Apollonian
Guest Columnist
Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults
Link: https://pubmed.ncbi.nlm.nih.gov/36055877/- PMID: 36055877
- PMCID: PMC9428332
- DOI: 10.1016/j.vaccine.2022.08.036
Abstract
Introduction: In 2020, prior to COVID-19 vaccine rollout, the Brighton Collaboration created a priority list, endorsed by the World Health Organization, of potential adverse events relevant to COVID-19 vaccines. We adapted the Brighton Collaboration list to evaluate serious adverse events of special interest observed in mRNA COVID-19 vaccine trials.Methods: Secondary analysis of serious adverse events reported in the placebo-controlled, phase III randomized clinical trials of Pfizer and Moderna mRNA COVID-19 vaccines in adults (NCT04368728 and NCT04470427), focusing analysis on Brighton Collaboration adverse events of special interest.
Results: Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI -0.4 to 20.6 and -3.6 to 33.8), respectively. Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95 % CI 2.1 to 22.9); risk ratio 1.43 (95 % CI 1.07 to 1.92). The Pfizer trial exhibited a 36 % higher risk of serious adverse events in the vaccine group; risk difference 18.0 per 10,000 vaccinated (95 % CI 1.2 to 34.9); risk ratio 1.36 (95 % CI 1.02 to 1.83). The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000 (95 % CI -23.2 to 37.4); risk ratio 1.06 (95 % CI 0.84 to 1.33). Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients: risk difference 13.2 (95 % CI -3.2 to 29.6); risk ratio 1.16 (95 % CI 0.97 to 1.39).
Discussion: The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes. These analyses will require public release of participant level datasets.
Keywords: Adverse events of special interest; Brighton Collaboration; COVID-19; COVID-19 vaccines; Coalition for Epidemic Preparedness Innovations; Moderna COVID-19 vaccine mRNA-1273; NCT04368728; NCT04470427; Pfizer-BioNTech COVID-19 vaccine BNT162b2; SARS-CoV-2; Safety Platform for Emergency vACcines; Serious adverse events; Vaccines; mRNA vaccines.
Copyright © 2022 Elsevier Ltd. All rights reserved.
Conflict of interest statement
Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.Comment in
- Serious adverse events following mRNA vaccination in randomized trials in adults.
Black S, Evans S.Vaccine. 2023 May 26;41(23):3473-3474. doi: 10.1016/j.vaccine.2023.04.040. Epub 2023 Apr 28.PMID: 37121802 No abstract available.
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References
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Publication types
- Clinical Trial, Phase III
- Randomized Controlled Trial
MeSH terms
- Adult
- COVID-19 Vaccines / adverse effects
- COVID-19* / prevention & control
- Humans
- RNA, Messenger
- Randomized Controlled Trials as Topic
- Vaccination / adverse effects
- Vaccines*
- Vaccines, Synthetic
- mRNA Vaccines
Substances
- COVID-19 Vaccines
- RNA, Messenger
- Vaccines
- Vaccines, Synthetic
- mRNA Vaccine
- mRNA Vaccines
Associated data
- ClinicalTrials.gov/NCT04368728
- ClinicalTrials.gov/NCT04470427
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