Safety of SARS-CoV-2 vaccines: a systematic review and meta-analysis of randomized controlled trials

• Published in: Infectious diseases of poverty Vol. 10; no. 1; pp. 94 - 12
• Main Authors: Chen, Musha, Yuan, Yue, Zhou, Yiguo, Deng, Zhaomin, Zhao, Jin, Feng, Fengling, Zou, Huachun, Sun, Caijun
• Format: Journal Article
• Language: English
• Published: London BioMed Central 05.07.2021; BioMed Central Ltd; BMC
• Subjects: Adolescent; Adult; Adverse events following immunization; Aged; Aged, 80 and over; Analysis; Bias; Clinical trials; Coronaviruses; COVID-19; COVID-19 - prevention & control; COVID-19 vaccine; COVID-19 vaccines; COVID-19 Vaccines - administration & dosage; COVID-19 Vaccines - adverse effects; Female; Health aspects; Humans; Immunization; Infectious Diseases; International economic relations; Male; Medical research; Medicine; Medicine & Public Health; Medicine, Experimental; Meta-analysis; Middle Aged; Pharmaceutical industry; Product development; Public Health; Randomized controlled trial; Randomized Controlled Trials as Topic; RNA; Safety; Safety regulations; Scoping Review; Severe acute respiratory syndrome coronavirus 2; Systematic review; Tropical Medicine; Vaccination; Vaccines; Young Adult; United States; United Kingdom > UK; United States > US; China; Germany; COVID-19 vaccine; Safety; Adverse events following immunization; Randomized controlled trial; Meta-analysis
• ISSN: 2049-9957; 2095-5162; 2049-9957
• DOI: 10.1186/s40249-021-00878-5

Background Various 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 text A 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). Conclusions 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 AEFI. Long-term surveillance of vaccine safety is required, especially among elderly people with underlying medical conditions. Graphic Abstract