FDA Announces New Safety Warning on All mRNA COVID Vaccines — Cites “Extremely High” Risk of Myocarditis and Long-Term Heart Damage in Young Men
FDA has issued a stark safety warning for all COVID mRNA vaccines, confirming they cause fatal heart damage as updated labeling for Pfizer’s Comirnaty and Moderna’s Spikevax now acknowledges.
By Jim Hᴏft
July 5, 2025
The U.S. Food and Drug Administration (FDA) under the Trump administration has formally updated the safety labeling on all mRNA COVID-19 vaccines to reflect what many Americans have been warning about for years: a disturbingly high risk of myocarditis—particularly in young men—and the possibility of long-term, irreversible heart damage.
The revised warnings apply to both Pfizer’s Comirnaty and Moderna’s Spikevax vaccines and follow months of mounting pressure over transparency and accountability regarding the true risks of these experimental injections.
The update stems from new studies and data showing persistent cardiac abnormalities months after vaccination—especially among males aged 12 to 24.
During a presentation of the new FDA safety data on Tuesday, Dr. Vinay Prasad, Director, Center for Biologics Evaluation & Research Chief Medical and Scientific Officer, walked the public through the harrowing evidence behind the label change.
Prasad detailed how FDA data reveals a myocarditis rate of 27 per million in young men—a figure that experts say is significantly underreported due to passive surveillance methods and political suppression of adverse event reports.
More troubling, Dr. Prasad cited late gadolinium enhancement (LGE) on cardiac MRIs as proof of sustained, potentially irreversible myocardial injury.
According to Prasad, in one FDA-funded study, 60% of patients who suffered post-vaccine myocarditis still showed signs of LGE five months later.
WATCH:
After denying and downplaying the risks for years, the FDA is now requiring both Pfizer and Moderna to update their Prescribing Information, Adverse Reactions sections, and Fact Sheets for patients and caregivers.
More from the press release:
mRNA COVID-19 Vaccines: FDA Safety Communication - FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following Vaccination
The FDA, under Trump’s administration, has issued a stark safety warning for all COVID mRNA vaccines, confirming they cause fatal heart damage, particularly myocarditis in young men, as updated labeling for Pfizer’s Comirnaty and Moderna’s Spikevax now acknowledges.
This move validates years of public outcry over the injections’ risks, spotlighting the potential for irreversible cardiac harm.
READ MORE:
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Cardiologist: Over 7 Million Americans may have some form of HEART INJURY due to COVID-19 vaccines
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only men have hearts so... they are the only ones endangered ???