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mRNA COVID-19 Vaccines To Add Warning Language On Myocarditis Risk

 
• By Sue Sutter

US FDA will rapidly update fact sheets with information on myocarditis/pericarditis occurring primarily in young men and adolescent males following the second dose, agency's Doran Fink tells the CDC’s Advisory Committee on Immunization Practices, which said benefit-risk of the Pfizer/BioNTech and Moderna vaccines remains favorable.

Myocarditis
US FDA will add warning language about myocarditis to fact sheets for the Pfizer and Moderna vaccines. • Source: Alamy

The US Food and Drug Administration will add warning language to COVID-19 mRNA vaccine fact sheets about the risk of myocarditis and pericarditis, an agency official told a Centers for Disease Control and Prevention panel on 23 June.

The CDC’s Advisory Committee on Immunization Practices convened to discuss reports of myocarditis/pericarditis following administration of the Pfizer Inc./BioNTech SE and Moderna, Inc. vaccines, particularly in older...

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