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20h ago

FDA Expands Heart Risk Warnings for Pfizer and Moderna COVID-19 Vaccines

New labels highlight myocarditis risks in males aged 16 to 25 as Senate report probes delayed public warnings by U.S. health officials.

The FDA is telling Pfizer and Moderna to expand warning labels about the risk of a rare heart condition after Covid-19 vaccination.
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Food and Drug Administration (FDA) commissioner Marty Makary speaks during a news conference on the FDA's intent to phase out the use of petroleum-based synthetic dyes in the nation's food supply at the Hubert Humphrey Building Auditorium in Washington, Tuesday, April 22, 2025. (AP Photo/Jose Luis Magana)

Overview

  • The FDA now requires Pfizer and Moderna to update vaccine labels to include expanded warnings about myocarditis and pericarditis risks, particularly for males aged 16 to 25.
  • The decision follows new data showing an estimated rate of 38 myocarditis cases per million doses in this age group, based on recent safety monitoring and studies.
  • A Senate subcommittee report alleges that Biden administration officials delayed informing the public about myocarditis risks in early 2021 to avoid vaccine hesitancy.
  • The report highlights debates within the CDC and FDA over issuing a formal Health Alert Network warning, which was ultimately replaced by a less prominent website notice in May 2021.
  • Health authorities emphasize that myocarditis cases after vaccination are rare and typically mild, with benefits of vaccination outweighing the risks for most individuals.