FDA Expands COVID-19 Vaccine Warning Over Rare Heart Risk
WASHINGTON (AP) — The Food and Drug Administration (FDA) announced Wednesday that it has broadened its warnings regarding a rare heart condition linked to the Pfizer and Moderna COVID-19 vaccines, primarily affecting young males.
Myocarditis, an inflammation of the heart muscle typically considered mild, was first identified as a rare side effect after the initial rollout of COVID-19 vaccines in 2021. Both Pfizer and Moderna’s prescribing labels already included information about this risk. However, in April, the FDA formally requested the companies update their labels to provide more detailed information and to reflect a wider affected population.
The revised labeling now states that the risk of myocarditis is approximately 8 cases per 1 million vaccine recipients aged 6 months to 64 years who received the 2023–2024 formulations. The updated warning also highlights that the highest risk remains among males aged 12 to 24, expanding the previous warning that focused on the 12 to 17 age group.
This updated FDA guidance appears to contrast with earlier findings from other U.S. health authorities. The Centers for Disease Control and Prevention (CDC) previously reported no increased risk of myocarditis in their vaccine injury monitoring systems from 2022 onwards. The CDC also emphasized that vaccine-related myocarditis cases are usually mild, resolve quickly, and are generally less severe than myocarditis caused by a COVID-19 infection itself.
The FDA’s announcement coincides with the first meeting of a newly appointed CDC advisory panel on COVID-19 vaccines. The panel was overhauled by Health Secretary Robert F. Kennedy Jr., who recently dismissed all 17 former members and replaced them with individuals, some of whom have made past statements critical of vaccines. This meeting includes discussions on continued vaccine use among key groups such as pregnant women.
This move is part of a broader shift under Kennedy’s leadership to reassess vaccine policy. FDA Commissioner Marty Makary, along with a top deputy, recently limited recommendations for annual COVID-19 boosters to only seniors and those at high risk. They’ve also argued that updated vaccines tailored to new variants should be treated as new products requiring additional clinical testing.
Many public health experts have pushed back on this approach.
Dr. Robert Morris, a public health expert at the University of Washington, said:
“It’s important to examine myocarditis risk, but the FDA’s new warning isn’t the right solution. We should focus on identifying individuals most susceptible to myocarditis so we can reduce their risk.”
Makary and other FDA officials rose to prominence during the pandemic by challenging what they saw as overstated benefits of booster shots and underreported risks, including myocarditis. In 2022, before joining the FDA, Makary and two current deputies co-authored a paper arguing that booster mandates for young people might result in more vaccine-related harm than hospitalizations prevented—directly contradicting guidance from the CDC and other public health experts at the time.
