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Efficacy of Approved Versus Unapproved Vaccines for Severe Acute Respiratory Syndrome Coronavirus 2 Infection in Randomized Blinded Clinical Trials.
Perez Navarro, Andrea; Pilkington, Victoria; Pepperrell, Toby; Mirchandani, Manya; Levi, Jacob; Hill, Andrew.
  • Perez Navarro A; Faculty of Medicine, Imperial College London, London, United Kingdom.
  • Pilkington V; Oxford University Clinical Academic Graduate School, University of Oxford, Oxford, United Kingdom.
  • Pepperrell T; School of Medicine and Veterinary Medicine, University of Edinburgh, Edinburgh, United Kingdom.
  • Mirchandani M; Faculty of Medicine, Imperial College London, London, United Kingdom.
  • Levi J; Royal Free University Hospital NHS Trust, London, United Kingdom.
  • Hill A; Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, United Kingdom.
Open Forum Infect Dis ; 9(9): ofac408, 2022 Sep.
Article in English | MEDLINE | ID: covidwho-2018040
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.
Keywords

Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials / Reviews / Systematic review/Meta Analysis Topics: Vaccines / Variants Language: English Journal: Open Forum Infect Dis Year: 2022 Document Type: Article Affiliation country: Ofid

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials / Reviews / Systematic review/Meta Analysis Topics: Vaccines / Variants Language: English Journal: Open Forum Infect Dis Year: 2022 Document Type: Article Affiliation country: Ofid