FDA requires updated warning about rare heart risk with COVID shots
[June 26, 2025]
By MATTHEW PERRONE
WASHINGTON (AP) — The Food and Drug Administration said Wednesday it has
expanded existing warnings on the two leading COVID-19 vaccines about a
rare heart side effect mainly seen in young men.
Myocarditis, a type of heart inflammation that is usually mild, emerged
as a complication after the first shots became widely available in 2021.
Prescribing information from both Pfizer and Moderna already advises
doctors about the issue.
In April, the FDA sent letters to both drugmakers asking them to update
and expand the warnings to add more detail about the problem and to
cover a larger group of patients. While the FDA can mandate label
changes, the process is often more of a negotiation with companies.
Specifically, the new warning lists the risk of myocarditis as 8 cases
per 1 million people who got the 2023-2024 COVID shots between the ages
of 6 months and 64 years old. The label also notes that the problem has
been most common among males ages 12 to 24. The previous label said the
problem mostly occurs in 12- to 17-year-olds.
The FDA’s labeling change appears to conflict with some prior findings
of scientists elsewhere in the U.S. government.
The Centers for Disease Control and Prevention previously concluded
there was no increased risk of myocarditis detected in government
vaccine injury databases for COVID-19 shots dating back to 2022.
Officials also noted that cases tend to resolve quickly and are less
severe than those associated with COVID-19 infection itself, which can
also cause myocarditis.
The FDA announcement came as new vaccine advisers appointed by Health
Secretary Robert F. Kennedy Jr. met to debate the continuing use of
COVID-19 vaccines for key groups, including pregnant women. It's the
first meeting of the CDC advisory panel since Kennedy abruptly dismissed
all 17 members of the group, naming a new panel that includes several
members with a history of anti-vaccine statements.
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 The FDA's label update is the latest
step by officials working under Kennedy to restrict or undercut use
of vaccines. FDA Commissioner Marty Makary and a top deputy recently
restricted annual COVID-19 shots to seniors and other Americans at
higher risk from the virus. They’ve also suggested seasonal tweaks
to match the latest circulating virus strains are new products that
require extra testing.
Outside experts said 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,” said Dr. Robert Morris, a public health
specialist at the University of Washington. “We should be
investigating who is prone to myocarditis to see if we can predict
and mitigate that risk.”
Makary and several other FDA officials gained prominence during the
pandemic by suggesting the federal government exaggerated the
benefits of COVID-19 boosters and downplayed serious side effects,
including myocarditis.
Before joining the government, Makary and two of his current FDA
deputies wrote a 2022 paper that said mandating booster shots in
young people would cause more vaccine-related injuries than
prevented hospitalizations from COVID-19 infections. The conclusion
contradicted that of many leading vaccine and public health experts
at the time, including at the CDC.
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