FRIDAY, June 27, 2025 (HealthDay News) — The U.S. Food and Drug Administration (FDA) has added new warnings to the Pfizer and Moderna COVID-19 vaccines about a rare heart condition that mostly affects young men.
The update expands earlier warnings about myocarditis, a type of heart inflammation, The Associated Press reported.
The condition is still very rare and usually mild, experts say.
The new label notes there were 8 cases of myocarditis for every 1 million people between 6 months and 64 years of age who received the 2023–2024 COVID-19 vaccine.
It also highlights that the highest risk group is males between ages 12 and 24. Previously, the label focused mostly on 12- to 17-year-olds.
The condition was first linked to COVID-19 vaccines in 2021. Doctors were already advised to watch for it, but the FDA asked Pfizer and Moderna in April to provide more detail and expand the age range included in the warning, The AP said.
Myocarditis is swelling in the heart muscle. It can cause chest pain, fatigue, or shortness of breath, according to the Mayo Clinic. In most cases, it gets better quickly with rest or medication.
Health experts stress that the condition is less severe than myocarditis caused by COVID-19 itself.
Some public health leaders worry the new warning is the wrong approach.
“They are right to suggest that we need to consider myocarditis risks associated with the vaccine, but what they propose is exactly the wrong solution,” Robert Morris, a public health expert at the University of Washington, told The AP.
“We should be investigating who is prone to myocarditis to see if we can predict and mitigate that risk,” he said.
The label update comes as a new U.S. Centers for Disease Control and Prevention (CDC) advisory panel, appointed by U.S. Health Secretary Robert F. Kennedy Jr., met to discuss vaccine guidance.
Kennedy recently removed all 17 previous members of the committee, replacing them with new members — some of whom have shared anti-vaccine views.
FDA Commissioner Dr. Marty Makary, a Kennedy appointee, has also restricted COVID-19 shots to seniors and high-risk individuals.
He and others have questioned the need for annual shots or seasonal tweaks to the vaccine, The Post reported.
More information
The U.S. Centers for Disease Control and Prevention has more on common vaccine safety questions and concerns.
SOURCE: The Associated Press, June 25, 2025
