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FDA updates COVID-19 vaccine warnings for risk of heart inflammation

  • The FDA requires Pfizer/BioNTech and Moderna COVID-19 vaccines to add expanded warning labels about rare heart inflammation as of April 17, 2025.
  • This update is based on data from 2020 to 2022 indicating that vaccination is linked to a measurable rise in myocarditis cases, particularly among males aged 16 to 25.
  • The labels extend previous myocarditis warnings to include pericarditis and specifically target males ages 16 to 25, while cases remain rare and acute myocarditis typically resolves quickly.
  • Analysis of vaccine safety data indicates approximately 38 instances of myocarditis and pericarditis per million doses in males aged 16 to 25, and about eight cases per million doses across individuals from six months to 64 years old; the CDC describes this review as the most thorough safety evaluation in U.S. History.
  • The FDA has tightened approval evidence for updated COVID-19 vaccines expected this fall and limits availability to adults 65+ and at-risk individuals, as officials call for further placebo-controlled trials before broader recommendations.
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FDA updates COVID-19 vaccine warnings for risk of heart inflammation

The FDA now requires Pfizer and Moderna COVID-19 vaccines to carry expanded warning labels about risks of myocarditis and pericarditis in certain age groups

·Pittsburgh, United States
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WKTV broke the news in on Thursday, May 22, 2025.
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