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(40), 5798-5805. https://doi.org/10.1016/j.vaccine.2022.08.036
Summary:
This article examines serious adverse events (SAEs) associated with mRNA COVID-19 vaccines (Pfizer and Moderna) reported in randomised trials. Researchers adapted a priority list of adverse events created by the Brighton Collaboration, which was endorsed by the WHO. The analysis revealed excess risks of serious adverse events of 10.1 and 15.1 per 10,000 vaccinated individuals for Pfizer and Moderna, respectively, leading to a combined risk of 12.5 per 10,000. Although the FDA previously stated that SAEs were balanced between treatment groups, this study found a higher incidence, particularly in the Pfizer trial, indicating that the actual risk of serious adverse events may have been underestimated. The authors argue for further harm-benefit analyses, emphasising the need for transparency in vaccine trial data to properly evaluate risks and benefits.