The U.S. Food and Drug Administration (FDA) is reportedly preparing to add a “black box” warning to certain COVID-19 vaccines, indicating potential life-threatening health risks.
Black box warnings are the FDA’s most severe advisory labels, reserved for medications with serious side effects that could cause death or significant disability—such as opioids. It remains unclear whether this alert would apply universally across all COVID-19 vaccines or specifically to mRNA-based ones like those produced by Pfizer and Moderna.
Dr. Vinay Prasad, the FDA’s chief medical and scientific officer, is reportedly overseeing the review process, though finalization details have not been confirmed. Andrew Nixon, a U.S. Department of Health and Human Services spokesman, has countered reports with: “Any claim not officially made by the FDA is pure speculation.”
In July, the FDA updated vaccine labels for Pfizer and Moderna’s COVID-19 mRNA vaccines to include new information about risks of myocarditis and pericarditis, particularly in young males. Common side effects of these vaccines typically involve mild symptoms such as arm pain, fatigue, and headaches.
