Moderna's RSV Vaccine Candidate Review Delayed

Moderna, Inc., today announced that the U.S. Food and Drug Administration (FDA) has notified it that due to administrative constraints, the agency does not expect to complete its review of the Biologics License Application for mRNA-1345, Moderna's investigational respiratory syncytial virus (RSV) vaccine, by the previously communicated Prescription Drug User Fee Act date of May 12, 2024.

The FDA informed Moderna on May 10, 2024, that it is working to conclude its review of mRNA-1345 by the end of May 2024.

The FDA has not informed Moderna of any issues related to vaccine safety, efficacy, or quality that would prevent the approval of mRNA-1345.