The United States Food and Drug Administration (FDA) has ordered pharmaceutical giants Pfizer and Moderna to issue warnings that their Covid mRNA “vaccines” carry a high risk of heart damage, particularly for young men.
The new guidance highlights the deadly risk of myocarditis from mRNA injections.
Myocarditis is an immune-driven inflammation of the heart muscle, called the myocardium.
The condition can reduce the heart’s ability to pump blood.
Myocarditis can cause blood clots, strokes, cardiac arrest, and ultimately, sudden death.
Doctors have been warning for some time that myocarditis acts as a ticking time bomb, as it’s often symptomless, meaning sufferers may not be aware that they have the condition until it’s too late.
The new ruling from the FDA has sparked renewed scrutiny over Covid “vaccine” safety policies.
According to a report from CBS News, the new guidelines signal growing federal scrutiny of Covid “vaccine” safety.
The FDA has now formally requested that Moderna and Pfizer-BioNTech expand age-based warnings about heart damage caused by their mRNA vaccines.
In letters to the Big Pharma companies, the FDA cited recent data on myocarditis and pericarditis (another form of heart inflammation) that link to these conditions to mRNA injections.
Both manufacturers have been ordered to update product labels to reflect increased risk in males ages 16 to 25, up from the current ranges of 12–17 (Pfizer) and 18–24 (Moderna).
The letters were signed by Richard Forshee, acting director of the FDA’s Office of Biostatistics and Pharmacovigilance under the Center for Biologics Evaluation and Research.
The agency’s move follows a 2024 FDA-funded study showing surging myocarditis cases following the second vaccine dose in young males.
The FDA-backed study, published in The Lancet, shows continued abnormalities in heart scans in some patients months after experiencing myocarditis post-vaccination.
The data cited by Forshee shows that nearly 60 percent of patients in a 333-person cohort still exhibited myocardial injury markers five months post-diagnosis.
“The clinical and prognostic significance of these findings is not known,” he wrote.
The new directive requires the vaccine makers to inform patients that the long-term significance of these MRI findings is unknown.
However, the heart abnormalities could reflect unresolved cardiac injury.
The department also emphasized that public awareness of these adverse events must be prioritized across both Pfizer and Moderna mRNA products.
In a statement, a Department of Health and Human Services spokesperson said:
“Americans deserve radical transparency around the safety and efficacy of Covid vaccines, and the FDA is delivering on its promise to do just that.”
The immune-driven condition has prompted fierce debate.
The scale of the crisis was amplified by a recent Senate hearing on “vaccine” safety and dissenting voices within the agency.
Meanwhile, FDA Commissioner Dr. Marty Makary and vaccine policy lead Dr. Vinay Prasad announced this week that Covid “booster” recommendations will now be limited to individuals over 65 or those with high-risk conditions.
The new rules continue to further shift the “vaccine” policy landscape.
READ MORE – Global Study: Covid Caused Zero Excess Deaths, mRNA Shots Caused Millions
