine- effective-teens  AstraZeneca COVID vaccine 70% effective vs B117 variant. March 31, 2021. https://www.cidrap.umn.edu/news-perspective/2021/03/astrazeneca-covid-vaccine-70- effective-vs-b117-variant  Risk of COVID very low in vaccinated medical workers: study. https://www.cidrap.umn.edu/news-perspective/2021/03/risk-covid-very-low-vaccinated- medical-workers-study  WHO review finds no blood clot link to AstraZeneca COVID vaccine. March 19, 2021. https://www.cidrap.umn.edu/news-perspective/2021/03/who-review-finds-no-blood-clot-link- astrazeneca-covid-vaccine  European regulators says AstraZeneca vaccine safe, but can’t rule out rare events. March 18, 2021. https://www.cidrap.umn.edu/news-perspective/2021/03/european-regulators-say- astrazeneca-vaccine-safe-cant-rule-out-rare-events  AstraZeneca vaccine doesn’t prevent B1351 COVID in early trial. March 16, 2021. https://www.cidrap.umn.edu/news-perspective/2021/03/astrazeneca-vaccine-doesnt-prevent- b1351-covid-early-trial

European Medicines Agency  AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets. April 7, 2021. https://www.ema.europa.eu/en/news/astrazenecas-covid-19-vaccine-ema-finds-possible-link- very-rare-cases-unusual-blood-clots-low-blood

The Conversation  COVID-19 vaccine FAQs: Efficacy, immunity to illness vs. infection (yes, they’re different), new variants and the likelihood of eradication. March 9, 2021. https://theconversation.com/covid- 19-vaccine-faqs-efficacy-immunity-to-illness-vs-infection-yes-theyre-different-new-variants-and- the-likelihood-of-eradication-154569

Global News  Vaccine mixing ‘possible’ in Canada as countries revamp AstraZeneca plans: Njoo. April 10, 2021. https://globalnews.ca/news/7745920/canada-covid-vaccine-mixing-astrazeneca/

CTV News  Moderna COVID-19 vaccine efficacy falls slightly to 90 per cent in U.S. trial. April 13, 2021. https://www.ctvnews.ca/health/coronavirus/moderna-covid-19-vaccine-efficacy-falls-slightly- to-90-per-cent-in-u-s-trial-1.5386263

BBC  Covid-19: Evidence does not suggest AstraZeneca jab linked to clots, MHRA says. March 15, 2021. https://www.bbc.com/news/uk-56397592

STAT News  The curious case of AstraZeneca’s Covid-19 vaccine. March 15, 2021. https://www.statnews.com/2021/03/15/the-curious-case-of-astrazenecas-covid-19-vaccine/

Evidence Search Report: INF031801v2 ESR 6

Science Mag  A rare clotting disorder may cloud the world’s hope for AstraZeneca’s COVID-19 vaccine. March 27, 2021. https://www.sciencemag.org/news/2021/03/rare-clotting-disorder-may-cloud-worlds- hopes-astrazenecas-covid-19-vaccine

CNBC  Mutations could render current Covid vaccines ineffective in a year or less, epidemiologists warn. March 30, 2021. https://www.cnbc.com/2021/03/30/mutations-could-make-current- covid-vaccines-ineffective-soon-survey.html

Press Releases Moderna  Moderna Announces First Participants Dosed in Phase 2/3 Study of COVID-19 Vaccine Candidate in Pediatric Population. March 16, 2021. https://investors.modernatx.com/news-releases/news- release-details/moderna-announces-first-participants-dosed-phase-23-study-0

University of Oxford  Oxford University extends COVID-19 vaccine study to children. February 12, 2021. https://www.ox.ac.uk/news/2021-02-12-oxford-university-extends-covid-19-vaccine-study- children

AstraZeneca  AZD1222 US Phase III trial met primary efficacy endpoint in preventing COVID-19 at interim analysis. March 22, 2021. https://www.astrazeneca.com/media-centre/press- releases/2021/astrazeneca-us-vaccine-trial-met-primary-endpoint.html

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

1. AboulFotouh K, Cui Z, Williams RO, 3rd. Next-Generation COVID-19 Vaccines Should Take Efficiency of Distribution into Consideration. AAPS PharmSciTech. 2021;22(3):126. DOI: 10.1208/s12249 -021-01974-3 ABSTRACT: The dire need for safe and effective coronavirus disease (COVID-19) vaccines is met with many vaccine candidates being evaluated in pre-clinical and clinical studies. The COVID-19 vaccine candidates currently in phase 3 or phase 2/3 clinical trials as well as those that recently received emergency use authorization (EUA) from the United States Food and Drug Administration (FDA) and/or other regulatory agencies worldwide require either cold (.e., 2 -8 degrees C) or even freezing temperatures as low as -70 degrees C for storage and distribution. Thus, existing cold chain will struggle to support both the standard national immunization programs and COVID -19 vaccination. The requirement for cold chain is now a major challenge towards worldwide rapid mass vaccination against COVID -19. In this commentary, we stress that thermostabilizing technologies are available to enable cold chain -free and distribution, as well as potential needle-free vaccination. Significant efforts on thermostabilizing technologies must now be applied on next-generation COVID-19 vaccines for more cost-effective worldwide mass vaccination and COVID-19 eradication. URL: https://www.ncbi.nlm.nih.gov/pubmed/33835300 DOI: 10.1208/s12249-021-01974-3

Evidence Search Report: INF031801v2 ESR 7 2. Akel KB, Masters NB, Shih SF, et al. Modification of a scale for use in adult vaccinations in the United States and China. Hum Vaccin Immunother. 2021:1-8. DOI: 10.1080/21645515.2021.1884476 ABSTRACT: Most research on vaccine hesitancy has focused on parental attitudes toward childhood vaccination, but it will be important to understand dimensions of vaccine hesitancy in the adult population as more adult vaccines are introduced in the future. We modified the Vaccine Hesitancy Scale to target adult vaccines and provide measures of its reliability and validity relative to uptake and COVID-19 vaccination acceptance in cross-sectional internet surveys in the United States and in China. We assessed the impact of vaccine hesitancy on influenza and COVID-19 vaccination using multivariable regression modeling, which informed concurrent validity of the adult Vaccine Hesitancy Scale (aVHS). Among 1103 participants in the March 2020 China survey, 5.4% would not accept a COVID-19 vaccine, whereas this figure was 18.8% for the March 2020 US survey and 27.3% for the June 2020 US survey. The aVHS exhibits good internal consistency in all three surveys. Models adjusted for age, gender and income level show that prevalence of COVID-19 vaccine acceptance was a fraction as high in those who scored higher on the VHS than those who scored lower on all three surveys. Prevalence of past and future flu vaccine acceptance was a fraction as high in those with higher aVHS scores than those with lower scores. Prevalence of COVID -19 vaccine acceptance is lower in those with higher vaccine hesitancy scores, which supports the scale's concurrent validity. The aVHS exhibits good internal consistency, making it a valid and reliable tool for measuring vaccination uptake. URL: https://www.ncbi.nlm.nih.gov/pubmed/33769209 DOI: 10.1080/21645515.2021.1884476

3. Alagoz O, Sethi AK, Patterson BW, et al. The Impact of Vaccination to Control COVID-19 Burden in the United States: A Simulation Modeling Approach. medRxiv. 2021;24:24. DOI: 10.1101/2021.03.22.21254131 ABSTRACT: Introduction: Vaccination programs aim to control the COVID-19 pandemic. However, the relative impacts of vaccine coverage, effectiveness, and capacity in the context of nonpharmaceutical interventions such as mask use and physical distancing on the spread of SARS-CoV-2 are unclear. Our objective was to examine the impact of vaccination on the control of SARS-CoV-2 using our previously developed agent-based simulation model. Methods: We applied our agent-based model to replicate COVID-19-related events in 1) Dane County, Wisconsin; 2) Milwaukee metropolitan area, Wisconsin; 3) New York City (NYC). We evaluated the impact of vaccination considering the proportion of the population vaccinated, probability that a vaccinated individual gains immunity, vaccination capacity, and adherence to nonpharmaceutical interventions. The primary outcomes were the number of confirmed COVID-19 cases and the timing of pandemic control, defined as the date after which only a small number of new cases occur. We also estimated the number of cases without vaccination. Results: The timing of pandemic control depends highly on vaccination coverage, effectiveness, and adherence to nonpharmaceutical interventions. In Dane County and Milwaukee, if 50% of the population is vaccinated with a daily va ccination capacity of 0.1% of the population, vaccine effectiveness of 90%, and the adherence to nonpharmaceutical interventions is 85%, controlled spread could be achieved by July 2021 and August 2021, respectively versus in March 2022 in both regions wit hout vaccine. If adherence to nonpharmaceutical interventions increases to 70%, controlled spread could be achieved by May 2021 and April 2021 in Dane County and Milwaukee, respectively. Discussion: In controlling the spread of SARS - CoV-2, the impact of vaccination varies widely depending not only on effectiveness and coverage, but also concurrent adherence to nonpharmaceutical interventions. The effect of SARS-CoV-2 variants was not considered. Primary Funding Source: National Institute of Allergy and Infectious Diseases. URL: https://www.ncbi.nlm.nih.gov/pubmed/33791738 DOI: 10.1101/2021.03.22.21254131

4. Allen JD, Abuelezam NN, Rose R, et al. Factors associated with the intention to obtain a COVID-19 vaccine among a racially/ethnically diverse sample of women in the USA. Transl Behav Med. 2021;11(3):785-92. DOI: 10.1093/tbm/ibab014 ABSTRACT: Widespread uptake of the COVID-19 vaccine is critical to halt the pandemic. At present, little is known about factors that will affect vaccine uptake, especially among diverse racial/ethnic communities that have experienced the highest burden of COVID. We administered an online survey to a Qualtrics respondent panel of women ages 27-45 years (N = 396) to assess vaccine intentions and attitudes, and trusted vaccine inf ormation sources. 56.8% intended to be vaccinated and 25.5% were unsure. In bivariate analyses, a greater percentage of non - Latina White (NLW) and Chinese women reported that they would be vaccinated, compared with Latina and non- Latina Black (NLB) women (p < 0.001). Those who were uninsured, unemployed and those with lower incomes were less likely to say that they would be vaccinated. In analyses stratified by race/ethnicity, NLB women remained

Evidence Search Report: INF031801v2 ESR 8 significantly less likely to report that they would be vaccinated compared with NLW women (adjusted odds ratio: 0.47; 95% confidence interval: 0.23, 0.94), controlling for age, marital status, income, education, employment, and insurance status. When analyses were additionally controlled for beliefs in vaccine safety and efficacy, racial/ethnic differences were no longer significant (adjusted odds ratio: 0.64; 95% confidence interval: 0.31, 1.34). Given that NLB women were less likely to report the intention to be vaccinated, targeted efforts will be needed to promote vaccine uptake. It will be critical to emphasize that the vaccine is safe and effective; this message may be best delivered by trusted community members. URL: https://www.ncbi.nlm.nih.gov/pubmed/33769536 DOI: 10.1093/tbm/ibab014

5. Al-Qahtani WS, Alsafhi FA. A Commentary on Realities of Developing COVID-19 Vaccines Discussed through the Global Health Safety Perspective. Vaccines (Basel). 2021;9(3):18. DOI: 10.3390/vaccines9030274 ABSTRACT: SARS-CoV-2 (or simply COVID-19) remains to be a global pandemic issue affecting millions, thus urging the world's scientific community to develop efficient vaccine and design adequate measures of disease control. Currently, the most economically viable solution to infections and viruses is vaccination, despite the possible concerns about side effects from implementing quickly developed vaccine. The current commentary intends to explain the health and safety related to COVID-19 vaccines via a prism of global health safety. Scientists across the globe, along with companies from both public and private sectors, have predictably arranged cooperative programs to learn about COVID-19, along with taking simultaneous steps on devising vaccine and preparing effective treatments plans. Presently, several clinical trials to approve the efficiency of proposed vaccine solutions have been made successfully. Global health safety concerns on vaccine's efficiency such as high costs of production, provision of vaccine to developing countries, and its influence on the global economy are addressed. This commentary reflects on current efforts related to the development of vaccine against COVID-19, which currently affects the global health status and economy. In addition, the commentary aims at addressing potential risks related to the development of COVID-19 vaccine from the global health safety perspective. URL: https://www.ncbi.nlm.nih.gov/pubmed/33803704 DOI: 10.3390/vaccines9030274

6. Alvarado-Socarras JL, Vesga-Varela AL, Quintero-Lesmes DC, et al. Perception of COVID-19 Vaccination Amongst Physicians in Colombia. Vaccines (Basel). 2021;9(3):19. DOI: 10.3390/vaccines9030287 ABSTRACT: Introduction: The SARS-CoV-2/COVID-19 pandemic has triggered the need to develop rapidly effective and safe vaccines to prevent infection, particularly in those at-risk populations such as medical personnel. This study's objective was to assess the perception of COVID-19 vaccination amongst Colombian physicians featuring two different scenarios of COVID-19 vaccination. Methods: A cross-sectional analytical study was carried out through an online survey directed at medical staff in several cities in Colombia. The percentage of physicians who have a positi ve perception to be vaccinated and the associated factors that determine that decision were determined. A binomial regression analysis adjusted for age and sex was carried out, taking as a dependent variable the acceptance of free vaccination with an effectiveness of 60 and 80%. The most significant factors were determined in the non-acceptance of vaccination. Results: Between 77.0% and 90.7% of physicians in Colombia accept COVID -19 vaccination, according to the scenario evaluated where the vaccine's effectiveness was 60 or 80%, respectively. Medical specialty, having never paid for a vaccine, recommending the administration of the vaccine to their parents or people over 70 years, and dispensing the vaccine to their children, were the factors to consider to be vaccinated for free with an effectiveness of 60% and 80%. Conclusions: There is a high perception of the intention to vaccinate physicians in Colombia against COVID-19, and this is very similar to that of the general population. URL: https://www.ncbi.nlm.nih.gov/pubmed/33808918 DOI: 10.3390/vaccines9030287

7. Amanpour S. The Rapid Development and Early Success of Covid 19 Vaccines Have Raised Hopes for Accelerating the Cancer Treatment Mechanism. Arch Razi Inst. 2021;76(1):1-6. DOI: 10.22092/ari.2021.353761.1612 ABSTRACT: The Covid-19 pandemic has brought about rapid change in medical science. The production of new generation vaccines for this disease has surprised even their most optimistic supporters. Not only have these vaccines proven to be effective, but the importance of this disease and pandemic situation also significantly shortened the long-standing process of validating such products. Vaccination is a type of immunotherapy. Researchers have long

Evidence Search Report: INF031801v2 ESR 9 been looking at vaccines as a possible treatment for cancer (Geynisman et al., 2014). In the same way that vaccines work against infectious diseases, attempts are being made to develop vaccines to identify specific proteins on cancer cells. This helps the recognize and attack cancer cells. Cancer vaccines may help: I) Prevent the growth of cancer cells (Bialkowski et al., 2016), II) Prevent recurrence of cancer (Stanton and Disis, 2015), III) Destroy cancer cells left over from other treatments. The following types of cancer vaccines are being studied: Antigen Vaccines. These vaccines are made from specific proteins or antigens of cancerous cells. Their purpose is to stimulate the immune system to attack cancer cells (Tagliamonte et al., 2014). Whole-Cell Vaccines. A whole-cell vaccine uses the entire cancer cell, not just a specific molecule (antigen), to generate the vaccine. (Keenan and Jaffee, 2012).Dendritic Cell Vaccines. Dendritic cells help the immune system identify abnormal cells, such as cancerous cells. Dendritic cells are grown with cancer cells in the laboratory to produce the vaccine. The vaccine then stimulates the immune system to attack cancer. (Wang et al., 2014; Mastelic-Gavillet et al., 2019). DNA Vaccines. These vaccines are made from DNA fragments of cancer cells. They can be injected into the body to facilitate immune system cells can better respond and kill cancer cells (Gatti-Mays et al., 2017).Other Types of Cancer Vaccines. such as Anti idiotype vaccines. This vaccine stimulates the body to generate against cancerous cells. An example of an anti-idiotype is Racotumomab or Vaxira (Cancer, 2016). However, conditions and considerations after Corona does not seem to be the same as before. The current pandemic situation has also led to major changes in the pharmaceutical and Vaccine production process and international protocols. Some of the most critical issues that can accelerate the introduction of cancer vaccines are: 1. Typical drug and vaccine development timeline. A typical vaccine needs 5 to 10 years and sometimes longer to design secure funding, and get approval (Figure 1). Less than 10 percent of new drugs, which are entered in the different phases of clinical trials, are advanced to approval by the Food and Drug Administration (FDA)(Cancer, 2020a). However, now the situation is not normal. Dozens of Covid 19 vaccines are starting clinical trials. Some of them use RNA and DNA technology, which delivers the body with missions to produce its antibodies against the virus. There are already at least 254 therapies and 95 vaccines related to Covid-19 being explored. However, it seems that the experiences gained in this pandemic, and advances in technology, may be effective in shortening the production path of other vaccines and drugs and the process of its approval at the national and international levels in the future. In Figure 2, the time course of production of conventional vaccines in comparison with Covid 19 vaccines (Cancer, 2020b) is shown.2. The introduction of messenger RNA (mRNA) technology in to the field of prevention and treatment. Over the past decades, this technology has been considered an excellent alternative to conventional vaccination methods. Proper potency and low side effects, the possibility of fast production and relatively low production cost are its advantages. However, until recently, the instability of this molecule has been a major problem in its application. This research was started many years ago by two companies that played a significant role in developing the first Covid vaccines, so BioNTech and Moderna were able to quickly transfer their experience in the field of Covid vaccine development (Pardi et al., 2018; Moderna, 2020). Figure 3 shows how mRNA vaccines work. Bout Pfizer &ndash; BioNTech and Moderna mRNA vaccines were more than 90 % effective in preclinical stages. Millions of doses of these two vaccines are currently being injected into eligible individuals worldwide. 3. Considering the use of artificial intelligence in assessing the effectiveness of vaccines. There are always doubts about the effectiveness of the new drug in treating the disease. Once the vaccine is widely available, we will know more about its effectiveness versus it works under carefully controlled scientific testing conditions. Vaccines will continue to be monitored after use. The data collected helps professionals understand how they work in different groups of people (depending on factors such as age, ethnicity, and people with different health conditions) and also the length of protection provided by the vaccine. Artificial intelligence (AI) is an emerging field, which reaches everywhere and not only as a beneficial industrial tool but also as a practical tool in medical science and plays a crucial role in developing the computation vision, risk assessment, diagnostic, prognostic, etc. models in the field of medicine (Amisha et al., 2019). According to the wide range of AI applications in the analysis of different types of data, it can be used in vaccine production, safety assessments, clinical and preclinical studies and Covid 19 vaccines adverse reactions (CDC, 2019). Indeed, most cancer vaccines are therapeutic, rather than prophylactic, and seek to stimulate cell -mediated responses, such as those from CTLs, capable of clearing or reducing tumor burden. There are currently FDA-approved products for helping cancer treatment such as BREYANZI, TECARTUS and YESCARTA for lymphoma, IMLYGIC for melanoma, KYMRIAH for acute lymphoblastic leukemia, and PROVENGE for prostate cancer. Over the past decad e, most of BioNTech&#39;s activities have been in the field of design and production for melanoma (two clinical trials), breast cancer (one clinical trial), and the rest concerning viral and veterinary vaccines (two clinica l trials). Also Maderno company has been working on Individualized cancer vaccines (one clinical trials), and vaccines for viral infections such as Zika and Influenza and veterinary vaccines (several clinical trials) (Pardi et al., 2018). Therefore, it can be said, mRNA technology that has been the subject of much research into the treatment of cancer

Evidence Search Report: INF031801v2 ESR 10 has been shifted and rapidly used to produce and use the Covid 19 vaccine. The current pandemic situation has necessitated the acceleration of Covid 19 vaccines and drugs and national and international protocols for their approval. If the currently produced vaccines can continue to be as successful as the preclinical and early phase studies, these changes and evolution have raised hopes for accelerating the use of these tech nologies and mechanisms in the field of cancer and other diseases vaccines, including HIV and influenza. URL: https://www.ncbi.nlm.nih.gov/pubmed/33818952 DOI: 10.22092/ari.2021.353761.1612

8. Amimo F, Lambert B, Magit A, et al. A review of prospective pathways and impacts of COVID-19 on the accessibility, safety, quality, and affordability of essential medicines and vaccines for universal health coverage in Africa. Global health. 2021;17(1):42. DOI: 10.1186/s12992 -021-00666-8 ABSTRACT: BACKGROUND: The ongoing pandemic of coronavirus disease 2019 (COVID-19) has the potential to reverse progress towards global targets. This study examines the risks that the COVID -19 pandemic poses to equitable access to essential medicines and vaccines (EMV) for universal h ealth coverage in Africa. METHODS: We searched medical databases and grey literature up to 2 October 2020 for studies reporting data on prospective pathways and innovative strategies relevant for the assessment and management of the emerging risks in accessibility, safety, quality, and affordability of EMV in the context of the COVID-19 pandemic. We used the resulting pool of evidence to support our analysis and to draw policy recommendations to mitigate the emerging risks and improve preparedness for future crises. RESULTS: Of the 310 records screened, 134 were included in the analysis. We found that the disruption of the international system affects more immediately the capability of low - and middle- income countries to acquire the basket of EMV. The COVID-19 pandemic may facilitate dishonesty and fraud, increasing the propensity of patients to take substandard and falsified drugs. Strategic regional cooperation in the form of joint tenders and contract awarding, joint price negotiation and supplier selectio n, as well as joint market research, monitoring, and evaluation could improve the supply, affordability, quality, and safety of EMV. Sustainable health financing along with international technology transfer and substantial investment in research and develo pment are needed to minimize the vulnerability of African countries arising from their dependence on imported EMV. To ensure equitable access, community-based strategies such as mobile clinics as well as fees exemptions for vulnerable and under-served segments of society might need to be considered. Strategies such as task delegation and telephone triage could help reduce physician workload. This coupled with payments of risk allowance to frontline healthcare workers and health-literate healthcare organization might improve the appropriate use of EMV. CONCLUSIONS: Innovative and sustainable strategies informed by comparative risk assessment are increasingly needed to ensure that local economic, social, demographic, and epidemiological risks and potentials are accounted for in the national COVID-19 responses. URL: https://www.ncbi.nlm.nih.gov/pubmed/33832487 DOI: 10.1186/s12992-021-00666-8

9. Angelis A, Darrow J. Safeguarding evidence-based decision making in the FDA for COVID-19 vaccines. Vaccine. 2021;22:22. DOI: 10.1016/j.vaccine.2021.03.053 URL: https://www.ncbi.nlm.nih.gov/pubmed/33785254 DOI: 10.1016/j.vaccine.2021.03.053

10. Angulo-Zamudio UA, Martinez-Villa FM, Leon-Sicairos N, et al. Analysis of Epidemiological and Clinical Characteristics of COVID-19 in Northwest Mexico and the Relationship Between the Influenza Vaccine and the Survival of Infected Patients. Front Public Health. 2021;9:570098. DOI: 10.3389/fpubh.2021.570098 ABSTRACT: The first cases of unexplained pneumonia were reported in , China, in December of 2019. Later, a novel coronavirus (SARS-CoV-2) was identified as the causal agent of pneumonia. This virus has sin ce spread to more than 180 countries and has been declared a pandemic by the World Health Organization. Herein, we aimed to determine the epidemiological and clinical characteristics of symptomatic patients with coronavirus disease 2019 (COVID-19) and the relationship between the influenza vaccine with a lower risk of severe COVID-19 infection in the state of Sinaloa. We collected demographic and clinical data of 4,040 patients with acute respiratory infections across Sinaloa state hospitals from February 28 to May 15, 2020. The prevalence of COVID-19 among hospitalized patients with respiratory symptoms in Sinaloa showed 45.2% of men were more affected than women (p < 0.001), and people aged 40-49 years were the most affected. The main symptoms of COVID-19 infection were cough and (p < 0.001), while hypertension, obesity, and type 2 were the chronic diseases associated with COVID -19 than

Evidence Search Report: INF031801v2 ESR 11 non-COVID-19 (p < 0.003). Healthcare workers were most likely to be infected compared to other occupations (p < 0.001). The general lethality rate was 14.1%, and males >62 years were the ones who had a higher lethality rate (p < 0.001); the aforementioned chronic diseases were related to higher lethality of COVID -19 (p < 0.001). Likewise, higher lethality was seen in housewives and patient retirees/pensioners compared with other occupations (p < 0.001). Finally, we found there was a relationship between influenza vaccination and a lower risk of severe COVID -19 infection and mortality (p < 0.001). These findings showed that healthcare workers, men >62 years with chronic diseases, and retired people were most affected. Furthermore, the influenza vaccine could decrease the severeness of COVID -19 cases. URL: https://www.ncbi.nlm.nih.gov/pubmed/33842415 DOI: 10.3389/fpubh.2021.570098

11. Anonymous. WHO adds Janssen vaccine to list of safe and effective emergency tools against COVID-19. Saudi Med J. 2021;42(4):463-4. URL: https://www.ncbi.nlm.nih.gov/pubmed/33795510

12. Ayers CK, Kondo KK, Williams BE, et al. Disparities in H1N1 Vaccination Rates: a Systematic Review and Evidence Synthesis to Inform COVID-19 Vaccination Efforts. J Gen Intern Med. 2021;31:31. DOI: 10.1007/s11606-021-06715-7 ABSTRACT: BACKGROUND: Data suggest that there were disparities in H1N1 vaccine uptake, and these may inform COVID-19 vaccination efforts. We conducted a systematic review to evaluate disparities in H1N1 vaccine uptake, factors contributing to disparities, and interventions to reduce them. METHODS: We searched English-language articles in MEDLINE ALL, PsycINFO, Cochrane Database of Systematic Reviews, and Cochrane Central Register of Controlled Trials from database inception through May 8, 2020. Observational studies examining H1N1 va ccine uptake by race/ethnicity, socioeconomic status, rurality, and disability status in US settings were included. Two reviewers independently assessed study eligibility. Single-reviewer data abstraction was confirmed by a second reviewer. We conducted independent dual quality assessment, and collective strength of evidence assessment. RESULTS: We included 21 studies. African American/Black, Latino, and low-socioeconomic status participants had disproportionately lower H1N1 vaccination rates (low - to moderate-strength evidence). However, Latinos were more likely than Whites to intend to be vaccinated, and African American/Blacks and participants with lower -socioeconomic status were just as likely to intend to be vaccinated as their White and higher-socioeconomic status counterparts (low-strength evidence). Vaccine uptake for other groups has been insufficiently studied. Factors potentially contributing to disparities in vaccine uptake included barriers to vaccine access, inadequate information, and concerns about vaccine safety and efficacy. Studies were largely cross-sectional. Many of the studies are a decade old and were conducted in the context of a different pandemic. The categorization of racial and ethnic groups was not consistent across studies and not all groups were well-studied. DISCUSSION: Efforts to avoid disparities in COVID-19 vaccination uptake should prioritize vaccine accessibility and convenience in African American/Black, Latino, and low -SES communities; engage trusted stakeholders to share vaccine information; and address concerns about vaccine safety and efficacy. PRIMARY FUNDING SOURCE: Department of Veterans Affairs, Veterans Health Administration, Health Services Research & Development. PROTOCOL REGISTRATION: PROSPERO CRD42020187078. URL: https://www.ncbi.nlm.nih.gov/pubmed/33791935 DOI: 10.1007/s11606-021-06715-7

13. Baay M, Neels P. Controlled Human Infection to Speed Up SARS-CoV-2 Vaccine Development. Front Immunol. 2021;12:658783. DOI: 10.3389/fimmu.2021.658783 URL: https://www.ncbi.nlm.nih.gov/pubmed/33777056 DOI: 10.3389/fimmu.2021.658783

14. Batty GD, Deary IJ, Fawns-Ritchie C, et al. Pre-pandemic Cognitive Function and COVID-19 Vaccine Hesitancy: Cohort Study. medRxiv. 2021;25:25. DOI: 10.1101/2021.03.16.21253634 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 is unknown. Objective: 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. Design Setting and Participants: We used individual-level data from a pandemic-focused study (COVID Survey), a prospective cohort

Evidence Search Report: INF031801v2 ESR 12 study nested within Understanding Society (Main Survey). In the week immediately following the announcement of successful testing of the first efficacious inoculation (November/December 2020), 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. Measurements: 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 general cognitive function adjusted for selected covariates. 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). Limitations: Our outcome was based on intention rather than behaviour. 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/33791726 DOI: 10.1101/2021.03.16.21253634

15. Bhopal SS, Olabi B, Bhopal R. Vaccines for COVID-19: learning from ten phase II trials to inform clinical and public health vaccination programmes. Public Health. 2021;193:57-60. DOI: 10.1016/j.puhe.2021.01.011 ABSTRACT: Public health professionals and clinicians, in many countries, are immersed in the ongoing and upcoming vaccination programmes for COVID-19. Published information from vaccine trials is complex. There are important and helpful insights about the nature of the available and forthcoming vaccines, immune responses and side -effects from phase II trials. We have systematically summarised information from 10 such trials on the nature of the vaccines, exclusions from the trials, immunological effects and side-effects. Some important information within these trial reports is not available in the phase III trial articles, so a complete picture requires examination of phase II and phase III trials for each vaccine. We recommend our systematic approach for the examination of other upcoming COVID -19 vaccine phase II and III trials. URL: https://www.ncbi.nlm.nih.gov/pubmed/33743214 DOI: 10.1016/j.puhe.2021.01.011

16. Black SB, Law B, Chen RT, et al. The critical role of background rates of possible adverse events in the assessment of COVID-19 vaccine safety. Vaccine. 2021;06:06. DOI: 10.1016/j.vaccine.2021.03.016 ABSTRACT: Beginning in December of 2019, a novel coronavirus, SARS-CoV-2, emerged in China and is now a global pandemic with extensive morbidity and mortality. With the emergence of this threat, an unprecedented effort to develop vaccines against this virus began. As vaccines are n ow being introduced globally, we face the prospect of millions of people being vaccinated with multiple types of vaccines many of which use new vaccine platforms. Since medical events happen without vaccines, it will be important to know at what rate event s occur in the background so that when adverse events are identified one has a frame of reference with which to compare the rates of these events so as to make an initial assessment as to whether there is a potential safety concern or not. Background rates vary over time, by geography, by sex, socioeconomic status and by age group. Here we describe two key steps for post - introduction safety evaluation of COVID-19 vaccines: Defining a dynamic list of Adverse Events of Special Interest (AESI) and establishing background rates for these AESI. We use multiple examples to illustrate use of rates and caveats for their use. In addition we discuss tools available from the Brighton Collaboration that facilitate case evaluation and understanding of AESI. URL: https://www.ncbi.nlm.nih.gov/pubmed/33846042 DOI: 10.1016/j.vaccine.2021.03.016

17. Bonadonna P, Brockow K, Niedoszytko M, et al. COVID-19 vaccination in mastocytosis: recommendations of the European Competence Network on Mastocytosis (ECNM) and American Initiative in Mast Cell Diseases (AIM). J Allergy Clin Immunol Pract. 2021;05:05. DOI: 10.1016/j.jaip.2021.03.041 ABSTRACT: Mastocytosis is a neoplasm characterized by an accumulation of mast cells in various organs and increased risk for severe anaphylaxis in patients with concomitant allergies. Covid-19 is a pandemic that is associated

Evidence Search Report: INF031801v2 ESR 13 with a relatively high rate of severe disease and mortality. The mortality is particularly high in those with certain comorbidities and increases with age. Recently, several companies have developed an effective vaccination against Covid-19. Although the reported frequency of severe side effects is low, there is an emerging discussion about the safety of Covid-19 vaccination in patients with severe allergies and mastocytosis. However, even in these patients, severe adverse reactions are rare. We therefore recommend the broad use of Covid -19 vaccination in patients with mastocytosis on a global basis. The only well-established exception is a known or suspected allergy against a constituent of the vaccine. Safety measures, including premedication and post-vaccination observation should be considered in all patients with mastocytosis, depending on the individual personal risk and overall situation in each case. The current article provides a summary of published data, observations and expert opinion that form the basis of these recommendations. URL: https://www.ncbi.nlm.nih.gov/pubmed/33831618 DOI: 10.1016/j.jaip.2021.03.041

18. Bottcher L, Nagler J. Decisive Conditions for Strategic Vaccination against SARS-CoV-2. medRxiv. 2021;10:10. DOI: 10.1101/2021.03.05.21252962 ABSTRACT: While vaccines that protect against SARS-CoV-2 are being approved, the number of available doses is limited as it may take months until the production of vaccines can meet the actual demand. The majority of available SARS-CoV-2 vaccines elicits strong immune responses when administered as prime-boost regimens. Since the immunological response to the first ("prime") injection may provide already a substantial reduction in infectiousness and protection against severe disease, it may be more effective-under certain conditions-to vaccinate as many people as possible with only one shot, instead of administering a person a second ("boost") shot. Such a strategic vaccination campaign may help to more effectively slow down the spread of SARS-CoV-2, reduce hospitalizations, and reduce fatalities. Yet, the conditions which make single-dose vaccination favorable over prime-boost administrations are not well understood. Here, we formulate a model that helps explore these decisive conditions as a function of the various time scales and epidemiological mechanisms at work. We study how these conditions arise from disease prevalence, vaccination rates, basic reproduction number, prime and prime-boost efficacies, prime-boost intervals, and waning rates. By combining epidemiological modeling, random sampling techniques, and decision tree learning, we find that prime-first vaccination is robustly favored over prime-boost vaccination campaigns, even for high vaccination rates, high disease prevalence, and a relatively low single-dose efficacy. URL: https://www.ncbi.nlm.nih.gov/pubmed/33758886 DOI: 10.1101/2021.03.05.21252962

19. Bourhanbour AD, Ouchetto O. Morocco achieves the highest COVID-19 vaccine rates in Africa in the first phase: what are reasons for its success? J Travel Med. 2021;20:20. DOI: 10.1093/jtm/taab040 URL: https://www.ncbi.nlm.nih.gov/pubmed/33748858 DOI: 10.1093/jtm/taab040

