CBS News reports:
The Food and Drug Administration is telling Pfizer and Moderna to expand the warning labels on their COVID-19 vaccines about the risk of a possible heart injury side effect linked to the mRNA shots, primarily in teen boys and young men, citing findings from a study published last year and new agency data. Orders to expand the warnings were posted Wednesday by the FDA, in letters dated April 17 to Pfizer and BioNTech about their Comirnaty vaccine and Moderna about its Spikevax vaccine.
They appeared on the FDA’s website hours ahead of a hearing organized by the Republican-led Senate Homeland Security and Governmental Affairs Committee on “how health officials downplayed and hid myocarditis and other adverse events associated with the COVID-19 vaccines.” Aaron Siri, an attorney who worked closely with Health and Human Services Secretary Robert F. Kennedy Jr. in the past to call on the FDA to pull COVID-19 and other vaccines and vet nominees during the transition, is among the witnesses.
Read the full article. The above-cited “new agency data” comes from claims made on the publicly open VAERS system, which has been deluged by QAnon nutbags since the early days of the pandemic. In 2023, Florida Surgeon General Joseph Ladapo was accused of altering data about the risk of the vaccines for young males.
FDA expands COVID vaccine warning about heart side effect risk for young males https://t.co/ifU0Z7DThQ
— CBS Evening News (@CBSEveningNews) May 21, 2025