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BMC Medicine

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Open Access 01-12-2021 | Coronavirus | Research article

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

Authors: Qianhui Wu, Matthew Z. Dudley, Xinghui Chen, Xufang Bai, Kaige Dong, Tingyu Zhuang, Daniel Salmon, Hongjie Yu

Published in: BMC Medicine | Issue 1/2021

Abstract

Background

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.

Methods

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.

Results

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.

Conclusions

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.

Available only for authorised users

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Title: Evaluation of the safety profile of COVID-19 vaccines: a rapid review
Authors: Qianhui Wu
Matthew Z. Dudley
Xinghui Chen
Xufang Bai
Kaige Dong
Tingyu Zhuang
Daniel Salmon
Hongjie Yu
Publication date: 01-12-2021
Publisher: BioMed Central
Keywords: Coronavirus
COVID-19 Vaccination
Vaccination
SARS-CoV-2
Published in: BMC Medicine / Issue 1/2021
Electronic ISSN: 1741-7015
DOI: https://doi.org/10.1186/s12916-021-02059-5

At a glance: The STEP trials

Springer Medicine

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

Abstract

Background

Methods

Results

Conclusions

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

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