20. Bousquet J, Agache I, Blain H, et al. Management of anaphylaxis due to COVID-19 vaccines in the elderly. Allergy. 2021;02:02. DOI: 10.1111/all.14838 ABSTRACT: Older adults, especially men and/or those with diabetes, and /or obesity, are prone to severe COVID-19. In some countries, older adults, particularly those residing in nursing homes, have been prioritised to receive COVID-19 vaccines due to high risk of death. In very rare instances,the COVID-19 vaccines can induce anaphylaxis, and the management of anaphylaxis in older people should be considered carefully. An ARIA-EAACI- EuGMS (Allergic Rhinitis and its Impact on , European Academy of Allergy and Clinical Immunology, and European Geriatric Medicine Society)Working Group has proposed some recommendations for older adults receiving the COVID-19 vaccines. Anaphylaxis to COVID-19 vaccines is extremely rare (from 1 per 100,000 to 5 per million injections). Symptoms are similar in younger and older adults but they tend to be more severe in the older patients. Adrenaline is the mainstay treatment and should be readily available. A flowchart is proposed to manage anaphylaxis in the older patients. URL: https://www.ncbi.nlm.nih.gov/pubmed/33811358 DOI: 10.1111/all.14838

21. Brandt EJ, Rosenberg J, Waselewski ME, et al. National Study of Youth Opinions on Vaccination for COVID- 19 in the U.S. J Adolesc Health. 2021;03:03. DOI: 10.1016/j.jadohealth.2021.02.013

Evidence Search Report: INF031801v2 ESR 14 ABSTRACT: PURPOSE: This study aimed to understand the potential barriers and facilitators to COVID-19 vaccination among youth. METHODS: Open-ended questions regarding COVID-19 vaccination were posed to a national cohort of 14- to 24-year-olds (October 30, 2020). Responses were coded through qualitative thematic analys is. Multivariable logistic regression tested the association of demographic characteristics with vaccination unwillingness. RESULTS: Among 911 respondents (response rate = 79.4%), 75.9% reported willingness to receive a COVID -19 vaccine, 42.7% had unconditional willingness, and 33.3% were conditionally willing, of which the majority (80.7%) were willing if experts deemed vaccination safe and recommended. Preferred vaccine information sources were medical organizations (42.3%; CDC, WHO) and health care professionals (31.7%). Frequent concerns with vaccination included side effects (36.2%) and efficacy (20.1%). Race predicted vaccination unwillingness (Black: odds ratio = 3.31; and Asian: odds ratio = .46, compared with white, p < .001). CONCLUSION: Most youth in our national sample were willing to receive a COVID-19 vaccine when they believe it is safe and recommended. Public health experts and organizations must generate youth-centered materials that directly address their vaccination concerns. URL: https://www.ncbi.nlm.nih.gov/pubmed/33824070 DOI: 10.1016/j.jadohealth.2021.02.013

22. Brockman MA, Mwimanzi F, Sang Y, et al. Weak humoral immune reactivity among residents of long -term care facilities following one dose of the BNT162b2 mRNA COVID-19 vaccine. medRxiv. 2021;24:24. DOI: 10.1101/2021.03.17.21253773 ABSTRACT: Background: Several Canadian provinces are extending the interval between COVID -19 vaccine doses to increase population vaccine coverage more rapidly. However, immunogenicity of these vaccines a fter one dose is incompletely characterized, particularly among the elderly, who are at greatest risk of severe COVID -19. Methods: We assessed SARS-CoV-2 humoral responses pre-vaccine and one month following the first dose of BNT162b2 mRNA vaccine, in 12 COVID-19 seronegative residents of long-term care facilities (median age, 82 years), 18 seronegative healthcare workers (HCW; median age, 36 years) and 4 convalescent HCW. Total antibody responses to SARS -CoV-2 nucleocapsid (N) and spike protein receptor binding domain (S/RBD) were assessed using commercial immunoassays. We quantified IgG and IgM responses to S/RBD and determined the ability of antibodies to block S/RBD binding to ACE2 receptor using ELISA. Neutralizing antibody activity was also assessed us ing pseudovirus and live SARS-CoV-2. Results: After one vaccine dose, binding antibodies against S/RBD were approximately 4-fold lower in residents compared to HCW (p<0.001). Inhibition of ACE2 binding was 3-fold lower in residents compared to HCW (p=0.01) and pseudovirus neutralizing activity was 2-fold lower (p=0.003).While six (33%) seronegative HCW neutralized live SARS-CoV-2, only one (8%) resident did (p=0.19). In contrast, convalescent HCW displayed 7- to 20-fold higher levels of binding antibodies and substantial ability to neutralize live virus after one dose. Interpretation: Extending the interval between COVID-19 vaccine doses may pose a risk to the elderly due to lower vaccine immunogenicity in this group. We recommend that second doses not be delayed in elderly individuals. URL: https://www.ncbi.nlm.nih.gov/pubmed/33791737 DOI: 10.1101/2021.03.17.21253773

23. 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 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

24. Canaday DH, Carias L, Oyebanji OA, et al. Reduced BNT162b2 mRNA vaccine response in SARS-CoV-2- naive nursing home residents. medRxiv. 2021;22:22. DOI: 10.1101/2021.03.19.21253920 ABSTRACT: The SARS-CoV-2 pandemic impact on nursing home (NH) residents prompted their prioritization for early vaccination. To fill the data gap for vaccine immunogenicity in NH residents, we examined antibody levels after BNT162b2 mRNA vaccine to spike, receptor binding domain (RBD) and for virus neutralization in 149 NH res idents and 111 health care worker controls. SARS-CoV-2-naive NH residents mount antibody responses with nearly 4-fold lower median neutralization titers and half the anti-spike level compared to SARS-CoV-2-naive healthcare workers. By contrast, SARS-CoV-2-recovered vaccinated NH residents had neutralization, anti-spike and anti-RBD titers similar to SARS-CoV-2-recovered vaccinated healthcare workers. NH residents' blunted antibody responses have important implications regarding the quality and durability of protection afforded by neoantigen vaccines. We urgently need

Evidence Search Report: INF031801v2 ESR 15 better longitudinal evidence on vaccine effectiveness specific to NH resident populations to inform best practices for NH infection control measures, outbreak prevention and potential indication for a vaccine boost. URL: https://www.ncbi.nlm.nih.gov/pubmed/33791727 DOI: 10.1101/2021.03.19.21253920

25. Candelli M, Pignataro G, Torelli E, et al. Effect of influenza vaccine on COVID-19 mortality: a retrospective study. Intern Emerg Med. 2021;20:20. DOI: 10.1007/s11739-021-02702-2 ABSTRACT: It has been proposed that vaccines may exert an unspecific protective effect against infectious agents, different than expected. Coronavirus disease 2019 (COVID-19) is a pandemic infection with high mortality in older patients due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The high number of vaccinations may be one of the reasons why children show a lower susceptibility to SARS-CoV-2 infection and milder severity when compared to adults. We have designed a study aimed at investigating whether the influenza vaccine may reduce the susceptibility and severity of SARS-CoV-2 infection. We retrospectively enrolled 635 patients who accessed our Emergency Department from March 1st to June 30th, 2020, and were diagnosed with COVID-19 infection confirmed by an RT-PCR on an oropharyngeal swab. Clinical data, outcomes, and influenza vaccination status were collected from the electronic medical records of our Hospital. We also used data from the Italian Hea lth Ministry to compare the prevalence of flu vaccination among the general population of the Lazio Region and our enrolled patients. We then compared clinical outcomes between vaccinated and non -vaccinated patients, by univariate and multivariate analysis. COVID-19-positive patients older than 65 years reported a lower prevalence of flu vaccination when compared to the general population residing in the Lazio (p = 0.004). After correction for gender, age, and comorbidities, we found a lower risk of death at 60 days in patients with flu vaccination than in not vaccinated patients (p = 0.001). Our study shows that flu vaccination could reduce the mortality of COVID -19. Prospective studies are needed to confirm this result. URL: https://www.ncbi.nlm.nih.gov/pubmed/33743150 DOI: 10.1007/s11739-021-02702-2

26. Carbone L, Mappa I, Sirico A, et al. Pregnant women perspectives on SARS-COV-2 vaccine: Condensation: Most of Italian pregnant women would not agree to get the SARS-COV-2 vaccine, irrespective of having features of high risk themselves, or being high-risk pregnancies. Am J Obstet Gynecol MFM. 2021:100352. DOI: 10.1016/j.ajogmf.2021.100352 ABSTRACT: BACKGROUND: Since COVID-19 vaccines have been distributed, a debate has raised on whether pregnant women should get the vaccine. No available data exist so far regarding safety, efficacy and toxicology of these vaccines when administered during pregnancy. Most of the Obstetrics and Gynecology societies suggested that pregnant could agree to be vaccinated, after a thorough counseling of risks and benefits with their gynecologists, thus leading to an autonomous decision. OBJECTIVE: The aim of this study was to evaluate the attitude to COVID -19 vaccination in pregnant and breastfeeding women in Italy. STUDY DESIGN: A survey was made at University of Naples Federico II and University of Rome Tor Vergata Ospedale Cristo Re on pregnant and breastfeeding women asking their perspectives on the available vaccines after reading the recommendations issued by our national Obst etrics, Gynecology and Neonatology societies. The questionnaire included 12 items finalized to evaluate general features of the women and 6 items specifically correlated to their attitudes towards the SARS-COV-2 vaccination. Chi square (chi(2)) or Fisher exact tests were used to compare group differences of categorical variables and Wilcoxon signed rank or Mann Whitney U test for continuous variables. The study was approved by the Institutional Review Boards of the University of Naples Federico II (ref. no. 409/2020), and University of Rome Tor Vergata Ospedale Cristo Re (ref. #Ost4-2020). RESULTS: Most of the included women did not agree to eventually receive SARS -COV-2 vaccine during pregnancy (40, 28.2% vs 102, 71.8%). Being pregnant was considered a determinant factor to refuse the vaccine prophylaxis (99, 69.7% vs 43, 30.3%; chi(2)= 24.187, p<0.001), even if a very large percentage declared to be generally in favor of vaccines (128, 90.1% vs 14, 9.9%; chi(2)= 6.091, p=0.014) and most of them confirmed th ey received or would receive other recommended vaccines during pregnancy (75, 52.8% vs 67, 47.2%; chi2= 10.996, p=0.001). CONCLUSION: Urgent data are needed on safety, efficacy and toxicology of SARS-COV-2 vaccines during pregnancy to modify this trend and to help obstetricians during the counselling. Furthermore, pregnant women should be included in future vaccine development trials to not incur again in such uncertainty. URL: https://www.ncbi.nlm.nih.gov/pubmed/33771762 DOI: 10.1016/j.ajogmf.2021.100352

Evidence Search Report: INF031801v2 ESR 16 27. Chen J, Lu H. New challenges to fighting COVID-19: Virus variants, potential vaccines, and development of antivirals. Biosci Trends. 2021;19:19. DOI: 10.5582/bst.2021.01092 ABSTRACT: Despite strict control measures implemented worldwide, the COVID-19 pandemic continues to rage. Several drugs, including lopinavir/ritonavir, hydroxychloroquine, , and remdesivir, have been evaluated for the treatment of COVID-19 during the past year. While most of the drugs failed to display efficacy in treat ing COVID-19, scientists have encouraged herd immunity to control the pandemic. Immunity generated after natural infection with SARS-CoV-2 is precarious, as indicated by real-world evidence in the form of epidemiological data from Manaus, Brazil. Vaccines using different platforms are therefore the most promising approach to help us return to normality. Although several vaccines have been authorized for emergency use, there are still many concerns regarding their accessibility, the vaccination rate, and most importantly, their efficacy in preventing infection with emerging virus variants. Continued virus surveillance and rapid redesign of new vaccines to counter new variants are crucial to fighting COVID-19. Rapid production and extensive vaccination are also essential to preventing the emergence of new variants. Nevertheless, antivirals including monoclonal antibodies and oral medicines need to be developed in light of uncertainties with regard to vaccination. In the battle between humans and SARS-CoV-2, the speed with which we fight the virus, and especially its emerging variants, is the key to winning. URL: https://www.ncbi.nlm.nih.gov/pubmed/33746183 DOI: 10.5582/bst.2021.01092

28. Chen Y, Cheng L, Lian R, et al. COVID-19 vaccine research focusses on safety, efficacy, immunoinformatics, and vaccine production and delivery: a bibliometric analysis based on VOSviewer. Biosci Trends. 2021;19:19. DOI: 10.5582/bst.2021.01061 ABSTRACT: Coronavirus Disease 2019 (COVID-19), caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), has affected tens of millions of people globally since it was declared a pandemic by the World Health Organization (WHO) on March 11, 2020. There is an urgent need for safe and effective preventive vaccines to curb this pandemic. A growing amount of related research has been published. This study aimed to provide the current status of COVID-19 vaccine using bibliometric analysis. We searched Embase.com and MEDLINE comprehensively and included articles, articles in press, reviews, short surveys, conference abstracts and conference papers about COVID-19 vaccine. VOSviewer1.6.11 (Leiden University, Leiden, Netherlands) was applied to perform the bibliometric analysis of these papers. A total of 1,312 papers were finally included. The BMJ has been the most popular journal in this field. The United States maintained a top position worldwide and has provided a pivotal influence, followed by China, India and United Kingdom. Among all the institutions, Harvard University was regarded as a leader for research collaboration. We analyzed the keywords and identified seven COVID-19 vaccine research hotspot clusters. COVID-19 vaccine research hotspots focus on clinical trials on vaccine safety and efficacy, research on vaccine immunology and immunoinformatics, and vaccine hesitancy. Our analysis results demonstrated that cooperation between countries, institutions, and authors were insufficient. The results suggested that clinical trials on vaccine safety, efficacy, immunology, immunoinformatics, production and delivery are research hotspots. Furthermore, we can predict that there will be a lot of research focusing on vaccine adverse reactions. URL: https://www.ncbi.nlm.nih.gov/pubmed/33746182 DOI: 10.5582/bst.2021.01061

29. Chew NWS, Cheong C, Kong G, et al. An Asia-Pacific study on healthcare workers' perceptions of, and willingness to receive, the COVID-19 vaccination. Int J Infect Dis. 2021;106:52-60. DOI: 10.1016/j.ijid.2021.03.069 ABSTRACT: OBJECTIVE: In the fight against COVID-19, vaccination is vital in achieving herd immunity. Many Asian countries are starting to vaccinate frontline workers; however, expedited vaccine development has led to hesitancy among the general population. We evaluated the willingness of healthcare workers to receive the COVID-19 vaccine. METHODS: From 12 to 21 December 2020, we recruited 1720 healthcare workers from 6 countries: China, India, Indonesia, Singapore, Vietnam and Bhutan. The self-administrated survey collected information on willingness to vaccinate, perception of COVID-19, vaccine concerns, COVID-19 risk profile, stigma, pro-socialness scale, and trust in health authorities. RESULTS: More than 95% of the healthcare workers surveyed were willing to vaccinate. These respondents were more likely to perceive the pandemic as severe, consider the vaccine safe, have less financial concerns, less stigmatization regarding the vaccine, higher pro -socialness mindset and trust in health authorities. A high perceived pandemic risk index, low vaccine harm index and high pro-socialness index were independent predictors in multivariable analysis. CONCLUSIONS: The majority of healthcare workers in Asia are willing to receive

Evidence Search Report: INF031801v2 ESR 17 COVID-19 vaccination. Perceived COVID-19 susceptibility, low potential risk of vaccine harm and pro-socialness are the main drivers. These findings may help formulate vaccination strategies in other countries. URL: https://www.ncbi.nlm.nih.gov/pubmed/33781902 DOI: 10.1016/j.ijid.2021.03.069

30. Choi EM. COVID-19 vaccines for low- and middle-income countries. Trans R Soc Trop Med Hyg. 2021;18:18. DOI: 10.1093/trstmh/trab045 ABSTRACT: The COVID-19 pandemic is the biggest threat to public health in a century. Through hard work and ingenuity, scientists have developed a number of safe and effective vaccines against COVID-19 disease. However, demand far outstrips supply and countries around the world are competing for available vaccines. This review describes how low- and middle-income countries access COVID-19 vaccines, what is being done to distribute vaccines fairly, as well as the challenges ahead. URL: https://www.ncbi.nlm.nih.gov/pubmed/33733663 DOI: 10.1093/trstmh/trab045

31. Ciarambino T, Barbagelata E, Corbi G, et al. Gender differences in vaccine therapy: where are we in COVID- 19 pandemic? Monaldi Arch Chest Dis. 2021;08:08. DOI: 10.4081/monaldi.2021.1669 ABSTRACT: Vaccination is one of the greatest achievements of public health. Vaccination programs have contributed to the decline in mortality and morbidity of various infectious diseases. This review aims to investigate the impact of sex/gender on the vaccine acceptance, responses, and outcomes. The studies were identif ied by using PubMed, until 30th June 2020. The search was performed by using the following keywords: SARS-CoV-2, COVID-19, gender, sex, vaccine, adverse reaction. Clinical trials, retrospective and prospective studies were included. Studies written in languages other than English were excluded. Studies were included if gender differences in response to vaccination trials were reported. All selected studies were qualitatively analyzed. Innate recognition and response to viruses, as well as, adaptive immune responses during viral infections, differ between females and males. Unfortunately, a majority of vaccine trials have focused on healthy people, with ages between 18 to 65 years, excluding the elderly, pregnant women, post-menopausal female and children. In conclusion, it is apparent that the design of vaccines and vaccine strategies should be sex-specific, to reduce adverse reactions in females and increase immunogenicity in males. It should be mandatory to examine sex-related variables in pre-clinical and clinical vaccine trials, such as their crucial role for successful prevention of pandemic COVID-19. URL: https://www.ncbi.nlm.nih.gov/pubmed/33840183 DOI: 10.4081/monaldi.2021.1669

32. Cioffi A, Cioffi F. COVID-19 vaccine: Risk of inequality and failure of public health strategies. Ethics Med Public Health. 2021;17:100653. DOI: 10.1016/j.jemep.2021.100653 URL: https://www.ncbi.nlm.nih.gov/pubmed/33758775 DOI: 10.1016/j.jemep.2021.100653

33. Cordina M, Lauri MA, Lauri J. Attitudes towards COVID-19 vaccination, vaccine hesitancy and intention to take the vaccine. Pharm Pract (Granada). 2021;19(1):2317. DOI: 10.18549/PharmPract.2021.1.2317 ABSTRACT: Background: The pandemic is at a paradoxical stage, with vaccine roll out initiated but a significantly elevated level of infection and death. Hope for recovery lies in high equitable vaccine uptake. Objective: The study aimed to: i) explore attitudes and factors influencing attitudes, towards the COVID -19 vaccine amongst people living in Malta, ii) identify the reasons as to why individuals are unsure or unwilling to take the vaccine. Methods: Two consecutive, short, anonymous online surveys using social media platforms were used to gather data from adult individuals. The first study was open to residents in Malta, while the second study invited international participation. Study 1 consisted of 17 questions inspired by the Theories of Planned Behaviour and Reasoned Action. Study 2 asked participates whether they were willing, unwilling or unsure of taking the vaccine and their reasons for being unsure or unwilling. Results: A total of 2,529 individuals participated in Study 1 and 834 in Study 2. In both studies respondents were predominantly female having a tertiary education. Over 50% declared that they were willi ng to take the vaccine, with males being more willing (t=5.83, df=1164.2, p<0.00005). Opinions of significant others - family and friends (r=0.22, p<0.005) and health professionals (r=0.74, p<0.005) were associated with willingness to take the vaccine. Vaccine hesitancy was present in the study population with 32.6% being unsure and 15.6% declaring that they were not willing to take the vaccine. Females were more likely to be unsure (Chi -squared=14.63, df=4, p=0.006). Lack of

Evidence Search Report: INF031801v2 ESR 18 vaccine safety was the main reason cited for unwillingness to take the vaccine. Predictors for willingness to take the vaccine were: i) The belief that the COVID-19 vaccine will protect the health of the people who take it; ii) Valuing the advice of health professionals regarding the effectiveness of COVID-19 vaccine; iii) Having taken the influenza vaccine last year and; iv) Encouraging their elderly parents to take the vaccine. Conclusions: COVID -19 vaccination information campaigns should promote group strategies, focusing on emphasising the safety of the vaccine and offer reassurance, especially to women. URL: https://www.ncbi.nlm.nih.gov/pubmed/33828623 DOI: 10.18549/PharmPract.2021.1.2317

34. Corti C, Crimini E, Tarantino P, et al. SARS-CoV-2 vaccines for cancer patients: a call to action. Eur J Cancer. 2021;148:316-27. DOI: 10.1016/j.ejca.2021.01.046 ABSTRACT: Coronavirus disease 2019 (COVID-19) has affected more than 96 million people worldwide, leading the World Health Organization (WHO) to declare a pandemic in March 2020. Altho ugh an optimal medical treatment of COVID-19 remains uncertain, an unprecedented global effort to develop an effective vaccine hopes to restore pre - pandemic conditions. Since cancer patients as a group have been shown to be at a higher risk of severe COVID -19, the development of safe and effective vaccines is crucial. However, cancer patients may be underrepresented in ongoing phase 3 randomised clinical trials investigating COVID-19 vaccines. Therefore, we encourage stakeholders to provide real-time data about the characteristics of recruited participants, including clearly identifiable subgroups, like cancer patients, with sample sizes large enough to determine safety and efficacy. Moreover, we envisage a prompt implementation of suitable registries for ph armacovigilance reporting, in order to monitor the effects of COVID-19 vaccines and immunisation rates in patients with cancer. That said, data extrapolation from other vaccine trials (e.g. anti-influenza virus) showed a favourable safety and efficacy profile for cancer patients. On the basis of the evidence discussed, we believe that the benefits of the vaccination outweigh the risks. Consequently, healthcare authorities should prioritise vaccinations for cancer patients, with the time-point of administration agreed on a case-by-case basis. In this regard, the American Society of Clinical Oncology and the European Society of Medical Oncology are advocating for cancer patients a high priority status, in the hope of attenuating the consequences of the pandemi c in this particularly vulnerable population. URL: https://www.ncbi.nlm.nih.gov/pubmed/33770576 DOI: 10.1016/j.ejca.2021.01.046

35. Costa Frossard-Franca L, Garcia-Dominguez JM, Moreno-Torres I, et al. [Vaccination against SARS-CoV-2 in patients with multiple sclerosis]. Rev Neurol. 2021;72(7):250-60. DOI: 10.33588/rn.7207.2021097 ABSTRACT: INTRODUCTION: The recent availability of SARS-CoV-2 vaccines has raised concerns in certain patient groups, such as those with multiple sclerosis. However, there are currently few publications that provide information on this issue. We pooled the information available on the safety and efficacy of vaccination against SARS-CoV-2 in patients with multiple sclerosis, with and without disease-modifying therapy. DEVELOPMENT: The study consisted in a literature search focused on the types of SARS-CoV-2 vaccines, the current status of their approval, an d the data available on the safety and efficacy of vaccines in patients with multiple sclerosis, including the new COVID -19 vaccines. Based on this search, the document has been designed taking into account current evidence and expert recommendations. There are no data on the safety and efficacy of SARS-CoV-2 vaccines in patients with multiple sclerosis. However, evidence does exist to suggest that messenger RNA (mRNA) vaccines against SARS -CoV-2 are as safe in these patients as in other individuals. Some therapies with immunosuppressants might reduce the effectiveness of these vaccines and require the scheduling of their administration, preferably before the start of treatment if possible. CONCLUSION: The data available make it possible to recommend mRNA va ccines against SARS- CoV-2 in patients with multiple sclerosis. In patients on fingolimod, cladribine, alemtuzumab, ocrelizumab and rituximab, vaccination prior to the initiation of medication administration would be recommendable whenever possible. URL: https://www.ncbi.nlm.nih.gov/pubmed/33764494 DOI: 10.33588/rn.7207.2021097

36. Covidsurg Collaborative GC. SARS-CoV-2 vaccination modelling for safe surgery to save lives: data from an international prospective cohort study. Br J Surg. 2021;24:24. DOI: 10.1093/bjs/znab101 ABSTRACT: BACKGROUND: Preoperative SARS-CoV-2 vaccination could support safer elective surgery. Vaccine numbers are limited so this study aimed to inform their prioritization by modelling. METHODS: The primary outcome

Evidence Search Report: INF031801v2 ESR 19 was the number needed to vaccinate (NNV) to prevent one COVID-19-related death in 1 year. NNVs were based on postoperative SARS-CoV-2 rates and mortality in an international cohort study (surgical patients), and community SARS-CoV-2 incidence and case fatality data (general population). NNV estimates were stratified by age (18-49, 50- 69, 70 or more years) and type of surgery. Best- and worst-case scenarios were used to describe uncertainty. RESULTS: NNVs were more favourable in surgical patients than the general population. The most favourable NNVs were in patients aged 70 years or more needing cancer surgery (351; best case 196, worst case 816) or non -cancer surgery (733; best case 407, worst case 1664). Both exceeded the NNV in the general population (1840; best case 1196, wor st case 3066). NNVs for surgical patients remained favourable at a range of SARS-CoV-2 incidence rates in sensitivity analysis modelling. Globally, prioritizing preoperative vaccination of patients needing elective surgery ahead of the general population could prevent an additional 58 687 (best case 115 007, worst case 20 177) COVID -19-related deaths in 1 year. CONCLUSION: As global roll out of SARS-CoV-2 vaccination proceeds, patients needing elective surgery should be prioritized ahead of the general population. URL: https://www.ncbi.nlm.nih.gov/pubmed/33761533 DOI: 10.1093/bjs/znab101

37. Craig BM. United States COVID-19 Vaccination Preferences (CVP): 2020 Hindsight. Patient. 2021;30:30. DOI: 10.1007/s40271-021-00508-0 ABSTRACT: BACKGROUND: Shortly after the 2020 US election, initial evidence on first-generation COVID-19 vaccines showed 70-95% efficacy and minimal risks. Yet, many US adults expressed reluctance. AIMS: The aim of this study was to compare persons willing and unwilling to be vaccinated against COVID-19 and to estimate the effects of vaccination attributes on uptake: proof of vaccination, vaccination setting, effectiveness, duration of immunity, and risk of severe side effects. METHOD: Between 9 and 11 November 2020, 1153 US adults completed a discrete choice experiment (DCE) on Phase 2 of the CDC Vaccination Program (August 2021). Each of its eight choice tasks had three vaccination alternatives and "no vaccination for 6 months." An opt-out inflated logit model was estimated to test for respondent differences and attribute effects. RESULTS: Respondent demographics were unrelated to one's willingness to be vaccinated (p value 0.533), but those with less education were more likely to be unwilling (p < 0.001). Among those willing, uptake ranged from 61.70 to 97.75%, depending on the vaccination attributes. Effectiveness and safety had the largest effects. Offering proof of vaccination and a choice of setting increased uptake as much as increasing immunity from 3 to 6 months. CONCLUSIONS: To maximize uptake, the CDC Program should standardize proof of vaccination and offer a choice of setting, instead of a one-size-fits-all approach. If the first-generation vaccines are efficacious, widely available, and free, overall predicted uptake is 68.81% by the end of Phase 2 (August 2021), which is well below the 75-90% needed for herd immunity. Further health preference research is necessary to uncover and address unwillingness and reluctance to vaccinate against COVID-19. URL: https://www.ncbi.nlm.nih.gov/pubmed/33783724 DOI: 10.1007/s40271-021-00508-0

38. Dal-Re R. Clinical Equipoise in COVID-19 Vaccine Candidates Trials. J Clin Pharmacol. 2021;07:07. DOI: 10.1002/jcph.1868 URL: https://www.ncbi.nlm.nih.gov/pubmed/33826784 DOI: 10.1002/jcph.1868

39. Dal-Re R. Will AstraZeneca be able to provide clinical trial data on its COVID-19 vaccine efficacy in older adults? Br J Clin Pharmacol. 2021;24:24. DOI: 10.1111/bcp.14828 URL: https://www.ncbi.nlm.nih.gov/pubmed/33760277 DOI: 10.1111/bcp.14828

40. 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;07:07. DOI: 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 October 2-30, 2020 (1,233 individuals) in a structured way for analyzing 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

Evidence Search Report: INF031801v2 ESR 20 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 analyzing the risks associated with this global pandemic. URL: https://www.ncbi.nlm.nih.gov/pubmed/33825348 DOI: 10.1111/tbed.14097

41. Desai A, Gainor JF, Hegde A, et al. Author Correction: COVID-19 vaccine guidance for patients with cancer participating in oncology clinical trials. Nat Rev Clin Oncol. 2021;23:23. DOI: 10.1038/s41571 -021-00503-2 URL: https://www.ncbi.nlm.nih.gov/pubmed/33758378 DOI: 10.1038/s41571-021-00503-2

42. Deva Priya SA, Kavitha S, Venugopal P, et al. Can mRNA Vaccines Turn the Tables During the COVID-19 Pandemic? Current Status and Challenges. Clin Drug Investig. 2021;23:23. DOI: 10.1007/s40261 -021-01022-9 ABSTRACT: The COVID-19 pandemic continues to affect millions of people across the world. The current global statistics for the disease are 111 million cases and 2.45 million deaths, with new cases emerging each day. Although several drugs including remdesivir have been approved for emergency use, they remain ineffective in bringing the infection under control. Therefore, there is a need for highly effective and safe vaccines against COVID -19. The recent advancements in mRNA vaccines have catapulted them to be forefront in the race to develop vaccines for COVID-19. Two mRNA vaccines, BNT162b2 and mRNA-1273, developed by Pfizer-BioNTech and Moderna Therapeutics, respectively, have been granted authorization for emergency use by the US Food and Drug Administrati on. Interim analysis of the clinical trials for BNT162b2 and mRNA-1273 vaccines reported an efficacy of 95% and 94.1%, respectively, after the second dose. The adverse events for both the vaccines have been found to be mild to moderate, with mostly injection-site reactions and . No serious adverse events have been reported. Moreover, Pfizer-BioNTech and Moderna Therapeutics have announced that their vaccines are effective even against the new strains (B.1.17 and B.1.351) of the virus. Both companies are now scaling up the production of the vaccines to meet the global demand. Although the long-term efficacy, safety, and immunogenicity of these vaccines is uncertain, there is hope that they can turn the tables against COVID-19 in this current pandemic situation. URL: https://www.ncbi.nlm.nih.gov/pubmed/33754328 DOI: 10.1007/s40261-021-01022-9

43. Di Giuseppe G, Pelullo CP, Della Polla G, et al. Exploring the Willingness to Accept SARS-CoV-2 Vaccine in a University Population in Southern Italy, September to November 2020. Vaccines (Basel). 2021;9(3):18. DOI: 10.3390/vaccines9030275 ABSTRACT: Understanding whether members of the university population are willing to receive a future vaccination against COVID-19 and identifying barriers may help public health authorities to develop effective strategies and interventions to contain COVID-19. This cross-sectional study explored the willingness to accept a future SARS-CoV-2 vaccine in a university population in Southern Italy. The perceived risk level of develo ping COVID-19 was 6.5 and it was significantly higher among females, younger subjects, and those who agreed/strongly agreed that COVID -19 is a severe disease. Only 21.4% of respondents were not worried at all regarding the safety of the vaccine. Males, not being married/cohabitant, being a faculty member, those who perceived a lower risk of developing COVID -19, and those who did not need information regarding the vaccination against COVID -19 were significantly more likely to have no concern at all regarding the safety of the vaccine. The vast majority (84.1%) were willing to receive a future vaccine against COVID-19. Almost coherently with predictors of concern on the safety of the vaccine, being male, not being married/cohabitant, being a faculty member, not being concerned at all that COVID-19 vaccination might not be safe, and agreeing that COVID-19 can have serious health consequences were significant predictors of the willingness to receive the vaccine against COVID-19. A considerable proportion of the population had a positive willingness to receive the future COVID-19 vaccine, although some concerns have been expressed regarding the effectiveness and safety and public health activities seem necessary to achieve the rate that can lead to the protection of the community. URL: https://www.ncbi.nlm.nih.gov/pubmed/33803730 DOI: 10.3390/vaccines9030275

Evidence Search Report: INF031801v2 ESR 21 44. Diem L, Friedli C, Chan A, et al. Vaccine Hesitancy in Patients With Multiple Sclerosis: Preparing for the SARS-CoV-2 Vaccination Challenge. Neurol Neuroimmunol Neuroinflamm. 2021;8(3):05. DOI: 10.1212/NXI.0000000000000991 ABSTRACT: OBJECTIVE: Vaccine hesitancy is a complex public health issue referring to concerns about safety, efficacy, or need for vaccination. Using pneumococcal vaccination, which is recommend in anti-CD20-treated multiple sclerosis (MS) patients, as a model, we assessed vaccination behavior in patients with MS to for the upcoming SARS - CoV-2 vaccination challenge. METHODS: By a medical chart review, we retrospectively identifie d patients with MS treated with ocrelizumab at the University Hospital Bern in 2018-2020. Pneumococcal vaccination was discussed with the patients during clinical visits and highlighted in the after-visit summary addressed to the general practitioner before ocrelizumab initiation as part of our clinical standard of care. RESULTS: Pneumococcal vaccination was performed in 71/121 (58.7%) of patients, and 50/121 (41.3%) patients were not vaccinated. Patients who did not get a pneumococcal vaccination were younger (no vaccination vs vaccination; mean [95% CI] 40.1 [36.1-44.1] vs 45.4 [41.9- 48.8], p = 0.028) and had more frequently a relapsing remitting disease course (no vaccination vs vaccination, n [%]; 43/50 [86.0%] vs 49/71 [69.0%], p = 0.031). Furthermore, patients who did not get vaccination had more frequently a history of comorbid psychiatric disorder (no vaccination vs vaccination, n (%); 12/50 [24.0] vs 7/71 [9.8], p = 0.035). CONCLUSION: Our study demonstrated that in our single-center cohort, 41.3% of patients with MS do not get the recommended pneumococcal vaccination. Future research should focus on vaccine hesitancy in the vulnerable cohort of patients with MS to improve the safety of MS immunotherapies. URL: https://www.ncbi.nlm.nih.gov/pubmed/33811158 DOI: 10.1212/NXI.0000000000000991

