We have determined that an analysis of spontaneous postmarketing adverse events [VAERS reports] reported under section 505(k)(1) of the FDCA [Federal Food, Drug and Cosmetic Act] will not be sufficient to assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis. Furthermore, the pharmacovigilance system that FDA is required to maintain under section 505(k)(3) of the FDCA is not sufficient to assess these serious risks.
