Moderna (MRNA) Issues Update on Investigational RSV Vaccine

Moderna, Inc. (NASDAQ: MRNA) today announced it has been notified by the U.S. Food and Drug Administration (FDA) 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 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.

"Moderna is very grateful to the FDA for their continued efforts and diligence," said Stephen Hoge, M.D., President of Moderna. "We look forward to helping the agency complete the review of our application, and to the June ACIP meeting."

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