45. Dooley M. COVID-19: Filling the Many Knowledge Gaps and Supporting Evidence-Based Vaccination. J Pharm Pract Res. 2021;51(1):4-6. DOI: 10.1002/jppr.1717 URL: https://www.ncbi.nlm.nih.gov/pubmed/33821145 DOI: 10.1002/jppr.1717

46. Dorman C, Perera A, Condon C, et al. Factors Associated with Willingness to be Vaccinated Against COVID- 19 in a Large Convenience Sample. J Community Health. 2021;09:09. DOI: 10.1007/s10900 -021-00987-0 ABSTRACT: Willingness and reasons to be vaccinated against COVID-19 were examined among 26,324 respondents who completed a survey on willingness and questions related to Confidence in vaccine safety, Complacency about the disease, Convenience of vaccination, tendency to Calculate risks versus benefits, and Concern for protecting others. Willingness to be vaccinated differed by age (p < 0.001), by race and ethnicity (p < 0.001) and by level of education (p < 0.001). Willingness generally increased with age and education. Asians were most wi lling to be vaccinated, followed by non-Hispanic Whites, Hispanics, and non-Hispanic Blacks (p < 0.001). Occupational groups differed in willingness (p < 0.001). Retired and students were more willing than all others (p < 0.001) followed by disabled or une mployed, healthcare workers, and educators. First Responders were least willing to be vaccinated (p < 0.001) followed by construction, maintenance and landscaping, homemakers, housekeeping, cleaning and janitorial workers, and retail and food service. The strongest predictor of willingness was confidence with the safety of the vaccine (r = 0.723, p < 0.001), followed by concern with protecting others by being vaccinated (r = 0.574, p < 0.001), and believing COVID -19 was serious enough to merit vaccination (r = 0.478, p < 0.00). Using multiple regression, confidence in safety was the strongest predictor for all groups. Protecting others was strongest for 13 of 15 demographic groups and 8 of 11 occupational groups. College educated, non-Hispanic Whites, first responders, construction, maintenance and landscape workers, housekeeping, cleaning and janitorial workers all gave greater weight to complacency about the disease. These results can help in designing programs to combat vaccine hesitancy. URL: https://www.ncbi.nlm.nih.gov/pubmed/33835369 DOI: 10.1007/s10900-021-00987-0

47. Doroftei B, Ciobica A, Ilie OD, et al. Mini-Review Discussing the Reliability and Efficiency of COVID-19 Vaccines. Diagnostics (Basel). 2021;11(4):24. DOI: 10.3390/diagnostics11040579 ABSTRACT: Severe Acute Respiratory Syndrome Coronavirus 2 is a novel strain of human beta -coronavirus that has produced over two million deaths and affected one hundred million individuals worldwide. As all the proposed drugs proved to be unstable, inducing side effects, the need to develop a vaccine crystallized in a short time. As a result, we searched the databases for articles in which the authors reported the efficacy and safety of the use of several vaccines vaccines by sex, age group, and frequency of adverse reactions. We identified a total of 19 relevant articles that were

Evidence Search Report: INF031801v2 ESR 22 discussed throughout this manuscript. We concluded that from all eleven vaccines, three had an efficacy >90% (Pfizer-BioNTech (~95%), Moderna (~94%), and Sputnik V (~92%)) except for Oxford-AstraZeneca (~81%). However, Moderna, Sputnik V, and Oxford-AstraZeneca also alleviate severe adverse reactions, whereas in Pfizer-BioNTech this was not revealed. The remaining five (Convidicea (AD5-nCOV); Johnson & Johnson (Ad26.COV2.S); Sinopharm (BBIBP- CorV); (BBV152), and Sinovac (CoronaVac)) were discussed based on their immunogenicity, and safety reported by the recipients since only phases 1 and 2 were conducted without clear evidence published regarding their efficacy. CoviVac and EpiVacCorona have just been approved, which is why no published article could be found. All adverse events reported following the administration of one of the four vaccines ranged from mild to moderate; limited exceptions in which the patients either developed severe forms or died, because most effects were dose- dependent. It can be concluded that aforementioned vaccines are efficient and safe, regardless of age and sex, being well-tolerated by the recipients. URL: https://www.ncbi.nlm.nih.gov/pubmed/33804914 DOI: 10.3390/diagnostics11040579

48. Doulberis M, Papaefthymiou A, Kotronis G, et al. Does COVID-19 Vaccination Warrant the Classical Principle "ofelein i mi vlaptin"? Medicina (Kaunas). 2021;57(3):09. DOI: 10.3390/medicina57030253 ABSTRACT: The current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic warrants an imperative necessity for effective and safe vaccination, to restrain Coronavirus disease 2019 (COVID -19) including transmissibility, morbidity, and mortality. In this regard, intensive medical and biological research leading to the development of an arsenal of vaccines, albeit incomplete preconditioned evaluation, due to emergency. The subsequent scientific gap raises some concerns in the medical community and the general public. More specifically, the accelerated vaccine development downgraded the value of necessary pre-clinical studies to elicit medium- and long-term beneficial or harmful consequences. Previous experience and pathophysiological background of coronaviruses' infections and vaccine technologies, combined with the global vaccines' application, underlined the obligation of a cautious and qualitative approach, to illuminate potential vaccination-related adverse events. Moreover, the high SARS-CoV-2 mutation potential and the already aggregated genetical alterations provoke a rational vagueness and uncertainty concerning vaccines' efficacy against dominant strains and the respective clinical immunity. This review critically summarizes existing evidence and queries regarding SARS-CoV-2 vaccines, to motivate scientists' and clinicians' interest for an optimal, individualized, and holistic management of this unprecedented pandemic. URL: https://www.ncbi.nlm.nih.gov/pubmed/33803295 DOI: 10.3390/medicina57030253

49. D'Souza RS, Wolfe I. COVID-19 vaccines in high-risk ethnic groups. Lancet. 2021;397(10282):1348. DOI: 10.1016/S0140-6736(21)00624-3 URL: https://www.ncbi.nlm.nih.gov/pubmed/33812474 DOI: 10.1016/S0140-6736(21)00624-3

50. Dugani SB, Geyer HL, Maniaci MJ, et al. Hospitalist perspectives on barriers to recommend and potential benefit of the COVID-19 vaccine. Hosp Pract (1995). 2021;07:07. DOI: 10.1080/21548331.2021.1914465 ABSTRACT: BACKGROUND: Hospitalists, comprised of nurse practitioners and physicia n assistants (collectively, advanced practice providers [APPs]) and physicians, have opportunities to counsel patients and reduce SARS -CoV-2 related coronavirus disease 2019 (COVID-19) vaccine hesitancy. However, hospitalist perspectives on the COVID-19 vaccine and potential differences between APPs and physicians are unknown. Understanding hospitalist perspectives could help to address vaccine hesitancy among patients. METHODS: We conducted an online survey of hospitalists at Mayo Clinic sites in Arizona, Florida, Minnesota, and Wisconsin from December 14, 2020, through January 4, 2021. We collected demographic information and assessed perspectives on the COVID-19 vaccine and, for comparison, on the influenza vaccine. Descriptive statistics were used to compare responses between APPs and physicians. RESULTS: The overall response rate was 42.7% (n=128/300) and comprised of 53.9% women (n=69/128) and 41.4% APPs (n=53/128). Most hospitalists reported receiving or planning to receive vaccination against COVID -19 (93.7%; n=119/128) and influenza (97.7%; n=125/128). Most hospitalists reported they would advise 100% of patients to receive the COVID-19 vaccine (66% for APPs; 74.7% for physicians) and influenza vaccine (83% for APPs; 80% for physicians). Barriers to recommending the COVID-19 vaccine included patient health status and vaccine safety profile. Hospitalists reported that patients and co-workers receiving the COVID-19 vaccine would reduce their anxiety (~80%

Evidence Search Report: INF031801v2 ESR 23 of hospitalists), social isolation (~64% of hospitalists), and improve their emotional support (~40% of hospitalists). APP and physician responses were similar. The possible reduction in social isolation was associated with higher odds of hospitalists advising all patients to receive the COVID-19 vaccine (adjusted odds ratio 2.95 [95% confidence interval, 1.32-6.59]; P<.008), whereas hospitalist age, gender, and profession showed no association. CONCLUSION: Most hospitalists would reportedly advise patients to receive the COVID-19 vaccine. Barriers to this recommendation included patient health status and vaccine safety. Hospitalists are an important resource to provide patient education and reduce COVID-19 vaccine hesitancy. URL: https://www.ncbi.nlm.nih.gov/pubmed/33826433 DOI: 10.1080/21548331.2021.1914465

51. Dyer O. Covid-19: Moderna and Pfizer vaccines prevent infections as well as symptoms, CDC study finds. Bmj. 2021;373:n888. DOI: 10.1136/bmj.n888 URL: https://www.ncbi.nlm.nih.gov/pubmed/33795218 DOI: 10.1136/bmj.n888

52. Eckstein L, Rid A, Kamuya D, et al. The essential role of DSMBs in ensuring the ethics of global vaccine trials to address COVID-19. Clin Infect Dis. 2021;24:24. DOI: 10.1093/cid/ciab239 ABSTRACT: COVID-19 vaccines are being developed and implemented with unprecedented speed. Accordingly, trials considered ethical at their inception may quickly become concerning. We provide recommendations for Data and Safety Monitoring Boards (DSMBs) on monitoring the ethical acceptability of COVID -19 vaccine trials, focusing on placebo-controlled trials in low- and middle-income countries. URL: https://www.ncbi.nlm.nih.gov/pubmed/33758912 DOI: 10.1093/cid/ciab239

53. Edwards B, Biddle N, Gray M, et al. COVID-19 vaccine hesitancy and resistance: Correlates in a nationally representative longitudinal survey of the Australian population. PLoS ONE. 2021;16(3):e0248892. DOI: 10.1371/journal.pone.0248892 ABSTRACT: BACKGROUND: High levels of vaccination coverage in populations will be required even with vaccines that have high levels of effectiveness to prevent and stop outbreaks of coronavirus. The World Health Organisation has suggested that governments take a proactive response to vaccine hesitancy 'hotspots' based on social and behavioural insights. METHODS: Representative longitudinal online survey of over 3000 adults from Australia that examines the demographic, attitudinal, political and social attitudes and CO VID-19 health behavior correlates of vaccine hesitance and resistance to a COVID-19 vaccine. RESULTS: Overall, 59% would definitely get the vaccine, 29% had low levels of hesitancy, 7% had high levels of hesitancy and 6% were resistant. Females, those livi ng in disadvantaged areas, those who reported that risks of COVID-19 was overstated, those who had more populist views and higher levels of religiosity were more likely to be hesitant or resistant while those who had higher levels of household income, those who had higher levels of , who downloaded the COVID-Safe App, who had more confidence in their state or territory government or confidence in their hospitals, or were more supportive of migration were more likely to intend to get vaccinated. CONCLUSIONS: Our findings suggest that vaccine hesitancy, which accounts for a significant proportion of the population can be addressed by public health messaging but for a significant minority of the population with strongly held beliefs, alternative policy measures may well be needed to achieve sufficient vaccination coverage to end the pandemic. URL: https://www.ncbi.nlm.nih.gov/pubmed/33760836 DOI: 10.1371/journal.pone.0248892

54. Emary KRW, Golubchik T, Aley PK, et al. Efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS- CoV-2 202012/01 (B.1.1.7): an exploratory analysis of a randomised controlled trial. Lancet. 2021;397(10282):1351-62. DOI: 10.1016/S0140-6736(21)00628-0 ABSTRACT: BACKGROUND: A new variant of SARS-CoV-2, B.1.1.7, emerged as the dominant cause of COVID-19 disease in the UK from November, 2020. We report a post-hoc analysis of the efficacy of the adenoviral vector vaccine, ChAdOx1 nCoV-19 (AZD1222), against this variant. METHODS: Volunteers (aged >/=18 years) who were enrolled in phase 2/3 vaccine efficacy studies in the UK, and who were randomly assigned (1:1) to receive ChAdOx1 nCoV-19 or a meningococcal conjugate control (MenACWY) vaccine, provided upper airway swabs on a weekly basis and also if they developed symptoms of COVID-19 disease (a cough, a fever of 37.8 degrees C or higher, shortness of

Evidence Search Report: INF031801v2 ESR 24 breath, , or ageusia). Swabs were tested by nucleic acid amplification test (NAAT) for SARS -CoV-2 and positive samples were sequenced through the COVID-19 Genomics UK consortium. Neutralising antibody responses were measured using a live-virus microneutralisation assay against the B.1.1.7 lineage and a canonical non-B.1.1.7 lineage (Victoria). The efficacy analysis included symptomatic COVID-19 in seronegative participants with a NAAT positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to vaccine received. Vaccine efficacy was calculated as 1 - relative risk (ChAdOx1 nCoV-19 vs MenACWY groups) derived from a robust Poisson regression model. This study is continuing and is registered with ClinicalTrials.gov, NCT04400838, and ISRCTN, 15281137. FINDINGS: Participants in efficacy cohorts were recruited between May 31 and Nov 13, 2020, and received booster doses between Aug 3 and Dec 30, 2020. Of 8534 participants in the primary efficacy cohort, 6636 (78%) were aged 18-55 years and 5065 (59%) were female. Between Oct 1, 2020, and Jan 14, 2021, 520 participants developed SARS-CoV-2 infection. 1466 NAAT positive nose and throat swabs were collected from these participants during the trial. Of these, 401 swabs from 311 participants were successfully sequenced. Laboratory virus neutralisation activity by vaccine-induced antibodies was lower against the B.1.1.7 variant th an against the Victoria lineage (geometric mean ratio 8.9, 95% CI 7.2-11.0). Clinical vaccine efficacy against symptomatic NAAT positive infection was 70.4% (95% CI 43.6-84.5) for B.1.1.7 and 81.5% (67.9-89.4) for non-B.1.1.7 lineages. INTERPRETATION: ChAdOx1 nCoV-19 showed reduced neutralisation activity against the B.1.1.7 variant compared with a non -B.1.1.7 variant in vitro, but the vaccine showed efficacy against the B.1.1.7 variant of SARS-CoV-2. FUNDING: UK Research and Innovation, National Institute for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midlands NIHR Clinical Research Network, and AstraZeneca. URL: https://www.ncbi.nlm.nih.gov/pubmed/33798499 DOI: 10.1016/S0140-6736(21)00628-0

55. Felemban RM, Tashkandi EM, Mohorjy DK. The willingness of the Saudi Arabian population to participate in the COVID-19 vaccine trial: A case-control study. J Taibah Univ Med Sci. 2021;30:30. DOI: 10.1016/j.jtumed.2021.03.001 ABSTRACT: Objectives: This study examines the Saudi Arabian population's willingness to participate in clinical trials for the coronavirus disease 2019 (COVID-19) vaccine, comparing recovered cases' willingness with that of healthy volunteers. Methods: A case-control study was conducted on the Saudi Arabian population during September 2020. The data were collected from recovered COVID-19 participants as the case group, and healthy volunteers as the control group. Results: The data showed that 42.2% (n = 315) of recovered COVID-19 cases were more willing to participate in the COVID-19 vaccine trial than healthy volunteers (299; 38.1%) with a p < 0.001. The proportion of the participants who were willing to donate plasma was significantly higher among recove red participants, 84.2% (n = 112), than healthy volunteers, 76.3% (n = 87), with a p < 0.0001. The most significant factor responsible for a willingness to participate was the belief that vaccine discovery would help scientific developments (r = 0.525 and 0.465 for case and control, respectively). In comparison, significant reasons behind the unwillingness to participate were the risk of exposure to an unproven vaccine, r = 0.377 and 0.497 for case and control, respectively (p < 0.001), and a discomfort with being treated as an experimental subject (r = 0.275 and 0.374 for case and control, respectively). Conclusions: The differences in readiness toward the COVID-19 vaccine trial in our study does not indicate any passive exposure of participants to an unproven clinical trial vaccine, nor does it shed light on well- informed risk-related decisions. However, certain factors can significantly influence decision -making while contributing toward clinical research. This study's results must not be used for the indi viduals' recruitment bias in a COVID-19 vaccine trial. URL: https://www.ncbi.nlm.nih.gov/pubmed/33815034 DOI: 10.1016/j.jtumed.2021.03.001

56. Follmann D, Fintzi J, Fay MP, et al. A Deferred-Vaccination Design to Assess Durability of COVID-19 Vaccine Effect After the Placebo Group Is Vaccinated. Ann Intern Med. 2021;13:13. DOI: 10.7326/M20-8149 ABSTRACT: Multiple candidate vaccines to prevent COVID-19 have entered large-scale phase 3 placebo-controlled randomized clinical trials, and several have demonstrated substantial short-term efficacy. At some point after demonstration of substantial efficacy, placebo recipients should be offered the efficacious vaccine from their trial, which will occur before longer-term efficacy and safety are known. The absence of a placebo group could compromise assessment of longer-term vaccine effects. However, by continuing follow-up after vaccination of the placebo group, this study shows that placebo-controlled vaccine efficacy can be mathematically derived by assuming

Evidence Search Report: INF031801v2 ESR 25 that the benefit of vaccination over time has the same profile for the original vaccine recipients and the original placebo recipients after their vaccination. Although this derivation provides less precise estimates than would be obtained by a standard trial w here the placebo group remains unvaccinated, this proposed approach allows estimation of longer-term effect, including durability of vaccine efficacy and whether the vaccine eventually becomes harmful for some. Deferred vaccination, if done open-label, may lead to riskier behavior in the unblinded original vaccine group, confounding estimates of long-term vaccine efficacy. Hence, deferred vaccination via blinded crossover, where the vaccine group receives placebo and vice versa, would be the preferred way t o assess vaccine durability and potential delayed harm. Deferred vaccination allows placebo recipients timely access to the vaccine when it would no longer be proper to maintain them on placebo, yet still allows important insights about immunologic and clinical effectiveness over time. URL: https://www.ncbi.nlm.nih.gov/pubmed/33844575 DOI: 10.7326/M20-8149

57. Forman R, Shah S, Jeurissen P, et al. COVID-19 vaccine challenges: What have we learned so far and what remains to be done? Health Policy. 2021;26:26. DOI: 10.1016/j.healthpol.2021.03.013 ABSTRACT: Developing and distributing a safe and effective SARS-CoV-2 (COVID-19) vaccine has garnered immense global interest. Less than a year after COVID-19 was declared a pandemic, several vaccine candidates had received emergency use authorization across a range of countries. Despite this scientific breakthrough, the journey from vaccine discovery to global herd immunity against COVID-19 continues to present significant policy challenges that require a collaborative, global response. We offer a framework for understanding remaining and new policy challenges for successful global vaccine campaigns against COVID-19 as well as potential solutions to address them. Decision-makers must be aware of these challenges and strategize solutions that can be implemented at scale. These include challenges around maintaining R&D incentives, running clinical trials, authorizations, post -market surveillance, manufacturing and supply, global dissemination, allocation, uptake, and clinical system adaption. Alongside these challenges, financial and ethical concerns must also be addressed. URL: https://www.ncbi.nlm.nih.gov/pubmed/33820678 DOI: 10.1016/j.healthpol.2021.03.013

58. Frank A, Radparvar S, Manasia A, et al. Prolonged Anaphylaxis to Pfizer Coronavirus Disease 2019 Vaccine: A Case Report and Mechanism of Action. Crit Care Explor. 2021;3(4):e0397. DOI: 10.1097/CCE.0000000000000397 ABSTRACT: Background: In response to the devastating effects of the coronavirus disease 2019 pandemic, several vaccine prototypes have been developed, with the Pfizer/BioNTech (BNT162b2) platform being the first to receive emergency use authorization. Although taken to market on an unpreceden ted timeline, the safety profile of the drug during clinical trials was shown to be favorable. Shortly after release, reports from the Centers for Disease Control and Prevention demonstrated a higher-than-average rate of anaphylaxis to the vaccine that has been the cause for concern for safety officials and the general public alike. Here, we present a unique case of protracted anaphylaxis in a recipient of the BNT162b2. Case Summary: The patient is a 55-year-old female with a history of multiple allergic reactions who presented with respiratory distress and hives after receiving the first dose of the BNT162b2, despite premedication with IV steroids and diphenhydramine. The refractory nature of her reaction was demonstrated by edema of her tongue (visualized on nasolaryngoscopy), requiring an epinephrine infusion for nearly 3 days. She was discharged from the hospital with instructions not to receive the second dose of the vaccine. Conclusion: Although the exact etiology of anaphylaxis secondary to this messen ger RNA-based vaccine is not completely clear, our literature search and review of the patient's course support either polyethylene glycol versus other excipient -related allergy as a possible cause. Based on the protracted nature to our patient's anaphylaxis, critical care management for patients with a true anaphylactic reaction to BNT162b2 may require monitoring for an extended period of time. URL: https://www.ncbi.nlm.nih.gov/pubmed/33834172 DOI: 10.1097/CCE.0000000000000397

59. 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):05. DOI: 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, China in December 2019. The pandemic has evoked widespread collateral damage t o societies and economies, and

Evidence Search Report: INF031801v2 ESR 26 has destabilized 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 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 g lobal COVID-19 pandemic. URL: https://www.ncbi.nlm.nih.gov/pubmed/33807839 DOI: 10.3390/v13030418

60. Galdiero M, Galdiero M, Folliero V, et al. SARS-CoV-2 vaccine development: where are we? Eur Rev Med Pharmacol Sci. 2021;25(6):2752-84. DOI: 10.26355/eurrev_202103_25439 ABSTRACT: The coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has proved to be one of the most challenging infectious diseases in the modern era, and despite several countermeasures to lessen its impact, the spread of the virus is still affecting most countries. This renders the goal of of the population through vaccination a worldwide public health priority. In fact, only when efficient vaccination programs will be successfully implemented, a return to pre-pandemic normality can be considered. The scientific community has made a tremendous effort to blow the lid off the pathogenesis of the disease, and unprecedented efforts are ongoing with governments, private organizations, and academics working together to expeditiously develop safe and efficacious vaccines. Previous research efforts in the development of vaccines for other coronaviruses (Severe Acute Respiratory Syndrome Coronavirus 1 and Middle East Respiratory Syndrome Coronavirus) as well other emerging viruses have opened the door for exploiting several strategies to design a new vaccine against the pandemic virus. Indeed, in a few months, a stunning number of vaccines have been proposed, and almost 50 putative vaccine candidates have entered clinical trials. The different vaccine candidates use different vaccine development platforms, from inactivated whole virus vaccine to , nucleic acid, and vectored vaccines. In this review, we describe strengths, flaws, and potential pitfalls of each approach to understand their chances of success. URL: https://www.ncbi.nlm.nih.gov/pubmed/33829462 DOI: 10.26355/eurrev_202103_25439

61. Gauci ML, Coutzac C, Houot R, et al. SARS-CoV-2 vaccines for cancer patients treated with immunotherapies: Recommendations from the French society for ImmunoTherapy of Cancer (FITC). Eur J Cancer. 2021;148:121-3. DOI: 10.1016/j.ejca.2021.02.003 URL: https://www.ncbi.nlm.nih.gov/pubmed/33743480 DOI: 10.1016/j.ejca.2021.02.003

62. Geisen UM, Berner DK, Tran F, et al. 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-2021-220272 ABSTRACT: INTRODUCTION: In light of the SARS-CoV-2 pandemic, protecting vulnerable groups has become a high priority. Persons at risk of severe disease, for example, those receiving immunosuppressive therapies for chronic inflammatory cdiseases (CIDs), are prioritised for vaccination. However, data concerning generation of protective antibody titres in immunosuppressed patients are scarce. Additionally, mRNA vaccines represent a new vaccine technology leading to increased insecurity especially in patients with CID. OBJECTIVE: Here we present for the first time, data on the efficacy and safety of anti-SARS-CoV-2 mRNA vaccines in a cohort of immunosuppressed patients as compared with healthy controls. METHODS: 42 health y controls and 26 patients with CID were included in this study (mean age 37.5 vs 50.5 years). Immunisations were performed according to national guidelines with mRNA vaccines. Antibody titres were assessed by ELISA before initial vaccination and 7 days af ter secondary vaccination. Disease activity and side effects were assessed prior to and 7 days after both vaccinations. RESULTS: Anti -SARS-CoV-2 antibodies as well as neutralising activity could be detected in all study participants. IgG titres were signif icantly lower in patients as compared with controls (2053 binding antibody units (BAU)/mL +/-1218 vs 2685+/-1102). Side effects were comparable in both groups. No severe adverse effects were observed, and no patients experienced a disease

Evidence Search Report: INF031801v2 ESR 27 flare. CONCLUSION: We show that SARS-CoV-2 mRNA vaccines lead to development of antibodies in immunosuppressed patients without considerable side effects or induction of disease flares. Despite the small size of this cohort, we were able to demonstrate the efficiency and safety of mRNA vaccines in our cohort. URL: https://www.ncbi.nlm.nih.gov/pubmed/33762264 DOI: 10.1136/annrheumdis-2021-220272

63. Gesualdo F, Bucci LM, Rizzo C, et al. Digital tools, multidisciplinarity and innovation for communicating vaccine safety in the COVID-19 era. Hum Vaccin Immunother. 2021:1-4. DOI: 10.1080/21645515.2020.1865048 ABSTRACT: The research on the anti-SARS-CoV-2 vaccines and their commercialization is an opportunity to test and consolidate the current knowledge along with the diverse available tools related to vaccine communication.In this paper we explore the value of a multidisciplinary approach in this field: vaccine communication activities can be combined with insights from data science, risk communication, behavior change, design thinking and digital marketing. Methodologies derived from innovation and human -centered design can contribute to the development and testing of vaccine promotion campaigns, speeding up processes and streamlining the production of evidence in this area. The multiple activities involving the anti-SARS-CoV-2 vaccine could be the fertile ground in which to develop, test and refine effective frameworks to transfer data acquired through listening strategies into effective vaccine promotion campaigns. The World Health Organization's Vaccine Safety Net is an interesting example of trusted information sources that aim toward using digital tools and innovative methodologies for communicating science-based information on vaccine safety at the global level. URL: https://www.ncbi.nlm.nih.gov/pubmed/33764272 DOI: 10.1080/21645515.2020.1865048

64. Giavina-Bianchi P, Kalil J. May polyethylene glycol be the cause of anaphylaxis to mRNA COVID-19 vaccines? World Allergy Organ J. 2021:100532. DOI: 10.1016/j.waojou.2021.100532 ABSTRACT: Vaccination against coronavirus is essential to minimize COVID-19 pandemic. Rare cases of anaphylaxis associated with the mRNA COVID-19 vaccines are being described, and the mechanisms involved in these reactions are poorly understood. A potential culprit agent of these vaccine-induced anaphylaxis is the polyethylene glycol, which has been reported as a cause of anaphylaxis. However, a cause-effect association has not been demonstrated and the cases of anaphylaxis to mRNA COVID-19 vaccines should be further investigated. In this scenario, the recommendations are inaccurate and can lead to misinterpretation. At the moment, a more accurate recommendation would be the contraindication of mRNA COVID-19 vaccines in patients with immediate hypersensitivity reaction to polyethylene glycol or polysorbate. Patients with history of anaphylaxis to other or unknown causes should be referral to an allergist-immunologist to further orientation. URL: https://www.ncbi.nlm.nih.gov/pubmed/33747340 DOI: 10.1016/j.waojou.2021.100532

65. Golob JL, Lugogo N, Lauring AS, et al. SARS-CoV-2 vaccines: a triumph of science and collaboration. JCI insight. 2021;06:06. DOI: 10.1172/jci.insight.149187 ABSTRACT: Roughly one year after the first case of COVID-19 was identified and less than one year after the sequencing of SARS-CoV-2, multiple SARS-CoV-2 vaccines with demonstrated safety and efficacy in phase III clinical trials are available. The most promising vaccines have targeted the surface glycoprotein (S -protein) of SARS-CoV-2 and achieved an approximate 85-95% reduction in the risk of symptomatic COVID-19, while retaining excellent safety profiles and modest side effects in the phase III clinical trials. The mRNA, replication -incompetent viral vector, and protein subunit vaccine technologies have all been successfully employed. Some novel SARS-CoV-2 variants evade but do not appear to fully overcome the potent immunity induced by these vaccines. Emerging real -world effectiveness data add evidence for protection from severe COVID-19. This is an impressive first demonstration of the effectiveness of the mRNA vaccine and vector vaccine platforms. The success of SARS-CoV-2 vaccine development should be credited to open science, industry partnerships, harmonization of clin ical trials, and the altruism of study participants. The manufacturing and distribution of the emergency use-authorized SARS-CoV-2 vaccines are ongoing challenges. What remains now is to ensure broad and equitable global vaccination against COVID -19. . URL: https://www.ncbi.nlm.nih.gov/pubmed/33822773 DOI: 10.1172/jci.insight.149187

Evidence Search Report: INF031801v2 ESR 28 66. Gordon C, Porteous D, Unsworth J. COVID-19 vaccines and vaccine administration. Br J Nurs. 2021;30(6):344-9. DOI: 10.12968/bjon.2021.30.6.344 ABSTRACT: This article provides an overview of current COVID-19 vaccines available within the UK, including their mode of action, storage and handling. It outlines the recommendations on priority groups for vaccination and provides insight into the training recommendations for vaccinators. URL: https://www.ncbi.nlm.nih.gov/pubmed/33769885 DOI: 10.12968/bjon.2021.30.6.344

67. Greco S, Bella A, Bonsi B, et al. SARS-CoV-2 infection and H1N1 vaccination: does a relationship between the two factors really exist? A retrospective analysis of a territorial cohort in Ferrara, Italy. Eur Rev Med Pharmacol Sci. 2021;25(6):2795-801. DOI: 10.26355/eurrev_202103_25441 ABSTRACT: OBJECTIVE: SARS-CoV-2 has been compared with other strains of coronaviruses, SARS-CoV and MERS- CoV, and with the flu viruses: all of them manifest themselves with respiratory symptoms and, although their genetic patterns are similar, the spread of SARS-CoV-2 infection has quickly reached global dimensions, demonstrating that SARS-CoV-2 is a virus with greater spreading capacity, albeit less lethal. Compared with influenza viruses, coronaviruses have a longer incubation period and the patients with coronaviruses' syndromes develop more severe diseases requiring frequent hospitalizations and intensive care admissions. The aim was to explore the relationships between seasonal influenza vaccination and coronavirus infection and to understand whether this hypothetic role by the flu vaccines modifies SARS-CoV-2 infection's outcomes. PATIENTS AND METHODS: In this retrospective, multicenter study, we enrolled 952 patients diagnosed with SARS-CoV-2 infection; 448 were admitted to our two main hospitals in Ferrara territory, while the remaining 504 were isolated at home. We compared the group of patients who had been vaccinated for influenza in the previous 12 months to that of unvaccinated patients. RESULTS: Significant differences were found for both the need for hospitalization and 30-day mortality between vaccinated and unvaccinated patients. We found age to be the only independent risk factor for a worse 30-day prognosis, while gender, influenza vaccinations and age itself were independent risk factors for undergoing hospitalization. CONCLUSIONS: In our groups of patients, we found a relationship between seasonal influenza vaccin ations and SARS- CoV-2 infection. Age seems to be the main risk factor for short-term mortality in COVID-19 inpatients, while the influenza vaccination is, together with gender and age itself, a determining factor in predicting the need for hospitalization. URL: https://www.ncbi.nlm.nih.gov/pubmed/33829464 DOI: 10.26355/eurrev_202103_25441

68. Gruca A, Ziemska-Legiecka J, Jarnot P, et al. Common low complexity regions for SARS-CoV-2 and human proteomes as potential multidirectional risk factor in vaccine development. BMC Bioinformatics. 2021;22(1):182. DOI: 10.1186/s12859-021-04017-7 ABSTRACT: BACKGROUND: The rapid spread of the COVID-19 demands immediate response from the scientific communities. Appropriate countermeasures mean thoughtful and educated choi ce of viral targets (epitopes). There are several articles that discuss such choices in the SARS-CoV-2 proteome, other focus on phylogenetic traits and history of the Coronaviridae genome/proteome. However none consider viral protein low complexity regions (LCRs). Recently we created the first methods that are able to compare such fragments. RESULTS: We show that five low complexity regions (LCRs) in three proteins (nsp3, S and N) encoded by the SARS-CoV-2 genome are highly similar to regions from human proteome. As many as 21 predicted T-cell epitopes and 27 predicted B-cell epitopes overlap with the five SARS-CoV-2 LCRs similar to human proteins. Interestingly, replication proteins encoded in the central part of viral RNA are devoid of LCRs. CONCLUSIONS: Similarity of SARS-CoV-2 LCRs to human proteins may have implications on the ability of the virus to counteract immune defenses. The vaccine targeted LCRs may potentially be ineffective or alternatively lead to autoimmune diseases development. These finding s are crucial to the process of selection of new epitopes for drugs or vaccines which should omit such regions. URL: https://www.ncbi.nlm.nih.gov/pubmed/33832440 DOI: 10.1186/s12859-021-04017-7

69. Hajissa K, Mussa A. Positive aspects of the mRNA platform for SARS-CoV-2 vaccines. Hum Vaccin Immunother. 2021:1-3. DOI: 10.1080/21645515.2021.1900713 ABSTRACT: The unprecedented need to acquire a safe and effective vaccine for the long -term control of coronavirus disease 2019 (COVID-19) is a global imperative. Researchers have been working urgently and collaboratively to

Evidence Search Report: INF031801v2 ESR 29 develop vaccines against the causative agent of COVID-19. The use of messenger RNA (mRNA) vaccine platform offers new opportunities for the development of effective vaccines. The first use of COVID-19 mRNA vaccines for individuals outside the clinical trials raised concerns over their safety and future efficacy. In social media, particularly in developing countries, widely shared false claims allege that the current mRNA-based COVID-19 vaccines potentially integrate into the host genome and thus may genetically modify humans. These vaccines are also assumed to lack efficacy due to the emergence of new strains. Such misinformation cause people to hesitate about receiving vaccination against COVID-19. This commentary aimed to outline the structure, mechanism of action and the major motive for the use of COVID-19 mRNA vaccine, with a focus on scientifically addressing challenges associated with conspiracy theories and dispelling misinformation around vaccination. URL: https://www.ncbi.nlm.nih.gov/pubmed/33830862 DOI: 10.1080/21645515.2021.1900713

