FDA expands warnings of heart risks on COVID shots
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 shots.
- The label changes were posted on Wednesday and communicated in April 17 letters to the companies. CBS News first reported the notices.
What they're saying: The agency said an analysis of insurance claims found an incidence of 8 cases per million doses for the 2023-2024 formulas of the shots.
