FDA official recommended COVID-19 vaccine myocarditis warnings

An FDA pharmacovigilance expert, Dr. Meghna Alimchandani, formally recommended adding warnings regarding fatal myocarditis to COVID-19 mRNA vaccine labels in a December 2025 email. This recommendation followed an internal memorandum from the Center for Biologics Evaluation and Research (CBER) that identified at least 10 pediatric deaths potentially linked to vaccine-induced myocarditis.

Documents released by Senator Ron Johnson indicate that one month after the CBER identified these 10 deaths, the figure was reduced to seven, and the perceived probability of a direct link to the vaccines was lowered. Despite the recommendation, the FDA has not updated the labels more than 10 months later. Former officials noted that the leaked documents and reports appeared to have unsettled the agency’s safety office.