Warnings now include expanded risk data for myocarditis, affecting a broader age range: 6 months to 64 years.
Myocarditis is a rare heart inflammation, usually mild. It emerged as a complication after COVID-19 vaccines began rolling out in 2021.
The updated label states a risk of 8 cases of myocarditis per 1 million people aged 6 months to 64 years who received the 2023–2024 COVID shots. The FDA has updated labels on Pfizer and Moderna COVID-19 vaccines to include more detailed warnings about rare heart inflammation risks, especially in young men.
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CDC data shows no increased risk of myocarditis from vaccines since 2022 and states vaccine-related cases are usually mild and temporary.
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U.S vaccine policy
FDA leadership is restricting annual shots to high-risk groups and suggesting new testing for updated vaccines, signaling a shift in U.S. vaccine policy.
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