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,

In an editorial article published in the New England Journal of Medicine, Dr. Vinay Prasad, the newly appointed head of the Center for Biologics Evaluation and research at the FDA, and Dr. Martin Makary, FDA commissioner, explained their plan for how the FDA will evaluate and recommend COVID-19 vaccines going forward.

An FDA committee on Thursday recommended that COVID-19 vaccines for the 2025-2026 respiratory virus season — which, for the first time, will be limited to certain groups — target the JN.1 lineage of SARS-CoV-2.