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(1), 1-9. https://doi.org/10.1016/j.vaccine.2022.08.036
Summary:
This article examines the serious adverse events (SAEs) associated with mRNA COVID-19 vaccines (Pfizer and Moderna) as identified in randomised trials. Using data from phase III trials, the authors found an increased risk of SAEs of special interest, with Pfizer showing an excess of 10.1 and Moderna 15.1 per 10,000 vaccinated compared to placebo. The combined risk indicated a 12.5 per 10,000 increase. Notably, while the Pfizer trial reported a 36% higher risk of SAEs among vaccinees, the Moderna trial showed no significant imbalance. The findings call for more in-depth harm-benefit analyses that consider the risk of serious COVID-19 outcomes, highlighting the necessity for public access to participant-level data and raising concerns about the vaccines’ safety profile.