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FDA: COVID-19 vaccines will not be widely recommended starting this fall

The FDA is also expanding its warning that some vaccines are linked to a risk of heart inflammation in young men.

Gillian Neff

and

Rose Shannon

May 25, 2025, 12:40 PM

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The Food and Drug Administration (FDA) has changed its guidance regarding who should receive a COVID-19 booster.

Earlier this week, the agency announced that starting this fall, the vaccines will not be widely recommended.

They will only be available for people over 65 or those who have underlying medical conditions that makes them more susceptible to infections.

The recommendation, detailed in the New England Journal of Medicine, is similar to other countries that have already started to limit vaccinations.

The FDA is also expanding its warning that some vaccines are linked to a risk of heart inflammation in young men.

Officials say they have expanded labels to make it clear that the risk of myocarditis, an inflammation of the heart muscle, that is associated with the shot applies to a broader group that originally known.

Pfizer had previously warned that the risk was for men 12 to 17 and Moderna had issued a warning for men 18 to 24.

The agency will now require vaccines from both manufacturers to have a warning highlighting the risk for men between 16 and 25.

Data has showed that condition happens with the second dose of the vaccine, with men experiencing chest pain, fever and shortness of breath.

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