Washington, D.C. — The U.S. Food and Drug Administration (FDA) is updating its safety labels for the Pfizer and Moderna COVID-19 vaccines to include expanded warnings about the risk of heart inflammation.
Both vaccines already carry warnings about myocarditis, a rare condition that causes inflammation of the heart muscle. Previously, the warning applied mainly to young males: ages 18 to 24 for Moderna and 12 to 17 for Pfizer.
Now, the updated guidance will include a broader group — males aged 16 to 25 — for both vaccines.
Myocarditis remains very rare. Health officials say the condition has occurred in about 38 out of every one million males in the newly expanded age range. In most cases, the inflammation is mild and goes away quickly with little or no treatment.
This update follows another major change in vaccine policy. Earlier this year, the FDA announced that, starting in the fall, COVID-19 vaccines will be offered only to people aged 65 and older or those with underlying health conditions.
The expanded warning label marks another cautious step in the FDA’s ongoing review of vaccine safety as the pandemic response continues to evolve.