Crude reporting rates of adverse events from post-authorization safety monitoring (passive surveillance) were lower than in clinical trials and varied between countries. Reporting rates of adverse events from post-authorization observational studies were similar to results from clinical trials. Vaccine platforms and age groups of vaccine recipients accounted for much of the heterogeneity in safety profiles between COVID-19 vaccines. The frequency of vaccine-related serious adverse events was low (< 0.1%) and balanced between treatment groups. Solicited injection-site pain was the most common local reactions, and fatigue and headache were the most common systemic reactions. 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%).
Forest plot of estimated results from meta-analysis of fever in adults from clinical trials.Ī 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. Forest plot of estimated results from meta-analysis of headache in adults from clinical trials. Forest plot of estimated results from meta-analysis of fatigue in adults from clinical trials. Forest plot of estimated results from meta-analysis of local injection pain in adults from clinical trials. Comparing rates of unsolicited adverse events by common system organ class (SOC) of COVID-19 vaccines versus placebos.
Forest plot of estimated results from meta-analysis of unsolicited adverse events by common system organ class (SOC). Table S16 Summary of COVID-19 vaccine safety surveillance data. Sources of nationwide safety surveillance data. Summary of post-authorization active surveillance studies among general population. Multivariate meta-regression determining factors accounting for the heterogeneity of safety profile. Meta-analyses for comparing the rates of most common AEFI of COVID-19 candidate vaccines versus placebo or control vaccine by platform among younger adults (18-65 years old). Age group comparison of most common adverse reactions and fever within 7 days post-vaccination between younger adults and elderly (n/N, %). Summary of unbalanced AESIs between intervention and control groups in phase 3 clinical trials of mRNA vaccines. Serious safety outcomes of vaccines in phase 3 clinical trials. Serious adverse events of COVID-19 vaccines by system organ class in phase 3 clinical trials (n/N, %). Raw data of common AEFIs in the total safety set for candidate vaccines in clinical trials among general population (n/N, %). Methodological characteristics of included studies of post-marketing studies: methodological index for non-randomized studies (MINORS) score. Methodological characteristics of included studies of clinical trials: risk of bias on specific items. Brief description of included COVID-19 candidate vaccines and platforms. Grading scale for selected clinical abnormalities. The Creative Commons Public Domain Dedication waiver ( ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.Īdditional file 1: Table S1. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made.
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