Affiliation:
1. Faculty of Medicine, Imperial College London , London , United Kingdom
2. Oxford University Clinical Academic Graduate School, University of Oxford , Oxford , United Kingdom
3. School of Medicine and Veterinary Medicine, University of Edinburgh , Edinburgh , United Kingdom
4. Royal Free University Hospital NHS Trust , London , United Kingdom
5. Department of Pharmacology and Therapeutics, University of Liverpool , Liverpool , United Kingdom
Abstract
Abstract
Background
Five severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines are approved in North America and/or Europe: Pfizer/BioNTech, Moderna, Janssen, Oxford-AstraZeneca, and Novavax. Other vaccines have been developed, including Sinopharm, SinoVac, QazVac, Covaxin, Soberana, Zifivax, Medicago, Clover, and Cansino, but they are not approved in high-income countries. This meta-analysis compared the efficacy of US Food and Drug Administration (FDA)/European Medicines Agency (EMA)-approved and -unapproved vaccines in randomized clinical trials (RCTs).
Methods
A systematic review of trial registries identified RCTs of SARS-CoV-2 vaccines. Risk of bias was assessed using the Cochrane tool (RoB 2). In the meta-analysis, relative risks of symptomatic infection and severe disease were compared for each vaccine versus placebo, using Cochrane-Mantel Haenszel Tests (random effects method).
Results
Twenty-two RCTs were identified and 1 was excluded for high-risk of bias. Ten RCTs evaluated 5 approved vaccines and 11 RCTs evaluated 9 unapproved vaccines. In the meta-analysis, prevention of symptomatic infection was 84% (95% confidence interval [CI], 68%–92%) for approved vaccines versus 72% (95% CI, 66%–77%) for unapproved vaccines, with no significant difference between vaccine types (P = .12). Prevention of severe SARS-CoV-2 infection was 94% (95% CI, 75%–98%) for approved vaccines versus 86% (95% CI, 76%–92%) for unapproved vaccines (P = .33). The risk of serious adverse events was similar between vaccine types (P = .12).
Conclusions
This meta-analysis of 21 RCTs in 390 459 participants showed no significant difference in efficacy between the FDA/EMA-approved and -unapproved vaccines for symptomatic or severe infection. Differences in study design, endpoint definitions, variants, and infection prevalence may have influenced results. New patent-free vaccines could lower costs of worldwide SARS-CoV-2 vaccination campaigns significantly.
Funder
International Treatment Preparedness Coalition/Make Medicines Affordabl
Publisher
Oxford University Press (OUP)
Subject
Infectious Diseases,Oncology
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