Saskatchewan Health Authority Library https://saskhealthauthority.libguides.com/home [email protected] Regina: 306-766-4142 Saskatoon: 306-655-5224 Prince Albert: 306-765-6026 EVIDENCE SEARCH REPORT RESEARCH QUESTION: How effective are COVID-19 vaccines? UNIQUE IDENTIFIER: INF122302-01 ESR CONTEXT: Benefits following dose/second dose; how well it prevents infections; evidence of limiting viral replication or spread; preventing hospitalization; preventing ventilation; preventing “long COVID” (long term symptoms), duration of immunity (natural and vaccinated). Does not include vaccine willingness/acceptance (to be run as a separate search). RESOURCES USED: OVID Medline ClinicalTrials.gov OVID Embase Cochrane Collaboration Clinical Trials Registry PubMed & LitCovid WHO website (COVID-19 Vaccines) LIMITS/EXCLUSIONS/INCLUSIONS: REFERENCE INTERVIEW COMPLETED: December 23, 2020 DATE: December 28, 2020 LIBRARIAN: Lukas Miller REQUESTOR: Cheryl Walder & Jenny Basran TEAM: INFECTIOUS DISEASES SEARCH ALERTS CREATED: Y/N (MEDLINE, ETC.) N SUBJECTS: IMMUNITY; CLINICAL PRESENTATION; INFECTION PREVENTION & CONTROL; CITE AS: Miller, L. How effective are COVID-19 vaccines? 2020 Dec 28; Document no.: INF122302-01 ESR. In: COVID-19 Rapid Evidence Reviews [Internet]. SK: SK COVID Evidence Support Team, c2020. 26 p. (CEST evidence search report) LIBRARIAN NOTES/COMMENTS Hello, The research team acknowledged that more time is needed for global mass vaccinations to roll-out in order for there to be more quality, independent data and evidence to inform these questions. It was decided to conduct an inventory/scan of vaccine trials to support future work spurned by the rollout of vaccines. Both the Cochrane Collaboration and WHO are tracking vaccine trials and provide summary tables that includes links/URLs to relevant publications or registry entries. I have included a pared-down version of this table below. I conducted a MEDLINE search to find any publications that might comment on or inform vaccine research for COVID-19. A total of 64 citations are included below (some of which include the published trials/commentary as indicated in the COVID-NMA table). Thank you, 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 retrie ved 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 arising from the use of, or reliance on, search results. Lukas 1 SEARCH RESULTS To obtain full-text articles email [email protected]. SUMMARIES, GUIDELINES & OTHER RESOURCES COVID-NMA Initiative Vaccines: Living Mapping https://covid-nma.com/vaccines/mapping/ o Table provides a complete list of trials, drawn from the Cochrane Clinical Trial Registry and the WHO clinical trials platform. Vaccines for COVID-19 Patients (Living Evidence Synthesis) https://covid-nma.com/vaccines/ o The “Description of Primary Studies” table provides general characteristics of identified relevant RCTs, including bias assessments. o The “Trial” column includes links to trial registries and/or published journal articles for the indicated vaccine or manufacturer. World Health Organization (WHO) Draft landscape of COVID-19 candidate vaccines https://www.who.int/publications/m/item/draft- landscape-of-covid-19-candidate-vaccines o Access to downloadable spreadsheet (.xlsx) – updated twice per week. Compiles detailed information on vaccine candidates including links to trial registries and/or publications (if present). COVID-19 TRIALS Primary Studies Table (23/12/2020 update) Trial Type Comparisons Desig Participants Sample Full n size description Intervention 1 Intervention 2 NCT04412538 Inactivate KMS-1 100 EU Adjuvant RCT Healthy N=750 Full Institute of Medical d virus D0/14 Phase SARS-CoV-2 descriptio Biology (IMB), KMS-1 150 EU Adjuvant 2 serology/DNA n Chinese Academy D0/14 negative of Medical Sciences KMS-1 100 EU Adjuvant adults in tw o (CAMS). D0/28 centres in Che Y,Clin Infect KMS-1 150 EU Adjuvant China Dis,2020 D0/28 Full text Commentary NCT04470427 RNA mRNA-1273 Placebo RCT Healthy N=3035 Full ModernaTX based Phase adults w ith no 1 descriptio COVE, 2020 vaccine 3 know n history n of SARS- new CoV-2 infection in 99 centers in the US Full text Full text Commentary NCT04324606; Non ChAdOx1 MenACWY RCT Healthy N=1077 Full ISRCTN15281137; replicating Phase adults w ith no descriptio EudraCT 2020- viral 1/2 history of n 001072-15 vector laboratory University of confirmed Oxford/AstraZenec SARS-CoV-2 2 a infection or of Folegatti PM COVID-19- (COV001), Lancet, like 2020 symptoms in five centres in Full text the UK Commentary Commentary NCT04368988 Non 2 dose 25mcg Placebo RCT Healthy adult N=134 Full Novavax replicating NVX-D0/21 Phase volunteers, descriptio Keech C., N