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FDA updates COVID-19 vaccine labels to warn of potential heart risks in young men.
The FDA has updated the safety labels on Pfizer and Moderna's mRNA COVID-19 vaccines to include a high risk of myocarditis, especially in young men aged 12 to 24, and the possibility of long-term heart issues.
This update is based on recent studies and data.
Both companies must now update their prescribing information, adverse reactions sections, and fact sheets for patients and caregivers to reflect these risks.
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La FDA actualiza las etiquetas de las vacunas contra la COVID-19 para advertir sobre los riesgos cardíacos potenciales en hombres jóvenes.