covid vaccines heart risk warning update
🧩 FDA Expands Heart‑Risk Warnings on mRNA COVID Vaccines FDA expands warning about rare heart side effect in two leading Covid vaccines On April 17, 2025 , the U.S. Food and Drug Administration (FDA) formally instructed Pfizer–BioNTech and Moderna to update their vaccine labels to include clearer, more detailed warnings about rare but important heart inflammation risks—specifically myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the heart lining) In a significant update to COVID-19 vaccine safety guidance, the U.S. Food and Drug Administration (FDA) has expanded the warning labels on Pfizer-BioNTech and Moderna mRNA vaccines to include more detailed information about rare cases of heart inflammation, specifically myocarditis and pericarditis. The updated labeling, issued in April 2025, reflects the most recent data on the incidence of these side effects—especially among young males—and aims to improve transparency while maintaining confidence i...