Engl J viral 2 dose 5mcg Placebo 1 SARS-CoV-2 n Med, 2020 vector NVX/M1-D0/21 infection-free Full text 2 dose 25mcg Placebo and no Commentary NVX/M1-D0/21 history of 1 dose 25mcg Placebo SARS-CoV-2 NVX/M1+Placebo infection in -D0/21 tw o centres in Australia. NCT04368728 RNA BNT162b2 Placebo RCT Healthy N=4354 Full BioNTech/Fosun based Phase SARS-CoV-2 8 descriptio Pharma/Pfizer vaccine 2/3 DNA negative n Polack FP,N Engl J adults in Med,2020 multiple centres in Full text Argentina, Commentary Brazil, Commentary Germany, Commentary South Africa, Commentary Turkey, and Commentary the USA NCT04412538 Inactivate KMS-1 D0/14 Adjuvant RCT Healthy N=192 Full The Institute of d virus KMS-1 D0/28 Adjuvant Phase adults aged descriptio Medical Biology 1 18 to 59 n (IMB), Chinese years, SARS- Academy of CoV-2 nucleic Medical Sciences acid or (CAM) antibodies Pu J, MedRxiv, negative in a 2020 single centre Full text in China. Commentary ; Commentary NCT04436276 Non Ad26.COV2.S Placebo RCT Healthy N=785 Full Janssen replicating 5x10^10vp Phase SARS-CoV-2 descriptio Pharmaceutical viral Ad26.COV2.S Placebo 1 nucleic acid n Companies vector 1x10^11vp negative Sadoff adults 18-55 J,MedRxiv,2020 years old and Full text elderly >65 Commentary years old in multiple centres in Belgium and the US NCT04400838 Non ChAdOx1 LD/SD 1/2 doses RCT Healthy N=7548 Full University of replicating MenACWY Phase adults in 18 descriptio Oxford/AstraZenec viral ChAdOx1 SD/SD 1/2 doses 2/3 centers in the n a vector MenACWY UK Voysey M (COV002), Lancet, 2020 Full text Commentary ISRCTN89951424 Non ChAdOx1 SD/SD MenACWY/salin RCT Healthy N=4088 Full 3 University of replicating e Phase SARS-CoV-2 descriptio Oxford/AstraZenec viral 3 serology/DNA n a vector negative Voysey M adults in six (COV003), Lancet, centres in 2020 Brazil Full text Commentary NCT04444674 Non ChAdOx1 std 2 Saline RCT Healthy N=2013 Full University of replicating doses Phase adults from descriptio Oxford/AstraZenec viral 1/2 four studies in n a vector multiple Voysey M centres in (COV005), Lancet, Brazil, South 2020 Africa, and the UK Full text Commentary NCT04368728 RNA BNT162b1 10 Placebo RCT Healthy N=195 Full BioNTech SE, based mcg D1/21 Phase SARS-CoV-2 descriptio Pfizer vaccine BNT162b1 20 Placebo 1 serology/DNA n Walsh E, N Engl J mcg D1/21 negative Med, 2020 BNT162b1 30 Placebo adults in four Full text mcg D1/21 centres in Commentary BNT162b1 100 Placebo USA mcg D1/21 BNT162b2 10 Placebo mcg D1/21 BNT162b2 20 Placebo mcg D1/21 BNT162b2 30 Placebo mcg D1/21 ChiCTR200003180 Inactivate Inactivated Adjuvant RCT Healthy N=96 Full 9 d virus 2.5mcg-D0/28/56 Phase adults, aged descriptio Wuhan Institute of Inactivated 5mcg- Adjuvant 1/2 18 to 59 n Biological Products D0/28/56 years, w ithout Co Ltd./Sinopharm Inactivated Adjuvant history Xia S, JAMA, 2020 10mcg-D0/28/56 ofSARS- Full text Inactivated 5mcg- Adjuvant CoV(via on- Commentary D0/14 site inquiry) Inactivated 5mcg- Adjuvant or SARS- D0/21 CoV-2 infection (via serologicalan d nucleic acid test ChiCTR200003245 Inactivate BBIBP-CorV Adjuvant RCT Healthy N=112 Full 9 d virus 8mcg Phase SARS-CoV-2 descriptio Beijing Institute of BBIBP-CorV Adjuvant 2 serology n Biological 4mcg D0/14 negative Products/Sinophar BBIBP-CorV Adjuvant adults 18-59 m 4mcg D0/21 years old and Xia S, Lancet Infect BBIBP-CorV Adjuvant ?60 years old Dis, 2020 4mcg D0/28 in a single Full text centre in Commentary China NCT04352608 Inactivate CoronaVac 3 Adjuvant RCT Healthy N=600 Full Sinovac d virus mcg D0/14 Phase SARS-CoV-2 descriptio Zhang Y,Lancet CoronaVac 6 Adjuvant 2 serology/DNA n Infect Dis,2020 mcg D0/14 negative Full text CoronaVac 3 Adjuvant adults in a Commentary mcg D0/28 single centre 4 CoronaVac 6 Adjuvant in China mcg D0/28 NCT04341389 Non Adenovirus type- Placebo RCT Healthy adult N=508 Full CanSino Biological replicating 5-vectored Phase volunteers descriptio Inc./Beijing Institute viral COVID-19 1 × 2 w ith HIV- n of Biotechnology vector 10¹¹ vp negative and Zhu F, The Lancet, SARS-CoV-2 2020 infection-free Full text in a single Commentary centre in Commentary China. ARTICLES Note: References are sorted by year (newest to oldest) 1. Marian AJ. Current state of vaccine development and targeted therapies for COVID-19: impact of basic science discoveries. Cardiovasc Pathol. 2021;50:107278. DOI: 10.1016/j.carpath.2020.107278 ABSTRACT: Coronavirus disease-19 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SARS-CoV-2 is closely related to two other coronaviruses that caused disease epidemic breakouts in humans in the last 2 decades, namely, severe acute respiratory distress syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV).