FDA expands COVID vaccine heart risk warnings

(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 rare.

Heart inflammation has been seen in about 38 males per million in the newly indicated age group.

It typically resolves quickly.

The news is another hit to COVID vaccines that comes after the FDA announced that, starting in the fall, it will only be available for people who are at least 65 years old or with underlying conditions.