Abstract
BackgroundVarious modalities of vaccines against coronavirus disease 2019 (COVID-19), based on different platforms and immunization procedures, have been successively approved for marketing worldwide. A comprehensive review for clinical trials assessing the safety of COVID-19 vaccines is urgently needed to make an accurate judgment for mass vaccination.Main textA systematic review and meta-analysis was conducted to determine the safety of COVID-19 vaccine candidates in randomized controlled trials (RCTs). Data search was performed in PubMed, Embase, Cochrane library, Scopus, Web of Science, and MedRxiv. Included articles were limited to RCTs on COVID-19 vaccines. A total of 73,633 subjects from 14 articles were included to compare the risks of adverse events following immunization (AEFI) after vaccinating different COVID-19 vaccines. Pooled risk ratios (RR) of total AEFI for inactivated vaccine, viral-vectored vaccine, and mRNA vaccine were 1.34 [95% confidence interval (CI) 1.11–1.61, P < 0.001], 1.65 (95% CI 1.31–2.07, P < 0.001), and 2.01 (95% CI 1.78–2.26, P < 0.001), respectively. No significant differences on local and systemic AEFI were found between the first dose and second dose. In addition, people aged ≤ 55 years were at significantly higher risk of AEFI than people aged ≥ 56 years, with a pooled RR of 1.25 (95% CI 1.15–1.35, P < 0.001).ConclusionsThe safety and tolerance of current COVID-19 vaccine candidates are acceptable for mass vaccination, with inactivated COVID-19 vaccines candidates having the lowest reported AEFI. Long-term surveillance of vaccine safety is required, especially among elderly people with underlying medical conditions.Graphic
Highlights
A systematic review and meta-analysis was conducted to determine the safety of COVID-19 vaccine candidates in randomized controlled trials (RCTs)
The safety and tolerance of current COVID-19 vaccine candidates are acceptable for mass vaccination, with inactivated COVID-19 vaccines candidates having the lowest reported adverse events following immunization (AEFI)
Included studies contained ten kinds of COVID-19 vaccines, and they were further classified into four vaccine types on the basis of different technology platforms: inactivated vaccines [25,26,27,28,29], viral vector vaccines [22,23,24], subunit vaccines [21] and mRNA vaccines [16,17,18,19,20]
Summary
A systematic review and meta-analysis was conducted to determine the safety of COVID-19 vaccine candidates in randomized controlled trials (RCTs). A total of 73,633 subjects from 14 articles were included to compare the risks of adverse events following immunization (AEFI) after vaccinating different COVID-19 vaccines. According to the latest data of World Health Organization (WHO), at least 10 kinds of COVID-19 vaccines based on multiple technologies, represented by inactivated vaccine, viral vector vaccine and mRNA vaccine, have been approved for emergency clinical use or conditional marketing [4]. Russia firstly approved the use of viral vector COVID-19 vaccine on August 11, 2020 [5], followed by the United States, the United Kingdom, Canada and the European Union who successively approved the emergency use or marketing of Pfizer-BioNTech’s mRNA vaccine (BNT162b2) [6]. The United States issued an EUA for Moderna mRNA-1273 vaccine [9]
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