The updated warnings highlight a rare risk of heart inflammation in teen boys and young men, CBS News reported. The warning applies to males ages 16 to 25 and is based on new data from FDA safety monitoring and a 2023 study. This includes both Pfizer's Comirnaty and Moderna's Spikevax vaccines.

Panel members had questions about whether a new FDA proposal to require randomized trials for vaccines in healthy adults might delay manufacture and limit access.

The Food and Drug Administration has approved Moderna's new COVID-19 vaccine, days after the federal government tightened vaccine standards for the virus.