FDA Announces New Safety Warning on All mRNA COVID Vaccines — Cites “Extremely High” Risk of Myocarditis and Long-Term Heart Damage in Young Men
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:
Dr. Vinay Prasad announces an updated FDA safety label for mRNA COVID vaccines “based on persistent and concerning cardiac MR findings” pic.twitter.com/tRqFeIsuk5
— Chief Nerd (@TheChiefNerd) July 2, 2025
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:
FDA has required and approved updates to the Prescribing Information for Comirnaty (COVID-19 Vaccine, mRNA) manufactured by Pfizer Inc. and Spikevax (COVID-19 Vaccine, mRNA) manufactured ModernaTX, Inc. to include new safety information about the risks of myocarditis and pericarditis following administration of mRNA COVID-19 vaccines.
Specifically, FDA has required each manufacturer to update the warning about the risks of myocarditis and pericarditis to include information about
- the estimated unadjusted incidence of myocarditis and/or pericarditis following administration of the 2023-2024 Formula of mRNA COVID-19 vaccines and
- the results of a study that collected information on cardiac magnetic resonance imaging (cardiac MRI) in people who developed myocarditis after receiving an mRNA COVID-19 vaccine.
FDA also required each manufacturer to describe the new safety information in the Adverse Reactions section of the Prescribing Information and in the Information for Recipients and Caregivers.
The Fact Sheets for Healthcare Providers and for Recipients and Caregivers for Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19, which are authorized for emergency use in individuals 6 months through 11 years of age, have also been updated to include the new safety information in alignment with the Comirnaty and Spikevax Prescribing Information and Information for Recipients and Caregivers.
You can watch the full 15-minute presentation below:
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