FDA expands warnings of heart risks on COVID shots
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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.
- The updated warnings apply to males ages 16 to 25. Earlier warnings of heart issues for Pfizer-BioNTech's vaccine covered males 12 to 17, and for Moderna's, males 18 to 24.
Pfizer and Moderna didn't immediately respond to requests for comment.
Catch up quick: Heart inflammation has been a known, but rare, side effect linked to the vaccines since early in the pandemic.
- The Centers for Disease Control in 2021 concluded there was a "likely association," especially in adolescents and young adults, but that there still was a benefit for the group to get the shot.
- While cases were rare, they drew concern from scientists responsible for evaluating risks who at the time were weighing whether to recommend the vaccines for children younger than 12.
- CDC officials told an agency advisory committee earlier this year that acute myocarditis after a COVID-19 vaccine tends to resolve itself quickly, and that it's associated with less severe cardiovascular events than myocarditis after COVID-19 infection.
The labeling orders come amid bigger changes in how FDA is regulating COVID vaccines.
- The agency on Tuesday said it would require drugmakers to conduct more scientific studies before approving updated COVID-19 vaccines for healthy adults under age 65 — a move that will likely limit access to the shots to seniors and people with pre-existing conditions.
- They also coincide with a Senate hearing held Wednesday to probe whether federal health officials downplayed the risk of myocarditis after COVID-19 vaccination.
Maya Goldman contributed to this story.
