Pfizer's RSVpreF Maternal Vaccine Receives Strong Endorsement from FDA Advisory Committee for Infant Protection

On May 18, Pfizer announced that the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that existing data support the efficacy and safety of its adjuvant-free bivalent Respiratory Syncytial Virus (RSV) prefusion F vaccine candidate, RSVpreF. The committee unanimously affirmed efficacy with a vote of 14 vs 0, and supported safety with a vote of 10 vs 4.

The candidate vaccine is awaiting FDA approval for market launch, intended for active immunization of pregnant women to prevent medically attended lower respiratory tract illness (MA-LRTI) and severe MA-LRTI caused by RSV infection in infants up to six months of age. The FDA is expected to decide whether to approve this indication for RSVpreF by the PDUFA date in August this year.

The VRBPAC recommendation is based on scientific evidence shared by Pfizer, including primary results from the pivotal Phase III clinical trial MATISSE (NCT04424316). 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%, with an efficacy of 51.3% during the 6-month follow-up period, showing no significant difference compared to the placebo group.

In addition, Pfizer submitted an application to the FDA for the approval of RSVpreF to prevent RSV infection in the elderly in December 2022, which received priority review. The PDUFA date is May 2023.

Dr. Annaliesa Anderson, Senior Vice President and Chief Scientific Officer of Pfizer Vaccine Research and Development, stated: "We are encouraged by the outcome of today's VRBPAC meeting, as it represents a significant step toward a long-standing goal in the scientific community: helping to prevent RSV disease in infants during their most vulnerable first six months. If approved, our RSV vaccine candidate has the potential to become the first maternal immunization vaccine to help protect infants from this potentially severe infection within the first six months after birth."

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