Pfizer and Moderna are required to update their COVID-19 vaccine labels to include stronger warnings about potential heart damage, according to the U.S. Food and Drug Administration (FDA). The FDA announced that these updates should expand information on age groups at risk and indicate that myocardial damage from vaccine-related myocarditis can be long-lasting.
The FDA's directive comes after a post-marketing analysis revealed higher risks of myocarditis and pericarditis than previously reported. The updated labels must reflect that the known rate of these conditions is approximately 8 cases per million doses for individuals under 65, with the highest incidence in males aged 16 to 25 years, where the rate is 38 cases per million.
A spokesperson for the U.S. Department of Health and Human Services said that this change aims to enhance "radical transparency." Neither Pfizer nor Moderna provided comments on this development.
The label changes were announced as the U.S. Senate's Permanent Subcommittee on Investigations released a report criticizing public health officials for not adequately warning about myocarditis risks associated with COVID-19 vaccines. The report includes internal communications showing reluctance among officials to issue formal warnings despite recognizing safety signals.
The FDA also plans to limit approvals for new COVID-19 vaccines to those over 65 or at high risk, requiring new clinical trials for children and teens. The agency's advisory committee is meeting today to discuss the composition of upcoming COVID-19 shots.
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