Reference:
Fraiman, J., Erviti, J., Jones, M., Greenland, S., Whelan, P., Kaplan, R. M., & Doshi, P. (2022). Serious adverse events of special interest following mRNA COVID-19 vaccination in randomised trials in adults. Vaccine, 40(5), 649-659. https://doi.org/10.1016/j.vaccine.2022.08.036
Summary:
This article assesses serious adverse events (SAEs) associated with mRNA COVID-19 vaccines (Pfizer and Moderna) through a secondary analysis of phase III trials. It utilised a list of adverse events of special interest provided by the Brighton Collaboration. The findings revealed a higher incidence of SAEs in vaccinated individuals compared to placebo, with excess risks calculated at 10.1 and 15.1 per 10,000 for Pfizer and Moderna respectively. Overall, there was a combined excess risk of 12.5 per 10,000 vaccinated individuals. The study highlighted significant discrepancies with FDA analyses, suggesting a need for formal harm-benefit evaluations, particularly considering varying risks of serious COVID-19 outcomes. It emphasised the importance of public access to trial data for future analyses.