Safety and efficacy of COVID‐19 vaccines: A systematic review and meta‐analysis of controlled and randomized clinical trials
Abstract
Vaccines against coronavirus disease 2019 (COVID‐19) have been discovered within a very small duration of time as compared to the traditional way for the development of vaccines, which raised the question about the safety and efficacy of the approved vaccines. The purpose of this study is to look at the effectiveness and safety of vaccine platforms against the incidence of COVID‐19. The literature search was performed on PubMed/Medline, Cochrane, and clinical trials.gov databases for studies published between 1 January 2020 and 19 February 2022. Preferred Reporting Items for Systemic Review and Meta‐Analysis Statement guidelines were followed. Among 284 articles received by keywords, a total of 11 studies were eligible according to the inclusion and exclusion criteria (studies in special populations, e.g., pregnant women, paediatric patients, editorials, case reports, review articles, preclinical and in vitro studies) of the study. A total of 247,186 participants were considered for randomisation at baseline, among them, 129,572 (52.42%) were provided with vaccine (Intervention group) and 117,614 (47.58%) with the placebo (Control group). A pooled fold change estimation of 0.19 (95% CI: 0.12–0.31, p < 0.0001) showed significant protection against the incidence of COVID‐19 in the vaccines received group versus the placebo group. mRNA based, inactivated vaccines and non‐replicating viral vector‐based vaccines showed significantly protection against the incidence of COVID‐19 compared to placebo with pooled fold change estimation was 0.08 (95% CI: 0.06–0.10), 0.20 (95% CI: 0.14–0.29) and 0.36 (95% CI: 0.28–0.46), respectively. Injection site discomfort and fatigue were the most common side effect observed in mRNA, non‐replicating viral vector, inactivated, and protein subunit‐based vaccines. All the approved vaccines were found safe and efficacious but mRNA‐based vaccines were found to be more efficacious against SARS‐CoV‐2 than other platforms.
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In this review, the pooled VE was 71% against SARS-CoV-2 infection, whereas systematic reviews of randomised clinical trials reported higher pooled vaccine efficacy of 83% and 77%.
“In our review, we found a pooled VE of 71% against SARS-CoV-2 infection, whereas systematic reviews of randomised clinical trials reported higher pooled vaccine efficacy of 83% [26] and 77% [27].”
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- Authors
- Beladiya, J., Kumar, A., Vasava, Y., Parmar, K., Patel, D., Patel, S., Dholakia, S., Sheth, D., Boddu, S. H. S., & Patel, C.
- Affiliations
- Department of Pharmacology L. M. College of Pharmacy Ahmedabad Gujarat India
- Department of Pharmaceutical Chemistry L. M. College of Pharmacy Ahmedabad Gujarat India
- Ajman University (AE)
- Corresponding author
- Patel, Chirag
- ORCID
- Venue
- Reviews in Medical Virology
- Publisher
- Wiley
- Published
- 2023-12-29
- Volume
- 34
- Issue
- 1
- Pages
- e2507-e2507
- ISSN
- 1052-9276 (ISSN-L)
- 1099-1654
- OpenAlex
- W4390450109
- Cited by
- 96
- References
- 45
- Citations by year
- 2026: 21 · 2025: 46 · 2024: 28 · 2015: 1
- FWCI
- 4.51
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Reviews in Medical Virology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
- Social Sciences › Health › Vaccine Coverage and Hesitancy
- Keywords
- COVID-19 vaccines, vaccine efficacy, vaccine safety, SARS-CoV-2, mRNA vaccines, inactivated vaccine, viral vector vaccines, subunit vaccine, vaccine side effects, injection site reactions, COVID-19 incidence
- MeSH terms
- COVID-19, SARS-CoV-2, COVID-19 Vaccines, Child, Female, Humans, Pregnancy, RNA, Messenger, Vaccines, Inactivated, Randomized Controlled Trials as Topic
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