70. Hayakawa S, Komine-Aizawa S, Takada K, et al. Anti-SARS-CoV-2 vaccination strategy for pregnant women in Japan. J Obstet Gynaecol Res. 2021;23:23. DOI: 10.1111/jog.14748 ABSTRACT: The current COVID-19 pandemic is a global concern. The recent introduction of vaccines has provided a reason for hope, but new problems, such as vaccine hesitancy, have arisen. One of the most important of these issues is the safety of vaccines for pregnant women. In this article, we collected worldwide indications for vaccin ation, including women who are pregnant or who wish to become pregnant, and reports of adverse reactions to COVID -19 vaccination. The Japan Society of Obstetrics and Gynecology and the Japanese Society of Infectious Diseases in Obstetrics and Gynecology have published recommendations for the vaccination of pregnant women with a COVID - 19 vaccine. The guidelines are as follows: (1) pregnant women should not be excluded from vaccination; (2) informed consent should be obtained before vaccination; (3) healthcare workers and pregnant women with complications such as diabetes, hypertension, and obesity should be vaccinated preferentially; (4) vaccination should be avoided until 12 weeks of gestation during organogenesis; (5) spouse and family members should be vaccinated actively; and (6) nursing mothers are not particularly affected. This policy has been adopted in government guidelines. Additional efforts should be made to protect pregnant women from infection and severe illness with COVID -19 by eliminating vaccine hesitancy. URL: https://www.ncbi.nlm.nih.gov/pubmed/33754418 DOI: 10.1111/jog.14748

71. Heine GH, Becker SL, Scheuer AL, et al. [SARS-CoV-2 vaccines - what the nephrologist should know]. Dtsch Med Wochenschr. 2021;146(7):466-70. DOI: 10.1055/a-1375-4471 ABSTRACT: Only fifteen months after the beginning of the COVID-19 pandemic, several vaccines are already available for clinical use. While the spike protein of SARS-CoV-2 constitutes the main target of all predominant SARS-CoV-2 vaccines, they work by different mechanisms (mRNA-based vaccines vs. vector-based vaccines vs. protein-based vaccines).Though there are slight differences regarding the level of protection against mild COVID -19, all five vaccines that have been through phase 3 trials were nearly 100 % effective in preventing severe or fatal cases of COVID-19. The side effects were of short duration.Patients with chronic kidney disease (or other significant comorbidities) were largely excluded from Phase 3 trials, which makes definite recommendatio ns concerning their vaccination difficult. The vaccine's effectiveness may be reduced in that population due to a uremic immune defect and/or immunosuppressive medication. However, these patients have an increased risk for severe or fatal COVID -19, so that they may particularly benefit from the vaccine. URL: https://www.ncbi.nlm.nih.gov/pubmed/33780993 DOI: 10.1055/a-1375-4471

72. Heldman MR, Limaye AP. SARS-CoV-2 Vaccines in Kidney Transplant Recipients: Will They Be Safe and Effective and How Will We Know? J Am Soc Nephrol. 2021;24:24. DOI: 10.1681/ASN.2021010023 URL: https://www.ncbi.nlm.nih.gov/pubmed/33762353 DOI: 10.1681/ASN.2021010023

73. Hiller N, Goldberg SN, Cohen-Cymberknoh M, et al. Lymphadenopathy Associated With the COVID-19 Vaccine. Cureus. 2021;13(2):e13524. DOI: 10.7759/cureus.13524 ABSTRACT: The coronavirus disease 2019 (COVID-19) pandemic has dominated nearly everyone's life since its initial outbreak in the Hubei province of China in December 2019. The disease had spread quickly throughout the world

Evidence Search Report: INF031801v2 ESR 30 causing extensive, widespread morbidity, over two million deaths, and economical and social devastation over the entire world. Researchers and pharmaceutical companies around the globe have been racing to develop potent and safe vaccines for the disease. Pfizer-BioNTech COVID-19 vaccine followed by Moderna COVID-19 mRNA-1273 vaccine were the first to receive FDA approval. These vaccines are based on messenger RNA novel technology and considered efficient in preventing contagion ensuring safety. Known side effects for this vaccine have been reported as very similar to those known for other vaccines. Specifically, lymphadenopathy has not been considered a common manifestation of COVID-19 vaccination. Israel has been cited as leading in the intro duction of these vaccines, which are available for every citizen older than 16 years. Here, we present the cases of three patients who developed lymphadenopathy after the first dose of Pfizer-BioNTech COVID-19 vaccine. Time elapsed from the injection until the appearance of the enlarged nodes, clinical symptoms, and sonographic features differed between the patients, but in all cases gradual regression was noted in the enlarged nodes until complete resolution. Accordingly, to our knowledge, this is the first report describing post-COVID-19 vaccine lymphadenopathy detailing the clinical aspects, sonographic features, and outcomes. URL: https://www.ncbi.nlm.nih.gov/pubmed/33786231 DOI: 10.7759/cureus.13524

74. Hughes K, Gogineni V, Lewis C, et al. Considerations for fair prioritization of COVID-19 vaccine and its mandate among healthcare personnel. Curr Med Res Opin. 2021:1-3. DOI: 10.1080/03007995.2021.1908245 ABSTRACT: With current COVID-19 vaccine demand outweighing supply and the emergency authorization/rollout of three novel vaccines in the United States, discussions continue regarding fair prioritization among various groups for this scarce resource. The US federal government's recommended , meant to assist states with vaccine allocation, demonstrates fair ethical considerations; however, difficulties remain comparing various groups to determine fair vaccine access and distribution. Although strides have been taken to analyze risks versus benefits of early vaccination across certain high-risk populations, prioritizing vulnerable populations versus essential workers remains challenging for multiple reasons. Similarly, as COVID-19 vaccine allocation and distribution continues in the US and in other countries, topics that require continued consideration include sub-prioritization among currently prioritized groups, prioritization among vulnerable groups disproportionately affected by the COVID -19 pandemic, like ethnic minorities, and holistic comparisons between groups who might receive various and disparate benefits from vaccination. Although all current COVID-19 vaccines are emergency authorization use only and a vaccine mandate would be considered only once these vaccines are licensed by the US Food and Drug Administration, future vaccination policies require time and deliberation. Similarly, given current vaccine hesitancy, mandatory vaccination of certain groups, like healthcare personnel, may need to be considered when these vaccines are licensed, especially if voluntary vaccination proves insufficient. Continued discussions regarding risks versus benefits of mandatory COVID - 19 vaccination and the unique role of healthcare personnel in providing a safe healthcare environment could lead to better deliberation regarding potential policies. This commentary aims to address both questions of fair prioritization and sub-prioritization of various groups, as well as ethical considerations for mandatory COVID -19 vaccination among healthcare personnel. URL: https://www.ncbi.nlm.nih.gov/pubmed/33760673 DOI: 10.1080/03007995.2021.1908245

75. Ibanez Guelfenbein C, Torres Torretti JP, Santolaya de Pablo ME. [SARS CoV-2 Vaccine studies currently in phase III]. Rev Chilena Infectol. 2021;38(1):88-98. DOI: 10.4067/S0716-10182021000100088 ABSTRACT: The coronavirus disease 2019, caused by the SARS-CoV2 virus, was declared a pandemic in March 2020 by the WHO. Protein S from the viral surface has been identified as the optimal antigen for vaccine development. In a pandemic, the traditional vaccine development process has had to be accelerated to advance in an adequate response to the problem, shortening the times. Safety, immunogenicity, protection against infection, antibody dependent enhancement phenomena and duration of protection are studied in parallel, unlike the traditional way in which it was carried out in successive stages. Currently in Phase III there are 4 types of vaccines: inactivated; based on purified or recombinant proteins, based on DNA / RNA nucleic acids and based on viral vectors. The objective of this review is to understand the studies that precede the vaccines that are currently in Phase III studies and to describe the main characteristics of these studies. Currently the world is in a situation unprecedented in the last century. Among the options to face this fact, one vaccine or, ideally, several, safe, effective and immunogenic, seem to be one of the best alternatives to regain lost normality within a reasonable time. URL: https://www.ncbi.nlm.nih.gov/pubmed/33844797

Evidence Search Report: INF031801v2 ESR 31 DOI: 10.4067/S0716-10182021000100088

76. Ioannou GN, Green P, Fan VS, et al. Development of COVIDVax Model to Estimate the Risk of SARS-CoV-2- Related Death Among 7.6 Million US Veterans for Use in Vaccination Prioritization. JAMA Netw Open. 2021;4(4):e214347. DOI: 10.1001/jamanetworkopen.2021.4347 ABSTRACT: Importance: A strategy that prioritizes individuals for SARS-CoV-2 vaccination according to their risk of SARS-CoV-2-related mortality would help minimize deaths during vaccine rollout. Objective: To develop a model that estimates the risk of SARS-CoV-2-related mortality among all enrollees of the US Department of Veterans Affairs (VA) health care system. Design, Setting, and Participants: This prognostic study used data from 7635064 individuals enrolled in the VA health care system as of May 21, 2020, to develop and internally validate a logistic regression model (COVIDVax) that predicted SARS-CoV-2-related death (n = 2422) during the observation period (May 21 to November 2, 2020) using baseline characteristics known to be associated with SARS-CoV-2-related mortality, extracted from the VA electronic health records (EHRs). The cohort was split into a training period (May 21 to September 30) and testing period (October 1 to November 2). Main Outcomes and Measures: SARS -CoV-2-related death, defined as death within 30 days of testing positive for SARS-CoV-2. VA EHR data streams were imported on a data integration platform to demonstrate that the model could be executed in real -time to produce dashboards with risk scores for all current VA enrollees. Results: Of 7635064 individuals, the mean (SD) age was 66.2 (13.8) years, and most were men (7051912 [92.4%]) and White individuals (4887338 [64.0%]), with 1116435 (14.6%) Black individuals and 399634 (5.2%) Hispanic individuals. From a starting pool of 16 potential predictors, 10 were included in the final COVIDVax model, as follows: sex, age, race, ethnicity, body mass index, Charlson Comorbidity Index, diabetes, chronic kidney disease, congestive heart failure, and Care Assessment Need score. The model exhibited excellent discrimination with area under the receiver operating characteristic curve (AUROC) of 85.3% (95% CI, 84.6% -86.1%), superior to the AUROC of using age alone to stratify risk (72.6%; 95% CI, 71.6%-73.6%). Assuming vaccination is 90% effective at preventing SARS-CoV-2-related death, using this model to prioritize vaccination was estimated to prevent 63.5% of deaths that would occur by the time 50% of VA enrollees are vaccinated, significantly higher than the estimate for prioritizing vaccination based on age (45.6%) or the US Centers for Disease Control and Prevention phases of vaccine allocation (41.1%). Conclusions and Relevance: In this prognostic study of all VA enrollees, prioritizing vaccination based on the COVIDVax model was estimated to prevent a large proportion of deaths expected to occur during vaccine rollout before sufficient herd immunity is achieved. URL: https://www.ncbi.nlm.nih.gov/pubmed/33822066 DOI: 10.1001/jamanetworkopen.2021.4347

77. Jadidi M, Jamshidiha S, Masroori I, et al. A two-step vaccination technique to limit COVID-19 spread using mobile data. Sustain Cities Soc. 2021;70:102886. DOI: 10.1016/j.scs.2021.102886 ABSTRACT: Vaccination is one of the most effective methods to prevent the spread of infectious di seases, but due to limitations in vaccines' availability, especially when faced with a new disease such as COVID -19, not all individuals in the community can be vaccinated. A limited number of candidates should be selected when the supply of vaccines is limited. In this paper, a method is introduced to prioritize the individuals for vaccination in order to achieve the best results in preventing the spread of COVID-19. We divide this problem into two steps: vaccine allocation and targeted vaccination. In vaccine allocation, vaccines are allocated among different population. An algorithm is proposed by defining the maximization of the total immunity among populations as an optimization problem. The aim of the targeted vaccination step is to select the individu als in each population that when vaccinated, create the greatest reduction in the transmission paths of the disease. The contact tracing data for this step is obtained from wireless communication networks and is modeled using graph theory. A metric is presented for selection of the candidates, based on centrality metrics. Simulations indicate that a 30% drop in infection rate could be achieved compared to random vaccination. URL: https://www.ncbi.nlm.nih.gov/pubmed/33816084 DOI: 10.1016/j.scs.2021.102886

78. Jain V, Schwarz L, Lorgelly P. A Rapid Review of COVID-19 Vaccine Prioritization in the U.S.: Alignment between Federal Guidance and State Practice. Int J Environ Res Public Health. 2021;18(7):27. DOI: 10.3390/ijerph18073483 ABSTRACT: BACKGROUND: Population groups to be prioritized for COVID-19 vaccinations in the U.S. have been determined at the Federal level, but there is variation in how States have implemented guidance. This review

Evidence Search Report: INF031801v2 ESR 32 examines how the position of population groups in vaccine priority lists varies between Federal guidance and State practice. METHODS: An online search of State vaccination prioritization plans was conducted. Data were extracted on each population group included and their relative position. A standardized ranking method was applied to provide a directional measure of variability in prioritization between State and Federal guidance, for each population group. RESULTS: Healthcare workers and those in long-term care facilities were largely prioritized in line with Federal guidance. Aside from early education staff, essential workers were often excluded at State level. Almost all States included the 65-74 year age group and most assigned them to a higher position than recommended in Federal guidance. Those with underlying medical conditions were similarly highly prioritized, although there was more variability across States. Some socially vulnerable groups (not included in Federal guidance) were highly prioritized by many States. CONCLUSIONS: The prioritization of groups for COVID-19 vaccination has been highly variable despite clear Federal guidance. Future guidance must be relevant to local needs, values, and constraints, to minimize any unwarranted heterogeneity in vaccine access across populations. URL: https://www.ncbi.nlm.nih.gov/pubmed/33801651 DOI: 10.3390/ijerph18073483

79. Jaspal R, Breakwell GM. Social support, perceived risk and the likelihood of COVID-19 testing and vaccination: cross-sectional data from the United Kingdom. Curr Psychol. 2021:1-13. DOI: 10.1007/s12144- 021-01681-z ABSTRACT: Two samples of 227 and 214 adults completed surveys of social support, perceived risk of COVID -19 and COVID-19 preventive activity - in Study 1 likelihood of testing was examined and in Study 2 likelihood of b oth testing and vaccination were examined during the COVID-19 pandemic in the United Kingdom. Path analysis showed, in Study 1, that access to help (as an indicator of social support) had a direct effect on likelihood of testing and indirect effects through self-efficacy, perceived risk and preventive behavior; and, in Study 2, that neighborhood identification (as an indicator of social support) had a direct effect on likelihood of testing and indirect effects on likelihood of both testing and vaccination through the mediators of strength of social network, loneliness, perceived risk of COVID -19, and preventive activity. Both studies suggest that level of social support (conceptualized in different ways) is an important determinant of COVID-19 testing and Study 2 shows it is also a determinant of likelihood of vaccination. As resurgences of COVID-19 occur, it will be necessary to monitor the likelihood of COVID-19 testing and vaccination behaviors and, especially, to promote confidence in the latter in individuals with decreased access to social support. URL: https://www.ncbi.nlm.nih.gov/pubmed/33846675 DOI: 10.1007/s12144-021-01681-z

80. Jentsch PC, Anand M, Bauch CT. Prioritising COVID-19 vaccination in changing social and epidemiological landscapes: a mathematical modelling study. Lancet Infect Dis. 2021;31:31. DOI: 10.1016/S1473 - 3099(21)00057-8 ABSTRACT: BACKGROUND: During the COVID-19 pandemic, authorities must decide which groups to prioritise for vaccination in a shifting social-epidemiological landscape in which the success of large-scale non-pharmaceutical interventions requires broad social acceptance. We aimed to compare projected COVID -19 mortality under four different strategies for the prioritisation of SARS-CoV-2 vaccines. METHODS: We developed a coupled social- epidemiological model of SARS-CoV-2 transmission in which social and epidemiological dynamics interact with one another. We modelled how population adherence to non -pharmaceutical interventions responds to case incidence. In the model, schools and workplaces are also closed and reopened on the basis of reported cases. The model was parameterised with data on COVID-19 cases and mortality, SARS-CoV-2 seroprevalence, population mobility, and demography from Ontario, Canada (population 14.5 million). Disease progression parameters came from the SARS- CoV-2 epidemiological literature. We assumed a vaccine with 75% efficacy against disease and transmissibility. We compared vaccinating those aged 60 years and older first (oldest-first strategy), vaccinating those younger than 20 years first (youngest-first strategy), vaccinating uniformly by age (uniform strategy), and a novel contact-based strategy. The latter three strategies interrupt transmission, whereas the first targets a vulnerable group to r educe disease. Vaccination rates ranged from 0.5% to 5% of the population per week, beginning on either Jan 1 or Sept 1, 2021. FINDINGS: Case notifications, non-pharmaceutical intervention adherence, and lockdown undergo successive waves that interact with the timing of the vaccine programme to determine the relative effectiveness of the four strategies. Transmission-interrupting strategies become relatively more effective with time as herd immunity builds. The model predicts that, in the absence of vaccination, 72 000 deaths (95% credible interval 40 000-122 000) would occur in Ontario from Jan 1, 2021, to March 14, 2025, and at a vaccination rate of 1.5% of the population per week,

Evidence Search Report: INF031801v2 ESR 33 the oldest-first strategy would reduce COVID-19 mortality by 90.8% on average (followed by 89.5% in the uniform, 88.9% in the contact-based, and 88.2% in the youngest-first strategies). 60 000 deaths (31 000-108 000) would occur from Sept 1, 2021, to March 14, 2025, in the absence of vaccination, and the contact -based strategy would reduce COVID-19 mortality by 92.6% on average (followed by 92.1% in the uniform, 91.0% in the oldest -first, and 88.3% in the youngest-first strategies) at a vaccination rate of 1.5% of the population per week. INTERPRETATION: The most effective vaccination strategy for reducing mortality due to COVID-19 depends on the time course of the pandemic in the population. For later vaccination start dates, use of SARS-CoV-2 vaccines to interrupt transmission might prevent more deaths than prioritising vulnerable age groups. FUNDING: Ontario Ministry of Colleges and Universities. URL: https://www.ncbi.nlm.nih.gov/pubmed/33811817 DOI: 10.1016/S1473-3099(21)00057-8

81. Kadali RAK, Janagama R, Peruru S, et al. Adverse effects of COVID-19 mRNA-1273 vaccine: A randomized, cross-sectional study on healthcare workers with detailed self-reported symptoms. J Med Virol. 2021;06:06. DOI: 10.1002/jmv.26996 ABSTRACT: IMPORTANCE: There are concerns regarding the side effects of the new COVID -19 mRNA-1273 vaccine among healthcare workers (HCWs) in the United States OBJECTIVE: To investigate the side effects of the mRNA -1273 vaccine with detailed review of organ systems METHODS: A randomized, cross-sectional study using an independent online survey questionnaire with responses from HCWs RESULTS: Of all participants, 87.8% (1116/1271) provided complete responses. Of them, 38.7 % (432/1116) received the mRNA-1273 vaccine, among which, 89.35% were females. 425 of these 432 mRNA-1273 vaccine recipients (98.34%) reported at least one or more symptoms. The results were classified based on the frequency of symptoms reported post vaccination. Of these, 254/432 (58.8%) were able to continue their daily routine activities. 108/432 (25%) were temporarily unable to perform daily activi ties, 120/432 (27.78%) required transient time off from work, 17/432 (3.94%) required help from an outpatient provider, 1/432 (0.23%) required help from emergency department, and none of them were hospitalized. Despite the wide array of self-reported symptoms, 97.02% of the HCWs did not intend to skip the second dose of vaccine CONCLUSIONS: Among all the symptoms reported, localized pain, generalized weakness, headache, myalgia, chills, fever, nausea, joint pains, sweating, localized swelling at the injection site, dizziness, itching, rash, decreased appetite, muscle spasm, decreased sleep quality, and brain fogging/confusion are the most commonly reported symptoms (in descending order of occurrence). Most of the symptoms reported were non -life threatening. Despite the wide array of self- reported symptoms, there appears to be a higher acceptance for the vaccine This article is protected by copyright. All rights reserved. URL: https://www.ncbi.nlm.nih.gov/pubmed/33822361 DOI: 10.1002/jmv.26996

82. Kalafat E, O'Brien P, Heath PT, et al. Benefits and potential harms of COVID-19 vaccination during pregnancy: evidence summary for patient counseling. Ultrasound Obstet Gynecol. 2021;18:18. DOI: 10.1002/uog.23631 URL: https://www.ncbi.nlm.nih.gov/pubmed/33734524 DOI: 10.1002/uog.23631

83. Kandeil A, Mostafa A, Hegazy RR, et al. Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine: Preclinical Studies. Vaccines (Basel). 2021;9(3):03. DOI: 10.3390/vaccines9030214 ABSTRACT: Since the emergence of SARS-CoV-2 at the end of 2019, 64 candidate vaccines are in clinical development and 173 are in the pre-clinical phase. Five types of vaccines are currently approved for emergency use in many countries (Inactivated, Sinopharm; Viral-vector, Astrazeneca, and Gamaleya Research Institute; mRNA, Moderna, and BioNTech/Pfizer). The main challenge in this pandemic was the availability to produce an effective vaccine to be distributed to the world's population in a short time. Herein, we developed a whole virus NRC -VACC-01 inactivated candidate SARS-CoV-2 vaccine and tested its safety and immunogenicity in laboratory animals. In the preclinical studies, we used four experimental animals (mice, rats, guinea pigs, and hamsters). Antibodies were detected as of week three post vaccination and continued up to week ten in the four experimental models. Safety evaluation of NRC-VACC-01 inactivated candidate vaccine in rats revealed that the vaccine was highly tolerable. By studying the effect of booster dose in the immunological profile of vaccinated mice, we observed an increase in neutralizing antibody titers after the booster shot, thus a booster dose was highly recommended after week three or four.

Evidence Search Report: INF031801v2 ESR 34 Challenge infection of hamsters showed that the vaccinated group had lower morbidity and shedding than the control group. A phase I clinical trial will be performed to assess safety in human subjects. URL: https://www.ncbi.nlm.nih.gov/pubmed/33802467 DOI: 10.3390/vaccines9030214

84. 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 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 prope rties. Therefore the importance of continuing investigations on a broad range of strategies. 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

85. Kasozi KI, Laudisoit A, Osuwat LO, et al. A Descriptive-Multivariate Analysis of Community Knowledge, Confidence, and Trust in COVID-19 Clinical Trials among Healthcare Workers in Uganda. Vaccines (Basel). 2021;9(3):12. DOI: 10.3390/vaccines9030253 ABSTRACT: Background-misinformation and mistrust often undermines community vaccine uptake, yet information in rural communities, especially of developing countries, is scarce. This stu dy aimed to identify major challenges associated with coronavirus disease 2019 (COVID-19) vaccine clinical trials among healthcare workers and staff in Uganda. Methods-a rapid exploratory survey was conducted over 5 weeks among 260 respondents (66% male) f rom healthcare centers across the country using an online questionnaire. Twenty-seven questions assessed knowledge, confidence, and trust scores on COVID-19 vaccine clinical trials from participants in 46 districts in Uganda. Results-we found low levels of knowledge (i.e., confusing COVID-19 with Ebola) with males being more informed than females (OR = 1.5, 95% CI: 0.7-3.0), and mistrust associated with policy decisions to promote herbal treatments in Uganda and the rushed international clinical trials, highlighting challenges for the upcoming Oxford-AstraZeneca vaccinations. Knowledge, confidence and trust scores were higher among the least educated (certificate vs. bachelor degree holders). We also found a high level of skepticism and possible community resistance to DNA recombinant vaccines, such as the Oxford-AstraZeneca vaccine. Preference for herbal treatments (38/260; 14.6%, 95% CI: 10.7-19.3) currently being promoted by the Ugandan government raises major policy concerns. High fear and mistrust for CO VID-19 vaccine clinical trials was more common among wealthier participants and more affluent regions of the country. Conclusion-our study found that knowledge, confidence, and trust in COVID-19 vaccines was low among healthcare workers in Uganda, especially those with higher wealth and educational status. There is a need to increase transparency and inclusive participation to address these issues before new trials of COVID -19 vaccines are initiated. URL: https://www.ncbi.nlm.nih.gov/pubmed/33809269 DOI: 10.3390/vaccines9030253

86. Katzman JG, Katzman JW. Primary Care Clinicians as COVID-19 Vaccine Ambassadors. J Prim Care Community Health. 2021;12:21501327211007026. DOI: 10.1177/21501327211007026 ABSTRACT: The development of highly efficacious COVID-19 vaccines has brought a feeling of hope to many in the US (United States) and across the globe. However, it is estimated that approximately one -third of the US and international population are hesitant to receive the COVID-19 vaccine. For most Western countries with the economic means to purchase sufficient vaccine for their citizens, the medical community now has the opportunity to lead the vaccination communication campaign. Because frontline clinicians were the first to be vaccinated in the United States (US), they are uniquely positioned to be the most trusted source of vaccine information. Primary care clinicians, more

Evidence Search Report: INF031801v2 ESR 35 than other groups of clinicians, scientists, government officials, media, etc. have the greatest chance for instilling confidence about the vaccine to their patients, including the most vulnerable and the most distrusting. They are considered credible and trustworthy allies for their patients in the US, however, clinicians receive little to no formal training in communication related to controversial topics, such as vaccine hesitancy. With the increasing worry about highly transmissible COVID-19 viral mutations and possible related vaccine resistance, it becomes even more critical to accelerate vaccination efforts across every community. Educating primary care clinicians regarding the importance of talking to their patients regarding their COVID-19 vaccination plans is essential. URL: https://www.ncbi.nlm.nih.gov/pubmed/33787395 DOI: 10.1177/21501327211007026

87. Kaur RJ, Dutta S, Bhardwaj P, et al. Adverse Events Reported From COVID-19 Vaccine Trials: A Systematic Review. Indian J Clin Biochem. 2021:1-13. DOI: 10.1007/s12291-021-00968-z ABSTRACT: COVID-19 infection originated in Wuhan, China in December 2019 and crippled human health globally in no time. The public health emergency required urgent efforts to develop and test the efficacy and safety of vaccines to combat the COVID-19 pandemic. The emergency use approval has been granted to COVID-19 vaccines before the completion of conventional phases of clinical trials. However, there is no comprehensive review of safety data reported from the vaccine trials, which is critical information to inform the policies in order to improve uptake of COVID-19 vaccines and mitigate the risk aversion perceived due to the COVID-vaccine side effects. This study aims to systematically review and synthesize the evidence on the safety data from the published COVID -19 vaccine trials. This study followed PRISMA guidelines. We searched three major electronic databases (PubMed, Embase, and Google Scholar) for published studies between Dec 2019 and 2020. Eligible study designs were randomized trials and pre -and post-intervention evaluations. Descriptive findings of included studies were reported stratified by target population, setting, outcomes, and overall results. From PubMed, Embase, WHO database, and Google Scholar screened titles and abstracts, 11 studies were identified in this review. Most of the reactions reported were mild to moderate whereas a few with severe intensity. All reactions resolved within 3-4 days. The commonly reported local adverse events were pain at the site of injection, swelling, and redness. The systemic reactions included fever, fatigue, myalgia, and headache. Some trials also reported laboratory derangements like decreased hemoglobin, increased bilirubin, altered SGOT and SGPT. None of these alterations were clinically manifested and were self -limiting. Few clinical trials reported serious adverse events, but they were unrelated to vaccination. This systematic review indicates that COVID -19 vaccines can be safe with no serious adverse events. However, long -term post-marketing surveillance data, particularly in high-risk vulnerable populations (elderly and those with co-morbidities, pregnant women, and children) is warranted to ensure the safety of COVID-19 vaccines. URL: https://www.ncbi.nlm.nih.gov/pubmed/33814753 DOI: 10.1007/s12291-021-00968-z

88. Kelly BJ, Southwell BG, McCormack LA, et al. Predictors of willingness to get a COVID-19 vaccine in the U.S. BMC Infect Dis. 2021;21(1):338. DOI: 10.1186/s12879-021-06023-9 ABSTRACT: BACKGROUND: As COVID-19 vaccine distribution efforts continue, public health workers can strategize about vaccine promotion in an effort to increase willingness among those who may be hesitant. METHODS: In April 2020, we surveyed a national probability sample of 2279 U.S. adults using an online panel recruited through address - based sampling. Households received a computer and internet access if needed to participate in the panel. Participants were invited via e-mail and answered online survey questions about their willingness to get a novel coronavirus vaccine when one became available. The survey was completed in English and Spanish. We report weighted percentages. RESULTS: Most respondents were willing to get the vaccine for themselves (75%) or their children (73%). Notably, Black respondents were less willing than White respondents (47% vs. 79%, p < 0.001), while Hispanic respondents were more willing than White respondents (80% vs. 75%, p < 0.003). Females were less likely than makes (72% vs. 79%, p < 0.001). Those without insurance were less willing than the insured (47% vs. 78%, p < 0.001). Willingness to vaccinate was higher for those age 65 and older than for some younger age groups (85% for those 65 and older vs. 75% for those 50-64, p < 0.017; 72% for those 35-49, p < 0.002; 70% for those 25-34, p = NS and 75% for ages 18-24, p = NS), but other groups at increased risk because of underlying medical conditions or morbid obesity were not more willing to get vaccinated than their lower risk counterparts. CONCLUSIONS: Most Americans were willing to get a COVID-19 vaccine, but several vulnerable populations reported low willingness. Public health efforts should address these gaps as national implementation efforts continue. URL: https://www.ncbi.nlm.nih.gov/pubmed/33845781

Evidence Search Report: INF031801v2 ESR 36 DOI: 10.1186/s12879-021-06023-9

89. Kendal A. Safety monitoring of COVID-19 vaccines - Lessons learned from the 1976 national influenza immunization program about detecting rare vaccine-related severe adverse events in emergency mass- vaccination programs. Vaccine. 2021;39(16):2187-9. DOI: 10.1016/j.vaccine.2021.03.015 URL: https://www.ncbi.nlm.nih.gov/pubmed/33757668 DOI: 10.1016/j.vaccine.2021.03.015

90. Khurana A, Allawadhi P, Khurana I, et al. Role of nanotechnology behind the success of mRNA vaccines for COVID-19. Nano Today. 2021;38:101142. DOI: 10.1016/j.nantod.2021.101142 ABSTRACT: The emergency use authorization (EUA) by the US-FDA for two mRNA-based vaccines BNT162b2 (Pfizer- BioNTech) and mRNA-1273 (Moderna) has brought hope of addressing the COVID-19 pandemic which has killed more than two million people globally. Nanotechnology has played a significant role in the success of these vaccines. Nanoparticles (NPs) aid in improving stability by protecting the encapsulated mRNA from ribonucleases and facilitate delivery of intact mRNA to the target site. The overwhelming success of these two mRNA based vaccines with ~95% efficacy in phase III clinical trials can be attributed to their unique nanocarrier, the "lipid nanoparticles" (LNPs). LNPs are unique compared with bilayered liposomes and provide improved stability of the cargo, possess rigid morphology, and aid in better cellular penetration. This EUA is a major milestone and showcases the immense potential of nanotechnology for vaccine delivery and for fighting against future pandemics. Currently, these two vaccines are aiding in the alleviation of the COVID-19 health crisis and demonstrate the potential utility of nanomedicine for tackling health problems at the global level. URL: https://www.ncbi.nlm.nih.gov/pubmed/33815564 DOI: 10.1016/j.nantod.2021.101142

91. Kiszewski AE, Cleary EG, Jackson MJ, et al. NIH funding for vaccine readiness before the COVID-19 pandemic. Vaccine. 2021;08:08. DOI: 10.1016/j.vaccine.2021.03.022 ABSTRACT: Rapid development of vaccines for COVID-19 has relied on the application of existing vaccine technologies. This work examines the maturity of ten technologies employed in candidate vaccines (as of July 2020) and NIH funding for published research on these technologies from 2000-2019. These technologies vary from established platforms, which have been used successfully in approved products, to emerging technologies with no prior clinical validation. A robust body of published research on vaccine technologies was supported by 16,358 fiscal years of NIH funding totaling $17.2 billion from 2000-2019. During this period, NIH funding for published vaccine research against specific pandemic threats such as coronavirus, Zika, Ebola, and dengue was not sustained. NIH funding contributed substantially to the advance of technologies available for rapid development of COVID -19 vaccines, suggesting the importance of sustained public sector funding for foundational technologies in the rapid response to emerging public health threats. URL: https://www.ncbi.nlm.nih.gov/pubmed/33781600 DOI: 10.1016/j.vaccine.2021.03.022

92. Kmietowicz Z. Covid-19: Officials query data from AstraZeneca's US vaccine trial. Bmj. 2021;372:n807. DOI: 10.1136/bmj.n807 URL: https://www.ncbi.nlm.nih.gov/pubmed/33757958 DOI: 10.1136/bmj.n807

93. Knottnerus JA. New placebo-controlled Covid-19 vaccine trials are ethically questionable; it's now about comparative effectiveness and availability of registered vaccines. J Clin Epidemiol. 2021;16:16. DOI: 10.1016/j.jclinepi.2021.03.006 URL: https://www.ncbi.nlm.nih.gov/pubmed/33741502 DOI: 10.1016/j.jclinepi.2021.03.006

94. Koch T, Mellinghoff SC, Shamsrizi P, et al. Correlates of Vaccine-Induced Protection against SARS-CoV-2. Vaccines (Basel). 2021;9(3):10. DOI: 10.3390/vaccines9030238 ABSTRACT: We are in the midst of a pandemic caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes the coronavirus disease 2019 (COVID-19). SARS-CoV-2 has caused more than two million

