Pfizer and Moderna have been ordered by the Food and Drug Administration to add warning labels to their mRNA COVID-19 vaccines (Comirnaty and Spikevax)
to emphasize a rare risk of myocarditis and pericarditis,
which are conditions characterized by inflammation of the heart, mainly in males aged 16 to 25.
Previously, the labels addressed ages 12–17 (Pfizer) and 18–24 (Moderna);
now, they mention an incidence rate of 38 cases per million doses in this group.
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At almost 8 cases per million doses, the overall risk is still low for all recipients under 65.
This action comes after the FDA examined vaccine safety data from 2023–2024,
including insurance claims and a study that revealed some patients had persistent cardiac MRI abnormalities five months after diagnosis.
However, according to the CDC, these cases are uncommon, usually go away quickly,
and are not as severe as those brought on by the COVID-19 virus itself.
The FDA’s ruling also runs counter to earlier CDC evaluations that showed no elevated risk of myocarditis in vaccine injury databases since 2022.
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It also supports larger initiatives to strengthen vaccine oversight by the administration of Health Secretary Robert F. Kennedy Jr.
Kennedy recently appointed anti-vaccine advocates to all 17 CDC advisory panel positions, and FDA Commissioner Marty Makary,
who opposes COVID-19 booster mandates, has limited yearly vaccinations to high-risk populations (such as senior citizens).
Critics however argue that the label expansion overlooks context: Studies confirm COVID-19 infection poses a 16-fold higher myocarditis risk than vaccination,
and most post-vaccine cases are mild, resolving with anti-inflammatory treatment.
Yale researchers also note the inflammation is transient, not autoimmune, allowing full recovery.
Meanwhile, Medical experts condemn the FDA’s approach as misleading.
“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 of the University of Washington.
“We should be investigating who is prone to myocarditis to see if we can predict and mitigate that risk,” according to a report by AP.