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FDA updates COVID-19 vaccine warnings for risk of heart inflammation
- The FDA required Pfizer/BioNTech and Moderna to expand COVID-19 vaccine warning labels on April 17, 2024, in the United States.
- This measure was taken after the CDC's 2020–2022 research indicated a notable rise in myocarditis cases following vaccination, particularly among young male individuals.
- The new labels clarify heart inflammation risks, focusing on males aged 16 to 25, with about 38 myocarditis or pericarditis cases per million doses within a week of vaccination.
- The CDC described this as an uncommon event and highlighted that the vaccines were subject to an unprecedented level of safety evaluation in the United States, while ongoing monitoring continues to assess their safety and effectiveness.
- The FDA also limited updated COVID-19 shots to adults 65 and older or those with risk factors, with advisers set to discuss fall vaccine strain selection amid calls for more placebo-controlled trials.
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15 Articles
FDA expands COVID vaccine heart risk warnings - WNKY News 40 Television
(CNN) – The U.S. Food and Drug Administration will now require COVID-19 vaccines from Pfizer and Moderna to come with new warning labels. The shots already come with a warning about heart inflammation called myocarditis. Moderna’s warning indicates it’s a risk for 18- to 24-year-old males, while Pfizer indicates 12- to 17-year-old boys. Moving forward, both shots will increase that range for males 16 to 25 years old. Myocarditis is extremely rar…
FDA Requires Covid Vaccine Makers to Expand Warning About Risk of Rare Heart Inflammation
The US Food and Drug Administration will now require Covid-19 vaccines from Pfizer/BioNTech and Moderna to use expanded warning labels with more information about the risk of a rare heart condition after vaccination.
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