Evidence Search Report: INF031801v2 ESR 37 deaths after one year of the pandemic. The world is experiencing a deep economic recession. Safe and effective vaccines are needed to prevent further morbidity and mortality. Vaccine candidates against COVID -19 have been developed at an unprecedented speed, with more than 200 vaccine candidates currently under investigation. Among those, 20 candidates have entered the clinical Phase 3 to evaluate efficacy, and three have been approved by the European Medicines Agency. The aim of immunization is to act against infection, disease and/or transmission. However, the measurement of vaccine efficacy is challenging, as efficacy trials need to include large cohorts with verum and placebo cohorts. In the future, this will be even more challenging as further vaccine candidates will receive approval, an increasing number of humans will receive vaccinations and incidence might decrease. To evaluate novel and second-generation vaccine candidates, randomized placebo-controlled trials might not be appropriate anymore. Correlates of protection (CoP) could be an important tool to evaluate novel vaccine candidates, but vaccine-induced CoP have not been clearly defined for SARS-CoV-2 vaccines. In this review, we report on immunogenicity against natural SARS-CoV-2 infection, vaccine-induced immune responses and discuss immunological markers that can be linked to protection. By discussing the immunogenicity and efficacy of forerunner vaccines, we aim to give a comprehensive overview of possible efficacy measures and CoP. URL: https://www.ncbi.nlm.nih.gov/pubmed/33801831 DOI: 10.3390/vaccines9030238

95. Kochhar S, Dube E, Graham J, et al. COVID-19 vaccine safety questions and answers for healthcare providers (CONSIDER). Vaccine. 2021;22:22. DOI: 10.1016/j.vaccine.2021.03.060 URL: https://www.ncbi.nlm.nih.gov/pubmed/33836897 DOI: 10.1016/j.vaccine.2021.03.060

96. Kounis NG, Koniari I, de Gregorio C, et al. Allergic Reactions to Current Available COVID-19 Vaccinations: Pathophysiology, Causality, and Therapeutic Considerations. Vaccines (Basel). 2021;9(3):05. DOI: 10.3390/vaccines9030221 ABSTRACT: Vaccines constitute the most effective medications in public health as they control and prevent the spread of infectious diseases and reduce mortality. Similar to other medications, allergic reactions can occur during vaccination. While most reactions are neither frequent nor serious, anaphylactic reactions are potentially life - threatening allergic reactions that are encountered rarely, but can cause serious complications. The allergic responses caused by vaccines can stem from activation of mast cells via Fcepsilon receptor-1 type I reaction, mediated by the interaction between immunoglobulin E (IgE) antibodies against a particular vaccine, and occur within minutes or up to four hours. The type IV allergic reactions initiate 48 h after vaccination and demonstrate their peak between 72 and 96 h. Non-IgE-mediated mast cell degranulation via activation of the complement system and via activation of the Mas - related G protein-coupled receptor X2 can also induce allergic reactions. Reactions are more often caused by inert substances, called excipients, which are added to vaccines to improve stability and absorption, increase solubility, influence palatability, or create a distinctive appearance, and not by the active vaccine itself. Polyethyl ene glycol, also known as macrogol, in the currently available Pfizer-BioNTech and Moderna COVID-19 mRNA vaccines, and polysorbate 80, also known as Tween 80, in AstraZeneca and Johnson & Johnson COVID -19 vaccines, are excipients mostly incriminated for allergic reactions. This review will summarize the current state of knowledge of immediate and delayed allergic reactions in the currently available vaccines against COVID-19, together with the general and specific therapeutic considerations. These considerations include: The incidence of allergic reactions and deaths under investigation with the available vaccines, application of vaccination in patients with mast cell disease, patients who developed an allergy during the first dose, vasovagal symptoms masquerading as allergic reactions, the COVID-19 vaccination in pregnancy, deaths associated with COVID-19 vaccination, and questions arising in managing of this current ordeal. Careful vaccine-safety surveillance over time, in conjunction with the elucidation o f mechanisms of adverse events across different COVID-19 vaccine platforms, will contribute to the development of a safe vaccine strategy. Allergists' expertise in proper diagnosis and treatment of allergic reactions is vital for the screening of high - risk individuals. URL: https://www.ncbi.nlm.nih.gov/pubmed/33807579 DOI: 10.3390/vaccines9030221

97. Kukreti S, Lu MY, Lin YH, et al. Willingness of Taiwan's Healthcare Workers and Outpatients to Vaccinate against COVID-19 during a Period without Community Outbreaks. Vaccines (Basel). 2021;9(3):12. DOI: 10.3390/vaccines9030246

Evidence Search Report: INF031801v2 ESR 38 ABSTRACT: To control the spread of the novel coronavirus disease 2019 (COVID-19), COVID-19 vaccination has been quickly developed. However, the COVID-19 pandemic will not be controlled if the COVID-19 vaccination uptake willingness is low. Therefore, the study aim was to explore the COVID-19 vaccination uptake willingness among the outpatient population and healthcare workers in Taiwan during the worldwide pandemic period without community outbreaks. A cross-sectional survey was conducted among healthcare workers (HCWs; n = 500; mean age = 32.96 years) of National Cheng Kung University Hospital (NCKUH) and outpatients (n = 238; mean age = 34.43 years) arriving at NCKUH. We used an online survey conducted between September 24 and 21 November 2020, for healthcare workers, and between 27 October and 31 December 2020, for the outpatient sample. Information regarding willingness to receive vaccination, willingness to rapid test, fear of COVID -19, risk perception, and preventive behaviors was collected in both samples; information regard ing willingness to care for patients was collected in healthcare workers. Willingness to receive vaccination was the main variable in the present study; willingness to rapid test, willingness to care for patients, fear of COVID-19, risk perception, and preventive behaviors were the secondary variables in the study. The factors associated with vaccination willingness were identified through logistic regression analysis. The participants' willingness to receive vaccination was low for both healthcare workers (23.4%) and the outpatient sample (30.7%). Similarly, their willingness to take rapid tests was low (23.6% for healthcare workers and 28.6% for outpatient sample). Risk perception (crude odds ratio (COR) = 1.29; 95% confidence interval (CI) = 1.03, 1.63), willingness to take rapid test (COR = 9.24; 95% CI = 5.76, 14.83), and preventive COVID -19 infection behaviors (COR = 2.32; 95% CI = 1.52, 3.56) were significant factors explaining the healthcare workers' willingness to receive vaccination. Willingness to take a rapid test (COR = 8.91; 95% CI = 4.71, 16.87) and preventive COVID-19 infection behaviors (COR = 1.69; 95% CI = 1.09, 2.60) were significant factors explaining the outpatient sample's willingness to receive vaccination. Willingness to vaccinate against COVID-19 among HCWs and outpatients is low due to the relatively safe status of COVID-19 infection in Taiwan. These findings can help policymakers advocate for the effectiveness of and provide transparent information on COVID -19 vaccination uptake in a country/region with a relatively safe COVID-19 outbreak status. URL: https://www.ncbi.nlm.nih.gov/pubmed/33808950 DOI: 10.3390/vaccines9030246

98. Lackner CL, Wang CH. Demographic, psychological, and experiential correlates of SARS-CoV-2 vaccination intentions in a sample of Canadian families. Vaccine X. 2021;8:100091. DOI: 10.1016/j.jvacx.2021.100091 ABSTRACT: The COVID-19 pandemic has been ongoing for close to a year, with second waves occurring presently and many viewing vaccine uptake as the most likely way to curb successive waves and promote herd immunity. Reaching herd immunity status likely necessitates that children, as well as their parents, receive a vaccine targeting SARS-CoV-2. In this exploratory study, we investigated the demographic, experiential, and psychological factors associated with the anticipated likelihood and speed of having children receive a SARS -CoV-2 vaccine in a sample of 455 Canadian families (858 children; parents' mean age = 38.2 +/- 6.82 years). Using linear mixed-effects and proportional odds logistic regression models, we demonstrated that older parental age, living in the Prairies (relative to Central Canada), more complete child vaccination history, and a greater tendency to prioritise the risks of the disease relative to the risks of side effects (i.e. lower omission bias) were associated with higher likelihoods of intention to vaccinate participants' children, with trend-level associations with lower perceived danger of the vaccine and higher psychological avoidance of the pandemic. Faster speed of intended vaccination was predicted by a similar constellation of variables with an additional predictor of a child in the family having a COVID -19 related health risk being associated with slower intended speed. Results are discussed concerning public health knowledge mobilisation and the unique Canadian health landscape. URL: https://www.ncbi.nlm.nih.gov/pubmed/33778480 DOI: 10.1016/j.jvacx.2021.100091

99. Ledda C, Costantino C, Cuccia M, et al. Attitudes of Healthcare Personnel towards Vaccinations before and during the COVID-19 Pandemic. Int J Environ Res Public Health. 2021;18(5):08. DOI: 10.3390/ijerph18052703 ABSTRACT: Vaccines constitute highly effective tools for controlling and eliminating vaccine-preventable diseases (VPDs) and are assessed to avert between two to three million deaths per year globally. Healthcare personnel (HCP) constitute a priority group for several vaccinations. However, stu dies indicate significant rates of vaccine hesitancy among them and, therefore, of acceptance of vaccination recommendations. This cross -sectional study was conducted in a university hospital in Southern Italy to assess the knowledge and attitudes of HCP a bout VPDs before and during the COVID-19 pandemic, estimate their intention to get vaccinated against COVID-19, and search for

Evidence Search Report: INF031801v2 ESR 39 determinants that may influence their choice. A self-administered questionnaire was used. HCP improved their knowledge about VPDs and were more favorable to vaccinations in September-December 2020 compared to January- December 2019. Overall, 75% of respondents would get a COVID-19 vaccine. Our findings indicate a potential role of the ongoing COVID-19 pandemic on Italian HCP's knowledge and attitudes towards vaccines. URL: https://www.ncbi.nlm.nih.gov/pubmed/33800187 DOI: 10.3390/ijerph18052703

100. Li X, Ostropolets A, Makadia R, et al. Characterizing the incidence of adverse events of special interest for COVID-19 vaccines across eight countries: a multinational network cohort study. medRxiv. 2021;28:28. DOI: 10.1101/2021.03.25.21254315 ABSTRACT: Background: As large-scale immunization programs against COVID-19 proceed around the world, safety signals will emerge that need rapid evaluation. We report population-based, age- and sex- specific background incidence rates of potential adverse events of special interest (AESI) in eight countries using thirteen databases. Methods: This multi-national network cohort study included eight electronic medical record and five administrative claims databases from Australia, France, Germany, Japan, Netherlands, Spain, the United Kingdom, and the United States, mapped to a common data model. People observed for at least 365 days before 1 January 201 7, 2018, or 2019 were included. We based study outcomes on lists published by regulators: acute myocardial infarction, anaphylaxis, appendicitis, Bell's palsy, deep vein , disseminated intravascular coagulation, encephalomyelitis, Guillain- Barre syndrome, hemorrhagic and non-hemorrhagic stroke, immune thrombocytopenia, myocarditis/pericarditis, narcolepsy, , and transverse myelitis. We calculated incidence rates stratified by age, sex, and database. We pooled rates across databases using random effects meta-analyses. We classified meta-analytic estimates into Council of International Organizations of Medical Sciences categories: very common, common, uncommon, rare, or very rare. Findings: We analysed 126,661,070 people. Rates vari ed greatly between databases and by age and sex. Some AESI (e.g., myocardial infarction, Guillain-Barre syndrome) increased with age, while others (e.g., anaphylaxis, appendicitis) were more common in young people. As a result, AESI were classified differently according to age. For example, myocardial infarction was very rare in children, rare in women aged 35-54 years, uncommon in men and women aged 55-84 years, and common in those aged >/=85 years. Interpretation: We report robust baseline rates of prioritised AESI across 13 databases. Age, sex, and variation between databases should be considered if background AESI rates are compared to event rates observed with COVID -19 vaccines. URL: https://www.ncbi.nlm.nih.gov/pubmed/33791732 DOI: 10.1101/2021.03.25.21254315

101. Lisewski AM. Interim estimates in null models of COVID-19 vaccine effectiveness. Int J Infect Dis. 2021;18:18. DOI: 10.1016/j.ijid.2021.03.050 ABSTRACT: Recently released interim numbers from advanced vaccine candidate clinical trials suggest that a COVID- 19 vaccine effectiveness (VE) above 90% is achievable. However, SARS-CoV-2 transmission dynamics is highly heterogeneous and exhibits localized bursts of transmission, which may lead to sharp localized peaks in the number of new cases, often followed by longer periods of low incidence. Here we show that, for interim estimates of VE, this characteristic burstiness in SARS-CoV-2 infection dynamics may introduce a strong positive bias in VE. Specifically, we generate null models of vaccine effectiveness, i.e., random models with burstiness that over longer times converge to exactly zero VE, but that for interim times frequently produce apparent VE near 100%. As an example, by following the relevant clinical trial protocol, we can reproduce recently reported interim outcomes from an ongoing phase 3 clinical trial of a RNA based vaccine candidate. Thus, to avoid potential random biases in VE, it is suggested that interim estimates on COVID-19 vaccine effectiveness should control for the intrinsic inhomogeneity in both SARS-CoV-2 infection dynamics and in reported cases. URL: https://www.ncbi.nlm.nih.gov/pubmed/33746095 DOI: 10.1016/j.ijid.2021.03.050

102. Liu R, Zhang Y, Nicholas S, et al. COVID-19 Vaccination Willingness among Chinese Adults under the Free . Vaccines (Basel). 2021;9(3):21. DOI: 10.3390/vaccines9030292 ABSTRACT: (1) Background: China will provide free coronavirus disease 2019 (COVID-19) vaccinations for the entire population. This study analyzed the COVID-19 vaccination willingness rate (VWR) and its determinants under China's free vaccination policy compared to a paid vaccine. (2) Methods: Data on 2377 respondents were collected through a nationwide questionnaire survey. Multivariate ordered logistic regression models were specified to explore the

Evidence Search Report: INF031801v2 ESR 40 correlation between the VWR and its determinants. (3) Results: China's free vaccination policy for COVID -19 increased the VWR from 73.62% to 82.25% of the respondents. Concerns about the safety and side -effects were the primary reason for participants' unwillingness to be vaccinated against COVID-19. Age, medical insurance and vaccine safety were significant determinants of the COVID-19 VWR for both the paid and free vaccine. Income, occupation and vaccine effectiveness were significant determinants of the COVID-19 VWR for the free vaccine. (4) Conclusions: Free vaccinations increased the COVID-19 VWR significantly. People over the age of 58 and without medical insurance should be treated as the target intervention population for improving the COVID-19 VWR. Contrary to previous research, high-income groups and professional workers should be intervention targets to improve the COVID -19 VWR. Strengthening nationwide publicity and education on COVID-19 vaccine safety and effectiveness are recommended policies for decision-makers. URL: https://www.ncbi.nlm.nih.gov/pubmed/33801136 DOI: 10.3390/vaccines9030292

103. Lombardi A, Bozzi G, Ungaro R, et al. Mini Review Immunological Consequences of Immunization With COVID-19 mRNA Vaccines: Preliminary Results. Front Immunol. 2021;12:657711. DOI: 10.3389/fimmu.2021.657711 ABSTRACT: Background: BNT162b2 and mRNA-1273 are the two recently approved mRNA-based vaccines against COVID-19 which has shown excellent safety and efficacy. Preliminary data about specific and neutralizing antibodies is available covering the first 100 days after vaccination. Methods: We reviewed all the publications regarding the immunologic consequences of BNT162b2 and mRNA-1273 vaccination. A summary of specific antibodies concentration and neutralizing antibodies titers elicited by each vaccine is provided. Results: BNT162b2 and mRNA - 1273 displayed a reassuring safety and efficacy profile, with the latter above 94%. They can elicit specific antib odies titers and neutralizing antibodies concentrations that are far superior from those observed among COVID -19 human convalescent serum, across a wide span of age, for at least 100 days after vaccination. Moreover, the vaccine -induced T cellular response is oriented toward a TH1 response and no evidence of vaccine-enhanced disease have been reported. Discussion: BNT162b2 and mRNA-1273 can elicit specific antibodies titers and neutralizing antibodies concentrations above those observed among COVID-19 human convalescent serum in the first 100 days after vaccination. Data about vaccine efficacy in those with previous COVID-19 or immunocompromised is still limited. URL: https://www.ncbi.nlm.nih.gov/pubmed/33777055 DOI: 10.3389/fimmu.2021.657711

104. Loo KY, Letchumanan V, Ser HL, et al. COVID-19: Insights into Potential Vaccines. Microorganisms. 2021;9(3):15. DOI: 10.3390/microorganisms9030605 ABSTRACT: People around the world ushered in the new year 2021 with a fear of COVID -19, as family members have lost their loved ones to the disease. Millions of people have been infected, and the livelihood of many has been jeopardized due to the pandemic. Pharmaceutical companies are racing against time to develop an effective vaccine to protect against COVID-19. Researchers have developed various types of candidate vaccines with the release of the genetic sequence of the SARS-CoV-2 virus in January. These include inactivated viral vaccines, protein subunit vaccines, mRNA vaccines, and recombinant viral vector vaccines. To date, several vaccines have been authorized for emergency use and they have been administered in countries across the globe. Meanwhile, there are also vaccine candidates in Phase III clinical trials awaiting results and approval from authorities. These candidates have shown positive results in the previous stages of the trials, whereby they could induce an immune response with minimal side effects in the participants. This review aims to discuss the different vaccine platforms and the clinical trials of the candidate vaccines. URL: https://www.ncbi.nlm.nih.gov/pubmed/33804162 DOI: 10.3390/microorganisms9030605

105. Lu L, Xiong W, Mu J, et al. The potential neurological effect of the COVID-19 vaccines: A review. Acta Neurol Scand. 2021;29:29. DOI: 10.1111/ane.13417 ABSTRACT: The coronavirus disease 2019 caused by the severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) has become a pandemic with people infected in almost all countries. The most efficient solution to end this pandemic is a safe and efficient vaccine. Classic platforms are used to develop vaccines including live -, , protein subunit vaccine, and viral vector. Nucleic acid vaccine uses next-generation platforms for their development. Vaccines are now rushing to the market. Eleven candidates are in advance

Evidence Search Report: INF031801v2 ESR 41 development. These comprise inactivated vaccines, , nucleic acid vaccine, and the protein subunit vaccine platform, which are now quite advanced in trials in various geographic and ethnic populations. The reported severe adverse effects raised the worries about their safety. It becomes critical to know whether these vaccines will cause neurologic disorders like previously recognized vaccine-related demyelinating diseases, fever-induced seizure, and other possible deficits. We reviewed the most promising COVID-2 vaccines with a particular interest in mechanism(s) and adverse effect(s). We exemplify potential neurological problems these vaccines could cause by looking at previous studies. The current evidence indicated a minor risk of the acute neurological disorders after the application. The observation of the long-time effect is still needed. URL: https://www.ncbi.nlm.nih.gov/pubmed/33779985 DOI: 10.1111/ane.13417

106. Lunsky Y, Kithulegoda N, Thai K, et al. Beliefs regarding COVID-19 vaccines among Canadian workers in the intellectual disability sector prior to vaccine implementation. J Intellect Disabil Res. 2021;31:31. DOI: 10.1111/jir.12838 ABSTRACT: BACKGROUND: Workers supporting adults with intellectual disabilities (ID) experience significant stress in their essential role during COVID-19 due to the high risk of their clients contracting COVID-19 and having adverse outcomes. The purpose of the current study was to describe the attitudes of workers towards COVID -19 vaccination prior to vaccination rollout, with a view to informing strategies to promote vaccine uptake within this high-risk sector. METHODS: An online survey was sent via email to workers supporting adults with ID in Ontario, Canada, between January 21 and February 3, 2021 by agency leadership and union representatives. R ESULTS: Three thousand and three hundred and seventy-one workers, representing approximately 11.2% of Ontario workers supporting adults with ID completed an online survey. Most reported that they were very likely (62%) or likely (20%) to get a COVID -19 vaccine (vaccination intent) although 18% reported they were less likely to do so (vaccination nonintent). Workers with vaccination nonintent were younger and were more likely to endorse the beliefs that (1) it will not benefit them or those around them, (2) it was not part of their job, (3) rapid development confers uncertainties and risks, and (4) they were scared of potential vaccine side effects. CONCLUSIONS: There is need to address common misconceptions among workers supporting adults with ID to help activate them as vaccine advocates in the communities they serve. Partnered efforts between workers, unions and agency leadership with public health experts to address concerns are required. URL: https://www.ncbi.nlm.nih.gov/pubmed/33788310 DOI: 10.1111/jir.12838

107. Mahase E. Covid-19: AstraZeneca vaccine is not linked to increased risk of blood clots, finds European Medicine Agency. Bmj. 2021;372:n774. DOI: 10.1136/bmj.n774 URL: https://www.ncbi.nlm.nih.gov/pubmed/33741638 DOI: 10.1136/bmj.n774

108. Makhoul M, Chemaitelly H, Ayoub HH, et al. Epidemiological Differences in the Impact of COVID-19 Vaccination in the United States and China. Vaccines (Basel). 2021;9(3):05. DOI: 10.3390/vaccines9030223 ABSTRACT: This study forecasts Coronavirus Disease 2019 (COVID-19) vaccination impact in two countries at different epidemic phases, the United States (US) and China. We assessed the impact of both a vaccine that prevents infection (VES of 95%) and a vaccine that prevents only disease (VEP of 95%) through mathematical modeling. For VES of 95% and gradual easing of restrictions, vaccination in the US reduced the peak incidence of infection, disease, and death by >55% and cumulative incidence by >32% and in China by >77% and >65%, respectively. Nearly three vaccinations were needed to avert one infection in the US, but only one was needed in China. For VEP of 95%, vaccination benefits were half those for VES of 95%. In both countries, impact of vaccination was substantially enhanced with rapid scale-up, vaccine coverage >50%, and slower or no easing of restrictions, particularly in the US. COVID-19 vaccination can flatten, delay, and/or prevent future epidemic waves. However, vaccine impact is destined to be heterogeneous across countries because of an underlying "ep idemiologic inequity" that reduces benefits for countries already at high incidence, such as the US. Despite 95% efficacy, actual vaccine impact could be meager in such countries if vaccine scale-up is slow, acceptance is poor, or restrictions are eased prematurely. URL: https://www.ncbi.nlm.nih.gov/pubmed/33807647 DOI: 10.3390/vaccines9030223

Evidence Search Report: INF031801v2 ESR 42 109. Marquez Loza AM, Holroyd KB, Johnson SA, et al. Guillain- Barre Syndrome in the Placebo and Active Arms of a COVID-19 Vaccine Clinical Trial: Temporal Associations Do Not Imply Causality. Neurology. 2021;06:06. DOI: 10.1212/WNL.0000000000011881 URL: https://www.ncbi.nlm.nih.gov/pubmed/33824169 DOI: 10.1212/WNL.0000000000011881

110. Mathioudakis AG, Ghrew M, Ustianowski A, et al. Self-Reported Real-World Safety and of COVID-19 Vaccines: A Vaccine Recipient Survey. Life (Basel). 2021;11(3):17. DOI: 10.3390/life11030249 ABSTRACT: An online survey was conducted to compare the safety, tolerability and reactogenicity of available COVID-19 vaccines in different recipient groups. This survey was launched in February 2021 and ran for 11 days. Recipients of a first COVID-19 vaccine dose >/=7 days prior to survey completion were eligible. The incidence and severity of vaccination side effects were assessed. The survey was completed by 2002 respondents of whom 26.6% had a prior COVID-19 infection. A prior COVID-19 infection was associated with an increased risk of any side eff ect (risk ratio 1.08, 95% confidence intervals (1.05-1.11)), fever (2.24 (1.86-2.70)), breathlessness (2.05 (1.28-3.29)), flu-like illness (1.78 (1.51-2.10)), fatigue (1.34 (1.20-1.49)) and local reactions (1.10 (1.06-1.15)). It was also associated with an increased risk of severe side effects leading to hospital care (1.56 (1.14-2.12)). While mRNA vaccines were associated with a higher incidence of any side effect (1.06 (1.01-1.11)) compared with viral vector-based vaccines, these were generally milder (p < 0.001), mostly local reactions. Importantly, mRNA vaccine recipients reported a considerably lower incidence of systemic reactions (RR < 0.6) including anaphylaxis, swelling, flu -like illness, breathlessness and fatigue and of side effects requiring hospital care (0.42 (0.31-0.58)). Our study confirms the findings of recent randomised controlled trials (RCTs) demonstrating that COVID-19 vaccines are generally safe with limited severe side effects. For the first time, our study links prior COVID-19 illness with an increased incidence of vaccination side effects and demonstrates that mRNA vaccines cause milder, less frequent systemic side effects but more local reactions. URL: https://www.ncbi.nlm.nih.gov/pubmed/33803014 DOI: 10.3390/life11030249

111. Matteo R, Nard F, Simona P. Mosaic vaccination schedule: an unexpected card to play against SARS-CoV- 2? Infect Dis Now. 2021;13:13. DOI: 10.1016/j.idnow.2021.03.001 URL: https://www.ncbi.nlm.nih.gov/pubmed/33748805 DOI: 10.1016/j.idnow.2021.03.001

112. Mazzocco G, Niemiec I, Myronov A, et al. AI Aided Design of Epitope-Based Vaccine for the Induction of Cellular Immune Responses Against SARS-CoV-2. Front Genet. 2021;12:602196. DOI: 10.3389/fgene.2021.602196 ABSTRACT: The heavy burden imposed by the COVID-19 pandemic on our society triggered the race toward the development of therapies or preventive strategies. Among these, antibodies and vaccines are particularly attractive because of their high specificity, low probability of drug-drug interaction, and potentially long-standing protective effects. While the threat at hand justifies the pace of research, the implementation of therapeutic strategies cannot be exempted from safety considerations. There are several potential adverse events reported after the vaccination or antibody therapy, but two are of utmost importance: antibody-dependent enhancement (ADE) and cytokine storm syndrome (CSS). On the other hand, the depletion or exhaustion of T-cells has been reported to be associated with worse prognosis in COVID-19 patients. This observation suggests a potential role of vaccines eliciting cellular immunity, which might simultaneously limit the risk of ADE and CSS. Such risk was proposed to be associated with FcR-induced activation of proinflammatory macrophages (M1) by Fu et al. (2020) and Iwasaki and Yang (2020). All aspects of the newly developed vaccine (including the route of administration, delivery system, and adjuvant selection) may affect its effectiveness and safety. In this work we use a novel in silico approach (based on AI and bioinformatics methods) developed to support the design of epitope-based vaccines. We evaluated the capabilities of our method for predicting the immunogenicity of epitopes. Next, the results of our approach were compare d with other vaccine-design strategies reported in the literature. The risk of immuno -toxicity was also assessed. The analysis of epitope conservation among other Coronaviridae was carried out in order to facilitate the selection of peptides shared across different SARS-CoV-2 strains and which might be conserved in emerging zootic coronavirus strains. Finally, the potential applicability of the selected epitopes for the development of a vaccine eliciting cellular immunity for COVID-19 was discussed, highlighting the benefits and challenges of such an approach. URL: https://www.ncbi.nlm.nih.gov/pubmed/33841493

Evidence Search Report: INF031801v2 ESR 43 DOI: 10.3389/fgene.2021.602196

113. McAlister FA, Bushnik T, Leung AA, et al. Informing COVID-19 vaccination priorities based on the prevalence of risk factors among adults in Canada. Cmaj. 2021;09:09. DOI: 10.1503/cmaj.210529 URL: https://www.ncbi.nlm.nih.gov/pubmed/33837040 DOI: 10.1503/cmaj.210529

114. Miles DK, Heald AH, Stedman M. How fast should social restrictions be eased in England as COVID-19 vaccinations are rolled out? Int J Clin Pract. 2021:e14191. DOI: 10.1111/ijcp.14191 ABSTRACT: INTRODUCTION: Vaccination against the COVID-19 virus began in December 2020 in the UK and is now running at 5% population/week. High Levels of social restrictions were implemented for the third time in January 2021 to control the second wave and resulting increases in hospitalisations and deaths. Easing those restrictions must balance multiple challenging priorities, weighing the risk of more deaths and hospitalisations against damage done to mental health, incomes and standards of living, education and provision of non -Covid-19 healthcare. METHODS: Weekly and monthly officially published values in 2020/21 were used to estimate the influence of seasonali ty and social restrictions on the spread of COVID-19 by age group, on the economy and healthcare services. These factors were combined with the estimated impact of vaccinations and immunity from past infections into a model that retrospectively reflected the actual numbers of reported deaths closely both in 2020 and early 2021. The model was applied prospectively to the next 6 months to evaluate the impact of different speeds of easing social restrictions. RESULTS: The results show vaccinations as significantly reducing the number of hospitalisations and deaths. The central estimate is that relative to rapid easing, the avoided loss of 57,000 life -years from a strategy of relatively slow easing over the next 4 months comes at a cost in terms of GDP reduction of around pound0.4 million/life-year loss avoided. This is over 10 times higher than the usual limit the NHS uses for spending against Quality Adjusted Life Years (QALYs) saved. Alternative assumptions for key factors affecting the spread of the virus give significantly different trade-offs between costs and benefits of different speeds of easing. Disruption of non -Covid-19 Healthcare provision also increases in times of higher levels of social restrictions. CONCLUSION: In most cases, the results favour a somewhat faster easing of restrictions in England than current policy implies. URL: https://www.ncbi.nlm.nih.gov/pubmed/33788370 DOI: 10.1111/ijcp.14191

115. Moore S, Hill EM, Tildesley MJ, et al. Vaccination and non-pharmaceutical interventions for COVID-19: a mathematical modelling study. Lancet Infect Dis. 2021;18:18. DOI: 10.1016/S1473-3099(21)00143-2 ABSTRACT: BACKGROUND: The dynamics of vaccination against SARS-CoV-2 are complicated by age-dependent factors, changing levels of infection, and the relaxation of non-pharmaceutical interventions (NPIs) as the perceived risk declines, necessitating the use of mathematical models. Our aims were to use epidemiological data from the UK together with estimates of vaccine efficacy to predict the possible long -term dynamics of SARS-CoV-2 under the planned vaccine rollout. METHODS: In this study, we used a mathematical model structured by age and UK region, fitted to a range of epidemiological data in the UK, which incorporated the planned rollout of a two -dose vaccination programme (doses 12 weeks apart, protection onset 14 days after vaccination). We assumed default vaccine uptake of 95% in those aged 80 years and older, 85% in those aged 50-79 years, and 75% in those aged 18-49 years, and then varied uptake optimistically and pessimistically. Vaccine efficacy against symptomatic disease was assumed to be 88% on the basis of Pfizer-BioNTech and Oxford-AstraZeneca vaccines being administered in the UK, and protection against infection was varied from 0% to 85%. We considered the combined interaction of the UK vaccination programme with multiple potential future relaxations (or removals) of NPIs, to predict the reproduction number (R) and pattern of daily deaths and hospital admissions due to COVID-19 from January, 2021, to January, 2024. FINDINGS: We estimate that vaccination alone is insufficient to contain the outbreak. In the absence of NPIs, even with our most optimistic assumption that the vaccine will prevent 85% of infections, we estimate R to be 1.58 (95% credible intervals [CI] 1.36-1.84) once all eligible adults have been offered both doses of the vaccine. Under the default uptake scenario, removal of all NPIs once the vaccination programme is complete is predicted to lead to 21 400 deaths (95% CI 1400-55 100) due to COVID-19 for a vaccine that prevents 85% of infections, although this number increases to 96 700 deaths (51 800-173 200) if the vaccine only prevents 60% of infections. Although vaccination substantially reduces total deaths, it only provides partial protection for the individual; we estimate that, for the default uptake scenario and 60% protection against infection, 48.3% (95% CI 48.1-48.5) and 16.0% (15.7-16.3) of deaths will be in individuals who have received one or two doses of the vaccine, respectively. INTERPRETATION: For

Evidence Search Report: INF031801v2 ESR 44 all vaccination scenarios we investigated, our predictions highlight the risks associated with early or rapid relaxation of NPIs. Although novel vaccines against SARS-CoV-2 offer a potential exit strategy for the pandemic, success is highly contingent on the precise vaccine properties and population uptake, both of which need to be carefully monitored. FUNDING: National Institute for Health Research, Medical Research Council, and UK Research and Innovation. URL: https://www.ncbi.nlm.nih.gov/pubmed/33743847 DOI: 10.1016/S1473-3099(21)00143-2

116. Moradi-Kalbolandi S, Majidzadeh AK, Abdolvahab MH, et al. The Role of Mucosal Immunity and Recombinant Probiotics in SARS-CoV2 Vaccine Development. Probiotics Antimicrob Proteins. 2021;26:26. DOI: 10.1007/s12602-021-09773-9 ABSTRACT: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2), causing the 2019 novel coronavirus disease (COVID-19), was introduced by WHO (World Health Organization) as "pandemic" in March 2020. Accordi ng to WHO, thus far (23 November 2020) 58,425,681 infected cases including 1,385,218 deaths have been reported worldwide. In order to reduce transmission and spread of this lethal virus, attempts are globally being made to develop an appropriate vaccine. Intending to neutralize pathogens at their initial entrance site, protective mucosal immunity is inevitably required. In SARS-CoV2 infection and transmission, respiratory mucosa plays a key role; hence, apparently mucosal vaccination could be a superior approach to elicit mucosal and systemic immune responses simultaneously. In this review, the advantages of mucosal vaccination to control COVID -19 infection, limitations, and outcomes of mucosal vaccines have been highlighted. Considering the gut microbiota d ysregulation in COVID-19, we further provide evidences on utilization of recombinant probiotics, particularly lactic acid bacteria (LAB) as vaccine carrier. Their intrinsic immunomodulatory features, natural adjuvanticity, and feasible expression of releva nt antigen in the mucosal surface make them more appealing as live cell factory. Among all available platforms, bioengineered probiotics are considered as the most affordable, most practical, and safest vaccination approach to halt this emerging virus. URL: https://www.ncbi.nlm.nih.gov/pubmed/33770348 DOI: 10.1007/s12602-021-09773-9

