Moderna, Inc. received notification from the U.S. Food and Drug Administration (FDA) regarding a delay in the review process for its investigational respiratory syncytial virus (RSV) vaccine, mRNA-1345. Due to administrative constraints, the FDA will not complete the review by the previously set Prescription Drug User Fee Act (PDUFA) date of May 12, 2024. The agency anticipates finalizing the review by the end of May 2024.

Moderna clarified that the delay is not related to any concerns about the vaccine's safety, efficacy, or quality. The company remains optimistic about mRNA-1345's prospects and is committed to assisting the FDA in completing the review process.

The next milestone for mRNA-1345 is the review at the CDC's Advisory Committee on Immunization Practices (ACIP) meeting scheduled for June 26-27, 2024. Moderna's President, Stephen Hoge, M.D., expressed gratitude to the FDA for their dedication and affirmed Moderna's readiness to support the ongoing review process.