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Review
. 2021 May 6;9(5):467.
doi: 10.3390/vaccines9050467.

Efficacy and Safety of COVID-19 Vaccines: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

Affiliations
Review

Efficacy and Safety of COVID-19 Vaccines: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

Ali Pormohammad et al. Vaccines (Basel). .

Abstract

The current study systematically reviewed, summarized and meta-analyzed the clinical features of the vaccines in clinical trials to provide a better estimate of their efficacy, side effects and immunogenicity. All relevant publications were systematically searched and collected from major databases up to 12 March 2021. A total of 25 RCTs (123 datasets), 58,889 cases that received the COVID-19 vaccine and 46,638 controls who received placebo were included in the meta-analysis. In total, mRNA-based and adenovirus-vectored COVID-19 vaccines had 94.6% (95% CI 0.936-0.954) and 80.2% (95% CI 0.56-0.93) efficacy in phase II/III RCTs, respectively. Efficacy of the adenovirus-vectored vaccine after the first (97.6%; 95% CI 0.939-0.997) and second (98.2%; 95% CI 0.980-0.984) doses was the highest against receptor-binding domain (RBD) antigen after 3 weeks of injections. The mRNA-based vaccines had the highest level of side effects reported except for diarrhea and arthralgia. Aluminum-adjuvanted vaccines had the lowest systemic and local side effects between vaccines' adjuvant or without adjuvant, except for injection site redness. The adenovirus-vectored and mRNA-based vaccines for COVID-19 showed the highest efficacy after first and second doses, respectively. The mRNA-based vaccines had higher side effects. Remarkably few experienced extreme adverse effects and all stimulated robust immune responses.

Keywords: COVID-19; SARS-CoV-2; efficacy; meta-analysis; randomized clinical trial; side effect; vaccines.

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Conflict of interest statement

The authors declare no competing interest. The author(s) declare no competing financial interests.

Figures

Figure 1
Figure 1
Flow diagram of literature search and study selection for meta-analysis (PRISMA flow chart).
Figure 2
Figure 2
Efficacy of different COVID-19 vaccines (a) after the first and (b) second doses.
Figure 2
Figure 2
Efficacy of different COVID-19 vaccines (a) after the first and (b) second doses.
Figure 3
Figure 3
Local and systemic side effects of different COVID-19 vaccines.
Figure 4
Figure 4
Association of adjuvant side effects of different COVID-19 vaccines.

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References

    1. V’kovski P., Kratzel A., Steiner S., Stalder H., Thiel V. Coronavirus biology and replication: Implications for SARS-CoV-2. Nat. Rev. Microbiol. 2020;19:1–16. doi: 10.1038/s41579-020-00468-6. - DOI - PMC - PubMed
    1. World Health Organization . Estimating Mortality from COVID-19: Scientific Brief, 4 August 2020. World Health Organization; Genova, Switzerland: 2020.
    1. Forni G., Mantovani A. COVID-19 vaccines: Where we stand and challenges ahead. Cell Death Differ. 2021;28:626–639. doi: 10.1038/s41418-020-00720-9. - DOI - PMC - PubMed
    1. World Health Organization . Draft Landscape and Tracker of COVID-19 Candidate Vaccines. World Health Organization; Genova, Switzerland: 2021.
    1. Pardi N., Hogan M.J., Porter F.W., Weissman D. mRNA vaccines—A new era in vaccinology. Nat. Rev. Drug Discov. 2018;17:261. doi: 10.1038/nrd.2017.243. - DOI - PMC - PubMed

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