by WorldTribune Staff, July 3, 2025 Real World News

The Food and Drug Administration (FDA) has updated the safety labeling on Pfizer and Moderna mRNA Covid shots to reflect a high risk of myocarditis — particularly in young men — and the possibility of long-term, irreversible heart damage.

The update stems from new studies and data showing persistent cardiac abnormalities months after injection, especially among males ages 12 to 24.

“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,” The Gateway Pundit’s Jim Hoft noted.

In a press release dated June 25, the FDA states it “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.

• The results of a study that collected information on cardiac magnetic resonance imaging (cardiac MRI) in people who developed myocarditis after receiving a mRNA COVID-19 vaccine.

The FDA said it 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 press release continued: “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.”

During a presentation of the new FDA safety data on July 1, Dr. Vinay Prasad, Director, Center for Biologics Evaluation & Research Chief Medical and Scientific Officer, detailed how FDA data reveals a myocarditis rate of 27 per million in young men.

This figure, experts say, “is significantly underreported due to passive surveillance methods and political suppression of adverse event reports,” Hoft wrote.

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.

🚨 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

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  FDA’s new warning on Pfizer, Moderna Covid shots: High risk of myocarditis in young men, WorldTribune.com