Evaluation of the safety profile of COVID-19 vaccines: a rapid review

• Published in: BMC medicine Vol. 19; no. 1; pp. 173 - 16
• Main Authors: Wu, Qianhui, Dudley, Matthew Z., Chen, Xinghui, Bai, Xufang, Dong, Kaige, Zhuang, Tingyu, Salmon, Daniel, Yu, Hongjie
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 28.07.2021; BioMed Central; BMC
• Subjects: Adolescent; Adverse events; Aged; Aged, 80 and over; BNT162 Vaccine; ChAdOx1 nCoV-19; Clinical trials; Coronaviruses; COVID-19; COVID-19 vaccines; COVID-19 Vaccines - adverse effects; Data search; Deoxyribonucleic acid; DNA; DNA vaccines; Documents; Headache; Heterogeneity; Humans; Immunization; Meta-analysis; Middle Aged; Novel coronavirus diseases 2019; Pain; Population studies; Public concern; R&D; Research & development; Review; Reviews; Safety; Safety profile; SARS-CoV-2; Severe acute respiratory syndrome coronavirus 2; Vaccine; Vaccines; Vaccines - adverse effects; Virus-like particles; Websites; China; Severe acute respiratory syndrome coronavirus 2; Vaccine; Review; Novel coronavirus diseases 2019; Safety profile
• ISSN: 1741-7015; 1741-7015
• DOI: 10.1186/s12916-021-02059-5

The rapid process of research and development and lack of follow-up time post-vaccination aroused great public concern about the safety profile of COVID-19 vaccine candidates. To provide comprehensive overview of the safety profile of COVID-19 vaccines by using meta-analysis technique. English-language articles and results posted on PubMed, Embase, Web of Science, PMC, official regulatory websites, and post-authorization safety surveillance data were searched through June 12, 2021. Publications disclosing safety data of COVID-19 candidate vaccines in humans were included. A meta-analysis of proportions was performed to estimate the pooled incidence and the pooled rate ratio (RR) of safety outcomes of COVID-19 vaccines using different platforms. A total of 87 publications with safety data from clinical trials and post-authorization studies of 19 COVID-19 vaccines on 6 different platforms were included. The pooled rates of local and systemic reactions were significantly lower among inactivated vaccines (23.7%, 21.0%), protein subunit vaccines (33.0%, 22.3%), and DNA vaccines (39.5%, 29.3%), compared to RNA vaccines (89.4%, 83.3%), non-replicating vector vaccines (55.9%, 66.3%), and virus-like particle vaccines (100.0%, 78.9%). Solicited injection-site pain was the most common local reactions, and fatigue and headache were the most common systemic reactions. The frequency of vaccine-related serious adverse events was low (< 0.1%) and balanced between treatment groups. Vaccine platforms and age groups of vaccine recipients accounted for much of the heterogeneity in safety profiles between COVID-19 vaccines. Reporting rates of adverse events from post-authorization observational studies were similar to results from clinical trials. Crude reporting rates of adverse events from post-authorization safety monitoring (passive surveillance) were lower than in clinical trials and varied between countries. Available evidence indicates that eligible COVID-19 vaccines have an acceptable short-term safety profile. Additional studies and long-term population-level surveillance are strongly encouraged to further define the safety profile of COVID-19 vaccines.