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The U.S. Food and Drug Administration has ordered Pfizer and Moderna to update their experimental COVID-19 shot labels to include warnings about the risk of heart inflammationβ€”specifically, myocarditis and pericarditisβ€”in adolescent and young adult males.

The directive, issued on April 17, 2025, expands existing warnings to cover males aged 16 to 25, broadening the previous age ranges of 12 to 17 for Pfizer’s Comirnaty and 18 to 24 for Moderna’s Spikevax.

The FDA cited insurance claims data showing an incidence rate of 8 cases of myocarditis or pericarditis per million doses for the 2023–2024 vaccine formulas.

“The observed risk is higher among men younger than 40 years for BNT162b2 and in men aged 18–24 years for mRNA-1273,” the FDA states in its letters to the manufacturers. 

The FDA is also requiring Pfizer and Moderna to conduct post-approval studies to assess long-term heart abnormalities, following evidence that such issues can persist months after vaccination.

After urging the public to adhere to the Biden administration’s COVID “vaccine” mandate, the Centers for Disease Control and Prevention acknowledged a “likely association” between mRNA vaccines and heart inflammation, particularly in young males after the second dose.

Pfizer and Moderna were given 30 days to comply with or contest the FDA’s order, though neither company has publicly confirmed compliance or issued a response to the updated labeling requirements.

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