The U.S. Food and Drug Administration (FDA) has issued a significant update regarding the risks associated with myocarditis following mRNA COVID-19 vaccinations, particularly highlighting an increased risk among young men. The FDA’s new safety label, published on June 25, 2025, adds an updated warning for myocarditis linked to all mRNA vaccines.
Dr. Vinay Prasad, Director of the FDA’s Center for Biologics Evaluation & Research, shared the details in a recent video. The safety update is based on both crude incident data from the 2023-2024 mRNA vaccine formulations and concerning findings related to late gadolinium enhancement (LGE) observed in cardiac MRIs.
According to the FDA’s analysis, myocarditis and pericarditis occur at a rate of 27 cases per million among young men aged 12 to 24. The risk is higher following the second dose of the vaccine. Dr. Prasad emphasised, “The updated unadjusted incidence of myocarditis and/or pericarditis was approximately twenty-seven per million or one in thirty-seven thousand in males twelve to twenty-four years of age for the 2023-2024 formulation.”
Notably, the data, which comes from the best observational system, does not differentiate by vaccine brand, so the warning applies universally to all mRNA vaccines.
The update also incorporates troubling findings on LGE, a marker seen in cardiac MRIs that suggests potential irreversible myocardial damage. Dr. Prasad explained, “Late gadolinium enhancement is not a benign clinical finding… LGE has been associated with increased future cardiovascular events and even increased mortality.”
Despite mounting evidence, the White House and health agencies have long downplayed the risks associated with vaccine-induced myocarditis. The first safety signals emerged as early as 2021, when Israeli reports linked myocarditis to the Pfizer vaccine. By April 2021, the CDC had already acknowledged myocarditis cases in young men but failed to issue a formal health alert.
On May 25, 2021, an internal FDA and CDC meeting confirmed myocarditis as a safety concern for young men. However, just one day later, the White House distributed talking points to health officials urging them to downplay the risks. The following day, acting FDA Commissioner Janet Woodcock and CDC Director Rochelle Walensky dismissed the need for a formal alert.
“One day following the meeting where the FDA and CDC officials acknowledged the safety concern, the Biden White House distributed talking points to top health officials downplaying the risk of myocarditis,” Dr. Prasad said.
“Two days after that meeting, then-acting FDA commissioner and CDC director notes quote, the FDA does not concur with the issuance of the health alert network and instead, it was published as a less formal clinical consideration on the website.”
At the time, the Department of Defense had already reported over a dozen myocarditis cases among military personnel, yet the White House continued to push back on the risks.
As myocarditis cases continued to surface, including reports of severe cases requiring ECMO and long-term cardiac medications, the FDA took action, adjusting safety labels and issuing warnings in 2021. However, these warnings came only after mounting evidence showed the elevated risks, particularly among men aged 16 to 29.
Publications in August 2021 revealed a myocarditis rate of 200 cases per million in young men following the Pfizer vaccine, with other studies in Hong Kong and the U.S. confirming similar trends, Dr. Prasad said.
The FDA’s new label aims to ensure that public trust is restored by being transparent about the risks associated with mRNA vaccines. Dr. Prasad noted, “The FDA will pursue safety signals with the best available scientific methods, and ensure that our marketing authorisations are made only to populations where we have substantial confidence that benefits outweigh the risks.”
This recent update underscores a concern that many have raised but were often dismissed or silenced for voicing. Despite years of downplaying by health officials and media outlets, who were slow to acknowledge or, in some cases, outright hostile to the idea of addressing the risks, the mounting body of evidence surrounding vaccine-related harm cannot be ignored.
The critical question now is whether our authorities will learn from these difficult lessons and reconsider the policies that sought to mandate vaccines for all, despite their proven risks for some.
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Author: Staff Writer
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