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