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FDA Approves Required Updated Warning in Labeling of mRNA . . . The Fact Sheets for Healthcare Providers and for Recipients and Caregivers for Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19, which are authorized for emergency use in individuals 6 months
FDA warns of heart risk with Pfizer, Moderna COVID vaccines The U S Food and Drug Administration (FDA) has ordered Pfizer and Moderna to expand their warning labels on COVID-19 vaccines The updated warnings highlight a rare risk of heart inflammation in
FDA Expands Heart Risk Warning for Pfizer and Moderna COVID . . . Washington, D C — The U S Food and Drug Administration (FDA) is updating its safety labels for the Pfizer and Moderna COVID-19 vaccines to include expanded warnings about the risk of heart inflammation Both vaccines already carry warnings about myocarditis, a rare condition that causes inflammation of the heart muscle
FDA finalizes myocarditis label updates for COVID vaccines The FDA has approved required updates to the labeling of Pfizer’s Comirnaty and Moderna’s Spikevax COVID-19 vaccines to include revised warnings about the risk of myocarditis and pericarditis