BRIEF—Moderna update on investigational RSV vaccine

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

The FDA has informed Moderna that it is working to conclude the review 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.

Moderna added that it remains on track for mRNA-1345 to be reviewed at the CDC's Advisory Committee on Immunization Practices (ACIP) June 26-27, 2024, meeting, which is necessary prior to commercial launch.