CAMBRIDGE, MA / ACCESS Newswire / May 23, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for review of its Spikevax 2025-2026 formula,

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.

Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine candidate after discussions with the U.S. Food and Drug Administration. The company said it would resubmit the application later this year with vaccine efficacy data from a late-stage trial of its experimental seasonal influenza vaccine,