117. Mosselhy DA, Virtanen J, Kant R, et al. COVID-19 Pandemic: What about the Safety of Anti-Coronavirus Nanoparticles? Nanomaterials (Basel). 2021;11(3):19. DOI: 10.3390/nano11030796 ABSTRACT: Every day, new information is presented with respect to how to best combat the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This manuscript sheds light on such recent findings, including new co -factors (i.e., neuropilin-1) and routes (i.e., olfactory transmucosal) allowing cell entry of SARS-CoV-2 and induction of neurological symptoms, as well as the new SARS-CoV-2 variants. We highlight the SARS-CoV-2 human-animal interfaces and elaborate containment strategies using the same vaccination (i.e., nanoparticle "NP" formulations of the BNT162b2 and mRNA-1273 vaccines) for humans, minks, raccoon dogs, cats, and zoo animals. We investigate the toxicity issues of anti-CoV NPs (i.e., plasmonic NPs and quantum dots) on different levels. Namely, nano -bio interfaces (i.e., protein corona), in vitro (i.e., lung cells) and in vivo (i.e., zebrafish embryos) assessments, and impacts on humans are discussed in a narrative supported by original figures. Ultimately, we express our skeptical opinion on the comprehensive administration of such antiviral nanotheranostics, even when integrated into facemasks, because of their reported toxicities and the different NP parameters (e.g., size, shape, surface charge, and purity and chemical composition of NPs) that govern their end toxicity. We believe that more toxicity studi es should be performed and be presented, clarifying the odds of the safe administration of nanotoxocological solutions and the relief of a worried public. URL: https://www.ncbi.nlm.nih.gov/pubmed/33808934 DOI: 10.3390/nano11030796

118. Nakagami H. Development of COVID-19 vaccines utilizing gene therapy technology. Int Immunol. 2021;27:27. DOI: 10.1093/intimm/dxab013 ABSTRACT: There is currently an outbreak of respiratory disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Coronavirus disease 2019 (COVID-19) is caused by infection with SARS-CoV-2. Individuals with COVID-19 have symptoms that are usually asymptomatic or mild in most initial cases. However, in some cases, moderate and severe symptoms have been observed with pneumonia. Many companies are developing COVID-19 vaccine candidates using different technologies that are classified into four grou ps (intact target viruses, proteins, viral vectors and nucleic acids). For rapid development, RNA vaccines and adenovirus vector vaccines have

Evidence Search Report: INF031801v2 ESR 45 been urgently approved, and their injection has already started across the world. These types of vaccine technolo gies have been developed over more than 20 years using translational research for use against cancer or diseases caused by genetic disorders but the COVID-19 vaccines are the first licensed drugs to prevent infectious diseases using RNA vaccine technology. Although these vaccines are highly effective in preventing COVID-19 for a short period, safety and efficiency evaluations should be continuously monitored over a long time period. As the time of writing, more than 10 projects are now in phase 3 to evaluate the prevention of infection in double-blind studies. Hopefully, several projects may be approved to ensure high-efficiency and safe vaccines. URL: https://www.ncbi.nlm.nih.gov/pubmed/33772572 DOI: 10.1093/intimm/dxab013

119. Nascimento Junior JAC, Santos AM, Cavalcante RCM, et al. Mapping the technological landscape of SARS, MERS, and SARS-CoV-2 vaccines. Drug Dev Ind Pharm. 2021:1-12. DOI: 10.1080/03639045.2021.1908343 ABSTRACT: PURPOSE: The last two decades have seen the emergence of several viral outbreaks. Some of them are the severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), and severe acute respiratory syndrome 2 (SARS-CoV2) - the cause of the coronavirus disease 2019 (COVID-19). Ever, vaccines for emergency use have been authorized for the control and prevention of COVID-19. Currently, there is an urgent need to develop a vaccine for prophylaxis of COVID-19 and for other future epidemics. METHODS: This review describes patented vaccines for SARS and MERS-CoV and vaccines developed and approved for emergency use against the new coronavirus (COVID-19). The European Patent Office and the World Intellectual Property Organization were the patent databases used using specific terms. In addition, another search was carried out in the Clinical Trials in search of ongoing clinical studies focused on the COVID-19 vaccine. RESULTS: The patent search showed that most vaccines are based on viral vector platforms, nucleic acids, or protein subunits. The review also includes an over view of completed and ongoing clinical trials for SARS-CoV-2 in several countries. CONCLUSION: The information provided here lists vaccines for other types of coronavirus that have been used in the development of vaccines for COVID -19. URL: https://www.ncbi.nlm.nih.gov/pubmed/33826439 DOI: 10.1080/03639045.2021.1908343

120. Nel AE, Miller JF. Nano-Enabled COVID-19 Vaccines: Meeting the Challenges of Durable Antibody Plus Cellular Immunity and Immune Escape. ACS nano. 2021;01:01. DOI: 10.1021/acsnano.1c0184 5 ABSTRACT: At the time of preparing this Perspective, large-scale vaccination for COVID-19 is in progress, aiming to bring the pandemic under control through vaccine-induced herd immunity. Not only does this vaccination effort represent an unprecedented scientific and technological breakthrough, moving us from the rapid analysis of viral genomes to design, manufacture, clinical trial testing, and use authorization within the time frame of less than a year, but it also highlights rapid progress in the implementation of nanotechnology to assist vaccine development. These advances enable us to deliver nucleic acid and conformation -stabilized subunit vaccines to regional lymph nodes, with the ability to trigger effective humoral and cellular immunity that prevents viral infection or controls disease severity. In addition to a brief description of the design features of unique cationic lipid and virus -mimicking nanoparticles for accomplishing spike protein delivery and presentation by the cognate immune system, we also discuss the importance of adjuvancy and design features to promote cooperative B- and T-cell interactions in lymph node germinal centers, including the use of epitope-based vaccines. Although current vaccine efforts have demonstrated short-term efficacy and vaccine safety, key issues are now vaccine durability and adaptability against viral variants. We present a forward-looking perspective of how vaccine design can be adapted to improve durability of the immune response and vaccine adaptation to overcome immune escape by viral variants. Finally, we consider the impact of nano-enabled approaches in the development of COVID-19 vaccines for improved vaccine design against other infectious agents, including pathogens that may lead to future pandemics. URL: https://www.ncbi.nlm.nih.gov/pubmed/33793189 DOI: 10.1021/acsnano.1c01845

121. Oldenburg J, Klamroth R, Langer F, et al. Diagnosis and Management of Vaccine-Related Thrombosis following AstraZeneca COVID-19 Vaccination: Guidance Statement from the GTH. Hamostaseologie. 2021;01:01. DOI: 10.1055/a-1469-7481 ABSTRACT: The COVID-19 pandemic is an ongoing global healthcare crisis. Based on reports of atypically located thromboses following vaccination with the AstraZeneca COVID-19 vaccine, the Society of Thrombosis and Haemostasis Research (GTH) has issued guidance statements on the recognition, diagnosis, and treatment of this rare

Evidence Search Report: INF031801v2 ESR 46 complication. It shares pathophysiological features with heparin -induced thrombocytopenia (HIT) and is referred to as vaccine-induced prothrombotic immune thrombocytopenia (VIPIT). URL: https://www.ncbi.nlm.nih.gov/pubmed/33822348 DOI: 10.1055/a-1469-7481

122. Olivares A, Staffetti E. Uncertainty quantification of a mathematical model of COVID-19 transmission dynamics with mass vaccination strategy. Chaos Solitons Fractals. 2021;146:110895. DOI: 10.1016/j.chaos.2021.110895 ABSTRACT: In this paper, the uncertainty quantification and sensitivity analysis of a mathematical model of the SARS - CoV-2 virus transmission dynamics with mass vaccination strategy has been carried out. More specifically, a compartmental epidemic model has been considered, in which vaccination, social distance measures, and testing of susceptible individuals have been included. Since the application of these mitigation measures entails a degree of uncertainty, the effects of the uncertainty about the application of social distance actions and testing of susceptible individuals on the disease transmission have been quantified, under the assumption of a mass va ccination program deployment. A spectral approach has been employed, which allows the uncertainty propagation through the epidemic model to be represented by means of the polynomial chaos expansion of the output random variables. In particular, a statistical moment-based polynomial chaos expansion has been implemented, which provides a surrogate model for the compartments of the epidemic model, and allows the statistics, the probability distributions of the interesting output variables of the model at a given time instant to be estimated and the sensitivity analysis to be conducted. The purpose of the sensitivity analysis is to understand which uncertain parameters have most influence on a given output random variable of the model at a given time instant. Se veral numerical experiments have been conducted whose results show that the proposed spectral approach to uncertainty quantification and sensitivity analysis of epidemic models provides a useful tool to control and mitigate the effects of the COVID -19 pandemic, when it comes to healthcare resource planning. URL: https://www.ncbi.nlm.nih.gov/pubmed/33814733 DOI: 10.1016/j.chaos.2021.110895

123. Olusanya OA, Bednarczyk RA, Davis RL, et al. Addressing Parental Vaccine Hesitancy and Other Barriers to Childhood/Adolescent Vaccination Uptake During the Coronavirus (COVID-19) Pandemic. Front Immunol. 2021;12:663074. DOI: 10.3389/fimmu.2021.663074 ABSTRACT: Routine childhood are proven to be one of the most effective public health interventions at controlling numerous deadly diseases. Therefore, the CDC recommends routine immunizations for children and adolescent populations against vaccine-preventable diseases e.g., tetanus, pertussis, diphtheria, etc. This current review sought to examine barriers to pediatric vaccine uptake behaviors during the COVID -19 pandemic. We also explored the implications for parental vaccine hesitancy/delay during an ongoing health crisis and proposed recommendations for increasing vaccine confidence and compliance. Our review determined that the receipt for vaccinations steadily improved in the last decade for both the United States and Tennessee. However, this incremental progress has been forestalled by the COVID-19 pandemic and other barriers i.e. parental vaccine hesitancy, social determinants of health (SDoH) inequalities, etc. which further exacerbate vaccination disparities. Moreover, non - compliance to routine vaccinations could cause an outbreak of diseases, thereby, worsening the ongoing health crisis and already strained health care system. Healthcare providers are uniquely positioned to offer effective recommendations with presumptive languaging to increase vaccination rates, as well as, address parental vaccine hesitancy. Best practices that incorporate healthcare providers' quality improvement coaching, vaccination reminder recall systems, adherence to standardized safety protocols (physical distancing, hand hygiene practices, etc.), as well as, offer telehealth and outdoor/drive-through/curbside vaccination services, etc. are warranted. Additionally, a concerted effort should be made to utilize public health surveillance systems to collect, analyze, and interpret data, thereby, ensuring the dissemination of timely, accurate health information for effective health policy decision -making e.g., vaccine distribution, etc. URL: https://www.ncbi.nlm.nih.gov/pubmed/33815424 DOI: 10.3389/fimmu.2021.663074

124. Ortiz JR, Robertson J, Hsu JS, et al. The potential effects of deploying SARS-Cov-2 vaccines on cold storage capacity and immunization workload in countries of the WHO African Region. Vaccine. 2021;39(15):2165-76. DOI: 10.1016/j.vaccine.2021.02.037

Evidence Search Report: INF031801v2 ESR 47 ABSTRACT: BACKGROUND: SARS-CoV-2 vaccines will be deployed to countries with limited immunization systems. METHODS: We assessed the effect of deploying SARS-Cov-2 vaccines on cold storage capacity and immunization workload in a simulated WHO African Region country using region-specific data on immunization, population, healthcare workers (HCWs), cold storage capacity (quartile values for national and subnational levels), and characteristics of an approved SARS-CoV-2 vaccine. We calculated monthly increases in vaccine doses, doses per vaccinator, and cold storage volumes for four-month SARS-CoV-2 vaccination campaigns targeting risk groups compared to routine immunization baselines. RESULTS: Administering SARS-CoV-2 vaccines to risk groups would increase total monthly doses by 27.0% for >/= 65 years, 91.7% for chronic diseases patients, and 1.1% for HCWs. Assuming median nurse density estimates adjusted for absenteeism and proportion providing immunization services, SARS-CoV-2 vaccination campaigns would increase total monthly doses per vaccinator by 29.3% for >/= 65 years, 99.6% for chronic diseases patients, and 1.2% for HCWs. When we applied quartiles of actual African Region country vaccine storage capacity, routine immunization vaccine volumes exceeded national-level storage capacity for at least 75% of countries, but subnational levels had sufficient storage capacity for SARS-CoV-2 vaccines for at least 75% of countries. CONCLUSIONS: In the WHO African Region, SARS-CoV-2 vaccination campaigns would substantially increase doses per vaccinator and cold storage capacity requirements over routine immunization baselines. Pandemic vaccination campaigns would increase storage requirements of national-level stores already at their limits, but sufficient capacity exists at subnational levels. Immediate attention to strengthening immunization systems is essential to support pandemic responses. URL: https://www.ncbi.nlm.nih.gov/pubmed/33744049 DOI: 10.1016/j.vaccine.2021.02.037

125. Palgi Y, Bergman YS, Ben-David B, et al. No psychological vaccination: Vaccine hesitancy is associated with negative psychiatric outcomes among Israelis who received COVID-19 vaccination. J Affect Disord. 2021;287:352-3. DOI: 10.1016/j.jad.2021.03.064 ABSTRACT: BACKGROUND: The widespread COVID-19 vaccination program, issued by the Israel Government, provides a unique opportunity to examine psychiatric morbidity and vaccine attitudes among individuals who have already been vaccinated. Accordingly, the current study examined how vaccine hesit ancy contributes to clinical levels of depression, anxiety, and peritraumatic stress among individuals who had received COVID -19 vaccinations. METHODS: We analyzed data obtained from 254 vaccinated individuals, and assessed vaccine hesitancy, depression, anxiety, and peritraumatic distress, as well as several demographic, health, and COVID -19-related factors. RESULTS: Logistic regressions demonstrated that above and beyond socio -demographic, health, and COVID-19-related factors, COVID-19 vaccine hesitancy was the most prominent risk factor for anxiety, depression, and peritraumatic distress. Higher levels of vaccine hesitancy were found to double the risk for depression and peritraumatic stress (ORs > 2), and to triple the risk for anxiety (OR > 3). LIMITATIONS: A cross-sectional design; a preliminary study requiring further investigation CONCLUSIONS: This study points to the importance of vaccine hesitancy among vaccinated populations and provides knowledge regarding its associations with negative psychiatric outcomes. These findings may offer important information for healthcare practitioners and policy makers in their attempt to encourage individuals to receive COVID-19 vaccinations and emphasize the need to further understand the underlying mechanisms of psychiatric morbidity among vaccinated individuals. URL: https://www.ncbi.nlm.nih.gov/pubmed/33819733 DOI: 10.1016/j.jad.2021.03.064

126. Park JK, Lee EB, Shin K, et al. COVID-19 Vaccination in Patients with Autoimmune Inflammatory Rheumatic Diseases: Clinical Guidance of the Korean College of Rheumatology. J Korean Med Sci. 2021;36(12):e95. DOI: 10.3346/jkms.2021.36.e95 ABSTRACT: The coronavirus disease 2019 (COVID-19) pandemic has caused more than 100 million infections and 2 million deaths worldwide. In up to 20% of cases, COVID-19 infection can take a severe, life-threatening course. Therefore, preventive measures such as mask-wearing, hand hygiene, and social distancing are important. COVID-19 vaccines that use novel vaccine technology can prevent up to 95% of infections. However, the uncertainty regarding the efficacy and safety of vaccination in patients with autoimmune inflammatory rheumatic disease (AIIRD), who are immunocompromised due to underlying immune dysfunction and concomitant immunosuppress ive treatment, warrants clear guidance. A task force of the Korean College of Rheumatology formulated a set of vaccination guidance based on the currently available data and expert consensus. The currently available COVID -19 vaccines are considered to be safe and effective. Every patient with AIIRD should receive one of the available COVID -19 vaccines

Evidence Search Report: INF031801v2 ESR 48 unless contraindicated for medical reasons such as prior allergy/anaphylaxis to the COVID -19 vaccine or its components. Patients should continue immunosuppressive treatment for their underlying AIIRD, including biological and targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs). Corticosteroids should be reduced to the lowest dose possible without aggravating the AIIRD. To improve the vaccine response, methotrexate can be withheld for 1-2 weeks after each vaccination, and the timing of rituximab and abatacept infusion should be adjusted if clinically acceptable. Rheumatologists should play a leading role in educating and vaccinating patients wi th AIIRD. URL: https://www.ncbi.nlm.nih.gov/pubmed/33783147 DOI: 10.3346/jkms.2021.36.e95

127. Paul G, Chad R. Newborn antibodies to SARS-CoV-2 detected in cord blood after maternal vaccination - a case report. BMC Pediatr. 2021;21(1):138. DOI: 10.1186/s12887-021-02618-y ABSTRACT: BACKGROUND: Maternal vaccination for Influenza and Tetanus, Dip htheria, acellular Pertussis (TDaP) have been well studied in terms of safety and efficacy for protection of the newborn by placental passage of antibodies. Similar newborn protection would be expected after maternal vaccination against severe acute respir atory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for coronavirus disease 2019 (COVID-19). There is a significant and urgent need for research regarding safety and efficacy of vaccination against SARS -CoV-2 during pregnancy. CASE PRESENTATION: A vigorous, healthy, full-term female was born to a COVID-19 naive mother who had received a single dose of messenger RNA (mRNA) vaccine for SARS-CoV-2 3 weeks prior to delivery. IgG cord blood antibodies were detected to SARS-CoV-2 at the time of birth. CONCLUSION: Here, we report the first known case of an infant with SARS-CoV-2 IgG antibodies detectable in cord blood after maternal vaccination. URL: https://www.ncbi.nlm.nih.gov/pubmed/33752624 DOI: 10.1186/s12887-021-02618-y

128. Peiffer-Smadja N, Rozencwajg S, Kherabi Y, et al. COVID-19 vaccines: A race against time. Anaesth Crit Care Pain Med. 2021;40(2):100848. DOI: 10.1016/j.accpm.2021.100848 URL: https://www.ncbi.nlm.nih.gov/pubmed/33774261 DOI: 10.1016/j.accpm.2021.100848

129. Pfaar O, Klimek L, Hamelmann E, et al. COVID-19 vaccination of patients with allergies and type-2 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;5:140-7. DOI: 10.5414/ALX02241E 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 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, 20 21).

Evidence Search Report: INF031801v2 ESR 49 URL: https://www.ncbi.nlm.nih.gov/pubmed/33842829 DOI: 10.5414/ALX02241E

130. Prescott MJ, Clark C, Dowling WE, et al. Opportunities for Refinement of Non-Human Primate Vaccine Studies. Vaccines (Basel). 2021;9(3):19. DOI: 10.3390/vaccines9030284 ABSTRACT: Non-human primates (NHPs) are used extensively in the development of vaccines and therapeutics for human disease. High standards in the design, conduct, and reporting of NHP vaccine studies are crucial for maximizing their scientific value and translation, and for making efficient use of precious resources. A key aspect is consideration of the 3Rs principles of replacement, reduction, and refinement. Funders of NHP research are placing increasing emphasis on the 3Rs, helping to ensure such studies are legitimate, ethical, and high-quality. The UK's National Centre for the 3Rs (NC3Rs) and the Coalition for Epidemic Preparedness Innovations (CEPI) have collaborated on a range of initiatives to support vaccine developers to implement the 3Rs, including hosting an international workshop in 2019. The workshop identified opportunities to refine NHP vaccine studies to minimize harm and improve welfare, which can yield better quality, more reproducible data. Careful animal selection, social housing, extensive environmental enrichment, training for cooperation with husbandry and procedures, provision of supportive care, and implementation of early humane endpoints are features of contemporary good practice that should and can be adopted more widely. The requirement for high-level biocontainment for some pathogens imposes challenges to implementing refinement but these are not insurmountable. URL: https://www.ncbi.nlm.nih.gov/pubmed/33808708 DOI: 10.3390/vaccines9030284

131. Qattan AMN, Alshareef N, Alsharqi O, et al. Acceptability of a COVID-19 Vaccine Among Healthcare Workers in the Kingdom of Saudi Arabia. Front Med (Lausanne). 2021;8:644300. DOI: 10.3389/fmed.2021.644300 ABSTRACT: Objective: This study aims to determine the acceptability of a COVID-19 vaccine among healthcare workers in Saudi Arabia and the factors affecting their intention to accept the vaccine. Methods: The study used data from an online cross-sectional survey that was conducted in Saudi Arabia betw een 8 December 2020 and 14 December 2020. This study employed bivariate and multivariable regression analyses. The bivariate was used to describe and tabulate the frequency of all the variables, including the sociodemographic characteristics, the risk perception and the acceptance of the COVID-19 vaccination and a chi-squared test of independence was calculated. Multivariable logistic regression models were employed to examine and identify the factors associated with an intention to have the COVID-19 vaccination and the factors associated with its immediate acceptance. Results: Of the total of 736 healthcare workers who began the online questionnaire, 673 completed it (a 91.44% completion rate). Among the study participants, 50.52% were willing to have the COVID-19 vaccine, of which 49.71% intended to have the vaccine as soon as it becomes available in the country, while 50.29% would delay until the vaccine's safety is confirmed. Being a male healthcare worker, perceiving a high risk of infection, and believi ng that the COVID-19 vaccine should be compulsory for all citizens and residents in the country increased the probability of intention to vaccinate against COVID-19 and the probability of accepting the COVID-19 vaccination as soon as possible. Conclusion: This study calls for more health-related education among healthcare workers to alleviate any fears that might be associated with the COVID-19 vaccine. URL: https://www.ncbi.nlm.nih.gov/pubmed/33732723 DOI: 10.3389/fmed.2021.644300

132. Rabi R, Maraqa B, Nazzal Z, et al. Factors affecting nurses' intention to accept the COVID-9 vaccine: A cross-sectional study. Public Health Nurs. 2021;12:12. DOI: 10.1111/phn.12907 ABSTRACT: OBJECTIVE: To measure COVID-19 vaccine acceptance and related factors to undercover nurses' concerns and fears. DESIGN: A cross-sectional study. SAMPLE: The study included 639 nurses; 83% were women and 80% under 50 years. MEASUREMENT: A self-administered questionnaire was used. It included demographic characteristics, COVID-19-related fears and concerns, COVID-19 vaccine perceived benefits, and intention toward getting the vaccine. RESULTS: Forty percent of the nurses planned to get the vaccine when available, 41% would take it later when adequate protection and safety were presented, and 18% would never take it. Significant factors associated with vaccination intention were as follows: age (adjusted OR 1.42, 95% CI: 1.02-1.99); lack of knowledge about the vaccine (adjusted OR 2.6, 95% CI 1.81-3.8); concern about long-term side effects (adjusted OR 2.0, 95% CI 1.4-2.9); fear of injection (adjusted OR 1.5, 95% CI 1.04-2.13); natural immunity preference (adjusted OR 5.8, 95% CI 4.5-8.3); media

Evidence Search Report: INF031801v2 ESR 50 misrepresentation (adjusted OR 1.7, 95% CI 1.2-2.4); and getting COVID-19 from the vaccine (adjusted OR 1.5, 95% CI 1.1-2.1). CONCLUSION: COVID-19 vaccine safety and side-effects concerns impact nurses' intentions to accept the vaccine and may result in low acceptance rates. Urgent action is needed to address these fears and raise confidence, as nurses' vaccine-related decisions can affect the public's vaccine acceptance. URL: https://www.ncbi.nlm.nih.gov/pubmed/33844870 DOI: 10.1111/phn.12907

133. Rachaniotis NP, Dasaklis TK, Fotopoulos F, et al. A Two-Phase Stochastic Dynamic Model for COVID-19 Mid-Term Policy Recommendations in Greece: A Pathway towards Mass Vaccination. Int J Environ Res Public Health. 2021;18(5):03. DOI: 10.3390/ijerph18052497 ABSTRACT: From 7 November 2020, Greece adopted a second nationwide lockdown policy to mitigate the transmission of SARS-CoV-2 (the first took place from 23 March to 4 May 2020), just as the second wave of COVID -19 was advancing, as did other European countries. To secure the full benefits of mass vaccination, which started in early January 2021, it is of utmost importance to complement it with mid-term non-pharmaceutical interventions (NPIs). The objective was to minimize human losses and to limit social and economic costs. In this paper a two -phase stochastic dynamic network compartmental model (a pre-vaccination SEIR until 15 February 2021 and a post- vaccination SVEIR from 15 February 2021 to 30 June 2021) is developed. Three scenarios are assessed for the first phase: (a) A baseline scenario, which lifts the national lockdown and all NPIs in January 2021; (b ) a "semi-lockdown" scenario with school opening, partial retail sector operation, universal mask wearing, and social distancing/teleworking in January 2021; and (c) a "rolling lockdown" scenario combining a partial lifting of measures in January 2021 followed by a third nationwide lockdown in February 2021. In the second phase three scenarios with different vaccination rates are assessed. Publicly available data along with some first results of the SHARE COVID -19 survey conducted in Greece are used as input. The results regarding the first phase indicate that the "semi-lockdown" scenario clearly outperforms the third lockdown scenario (5.7% less expected fatalities); the second phase is extremely sensitive on the availability of sufficient vaccine supplies and high vaccination rates. URL: https://www.ncbi.nlm.nih.gov/pubmed/33802501 DOI: 10.3390/ijerph18052497

134. Ricotta EE, Kwan JL, Smith BA, et al. Chronic diseases: Perceptions about Covid-19 risk and vaccination. medRxiv. 2021;24:24. DOI: 10.1101/2021.03.17.21253760 ABSTRACT: Background: Individuals with chronic disease may be at higher risk of dying from COVID-19, yet no association has been established between chronic illness and COVID-19 risk perception, engagement with nonpharmaceutical interventions (NPIs), or vaccine acceptance. Methods: We surveyed US residents who self -reported a chronic respiratory or autoimmune disease in February 2021. Respondents reported beliefs about the risk of COVID - 19 to personal and public health, adoption and support of NPIs, willingness to be vaccinated against COVID -19, and reasons for vaccination willingness. We evaluated the association between disease status and COVID-19 behaviors or attitudes, adjusting for demographic and political factors. Results: Compared to healthy controls, chronic disease was associated with increased belief that COVID-19 was a personal (Respiratory = 0.12, 95% confidence interval (CI) = 0.10 - 0.15; Autoimmune = 0.11, CI = 0.08 - 0.14) and public threat (Respiratory = 0.04, CI = 0.02 - 0.06; Autoimmune = 0.03, CI = 0.01 - 0.06), and support for NPIs. Chronic respiratory disease was associated w ith willingness to be vaccinated (0.6, CI = 0.05 - 0.09). Personal protection was associated with vaccination (Respiratory = 1.08, CI = 1.03 - 1.13; Autoimmune = 1.06, CI = 1.01 - 1.11). Autoimmune disease was associated with fear of a bad vaccine reaction (1.22, CI = 1.06 - 1.41) among those unwilling to be vaccinated. Conclusions: In the US, chronic disease status is significantly related to risk perceptions of COVID, support of personal and community risk mitigation measures, and willingness to be vaccinated. URL: https://www.ncbi.nlm.nih.gov/pubmed/33791714 DOI: 10.1101/2021.03.17.21253760

135. Ring J, Worm M, Wollenberg A, et al. Risk of severe allergic reactions to COVID-19 vaccines among patients with allergic skin diseases - practical recommendations. A position statement of ETFAD with external experts. J Eur Acad Dermatol Venereol. 2021;22:22. DOI: 10.1111/jdv.17237 URL: https://www.ncbi.nlm.nih.gov/pubmed/33752263 DOI: 10.1111/jdv.17237

Evidence Search Report: INF031801v2 ESR 51 136. Rogliani P, Chetta A, Cazzola M, et al. SARS-CoV-2 Neutralizing Antibodies: A Network Meta-Analysis across Vaccines. Vaccines (Basel). 2021;9(3):05. DOI: 10.3390/vaccines9030227 ABSTRACT: Background: There are no studies providing head-to-head comparison across SARS-CoV-2 vaccines. Therefore, we compared the efficacy of candidate vaccines in inducing neutralizing antibodies against SARS -CoV-2. Methods: A network meta-analysis was performed to compare the peak levels of SARS-CoV-2 neutralizing antibodies across candidate vaccines. Data were reported as standardized mean difference (SMD) since the outcome was assessed via different metrics and methods across the studies. Results: Data obtained from 836 healthy adult vaccine recipients were extracted from 11 studies. BBIBP-CorV, AZD1222, BNT162b2, New Crown COVID-19, and Sputnik V induced a very large effect on the level of neutralizing antibodies (SMD > 1.3); CoVLP, CoronaVac, NVX-CoV2373, and Ad5-nCoV induced a large effect (SMD > 0.8 to 0.5 to /=70 years. Compared with AZD1222, BNT162b and mRNA -1237 have the advantage that they can be quickly re-engineered to mimic new mutations of SARS-CoV-2. URL: https://www.ncbi.nlm.nih.gov/pubmed/33807818 DOI: 10.3390/vaccines9030227

137. Russo AG, Decarli A, Valsecchi MG. Strategy to identify priority groups for COVID-19 vaccination: A population based cohort study. Vaccine. 2021;26:26. DOI: 10.1016/j.vaccine.2021.03.076 ABSTRACT: BACKGROUND: Evidence from COVID-19 outbreak shows that individuals with specific chronic diseases are at higher risk of severe prognosis after infection. Public health authorities are developing vaccination programmes with priorities that minimize the risk of mortality and severe events in individuals and communities. We propose an evidence-based strategy that targets the frailest subjects whose timely vaccination is likely to minimize future deaths and preserve the resilience of the health service by preventing inf ections. METHODS: The cohort includes 146,087 cases with COVID-19 diagnosed in 2020 in Milan (3.49 million inhabitants). Individual level data on 42 chronic diseases and vital status updated as of January 21, 2021, were available in administrative data. An alyses were performed in three sub-cohorts of age (16-64, 65-79 and 80+ years) and comorbidities affecting mortality were selected by means of LASSO cross-validated conditional logistic regression. Simplified models based on previous results identified high-risk categories worth targeting with highest priority. Results adjusted by age and gender, were reported in terms of odds ratios and 95%CI. RESULTS: The final models include as predictors of mortality (7,667 deaths, 5.2%) 10, 12, and 5 chronic diseases, respectively. The older age categories shared, as risk factors, chronic renal failure, chronic heart failure, cerebrovascular disease, Parkinson disease and psychiatric diseases. In the younger age category, predictors included neoplasm, organ transplantation and psychiatric conditions. Results were consistent with those obtained on mortality at 60 days from diagnosis (6,968 deaths). CONCLUSION: This approach defines a two-level stratification for priorities in the vaccination that can easily be applied by health authorities, eventually adapted to local results in terms of number and types of comorbidities, and rapidly updated with current data. After the early phase of vaccination, data on effectiveness and safety will give the opportunity to revise priorit ization and discuss the future approach in the remaining population. URL: https://www.ncbi.nlm.nih.gov/pubmed/33824037 DOI: 10.1016/j.vaccine.2021.03.076

138. Rutkowski K, Mirakian R, Till S, et al. Adverse reactions to COVID-19 vaccines: a practical approach. Clin Exp Allergy. 2021;04:04. DOI: 10.1111/cea.13880 ABSTRACT: COVID-19 related mortality in high-risk individuals is substantial and current treatment options are limited. There is emerging evidence that the COVID-19 vaccines can reduce the severity of infection and prevent deaths. Three COVID-19 vaccines are approved in the United Kingdom with many more in development. There is 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 immunised. Finally, we propose a practical algorithm for the investigations of anaphylaxis to these vaccines.

