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.
【저자키워드】 COVID-19, SARS-CoV-2, Vaccines, mRNA vaccines, COVID-19 vaccines, Coalition for Epidemic Preparedness Innovations, Serious Adverse Events, Pfizer-BioNTech COVID-19 vaccine BNT162b2, Moderna COVID-19 vaccine mRNA-1273, NCT04368728, NCT04470427, Adverse events of special interest, Brighton Collaboration, Safety Platform for Emergency vACcines, 【초록키워드】 randomized clinical trial, COVID-19 vaccine, Trial, mRNA vaccine, risk, Pfizer, outcomes, mRNA, adverse event, Placebo, collaboration, placebo-controlled, Moderna, Analysis, World Health Organization, mRNA COVID-19 vaccine, Serious Adverse Event, higher risk, COVID-19 vaccine trials, serious COVID-19, datasets, secondary, Combined, 95 % CI, Result, evaluate, reported, exhibited, analysis, the vaccine, analyses, stratified, baseline, 【제목키워드】 randomized trial, COVID-19 vaccination, mRNA, adverse event,