The FDA announced that Pfizer and Moderna must enhance their COVID-19 vaccine labels to reflect greater risks of myocardial damage associated with vaccination. The changes include expanding the age groups at risk and disclosing that myocardial injury can persist in some patients. New data shows a rate of 8 myocarditis cases per million doses in individuals under 65, with the highest incidence in young males aged 16 to 25. The aim is to ensure better informed consent among recipients and address concerns about long-term heart issues post-vaccination.
The FDA has mandated Pfizer and Moderna to revise their COVID-19 vaccine labels to include expanded warnings about the risks of myocarditis and pericarditis.
The new labels will indicate that myocarditis and pericarditis occur at a rate of about 8 cases per million doses for individuals under 65.
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