Moderna shares update on RSV vaccine

Betsy Goodfellow | May 13, 2024 | News story | Medical Communications FDA, Immunology, Moderna, Vaccine 

Moderna has announced that the US Food and Drug Administration (FDA) has shared that it will not complete its review of the Biologics License Agreement (BLA) for mRNA-1345 by its Prescription Drug User Fee Act (PDUFA) date of 12 May 2024.

The FDA has shared that this delay is due to administrative constraints, and that it intends to complete the review by the end of May 2024.

The drug is Moderna’s investigational vaccine for the prevention of respiratory syncytial virus (RSV). The FDA has not mentioned any issues regarding the vaccine’s safety, efficacy or quality that could prevent approval thus far.

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mRNA-1345 is still on track to be reviewed at the Center for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) meeting, which is taking place on 26-27 June 2024.

Stephen Hoge MD, president of Moderna, commented: “Moderna is very grateful to the FDA for their continued efforts and diligence. We look forward to helping the agency complete the review of our application, and to the June ACIP meeting.”

Betsy Goodfellow

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