Pfizer's Infant RSV Vaccine Candidate Receives FDA Priority Review for Maternal Immunization

On February 21, Pfizer announced that the Biologics License Application (BLA) for its respiratory syncytial virus (RSV) candidate vaccine PF-06928316 (RSVpreF) has been granted Priority Review by the FDA. It is intended for the active immunization of pregnant women to prevent medically attended lower respiratory tract disease (MA-LRTI) and severe MA-LRTI caused by RSV infection in infants up to six months of age. The PDUFA date is August 2023.

RSV is the most common cause of lower respiratory tract infections and the leading cause of global infant hospitalization, with the majority of hospitalizations occurring in healthy full-term infants. The elderly are also a susceptible population for RSV. Statistics show that approximately 102,000 children die annually worldwide due to RSV infection. Currently, there are no preventive measures available for all infants and the elderly, and treatment is limited to symptom relief.

This BLA is primarily based on the positive pivotal results from the Phase III MATISSE study. The study enrolled 7,400 pregnant participants and aimed to evaluate the efficacy, safety, and immunogenicity of RSVpreF in preventing MA-LRTI and severe MA-LRTI.

The results of the interim analysis showed that, within the first 90 days after birth, RSVpreF had an efficacy of 81.8% against severe MA-LRTI, and an efficacy of 69.4% during the 6-month follow-up period, significantly outperforming the placebo group; however, its efficacy against MA-LRTI was 57.1%, and 51.3% during the 6-month follow-up period, showing no significant difference compared to the placebo group.

In addition, Pfizer submitted a BLA to the FDA in December 2022 for the prevention of RSV infection in the elderly, and this BLA also received priority review from the FDA, with a PDUFA date in May 2023.

In addition to Pfizer, GSK has also submitted a BLA to the FDA for its RSV vaccine GSK3844766A for the prevention of RSV infection in adults aged 60 and above. The PDUFA date is May 3, 2023. Who will become the first marketed RSV vaccine? Let's wait and see.

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