Evidence Search Report: INF031801v2 ESR 52 URL: https://www.ncbi.nlm.nih.gov/pubmed/33813758 DOI: 10.1111/cea.13880

139. Sadarangani M, Abu Raya B, Conway JM, et al. Importance of COVID-19 vaccine efficacy in older age groups. Vaccine. 2021;39(15):2020-3. DOI: 10.1016/j.vaccine.2021.03.020 ABSTRACT: IMPORTANCE: An effective vaccine against SARS-CoV-2 will reduce morbidity and mortality and allow substantial relaxation of physical distancing policies. However, the ability of a vaccine to prevent infection or disease depends critically on protecting older individuals, who are at highest risk of severe disease. OBJECTIVE: We quantitatively estimated the relative benefits of COVID-19 vaccines, in terms of preventing infection and death, with a particular focus on effectiveness in elderly people. DESIGN: We applied compartmental mathematical modelling to determine the relative effects of vaccines that block infection and onward transmission, and those that prevent severe disease. We assumed that vaccines showing high efficacy in adults would be deployed, and examined the effects of lower vaccine efficacy among the elderly population. SETTING AND PARTICIPANTS: Our mathematical model was calibrated to simulate the course of an epidemic among the entire population of British Columbia, Canada. Within our model, the population was structured by age and levels of contact. MAIN OUTCOME(S) AND MEASURE(S): We assessed the effectiveness of possible vaccines in terms of the predicted number of infections within the entire population, and deaths among people aged 65 years and over. RESULTS: In order to reduce the overall rate of infections in the population, high rates of deployment to all age groups will be critical. However, to substantially reduce mortality among people aged 65 years and over, a vaccine must directly protect a high proportion of people in that group. CONCLUSIONS AND RELEVANCE: Effective vaccines deployed to a large fraction of the population are projected to substantially reduce infection in an otherwise susceptible population. However, even if tr ansmission were blocked highly effectively by vaccination of children and younger adults, overall mortality would not be substantially reduced unless the vaccine is also directly protective in elderly people. We strongly recommend: (i) the inclusion of people aged 65 years and over in future trials of COVID-19 vaccine candidates; (ii) careful monitoring of vaccine efficacy in older age groups following vaccination. URL: https://www.ncbi.nlm.nih.gov/pubmed/33736921 DOI: 10.1016/j.vaccine.2021.03.020

140. Sajjadi NB, Nowlin W, Nowlin R, et al. United States internet searches for "infertility" following COVID-19 vaccine misinformation. J Osteopath Med. 2021;12:12. DOI: 10.1515/jom-2021-0059 ABSTRACT: CONTEXT: On December 1, 2020, Drs. Wolfgang Wodarg and Micheal Yeadon petitioned to withhold emergency use authorization of the BNT162b2 messenger ribonucleic acid vaccine for coronavirus disease 2019 (COVID-19) manufactured by BioNTech and Pfizer, raising concern for female infertility risks but acknowledg ing the lack of evidence. The European Medicines Agency and the US Food and Drug Administration ultimately issued emergency use authorizations, but misinformation claiming that COVID-19 vaccines cause female infertility began circulating on social media, potentially influencing public perception and medical decision making among pregnant patients or those seeking to become pregnant. OBJECTIVES: To determine the potential influence misinformation may have had on public interest in infertility related topics, as analyzed through internet search statistics in the US. METHODS: The Google Trends tool was used to analyze results for the search terms "infertility," "infertility AND vaccine," and "infertility AND COVID vaccine" in the US from February 4, 2020 to Feb ruary 3, 2021. We applied autoregressive integrated moving average models to forecast expected values, comparing them with actual observed values. RESULTS: At peak interest (100), the forecasted relative search volumes interest for the search terms "infertility," "infertility AND vaccine," and "infertility AND COVID vaccine" were 45.47 (95% CI, 33.27-57.66; p<0.001), 0.88 (95% CI, 2.87-4.63; p<0.001), and 0.29 (95% CI, -2.25-2.82; p<0.001). The actual relative search volumes at peak searching represented 119.9, 11,251, and 34,900% increases, respectively, when compared with forecasted values. CONCLUSIONS: COVID-19 vaccine misinformation corresponded with increased internet searches for topics related to infertility in the US. Dispelling misinformation and in forming patients about the risks and benefits of COVID-19 vaccination may prevent unnecessary vaccine hesitancy or refusal, contributing to successful vaccination efforts. URL: https://www.ncbi.nlm.nih.gov/pubmed/33838086 DOI: 10.1515/jom-2021-0059

141. Sallam M, Dababseh D, Eid H, et al. Low COVID-19 Vaccine Acceptance Is Correlated with Conspiracy Beliefs among University Students in Jordan. Int J Environ Res Public Health. 2021;18(5):01. DOI: 10.3390/ijerph18052407

Evidence Search Report: INF031801v2 ESR 53 ABSTRACT: Vaccination to prevent coronavirus disease 2019 (COVID-19) emerged as a promising measure to overcome the negative consequences of the pandemic. Since university students could be considered a knowledgeable group, this study aimed to evaluate COVID-19 vaccine acceptance among this group in Jordan. Additionally, we aimed to examine the association between vaccine conspiracy beliefs and vaccine hesitancy. We used an online survey conducted in January 2021 with a chain -referral sampling approach. Conspiracy beliefs were evaluated using the validated Vaccine Conspiracy Belief Scale (VCBS), with higher scores implying embrace of conspiracies. A total of 1106 respondents completed the survey with female predominance (n = 802, 72.5%). The intention to get COVID-19 vaccines was low: 34.9% (yes) compared to 39.6% (no) and 25.5% (maybe). Higher rates of COVID-19 vaccine acceptance were seen among males (42.1%) and students at Health Schools (43.5%). A Low rate of influenza vaccine acceptance was seen as well (28.8%), in addition to 18.6% of resp ondents being anti-vaccination altogether. A significantly higher VCBS score was correlated with reluctance to get the vaccine (p < 0.001). Dependence on social media platforms was significantly associated with lower intention to get COVID -19 vaccines (19.8%) compared to dependence on medical doctors, scientists, and scientific journals (47.2%, p < 0.001). The results of this study showed the high prevalence of COVID-19 vaccine hesitancy and its association with conspiracy beliefs among university students in Jordan. The implementation of targeted actions to increase the awareness of such a group is highly recommended. This includes educational programs to dismantle vaccine conspiracy beliefs and awareness campaigns to build recognition of the safety and eff icacy of COVID-19 vaccines. URL: https://www.ncbi.nlm.nih.gov/pubmed/33804558 DOI: 10.3390/ijerph18052407

142. Salmeron Rios S, Mas Romero M, Cortes Zamora EB, et al. Immunogenicity of the BNT162b2 vaccine in frail or disabled nursing home residents: COVID-A study. J Am Geriatr Soc. 2021;25:25. DOI: 10.1111/jgs.17153 ABSTRACT: BACKGROUND/OBJECTIVES: The safety and immunogenicity of the BNT162b2 coronavirus disease 2019 (COVID-19) vaccine in older adults with different frailty and disability profiles have not been well determined. Our objective was to analyze immunogenicity of the BNT162b2 mRNA COVID-19 vaccine in older adults across frailty and disability profiles. DESIGN: Multicenter longitudinal cohort study. SETTING AND PARTICIPANTS: A total of 134 residents aged >/=65 years with different frailty and disability profiles in five long -term care facilities (LTCFs) in Albacete, Spain. INTERVENTION AND MEASUREMENTS: Residents were administered two vaccine doses as per the label, and antibody levels were determined 21.9 days (SD 9.3) after both the first and second dose. Functional variables were assessed using activities of daily living (Barthel Index), and frailty status was determined with the FRAIL instrument. Cognitive status and comorbidity were also evaluated. RESULTS: Mean age was 82.9 years (range 65-99), and 71.6% were female. The mean antibody titers in residents with and without previous COVID -19 infection were 49,878 AU/ml and 15,274 AU/ml, respectively (mean difference 34,604; 95% confidence inter val [CI]: 27,699-41,509). No severe adverse reactions were observed, after either vaccine dose. Those with prevaccination COVID -19 had an increased antibody level after the vaccine (B = 31,337; 95% CI: 22,725-39,950; p < 0.001). Frailty, disability, older age, sex, cognitive impairment, or comorbidities were not associated with different antibody titers. CONCLUSIONS: The BNT162b2 mRNA COVID-19 vaccine in older adults is safe and produces immunogenicity, independently of the frailty and disability profiles. Older adults in LTCFs should receive a COVID-19 vaccine. URL: https://www.ncbi.nlm.nih.gov/pubmed/33768521 DOI: 10.1111/jgs.17153

143. Salmon DA, Dudley MZ, Brewer J, et al. COVID-19 vaccination attitudes, values and intentions among United States adults prior to emergency use authorization. Vaccine. 2021;24:24. DOI: 10.1016/j.vaccine.2021.03.034 ABSTRACT: INTRODUCTION: Safe and effective vaccines against Coronavirus Disease 2019 (COVID -19) provide the best opportunity to control the pandemic. Having safe and efficacious vaccines available is only half the equation; people must also take them. We describe a study to identify COVID-19 vaccine attitudes, values and intentions immediately preceding authorization of COVID-19 vaccines in the US. METHODS: A national panel survey was conducted to measure intent to receive COVID-19 vaccines as well as disease and vaccine attitudes, values and trust in local, state and federal public health authorities. RESULTS: Greater than 80% of respondents reported confidence they could adhere to COVID recommendations such as mask wearing, social distancing and hand washing. The majority of respondents (70%) reported believing that current drugs were somewhat or very good at treating COVID - 19 infection. Vaccine intent fell into three groups: Intenders (50%), Wait and Learn (40%), and Unlikelys (10%). Intent to get vaccinated was substantially lower among African American (32%), and higher among men (56%), those over

Evidence Search Report: INF031801v2 ESR 54 60 years of age (61%), those with a Bachelor's degree or higher (63%), and Democrats (63%). The Wait and Learn group, compared to the Intenders, were less likely to report being diagnosed with a high risk condition for COVID -19, receiving an influenza vaccine in the past 12 months, discussing COVID-19 vaccine with their healthcare provider, perceiving COVID-19 as severe, considering a COVID-19 vaccine important to stop the spread of infection, and wering a mask usually or almost always. CONCLUSION: Only half of US adults intend to accept COVID -19 vaccines; most others (40%) are uncertain. Levels of immunity associated with community protection will not be achieved without reaching those who are currently uncertain. Characterizing COVID-19 vaccine attitudes and intentions and ascertaining values and trust in local, state, and federal public health authorities that impact vaccine decision -making are essential. URL: https://www.ncbi.nlm.nih.gov/pubmed/33781601 DOI: 10.1016/j.vaccine.2021.03.034

144. Sampath V, Rabinowitz G, Shah M, et al. Vaccines and Allergic reactions: the past, the current COVID-19 pandemic, and future perspectives. Allergy. 2021;02:02. DOI: 10.1111/all.14840 ABSTRACT: Vaccines are essential public health tools with a favorable safety profile and prophylactic effectiveness that have historically played significant roles in reducing infectious disease burden in populations, when the majority of individuals are vaccinated. The COVID-19 vaccines are expected to have similar positive impacts on health across the globe. While serious allergic reactions to vaccines are rare, their underlying mechanisms and implications for clinical management should be considered to provide individuals with the safest care possible. In this review, w e provide an overview of different types of allergic adverse reactions that can potentially occur aftervaccination and individual vaccine components capable of causing the allergic adverse reactions. We present the incidence of allergic adverse reactions during clinical studies and through post-authorization and post-marketing surveillance and provide plausible causes of these reactions based on potential allergenic components present in several common vaccines. Additionally, we review implications for individual diagnosis and management and vaccine manufacturing overall. Finally, we suggest areas for future research. URL: https://www.ncbi.nlm.nih.gov/pubmed/33811364 DOI: 10.1111/all.14840

145. Saudagar V, Patil S, Goh S, et al. Vigilance regarding immune thrombocytopenic purpura after COVID-19 vaccine. Ir J Med Sci. 2021;31:31. DOI: 10.1007/s11845-021-02614-2 ABSTRACT: INTRODUCTION: Based on the severity of thrombocytopenia, patients with immune thrombocytopenic purpura (ITP) are at an increased risk of mucocutaneous or major bleeding. DISCUSSION: There has been an increased risk of ITP after administration of various vaccines like influenza, measles-mumps-rubella, hepatitis B, and diphtheria- tetanus-pertussis. The pathogenesis of vaccine-related thrombocytopenia is not completely clear and is probably caused by molecular mimicry. Till date, there have been few reported cases of thrombocytopenia in the pharmacovigilance databases after patients received the Pfizer and Moderna coronavirus disease-19 (COVID-19) vaccines. CONCLUSION: Emergency physicians should be aware of the occurrence of vaccine -induced ITP in patients who present with bleeding manifestations, especially after the current boo st in COVID-19 vaccination drive worldwide. URL: https://www.ncbi.nlm.nih.gov/pubmed/33788135 DOI: 10.1007/s11845-021-02614-2

146. Sharma P, Pardeshi G. Roll out of COVID-19 vaccination in India: A SWOT analysis. Disaster Med Public Health Prep. 2021:1-13. DOI: 10.1017/dmp.2021.111 ABSTRACT: OBJECTIVE: To identify the strengths, weaknesses, opportuntities, and threats (SWOT) in the rollout of COVID-19 vaccination campaign in India. METHODS: The internal and external attributes affecting the vaccination rollout identifed by reviewing the scientific literature, government guidelines and press statements along with media reports were categorized into the SWOT matrix. RESULTS: The existing immunization program, indigenous vaccine production, setting up of NEGVAC, updated guidelines, and training followed by dry runs were identified as strengths. The weaknesses identified in the program were knowledge gap about vaccines, apprehensions, lack of temperature loggers and VVM, space contraints in health care set up, demand supply gap, and digital divide.The experience of conducting the general elections, intersectoral coordination forged during the pandemic response, Information Technology platform, and vaccine eagerness present opportunitnies to strenghten program. T he emergence of virus variants, commercial interests, laxity in COVID appropriate behaviour, and receding wave of the pandemic can pose significant threats to the implementation of the vaccination campaign. CONCLUSION: The study identified factors

Evidence Search Report: INF031801v2 ESR 55 which can aid design effective measures and countermeasures for COVID-19 vaccination rollout. This SWOT analysis is relevant to Low and Middle Income countries planning to implement COVID vaccine in the near future. URL: https://www.ncbi.nlm.nih.gov/pubmed/33820581 DOI: 10.1017/dmp.2021.111

147. Shevzov-Zebrun N, Caplan AL. Priority vaccination for mental illness, developmental or intellectual disability. J Med Ethics. 2021;07:07. DOI: 10.1136/medethics-2021-107247 ABSTRACT: Coronavirus vaccines have made their debut. Now, allocation practices have stepped into the spotlight. Following Centers for Disease Control and Prevention guidelines, states and healthcare institutions initially prioritised healthcare personnel and elderly residents of congregant facilities; other groups at elevated risk for severe complications are now becoming eligible through locally administered programmes. The question remains, however: who else should be prioritised for immunisation? Here, we call attention to individuals institutionalis ed with severe mental illnesses and/or developmental or intellectual disabilities-a group highly susceptible to the damages of COVID-19, recent research shows, and critical to consider for priority vaccination. The language describing both federal-level and state-level intentions for this population remains largely vague, despite the population's diversity across age, diagnosis, functional status and living arrangement. Such absence of specificity, in turn, leaves room for confusion and even neglect of various subgroups. We review data stressing this group's vulnerability, as well as select state plans for priority vaccination, highlighting the importance of clarity when describing intentions to vaccinate, or even generally care for, diverse populations composed of distinct subgroups in need. URL: https://www.ncbi.nlm.nih.gov/pubmed/33827909 DOI: 10.1136/medethics-2021-107247

148. Shi Y, Guo M, Yang W, et al. Is SARS-CoV-2 vaccination safe and effective for elderly individuals with neurodegenerative diseases? Expert Rev Vaccines. 2021:1-9. DOI: 10.1080/14760584.2021.1911653 ABSTRACT: INTRODUCTION: Coronavirus Disease 2019 (COVID-19) poses a substantial threat to the lives of the elderly, especially those with neurodegenerative diseases, and vaccination against viral infections is recognized as an effective measure to reduce mortality. However, elderly patients with neurodegenerative diseases often suffer from abnormal immune function and take multiple medications, which may complicate the role of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines. Currently, there is no expert consensus on whether SARS-CoV-2 vaccines are suitable for patients with neurodegenerative diseases. AREAS COVERED: We searched Pubmed to conduct a systematic review of published studies, case reports, reviews, meta -analyses, and expert guidelines on the impact of SARS-CoV-2 on neurodegenerative diseases and the latest developments in COVID-19 vaccines. We also summarized the interaction between vaccines and age-related neurodegenerative diseases. The compatibility of future SARS-CoV-2 vaccines with neurodegenerative diseases is discussed. EXPERT OPINION: Vaccines enable the body to produce immunity by activating the body's immune response. The pathogenesis and treatment of neurodegenerative diseases is complex, and these diseases often involve abnormal immune function, which can substantially affect the safety and effectiveness of vaccines. In short, this article provides recommendations for the use of vaccine candidates in patients with neurodegenerative diseases. URL: https://www.ncbi.nlm.nih.gov/pubmed/33787439 DOI: 10.1080/14760584.2021.1911653

149. Soares P, Rocha JV, Moniz M, et al. Factors Associated with COVID-19 Vaccine Hesitancy. Vaccines (Basel). 2021;9(3):22. DOI: 10.3390/vaccines9030300 ABSTRACT: It is critical to develop tailored strategies to increase acceptability of the COVID-19 vaccine and decrease hesitancy. Hence, this study aims to assess and identify factors associated with COVID -19 vaccine hesitancy in Portugal. We used data from a community-based survey, "COVID-19 Barometer: Social Opinion", which includes data regarding intention to take COVID-19 vaccines, health status, and risk perception in Portugal from September 2020 to January 2021. We used multinomial regression to identify factors associated with intention to delay or refuse to take COVID-19 vaccines. COVID-19 vaccine hesitancy in Portugal was high: 56% would wait and 9% refuse. Several factors were associated with both refusal and delay: being younger, loss of income during the pandemic, no intention of taking the flu vaccine, low confidence in the COVID-19 vaccine and the health service response during the pandemic, worse perception of government measures, perception of the information provided as inconsistent and contradictory, and answering the questionnaire before the release of information regarding the sa fety and efficacy of COVID-19 vaccines. It is crucial to build confidence in the COVID-19 vaccine as its perceived safety and efficacy were strongly

Evidence Search Report: INF031801v2 ESR 56 associated with intention to take the vaccine. Governments and health authorities should improve communicat ion and increase trust. URL: https://www.ncbi.nlm.nih.gov/pubmed/33810131 DOI: 10.3390/vaccines9030300

150. Speeckaert R, Lambert J, Puig L, et al. Comment on "An Evidence-Based Guide to SARS-Cov-2 Vaccination of Patients on Immunotherapies in Dermatology.". J Am Acad Dermatol. 2021;17:17. DOI: 10.1016/j.jaad.2021.03.038 URL: https://www.ncbi.nlm.nih.gov/pubmed/33744352 DOI: 10.1016/j.jaad.2021.03.038

151. Staquicini DI, Tang FHF, Markosian C, et al. Design and proof-of-concept for targeted phage-based COVID-19 vaccination strategies with a streamlined cold-free supply chain. bioRxiv. 2021;16:16. DOI: 10.1101/2021.03.15.435496 ABSTRACT: Development of effective vaccines against Coronavirus Disease 2019 (COVID-19) is a global imperative. Rapid immunization of the world human population against a widespread, continually evolving, and highly pathogenic virus is an unprecedented challenge, and many differen t vaccine approaches are being pursued to meet this task. Engineered filamentous bacteriophage (phage) have unique potential in vaccine development due to their inherent immunogenicity, genetic plasticity, stability, cost-effectiveness for large-scale production, and proven safety profile in humans. Herein we report the design, development, and initial evaluation of targeted phage -based vaccination approaches against Severe Acute Respiratory Syndrome Coronavirus -2 (SARS-CoV-2) by using dual ligand peptide-targeted phage and adeno-associated virus/phage (AAVP) particles. Towards a unique phage- and AAVP- based dual-display candidate approach, we first performed structure-guided antigen design to select six solvent- exposed epitopes of the SARS-CoV-2 spike (S) protein for display on the recombinant major capsid coat protein pVIII. Targeted phage particles carrying one of these epitopes induced a strong and specific humoral response. In an initial experimental approach, when these targeted phage particles were further genetically engineered to simultaneously display a ligand peptide (CAKSMGDIVC) on the minor capsid protein pIII, which enables receptor -mediated transport of phage particles from the lung epithelium into the systemic circulation (termed "dual -display"), they enhanced a systemic and specific spike (S) protein-specific antibody response upon aerosolization into the of mice. In a second line of investigation, we engineered targeted AAVP particles to deliver the entire S protein gene under the control of a constitutive cytomegalovirus (CMV) promoter, which induced tissue-specific transgene expression stimulating a systemic S protein-specific antibody response. As proof-of-concept preclinical experiments, we show that targeted phage- and AAVP-based particles serve as robust yet versatile enabling platforms for ligand-directed immunization and promptly yield COVID-19 vaccine prototypes for further translational development. Significance: The ongoing COVID-19 global pandemic has accounted for over 2.5 million deaths and an unprecedented impact on the health of mankind worldwide. Over the past several months, while a few COVID -19 vaccines have received Emergency Use Authorization and are currently being administered to the entire human population, the deman d for prompt global immunization has created enormous logistical challenges--including but not limited to supply, access, and distribution--that justify and reinforce the research for additional strategic alternatives. Phage are viruses that only infect bacteria and have been safely administered to humans as antibiotics for decades. As experimental proof - of-concept, we demonstrated that aerosol pulmonary vaccination with lung-targeted phage particles that display short epitopes of the S protein on the capsid as well as preclinical vaccination with targeted AAVP particles carrying the S protein gene elicit a systemic and specific immune response against SARS-CoV-2 in immunocompetent mice. Given that targeted phage- and AAVP-based viral particles are sturdy yet simple to genetically engineer, cost-effective for rapid large-scale production in clinical grade, and relatively stable at room temperature, such unique attributes might perhaps become additional tools towards COVID-19 vaccine design and development for immediate and future unmet needs. URL: https://www.ncbi.nlm.nih.gov/pubmed/33758865 DOI: 10.1101/2021.03.15.435496

152. Stern MF, Piasecki AM, Strick LB, et al. Willingness to Receive a COVID-19 Vaccination Among Incarcerated or Detained Persons in Correctional and Detention Facilities - Four States, September-December 2020. MMWR Morb Mortal Wkly Rep. 2021;70(13):473-7. DOI: 10.15585/mmwr.mm7013a3

Evidence Search Report: INF031801v2 ESR 57 ABSTRACT: Incarcerated and detained persons are at increased risk for acquiring COVID -19. However, little is known about their willingness to receive a COVID-19 vaccination. During September-December 2020, residents in three prisons and 13 jails in four states were surveyed regarding their willingness to receive a COVID-19 vaccination and their reasons for COVID-19 vaccination hesitancy or refusal. Among 5,110 participants, 2,294 (44.9%) said they would receive a COVID-19 vaccination, 498 (9.8%) said they would hesitate to receive it, and 2,318 (45.4%) said they would refuse to receive it. Willingness to receive a COVID-19 vaccination was lowest among Black/African American (Black) (36.7%; 510 of 1,390) persons, participants aged 18-29 years (38.5%; 583 of 1,516), and those who lived in jails versus prisons (43.7%; 1,850 of 4,232). Common reasons reported for COVID-19 vaccine hesitancy were waiting for more information (54.8%) and efficacy or safety concerns (31.0%). The most common reason for COVID -19 vaccination refusal was distrust of health care, correctional, or government personnel or institutions (20.1%). Public health interventions to improve vaccine confidence and trust are needed to increase vaccination acceptance by incarcerated or detained persons. URL: https://www.ncbi.nlm.nih.gov/pubmed/33793457 DOI: 10.15585/mmwr.mm7013a3

153. Stevens J. The PANDEMIC framework for encouraging COVID-19 vaccinations. Am J Manag Care. 2021;27(5):04. DOI: 10.37765/ajmc.2021.88605 ABSTRACT: After sufficient doses are manufactured and logistical barriers are reduced, convincing an overwhelming majority of people to receive a COVID-19 vaccination may be the next major challenge during this pandemic. A group of experts recently proposed strategies that have compelling rationales and are well grounded in behavioral science. However, their approaches may sometimes be unacceptable, impractical, and/or unsuccessful. Therefore, other strategies will be greatly needed to address vaccine hesitancy. The present commentary offers 8 additio nal promising approaches forming a framework known as PANDEMIC. This acronym stands for the following strategies: presumptive language, asking for advice, norms on an anonymous level, description of favorable attributes, emphasizing clinicians' own experiences, mandated choice, images, and communication of risk. Each of the strategies is discussed in turn. Many of the proposed strategies have empirical support for achieving desired outcomes in other domains. However, the PANDEMIC framework is untested in regard to increasing the uptake of COVID-19 vaccinations. Therefore, the strategies should be carefully evaluated before they are widely disseminated through public health announcements, email distribution lists, electronic health record messages, and other outlets. URL: https://www.ncbi.nlm.nih.gov/pubmed/33733721 DOI: 10.37765/ajmc.2021.88605

154. Sun S, Lin D, Operario D. Interest in COVID-19 vaccine trials participation among young adults in China: Willingness, reasons for hesitancy, and demographic and psychosocial determinants. Prev Med Rep. 2021;22:101350. DOI: 10.1016/j.pmedr.2021.101350 ABSTRACT: With the demand for rapid COVID-19 vaccine development and evaluation, this paper aimed to describe the prevalence and correlates of willingness to participate in COVID-19 vaccine trials among university students in China. A cross-sectional survey with 1912 Chinese university students was conducted during March and April 2020. Bivariate and multivariate analyses were performed to identify variables associate d with willingness to participate. The majority of participants (64.01%) indicated willingness to participate in COVID-19 vaccine trials. Hesitancy over signing informed consent documents, concerns over time necessary for participating in a medical study, and perceived COVID-19 societal stigma were identified as deterrents, whereas lower socioeconomic status, female gender, perception of likely COVID-19 infection during the pandemic, and COVID-19 prosocial behaviors were facilitative factors. Further, public health mistrust and hesitancy over signing informed consent documents had a significant interactive effect on vaccine trial willingness. High standards of ethical and scientific practice are needed in COVID -19 vaccine research, including providing potential participants full and accurate information and ensuring participation free of coercion, socioeconomic inequality, and stigma. Attending to the needs of marginalized groups and addressing psychosocial factors including stigma and public health mistrust may also be important to COVID-19 vaccine development and future uptake. URL: https://www.ncbi.nlm.nih.gov/pubmed/33816087 DOI: 10.1016/j.pmedr.2021.101350

155. Szigeti R, Kellermayer R. Natural unblinding of BCG vaccination trials. Vaccine. 2021;39(15):2017-9. DOI: 10.1016/j.vaccine.2021.03.039

Evidence Search Report: INF031801v2 ESR 58 ABSTRACT: There is significant public and clinical interest in the potential for Bacillus Calmette -Guerin (BCG) vaccination to protect against type 2 Severe Acute Respiratory Syndrome Coronavirus (SARS -CoV-2) induced COVID- 19. This question could be best answered by blinded and placebo controlled clinical trials. However, a skin reaction occurs within days at the site of BCG injection, making it rather challenging to blind this vaccination. Here, we examined registered clinical trials in ClinicalTrials.gov on BCG against COVID-19 by October 9th 2020, and found that 94.7% of such trials were listed as placebo controlled (all with normal saline as placebo), and single to quadruple blinded. The mode of overcoming the natural unblinding by the BCG induced skin reaction was not clarified on the website in either of the trials. We conclude that detailed description of the strategy towards overcoming the BCG vaccination induced skin reaction associated unblinding hurdle will be important for the interpretation of the theoretically blinded COVID-19 directed clinical trials. URL: https://www.ncbi.nlm.nih.gov/pubmed/33744042 DOI: 10.1016/j.vaccine.2021.03.039

156. Tanne JH. Covid-19: All Johnson and Johnson vaccine in use is safe, says US regulator. Bmj. 2021;373:n897. DOI: 10.1136/bmj.n897 URL: https://www.ncbi.nlm.nih.gov/pubmed/33824134 DOI: 10.1136/bmj.n897

157. Taylor L. Scandal over COVID vaccine trial at Peruvian universities prompts outrage. Nature. 2021;592(7853):174-5. DOI: 10.1038/d41586-021-00576-0 URL: https://www.ncbi.nlm.nih.gov/pubmed/33772240 DOI: 10.1038/d41586-021-00576-0

158. Teixeira da Silva D, Biello K, Lin WY, et al. COVID-19 Vaccine Acceptance among an Online Sample of Sexual and Gender Minority Men and Transgender Women. Vaccines (Basel). 2021;9(3):01. DOI: 10.3390/vaccines9030204 ABSTRACT: Sexual and gender minority (SGM) populations are particularly vulnerable to poor COVID-19 outcomes and are more likely to experience stigma and medical mistrust that may impact COVID -19 vaccine acceptance. This study examined the prevalence of COVID testing and diagnosis and assessed COVID -19 vaccine acceptance among a large sample of SGM. Participants were recruited as part of an online cross -sectional study focused on an HIV biomedical prevention technology willingness in the United States at increased risk for HIV sero -conversion. Multivariate linear analysis was conducted to examine COVID-19 vaccine acceptance. The study sample included 1350 predominately gay (61.6%), Black (57.9%), cis-gender (95.7%) males with a mean age of 32.9 years. Medical mistrust and social concern regarding COVID-19 vaccine stigma were significantly associated with decreased COVID-19 vaccine acceptance, and altruism was significantly associated with increased vaccine acceptance. Black participants were significantly less likely to accept a COVID-19 vaccine, and Asian participants were significantly more likely to accept a vaccine, compared to White peers. As the planning of COVID-19 vaccine rollout efforts is conceptualized and designed, these data may inform equitable implementation strategies and prevent worsening health i nequities among SGM populations. URL: https://www.ncbi.nlm.nih.gov/pubmed/33804530 DOI: 10.3390/vaccines9030204

159. Teo SP. Review of COVID-19 mRNA Vaccines: BNT162b2 and mRNA-1273. J Pharm Pract. 2021:8971900211009650. DOI: 10.1177/08971900211009650 ABSTRACT: The United States Food and Drug Administration recently issued emergency use authorization for 2 mRNA vaccines for preventing COVID-19 disease caused by SARS-CoV-2 virus infections. BNT162b2 from Pfizer- BioNTech and mRNA-1273 by Moderna are planned for use in mass-immunization programs to curb the pandemic. A brief overview of COVID-19 mRNA vaccines is provided, describing the SARS-CoV-2 RNA, how mRNA vaccines work and the advantages of mRNA over other vaccine platforms. The Pfizer-BioNTech collaboration journey to short-list mRNA vaccine candidates and finally selecting BNT162b2 based on safety data is outlined, followed by the Phase 3 study of BNT162b2 demonstrating 95% efficacy in preventing COVID-19 infections. Studies regarding mRNA-1273 (Moderna) are described, including extended immunogenicity data up to 119 days. The Phase 3 COVE study of mRNA-1273 eventually showed vaccine efficacy of 94.5%. Recommendations for future mRNA vaccine development are provided, including ongoing safety surveillance, evaluation in under-represented groups in previous studies and

Evidence Search Report: INF031801v2 ESR 59 improving mRNA vaccine thermostability. Finally, further logistical considerations are required for manufacturing, storing, distribution and implementing mass vaccination programs to curb th e pandemic. URL: https://www.ncbi.nlm.nih.gov/pubmed/33840294 DOI: 10.1177/08971900211009650

160. Thompson MG, Burgess JL, Naleway AL, et al. Interim Estimates of Vaccine Effectiveness of BNT162b2 and mRNA-1273 COVID-19 Vaccines in Preventing SARS-CoV-2 Infection Among Health Care Personnel, First Responders, and Other Essential and Frontline Workers - Eight U.S. Locations, December 2020-March 2021. MMWR Morb Mortal Wkly Rep. 2021;70(13):495-500. DOI: 10.15585/mmwr.mm7013e3 ABSTRACT: Messenger RNA (mRNA) BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) COVID-19 vaccines have been shown to be effective in preventing symptomatic COVID-19 in randomized placebo-controlled Phase III trials (1,2); however, the benefits of these vaccines for preventing asymptomatic and symptomatic SARS-CoV-2 (the virus that causes COVID-19) infection, particularly when administered in real-world conditions, is less well understood. Using prospective cohorts of health care personnel, first responders, and other essential and fron tline workers* in eight U.S. locations during December 14, 2020-March 13, 2021, CDC routinely tested for SARS-CoV-2 infections every week regardless of symptom status and at the onset of symptoms consistent with COVID -19-associated illness. Among 3,950 participants with no previous laboratory documentation of SARS-CoV-2 infection, 2,479 (62.8%) received both recommended mRNA doses and 477 (12.1%) received only one dose of mRNA vaccine.(dagger) Among unvaccinated participants, 1.38 SARS-CoV-2 infections were confirmed by reverse transcription-polymerase chain reaction (RT-PCR) per 1,000 person-days.( section sign) In contrast, among fully immunized (>/=14 days after second dose) persons, 0.04 infections per 1,000 person -days were reported, and among partially immunized (>/=14 days after first dose and before second dose) persons, 0.19 infections per 1,000 person -days were reported. Estimated mRNA vaccine effectiveness for prevention of infection, adjusted for study site, was 90% for full immunization and 80% for partial immunization. These findings indicate that authorized mRNA COVID-19 vaccines are effective for preventing SARS-CoV-2 infection, regardless of symptom status, among working-age adults in real-world conditions. COVID-19 vaccination is recommended for all eligible persons. URL: https://www.ncbi.nlm.nih.gov/pubmed/33793460 DOI: 10.15585/mmwr.mm7013e3

161. Tong J, Zhu C, Lai H, et al. Potent Neutralization Antibodies Induced by a Recombinant Trimeric Spike Protein Vaccine Candidate Containing PIKA Adjuvant for COVID-19. Vaccines (Basel). 2021;9(3):22. DOI: 10.3390/vaccines9030296 ABSTRACT: The structures of immunogens that elicit the most potent neutralization antibodies to prevent COVID -19 infection are still under investigation. In this study, we tested the efficacy of a recombinant trimeric Spike protein containing polyI:C (PIKA) adjuvant in mice immunized by a 0-7-14 day schedule. The results showed that a Spike protein-specific antibody was induced at Day 21 with titer of above 50,000 on average, as measured by direct binding. The neutralizing titer was above 1000 on average, as determined by a pseu do-virus using monoclonal antibodies (40592-MM57 and 40591-MM43) with IC50 at 1 mug/mL as standards. The protein/peptide array-identified receptor- binding domain (RBD) was considered as immunodominant. No linear epitopes were found in the RBD, although several linear epitopes were found in the C-terminal domain right after the RBD and heptad repeat regions. Our study supports the efficacy of a recombinant trimeric Spike protein vaccine candidate for COVID -19 that is safe and ready for storage and distribution in developing countries. URL: https://www.ncbi.nlm.nih.gov/pubmed/33810026 DOI: 10.3390/vaccines9030296

162. Tran VD, Pak TV, Gribkova EI, et al. Determinants of COVID-19 vaccine acceptance in a high infection-rate country: a cross-sectional study in Russia. Pharm Pract (Granada). 2021;19(1):2276. DOI: 10.18549/PharmPract.2021.1.2276 ABSTRACT: Background: COVID-19 vaccine development is proceeding at an unprecedented pace. Once COVID -19 vaccines become widely available, it will be necessary to maximize public vaccine acceptance and coverage. Objective: This research aimed to analyze the predictors of COVID-19 vaccine acceptance in Russia. Methods: A cross-sectional online survey was conducted among Russian adults from September 26(th) to November 9(th), 2020. Predictors of the intent to take up COVID-19 vaccination were explored using logistic regression. Results: Out of 876 participants, 365 (41.7%) would be willing to receive the vaccine if it became available. Acceptance increased for a vaccine with verified

Evidence Search Report: INF031801v2 ESR 60 safety and effectiveness (63.2%). Intention to receive the COVID-19 vaccine was relatively higher among males (aOR=2.37, 95% CI 1.41-4.00), people with lower monthly income (aOR=2.94, 95%CI 1.32-6.57), and with positive trust in the healthcare system (aOR=2.73, 95% CI 1.76-4.24). The Russian people were more likely to accept the COVID-19 vaccine if they believed that the vaccine reduces the risk of virus infection (aOR=8.80, 95%CI 5.21 -14.87) or relieves the complications of the disease (aOR=10.46, 95%CI 6.09-17.96). Other barriers such as being unconcerned about side-effects (aOR=1.65, 95%CI 1.03-2.65) and the effectiveness and safety of the vaccination (aOR=2.55, 95%CI 1.60- 4.08), also affected acceptance. Conclusions: The study showed the usefulness of the health belief model constructs in understanding the COVID-19 vaccination acceptance rate in the Russian population. This rate was influenced by sociodemographic and health-related characteristics, and health beliefs. These findings might help guide future efforts for policymakers and stakeholders to improve vaccination rates by enhancing trust in the healthcare system. URL: https://www.ncbi.nlm.nih.gov/pubmed/33828622 DOI: 10.18549/PharmPract.2021.1.2276

