The updated warnings highlight a rare risk of heart inflammation in teen boys and young men, CBS News reported. The warning applies to males ages 16 to 25 and is based on new data from FDA safety monitoring and a 2023 study. This includes both Pfizer's Comirnaty and Moderna's Spikevax vaccines.

The FDA is requiring COVID vaccine makers Pfizer and Moderna to update their warnings about the possible risk of myocarditis and pericarditis.

The Food and Drug Administration is requiring Pfizer and Moderna to expand warnings on the labels of their COVID-19 vaccines for the risk of heart inflammation in adolescents and young men. The big picture: The agency cited updated estimates of cases of myocarditis and pericarditis — inflammation of heart muscle and surrounding tissue — and a post-approval study showing the persistence of heart abnormalities months after getting the mRNA