Pfizer Announces FDA Approval of Abrysvo as First Maternal RSV Vaccine to Protect Infants from Birth Through 6 Months

On August 21, Pfizer announced that the FDA had approved a new indication for its bivalent respiratory syncytial virus (RSV) vaccine Abrysvo (RSVpreF, PF-06928316). The vaccine is indicated for active immunization of pregnant women to prevent RSV-related lower respiratory tract disease (LRTD) in infants from birth up to 6 months of age. This marks the first maternal vaccine approved by the FDA to protect infants from birth to 6 months of age against LRTD and severe LRTD caused by RSV. The FDA granted the vaccine Breakthrough Therapy Designation in March 2022 and Priority Review status in February 2023.

RSV is a common contagious virus that can affect the lungs and respiratory tract. According to statistics, the global annual incidence of RSV is about 3~10%, and approximately 102,000 children die each year from RSV infections. Moreover, the elderly are also a susceptible group for RSV. Due to age-related decline in immunity and underlying health conditions, the elderly are at high risk of developing severe RSV-related illnesses.

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 medically attended lower respiratory tract infections (MA-LRTI) and severe MA-LRTI caused by RSV infection.

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 better than the placebo group; the 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. The vaccine was well tolerated, and no safety issues were observed in the vaccinated pregnant women or their newborns.

Partial Data from Phase III MATISSE Study (Source: NEJM)

Notably, the indication for RSVpreF to prevent lower respiratory tract disease caused by RSV in individuals aged 60 and above was approved by the FDA on May 31. This is the world's second RSV vaccine for this indication, while the world’s first (GSK3844766A) is from GSK.

In addition to the two approved indications, Pfizer has launched two new Phase III clinical trials for PF-06928316 to evaluate the safety, tolerability, and immunogenicity of the vaccine in preventing RSV infection in high-risk adult populations and in children aged 2 to under 18 who are at high risk for severe RSV.

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