The U.S. Food and Drug Administration (FDA) under the Trump administration has formally updated the safety labeling on all mRNA COVID-19 vaccines due to studies showing 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.