The FDA has recently expanded requests for detailed warnings on leading COVID-19 vaccines, focusing on a rare but notable side effect—myocarditis, primarily affecting young men. This update reveals a risk of 8 cases per million vaccine doses administered to individuals aged 6 months to 64 years, with a particular prevalence in males aged 12 to 24. This announcement contradicts previous CDC findings that showed no increased risk from the vaccines. The changes come amid discussions on vaccine guidelines for various populations—including children and pregnant women—following a significant shift in the CDC advisory panel's composition.
The FDA expanded warnings on COVID-19 vaccines regarding a rare heart side effect, particularly in young men, amidst conflicting scientific findings on myocarditis.
The FDA’s warning indicates 8 myocarditis cases per 1 million vaccine doses for individuals aged 6 months to 64 years, mainly affecting males aged 12-24.
While cases are typically mild and resolve quickly, the FDA has been urged to explain the myocarditis risk more thoroughly, leading to ongoing negotiations with drugmakers.
The CDC previously found no increased risk for myocarditis in vaccine injury databases, contrasting with the new FDA warnings amid changes in vaccine advisory panel membership.
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