163. Traynor K. Children's hospital celebrates successful COVID-19 vaccine rollout. Am J Health Syst Pharm. 2021;01:01. DOI: 10.1093/ajhp/zxab107 URL: https://www.ncbi.nlm.nih.gov/pubmed/33791780 DOI: 10.1093/ajhp/zxab107

164. 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;31:31. DOI: 10.1016/j.jinf.2021.03.025 URL: https://www.ncbi.nlm.nih.gov/pubmed/33811939 DOI: 10.1016/j.jinf.2021.03.025

165. Tsourdi E, Yu EW, Jan de Beur SM, et al. Vaccination for Covid-19 and relationship to osteoporosis care: Current evidence and suggested approaches. J Bone Miner Res. 2021;08:08. DOI: 10.1002/jbmr.4304 ABSTRACT: The development of COVID-19 vaccines has proceeded at an unprecedented pace, with numerous trials conducted simultaneously across the world as a result of massive technological and financial resource expenditures. With multiple vaccines having now received regu latory approval, public health efforts to promote widespread vaccine dissemination are currently underway. There has been particular emphasis placed on vaccination of older populations, the age group in which COVID-19 infection has been most lethal. However, such widespread vaccination approaches have necessarily raised important questions related to potential interactions with underlying diseases and concomitant treatments among persons to be vaccinated. Osteoporosis is a chronic condition marked by reduce d bone strength and an associated increased risk for fracture which generally requires sustained medical intervention(s). Osteoporosis is neither associated with a higher risk of COVID-19 infection nor by more pronounced disease severity following infection, such that individuals with osteoporosis need not be more highly prioritized for COVID -19 vaccination. Osteoporosis therapies do not interfere with the efficacy or side effect profiles of COVID -19 vaccines and should not be stopped or indefinitely delayed because of vaccination. Depending on the specific drug profile within an anti-osteoporosis medication category, minor adjustments to the timing of drug administration may be considered with respect to the patient's COVID-19 vaccination schedule. Herein w e provide practical recommendations for the care of patients requiring treatment for osteoporosis in the setting of COVID -19 vaccination. This article is protected by copyright. All rights reserved. URL: https://www.ncbi.nlm.nih.gov/pubmed/33831269 DOI: 10.1002/jbmr.4304

166. Tuyls S, Van Der Brempt X, Faber M, et al. Allergic reactions to COVID-19 vaccines: statement of the Belgian Society for Allergy and Clinical Immunology (BelSACI). Acta Clin Belg. 2021:1-6. DOI: 10.1080/17843286.2021.1909447 ABSTRACT: Vaccination against COVID-19 constitutes a huge hope and a major challenge. For the first time in modern history, a global vaccination campaign has started worldwide in a short period of time and with products that were recently developed. Consequently, legitimate concerns regarding the safety and tolerability of COVID-19 vaccines arise.In line with international allergy societies, the Belgian Society for Allergy and Clinical Immunology (BelSACI) provides this statement to guide health care providers (g eneral practitioners, specialists including allergists) and stakeholders.In this statement, we first review current evidence on allergic reactions to vaccines and the potential

Evidence Search Report: INF031801v2 ESR 61 risk factors that have been identified.Second, we provide a risk stratification method that may be used as a worksheet during the vaccination campaign.Finally, we discuss the management of suspected or confirmed allergic reactions following vaccination. URL: https://www.ncbi.nlm.nih.gov/pubmed/33792500 DOI: 10.1080/17843286.2021.1909447

167. Vallee A, Fourn E, Majerholc C, et al. COVID-19 Vaccine Hesitancy among French People Living with HIV. Vaccines (Basel). 2021;9(4):24. DOI: 10.3390/vaccines9040302 ABSTRACT: People living with HIV are a high-risk population concerning the coronavirus 19 (COVID-19) infection, with a poorer prognosis. It is important to achieve high COVID-19 vaccination coverage rates in this group as soon as possible. This project used self-reporting to assess vaccine hesitancy and acceptance among people living w ith HIV towards the novel COVID-19 vaccine. Sixty-eight (28.7%) participants among the 237 declared their hesitancy to be vaccinated against COVID-19. Participants who expressed concerns about their health (p < 0.001), the requirement of mandatory COVID-19 vaccination (p = 0.017), and their chronic disease status (p = 0.026) were independently associated with the acceptance of vaccination. Conversely, participants presenting general vaccine refusal (p < 0.001), concerns about the serious side effects of COVID-19 vaccines (p < 0.001), and those already thinking having an immune status to COVID-19 (p = 0.008) were independently associated with COVID-19 vaccine hesitancy. Our results suggest that vaccine strategy would be more successful in France with a commun ication strategy emphasizing the collective benefits of herd immunity in the population living with HIV and reassuring patients with chronic diseases about the safety of the proposed vaccines. URL: https://www.ncbi.nlm.nih.gov/pubmed/33804808 DOI: 10.3390/vaccines9040302

168. Vallis M, Glazer S. Protecting Individuals Living with and Obesity: Attitudes and Concerns Towards COVID-19 Vaccination in Canada. Obesity (Silver Spring). 2021;28:28. DOI: 10.1002/oby.23182 ABSTRACT: OBJECTIVE: To assess attitudes toward COVID-19 vaccination and degree of fear of COVID-19 amongst those living with obesity. METHODS: Two samples were recruited for an on -line survey; one sample a representative sample of Canadians living with overweight and obesity (N = 1089), the second a convenience sample of individuals recruited from obesity clinical services or patient organizations (N = 980). Respondents completed ratings of their comfort receiving a COVID-19 vaccination along with the Vaccine Hesitancy Scale and the Fear of COVID-19 Scale. RESULTS: Approximately one-third of respondents, regardless of sample or weight category, were not comfortable receiving a vaccination and one-half expressed moderate or greater perceived risks of vaccination. Confidence in vaccinations was extremely low, especially for those in the clinical sample. Fear of COVID-19 was substantial and predicted attitudes toward vaccination. Females were less comfortable receiving the vaccine and perceived more risks than males. CONCLUSIONS: These results suggest those living with obesity are highly ambivalent about COVID-19 vaccination. Despite being at high risk confidence in vaccines is very low. Results suggesting the need for patient centered counselling, with a focus on shared decision making to strengthen confidence and reduce perceived risk. URL: https://www.ncbi.nlm.nih.gov/pubmed/33774916 DOI: 10.1002/oby.23182

169. Vilches TN, Zhang K, Van Exan R, et al. Projecting the impact of a two-dose COVID-19 vaccination campaign in Ontario, Canada. Vaccine. 2021;20:20. DOI: 10.1016/j.vaccine.2021.03.058 ABSTRACT: BACKGROUND: A number of highly effective COVID-19 vaccines have been developed and approved for mass vaccination. We evaluated the impact of vaccination on COVID-19 outbreak and disease outcomes in Ontario, Canada. METHODS: We used an agent-based transmission model and parameterized it with COVID-19 characteristics, demographics of Ontario, and age-specific clinical outcomes. We implemented a two-dose vaccination program according to tested schedules in clinical trials for Pfizer-BioNTech and Moderna vaccines, prioritizing healthcare workers, individuals with comorbidities, and those aged 65 and older. Daily vaccination rate was parameterized based on vaccine administration data. Using estimates of vaccine efficacy, we projected the impact of vaccination on the overall attack rate, hospitalizations, and deaths. We further investigated the effect of increased daily contacts at different stages during vaccination campaigns on outbreak control. RESULTS: Maintaining non-pharmaceutical interventions (NPIs) with an average of 74% reduction in daily contacts, vaccination w ith Pfizer-BioNTech and Moderna vaccines was projected to reduce hospitalizations by 27.3% (95% CrI: 22.3% - 32.4%) and 27.0% (95% CrI: 21.9% - 32.6%), respectively, over a one-year time horizon. The largest benefits of vaccination were observed in

Evidence Search Report: INF031801v2 ESR 62 preventing deaths with reductions of 31.5% (95% CrI: 22.5% - 39.7%) and 31.9% (95% CrI: 22.0% - 41.4%) for Pfizer- BioNTech and Moderna vaccines, respectively, compared to no vaccination. We found that an increase of only 10% in daily contacts at the end of lockdown, when vaccination coverage with only one dose was 6%, would trigger a surge in the outbreak. Early relaxation of population-wide measures could lead to a substantial increase in the number of infections, potentially reaching levels observed during the peak of the second wave in Ontario. CONCLUSIONS: Vaccination can substantially mitigate ongoing COVID-19 outbreaks. Sustaining population-wide NPIs, to allow for a sufficient increase in population-level immunity through vaccination, is essential to prevent future outbreaks. URL: https://www.ncbi.nlm.nih.gov/pubmed/33812742 DOI: 10.1016/j.vaccine.2021.03.058

170. Villena J, Li C, Vizoso-Pinto MG, et al. Lactiplantibacillus plantarum as a Potential Adjuvant and Delivery System for the Development of SARS-CoV-2 Oral Vaccines. Microorganisms. 2021;9(4):26. DOI: 10.3390/microorganisms9040683 ABSTRACT: The most important characteristics regarding the mucosal infection and immune responses against the Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) as well as the current vaccines against coronavirus disease 2019 (COVID-19) in development or use are revised to emphasize the opportunity for lactic acid bacteria (LAB)-based vaccines to offer a valid alternative in the fight against this disease. In addition, this article revises the knowledge on: (a) the cellular and molecular mechanisms involved in the improvemen t of mucosal antiviral defenses by beneficial Lactiplantibacillus plantarum strains, (b) the systems for the expression of heterologous proteins in L. plantarum and (c) the successful expressions of viral antigens in L. plantarum that were capable of inducing protective immune responses in the gut and the respiratory tract after their oral administration. The ability of L. plantarum to express viral antigens, including the spike protein of SARS-CoV-2 and its capacity to differentially modulate the innate an d adaptive immune responses in both the intestinal and respiratory mucosa after its oral administration, indicates the potential of this LAB to be used in the development of a mucosal COVID-19 vaccine. URL: https://www.ncbi.nlm.nih.gov/pubmed/33810287 DOI: 10.3390/microorganisms9040683

171. Waissengrin B, Agbarya A, Safadi E, et al. Short-term safety of the BNT162b2 mRNA COVID-19 vaccine in patients with cancer treated with immune checkpoint inhibitors. Lancet Oncol. 2021;01:01. DOI: 10.1016/S1470-2045(21)00155-8 URL: https://www.ncbi.nlm.nih.gov/pubmed/33812495 DOI: 10.1016/S1470-2045(21)00155-8

172. Walls C, Gavaghan S, Gorman D, et al. Scheduling of COVID-19 vaccination for at-risk employees. N Z Med J. 2021;134(1531):123-4. URL: https://www.ncbi.nlm.nih.gov/pubmed/33767494

173. Wang C, Rademaker M, Tate B, et al. SARS-CoV-2 (COVID-19) vaccination in dermatology patients on immunomodulatory and biologic agents: Recommendations from the Australasian Medical Dermatology Group. Australas J Dermatol. 2021;30:30. DOI: 10.1111/ajd.13593 ABSTRACT: As the phase III COVID-19 vaccine trials excluded patients on immunosuppressive treatments, or patients with significant , the Australasian Medical Dermatology Group make the following preliminary recommendations around COVID-19 vaccination in dermatology patients on immunomodulatory and/or biologic agents. Vaccination against COVID-19 is strongly encouraged for all patients on immunomodulatory drugs and/or biologic agents. There are currently insufficient data to recommend one COVID-19 vaccine or vaccine type (mRNA, recombinant, inactivated virus) over another. No specific additional risk in patients on immunomodulatory or biologic therapies has so far been identified. Data on vaccine efficacy in patien ts on immunomodulatory or biologic therapies are missing, so standard vaccination protocols are recommended until otherwise advised. URL: https://www.ncbi.nlm.nih.gov/pubmed/33786833 DOI: 10.1111/ajd.13593

174. Wentzell E, Racila AM. The social experience of participation in a COVID-19 vaccine trial: Subjects' motivations, others' concerns, and insights for vaccine promotion. Vaccine. 2021;10:10. DOI: 10.1016/j.vaccine.2021.03.036

Evidence Search Report: INF031801v2 ESR 63 ABSTRACT: BACKGROUND: Vaccine hesitancy could undermine the effectiveness o f COVID-19 vaccination programs. Knowledge about people's lived experiences regarding COVID-19 vaccination can enhance vaccine promotion and increase uptake. AIM: To use COVID-19 vaccine trial participants' experiences to identify key themes in the lived experience of vaccination early in the vaccine approval and distribution process. METHODS: We interviewed 31 participants in the Iowa City, Iowa US site of the Pfizer/BioNTech COVID-19 vaccine phase 3 clinical trial. While trial participation differs from clinical receipt of an approved vaccine in key ways, it offers the first view of people's lived experiences of potentially receiving a COVID-19 vaccine. The trial context is also useful since decision -making about vaccination and medical research participation often involve similar hopes and concerns, and because the public appears to view even approved COVID-19 vaccines as experimental given their novelty. Semi-structured interviews addressed subjects' experiences, including decision-making and telling others about their trial participation. We analyzed verbatim transcripts of these interviews thematically and identified common themes relevant for vaccination decision-making. RESULTS: Participants across demographic groups, including age, sex/gender, race/et hnicity, and political affiliation, described largely similar experiences. Key motivations for participation included ending the pandemic/restoring normalcy, protecting oneself and others, doing one's duty, promoting/modeling vaccination, and expressing aspects of identity like being a helper, career-related motivations, and support of science/vaccines. Participants often felt uniquely qualified to help via trial participation due to personal attributes like health, sex/gender or race/ethnicity. They reported hearing concerns about side effects and the speed and politicization of vaccine development. Participants responded by normalizing and contextualizing side effects, de -politicizing vaccine development, and explaining how the rapid development process was nevertheless safe. CONCLUSION: These findings regarding participants' reported motivations for trial participation and interactions with concerned others can be incorporated into COVID-19 vaccine promotion messaging aimed at similar populations. URL: https://www.ncbi.nlm.nih.gov/pubmed/33745730 DOI: 10.1016/j.vaccine.2021.03.036

175. Wrigley-Field E, Kiang MV, Riley AR, et al. Geographically-targeted COVID-19 vaccination is more equitable than age-based thresholds alone. medRxiv. 2021;27:27. DOI: 10.1101/2021.03.25.21254272 ABSTRACT: COVID-19 mortality increases dramatically with age and is also substantially higher among Black, Indigenous, and People of Color (BIPOC) populations in the United States. These two facts introduce tradeoffs because BIPOC populations are younger than white populations. In analyses of California and Min nesota-- demographically divergent states--we show that COVID vaccination schedules based solely on age benefit the older white populations at the expense of younger BIPOC populations with higher risk of death from COVID -19. We find that strategies that prioritize high-risk geographic areas for vaccination at all ages better target mortality risk than age-based strategies alone, although they do not always perform as well as direct prioritization of high-risk racial/ethnic groups. One-sentence summary: Age-based COVID-19 vaccination prioritizes white people above higher-risk others; geographic prioritization improves equity. URL: https://www.ncbi.nlm.nih.gov/pubmed/33791718 DOI: 10.1101/2021.03.25.21254272

176. Yadav UCS. Vaccines and drugs under clinical trials for prevention and treatment of COVID-19. Virusdisease. 2021:1-7. DOI: 10.1007/s13337-020-00650-7 ABSTRACT: The uncertainty related to prevention and treatment of Coronavirus disease 2019 due to lack of effective vaccine candidates or drug molecules has resulted in extensive spread of infection and mortality worldwide. Although the asymptomatic or mild patients are becoming healthy with regular over-the-counter medicines and proper rest and care, for the severe patients, in the absence of definite cure, different drug combinations are being used to treat on trial basis without the assurance of efficacy and safety. This scenario has however changed now with some medicines including antiviral Remdesivir and Favipiravir and anti-inflammatory drugs like dexamethasone and tocilizumab which have shown some positive results in trials such as decreasing need of mechanical or non -invasive ventilation or mortality. Further, a number of vaccine candidates are currently in pipeline and in advance stages of clinical trials, which will enhance their prospects in determining how the disease will be controlled in the times to come. In this article, an account of the under-trial potential drugs and vaccine candidates has been provided, and their future prospects have been discussed. URL: https://www.ncbi.nlm.nih.gov/pubmed/33778130 DOI: 10.1007/s13337-020-00650-7

Evidence Search Report: INF031801v2 ESR 64 177. Yang S, Li Y, Dai L, et al. Safety and immunogenicity of a recombinant tandem-repeat dimeric RBD-based protein subunit vaccine (ZF2001) against COVID-19 in adults: two randomised, double-blind, placebo- controlled, phase 1 and 2 trials. Lancet Infect Dis. 2021;24:24. DOI: 10.1016/S1473 -3099(21)00127-4 ABSTRACT: BACKGROUND: Although several COVID-19 vaccines have been developed so far, they will not be sufficient to meet the global demand. Development of a wider range of vaccines, with different mechanisms of action, could help control the spread of SARS-CoV-2 globally. We developed a protein subunit vaccine against COVID-19 using a dimeric form of the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein as the antigen. We aimed to assess the safety and immunogenicity of this vaccine, ZF2001, and determine the appropriate dose and schedule for an efficacy study. METHODS: We did two randomised, double-blind, placebo-controlled, phase 1 and phase 2 trials. Phase 1 was done at two university hospitals in Chongqing and Beijing, China, and phase 2 was done at the Hunan Provincial Center for Disease Control and Prevention in Xiangtan, China. Healthy adults ag ed 18-59 years, without a history of SARS-CoV or SARS-CoV-2 infection, an RT-PCR-positive test result for SARS-CoV-2, a history of contact with confirmed or suspected COVID-19 cases, and severe allergies to any component of the vaccine were eligible for enrolment. In phase 1, participants were randomly assigned (2:2:1) to receive three doses of the vaccine (25 mug or 50 mug) or placebo intramuscularly, 30 days apart. In phase 2, participants were randomly assigned (1:1:1:1:1:1) to receive the vaccine (25 mug or 50 mug) or placebo intramuscularly, 30 days apart, in either a two -dose schedule or a three-dose schedule. Investigators, participants, and the laboratory team were masked to group allocation. For phase 1, the primary outcome was safety, measured by the occurrence of adverse events and serious adverse events. For phase 2, the primary outcome was safety and immunogenicity (the seroconversion rate and the magnitude, in geometric mean titres [GMTs], of SARS-CoV-2-neutralising antibodies). Analyses were done on an intention-to-treat and per-protocol basis. These trials are registered with ClinicalTrials.gov (NCT04445194 and NCT04466085) and participant follow-up is ongoing. FINDINGS: Between June 22 and July 3, 2020, 50 participants were enrolled into the phase 1 trial and randomly assigned to receive three doses of placebo (n=10), the 25 mug vaccine (n=20), or the 50 mug vaccine (n=20). The mean age of participants was 32.6 (SD 9.4) years. Between July 12 and July 17, 2020, 900 participants were enrolled in to the phase 2 trial and randomly assigned to receive two doses of placebo (n=150), 25 mug vaccine (n=150), or 50 mug vaccine (n=150), or three doses of placebo (n=150), 25 mug vaccine (n=150), or 50 mug vaccine (n=150). The mean age of participants was 43.5 (SD 9.2) years. In both phase 1 and phase 2, adverse events reported within 30 days after vaccination were mild or moderate (grade 1 or 2) in most cases (phase 1: six [60%] of ten participants in the placebo group, 14 [70%] of 20 in the 25 mug group, an d 18 [90%] of 20 in the 50 mug group; phase 2: 37 [25%] of 150 in the two -dose placebo group, 43 [29%] of 150 in the two-dose 25 mug group, 50 [33%] of 150 in the two-dose 50 mug group, 47 [31%] of 150 in the three-dose placebo group, 72 [48%] of 150 in the three-dose 25 mug group, and 65 [43%] of 150 in the three-dose 50 mug group). In phase 1, two (10%) grade 3 or worse adverse events were reported in the 50 mug group. In phase 2, grade 3 or worse adverse events were reported by 18 participants (four [3%] in the two-dose 25 mug vaccine group, two [1%] in the two-dose 50 mug vaccine group, two [1%] in the three-dose placebo group, four [3%] in the three-dose 25 mug vaccine group, and six [4%] in the three-dose 50 mug vaccine group), and 11 were considered vaccine related (two [1%] in the two- dose 25 mug vaccine group, one [1%] in the two-dose 50 mug vaccine group, one [1%] in the three-dose placebo group, two [1%] in the three-dose 25 mug vaccine group, and five [3%] in the three-dose 50 mug vaccine group); seven participants reported serious adverse events (one [1%] in the two -dose 25 mug vaccine group, one [1%] in the two-dose 50 mug vaccine group, two [1%] in the three-dose placebo group, one [1%] in the three-dose 25 mug vaccine group, and two [1%] in the three-dose 50 mug vaccine group), but none was considered vaccine related. In phase 2, on the two-dose schedule, seroconversion rates of neutralising antibodies 14 days after the second dose were 76% (114 of 150 participants) in the 25 mug group and 72% (108 of 150) in the 50 mug group; on the three- dose schedule, seroconversion rates of neutralising antibodies 14 days after the third dose were 97% (143 of 148 participants) in the 25 mug group and 93% (138 of 148) in the 50 mug group. In the two -dose groups in phase 2, the SARS-CoV-2-neutralising GMTs 14 days after the second dose were 17.7 (95% CI 13.6-23.1) in the 25 mug group and 14.1 (10.8-18.3) in the 50 mug group. In the three-dose groups in phase 2, the SARS-CoV-2-neutralising GMTs 14 days after the third dose were 102.5 (95% CI 81.8-128.5) in the 25 mug group and 69.1 (53.0-90.0) in the 50 mug group. INTERPRETATION: The protein subunit vaccine ZF2001 appears to be well tolerated and immunogenic. The safety and immunogenicity data from the phase 1 and 2 trials support the use of the 25 mug dose in a three-dose schedule in an ongoing phase 3 trial for large-scale evaluation of ZF2001's safety and efficacy. FUNDING: National Program on Key Research Project of China, National Science and Technology Major Projects of Drug Discovery, Strategic Priority Research Program of the Chinese Academy of Sciences, and Anhui Zhifei Longcom Biopharmaceutical. TRANSLATION: For the Chinese translation of the abstract see Supplementary Materials section.

Evidence Search Report: INF031801v2 ESR 65 URL: https://www.ncbi.nlm.nih.gov/pubmed/33773111 DOI: 10.1016/S1473-3099(21)00127-4

178. Yao YF, Wang ZJ, Jiang RD, et al. Protective Efficacy of Inactivated Vaccine against SARS-CoV-2 Infection in Mice and Non-Human Primates. Virol Sin. 2021;09:09. DOI: 10.1007/s12250-021-00376-w ABSTRACT: The ongoing coronavirus disease 2019 (COVID-19) pandemic caused more than 96 million infections and over 2 million deaths worldwide so far. However, there is no approved vaccine available for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the disease causative agent. Vaccine is the most effective approach to eradicate a pathogen. The tests of safety and efficacy in animals are pivotal for developing a vaccine and before the vaccine is applied to human populations. Here we evaluated the safety, immunogenicity, and efficacy of an inactivated vaccine based on the whole viral particles in human ACE2 transgenic mouse and in non -human primates. Our data showed that the inactivated vaccine successfully induced SARS-CoV-2-specific neutralizing antibodies in mice and non-human primates, and subsequently provided partial (in low dose) or full (in high dose) protection of challenge in the tested animals. In addition, passive serum transferred from vaccine-immunized mice could also provide full protection from SARS-CoV-2 infection in mice. These results warranted positive outcomes in future clinical trials in humans. URL: https://www.ncbi.nlm.nih.gov/pubmed/33835391 DOI: 10.1007/s12250-021-00376-w

179. Yeh YC, Chen IH, Ahorsu DK, et al. Measurement Invariance of the Drivers of COVID-19 Vaccination Acceptance Scale: Comparison between Taiwanese and Mainland Chinese-Speaking Populations. Vaccines (Basel). 2021;9(3):22. DOI: 10.3390/vaccines9030297 ABSTRACT: The impacts of novel coronavirus disease-2019 (COVID-19) on human life continue to be serious. To control the spread of COVID-19, the production of effective vaccines is likely to be one of the best solutions. However, vaccination hesitancy may decrease individuals' willingness to get vaccinated. The Drivers of COVID-19 Vaccination Acceptance Scale (DrVac-COVID19S) was recently developed to help healthcare professionals and researchers better understand vaccination acceptance. The present study examined whether DrVac-COVID19S is measurement invariant across different subgroups (Taiwanese vs. mainland Chinese university students; males vs. females; and health -related program majors vs. non-health-related program majors). Taiwanese (n = 761; mean age = 25.51 years; standard deviation (SD) = 6.42; 63.5% females) and mainland Chinese university students (n = 3145; mean age = 20.72 years; SD = 2.06; 50.2% females) were recruited using an online survey between 5 January and 21 February 2021. Factor structure and measurement invariance of the two DrVac-COVID19S scales (nine-item and 12-item) were tested using confirmatory factor analysis (CFA). The findings indicated that the DrVac-COVID19S had a four-factor structure and was measurement invariant across the subgroups. The DrVac-COVID19S's four-factor structure was supported by the CFA results is a practical and valid instrument to quickly capture university students' willingness to get COVID -19 vaccination. Moreover, the DrVac-COVID19S can be used to compare university students' underlying reasons to get COVID-19 vaccination among different subgroups. URL: https://www.ncbi.nlm.nih.gov/pubmed/33810036 DOI: 10.3390/vaccines9030297

180. Yurttas B, Poyraz BC, Sut N, et al. Willingness to get the COVID-19 vaccine among patients with rheumatic diseases, healthcare workers and general population in Turkey: a web-based survey. Rheumatol Int. 2021;29:29. DOI: 10.1007/s00296-021-04841-3 ABSTRACT: OBJECTIVES: Vaccination against COVID-19 emerges as an effective strategy for combating the pandemic. While many of our patients with rheumatic diseases (RD) wonder whether it is safe to get the vaccine, vaccine hesitancy is rising among the general population. We assessed the willingness to get vaccination and its probable predictors among patients with RD compared to healthcare workers and a sample from the general population. METHODS: We conducted a web-based questionnaire survey in a cross-sectional design in 3 groups of participants just before the mass vaccination program in Istanbul, Turkey. The questionnaire sought socio - demographic variables, COVID-19 related risk factors, willingness to get vaccination, and concerns and thoughts about vaccine. COVID-19 anxiety scale (CAS) was also evaluated. RESULTS: We studied in total 732 patients with RD (Group 1), 763 individuals representing general population (Group 2) and 320 hospital workers (Group 3). Dysfunctional anxiety related to COVID-19 was found in 4.9%, 3.8% and 4.1%, in Group 1, 2 and 3, respectively. Of the patients with RD, 29.2% were willing to be vaccinated, 19.0% were unwilling and 51.8% were undecided. These were

Evidence Search Report: INF031801v2 ESR 66 somewhat similar among the general population (yes: 34.6%, no: 23.3% and unsure: 42.1%), with significantly less undecided individuals (p < 0.001). On the other hand, hospital workers were significantly more willing (yes: 52.5%, no: 20.9% and unsure: 26.6%) (p < 0.001). Main concerns were probable side effects, unknown scientific results and having no trust. Being male, older age, working in a hospital, not having contracted COVID -19 and high scores on CAS were found to be independently associated with willingness. CONCLUSIONS: The low rate of vaccine acceptance among patients with RD, as well as general population sampling is worrying. Healthcare policies should aim to implement communication, promote confidence and increase demand for COVID -19 vaccine. URL: https://www.ncbi.nlm.nih.gov/pubmed/33779780 DOI: 10.1007/s00296-021-04841-3

181. Dash P, Mohapatra S, Ghosh S, et al. A Scoping Insight on Potential Prophylactics, Vaccines and Therapeutic Weaponry for the Ongoing Novel Coronavirus (COVID-19) Pandemic- A Comprehensive Review. Front Pharmacol. 2020;11:590154. DOI: 10.3389/fphar.2020.590154 ABSTRACT: The emergence of highly virulent CoVs (SARS-CoV-2), the etiologic agent of novel ongoing "COVID-19" pandemics has been marked as an alarming case of pneumonia posing a large global healthcare crisis of unprecedented magnitude. Currently, the COVID-19 outbreak has fueled an international demand in the biomedical field for the mitigation of the fast-spreading illness, all through the urgent deployment of safe, effective, and rational therapeutic strategies along with epidemiological control. Confronted with such contagious respiratory distress, the global population has taken significant steps towards a more robust strategy of containment and quarantine to halt the total number of positive cases but such a strategy can only delay the spread. A substantial number of potential vaccine candidates are undergoing multiple clinical trials to combat COVID-19 disease, includes live-attenuated, inactivated, viral-vectored based, sub-unit vaccines, DNA, mRNA, peptide, adjuvant, plant, and nanoparticle-based vaccines. However, there are no licensed anti-COVID-19 drugs/therapies or vaccines that have proven to work as more effective therapeutic candidates in open -label clinical trial studies. To counteract the infection (SARS-CoV-2), many people are under prolonged treatment of many chemical drugs that inhibit the PLpro activity (Ribavirin), viral proteases (Lopinavir/Ritonavir), RdRp activity (Favipiravir, Remdesivir), viral membrane fusion (Umifenovir, Chloroquine phosphate (CQ), Hydroxychloroquine phosphate (HCQ), IL-6 overexpression (Tocilizumab, Siltuximab, Sarilumab). Mesenchymal Stem Cell therapy and Convalescent Plasma Therapy have emerged as a promising therapeutic strategy against SARS-CoV-2 virion. On the other hand, repurposing previously designed antiviral agents with tolerable safety profile and efficacy could be the only promising approach and fast response to the novel virion. In addition, research institutions and corporations have commenced the redesign of the available therapeutic strategy to manage the global crisis. Herein, we present succinct information on selected anti-COVID-19 therapeutic medications repurposed to combat SARS-CoV-2 infection. Finally, this review will provide exhaustive detail on recent prophylactic strategies and ongoing clinical trials to curb this deadly pandemic, outlining the major therapeutic areas for researchers to step in. URL: https://www.ncbi.nlm.nih.gov/pubmed/33815095 DOI: 10.3389/fphar.2020.590154

Appendix 1: Evidence Search Details

Filters, Limits March 18, 2021 – April 14,2021 & Exclusions:

Sources  Agency for Clinical Innovation  Medline Searched: and New South Wales  MedRViX Government  National Collaborating Centre for  BCCDC Methods and Tools  CBC  Newfoundland & Labrador Centre  Centre for Evidence-Based for Applied Health Research Medicine  CIDRAP

Evidence Search Report: INF031801v2 ESR 67  Embase  Nova Scotia Health COVID-19  European Centre for Disease information for clinical Prevention and Control management and pathways  Evidence Aid  Prevent Epidemics  Google  Public Health Ontario  Imperial College London, MRC  VA Evidence Synthesis Program Centre for Global Infectious  WHO Disease Analysis

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

Appendix 2: Search Strategies

Database: Ovid MEDLINE(R) ALL <1946 to April 13, 2021> Search Strategy: ------1 (nCoV* or 2019nCoV or 19nCoV or COVID19* or COVID or SARS-COV-2 or SARSCOV-2 or SARSCOV2 or Severe Acute Respiratory Syndrome Coronavirus 2 or Severe Acute Respiratory Syndrome Corona Virus 2 or coronavirus*).ti,kf,nm,ox,rx,px. (124236) 2 ((new or novel or "19" or "2019" or Wuhan or Hubei or China or Chinese) adj3 (coronavirus* or corona virus* or betacoronavirus* or CoV or HCoV)).ti,kf. (13091) 3 ((coronavirus* or corona virus* or betacoronavirus*) adj3 (pandemic* or epidemic* or outbreak* or crisis)).ti,kf. (2365) 4 or/1-3 (124331) 5 (vaccinat* or vaccine? or inoculat* or immunization? or immunize? or immunogenicity).ti,kf. or (vaccinat* or vaccine? or inoculat* or immunization? or immunize? or immunogenicity).ab. /freq=2 (338875) 6 4 and 5 (5995) 7 (moderna? or mrna-1273 or mrna1273).mp. (1161) 8 (pfizer* or biontech* or tozinameran or BNT162b2).mp. (3275) 9 (astrazeneca or astra zeneca or "ChAdOx1-S" or ChAdOx1* or COVISHIELD or (oxford adj3 astrazeneca)).mp. (1364) 10 (janssen? or "ad26.cov2.s" or ad26cov2s or ad26cov2* or (johnson adj2 johnson)).mp. (16223) 11 or/7-10 (21650) 12 4 and 11 (411) 13 (safe* or risk? or harm* or unsafe* or effect* of efficacy or viability or viable or success* or valid* or evidence-based? or outcome? or guidance or best practice? or guideline? or recommendation? or advisor* or standard*).ti,kf. (1715548) 14 (safe* or risk? or harm* or unsafe* or effect* of efficacy or viability or viable or success* or valid* or evidence-based? or outcome? or guidance or best practice? or guideline? or recommendation? or advisor* or standard*).ab. /freq=2 (3322204) 15 (random* or placebo or clinical trial? or control* trial? or trial?).ti,kf. (431619) 16 (random* or placebo or clinical trial? or control* trial?).ab. /freq=2 (583298)

Evidence Search Report: INF031801v2 ESR 68 17 ((prevent* or control* or reduce?) adj2 (infect* or re-infect* or reinfect* or spread* 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,kf. (28051) 18 ((prevent* or control* or reduce?) adj2 (infect* or re-infect* or reinfect* or spread* 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 (19758) 19 or/13-18 (4531917) 20 4 and 5 and 11 and 19 (130) 21 limit 20 to dt=20210318-20210414 (36) 22 4 and 5 and 19 (1580) 23 limit 22 to dt=20210318-20210414 (232) 24 23 not 21 (196) 25 (vaccinat* or vaccine? or inoculat* or immunization? or immunize? or immunogenicity or (vaccinat* or vaccine? or inoculat* or immunization? or immunize? or immunogenicity)).ti. and 24 (145) 26 21 or 25 (181)

*************************** Other sources (vaccine) AND (efficacy) AND (COVID)

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Evidence Search Report: INF031801v2 ESR 69