FDA Expands Warning on Heart Inflammation Risk Linked to COVID-19 Vaccines
FDA COVID vaccine heart risk update: On June 25, 2025, the FDA announced new warning labels for Moderna and Pfizer shots. The updated label highlights an increased risk of myocarditis, a rare heart condition most often affecting males aged 12 to 24.
What the New Label Has to Say
The updated warning now reports that health officials observed 8 cases of myocarditis per million doses during the 2023–2024 vaccine cycle in people aged 6 months to 64 years. In the past, the warning’s age range was more restricted, primarily targeting teenagers.
This change comes after Pfizer and Moderna received a letter from the FDA in April asking for more thorough and age-inclusive risk information.
Conflicting Data Between Agencies
The FDA’s updated position appears to contrast findings from the Centers for Disease Control and Prevention (CDC). Based on 2022 data, the CDC found no elevated risk of myocarditis from COVID-19 vaccines. It emphasized that vaccine-linked cases were milder than heart inflammation caused by the virus itself.
The Advisory Process with Political Overtones
With the recent replacement of all 17 members of the CDC vaccine advisory council by Health Secretary Robert F. Kennedy Jr., the label amendment comes amid controversy. Anti-vaccine statements from several recent appointees have fueled concerns about political influence in public health policy.
At the same time, FDA Commissioner Marty Makary and his team limited annual COVID-19 shots to higher-risk groups like seniors. They cited the need for new trials before approving seasonal updates.
Public Health Experts Speak Out
Critics argue the new label may deter vaccination without solving the underlying issue.
“We should be investigating who is prone to myocarditis to predict and prevent it,” said Dr. Robert Morris, University of Washington.
Makary previously co-authored a controversial 2022 paper claiming COVID-19 boosters may harm more than help young adults. The CDC did not support this view at the time.
Source: AP News
