Pfizer's RSV Vaccine ABRYSVO Receives FDA Approval as the World's Second RSV Vaccine for Adults Aged 60 and Older

On May 31, Pfizer announced that the FDA had approved its bivalent respiratory syncytial virus (RSV) vaccine ABRYSVO (RSVpreF, PF-06928316) for marketing to prevent lower respiratory tract disease (LRTD) caused by RSV in individuals aged 60 years and older. In March 2022, the FDA granted the vaccine Breakthrough Therapy designation; in December of the same year, the FDA also granted it Priority Review and shortened the BLA review period by four months.

RSV is a common contagious virus that can affect the lungs and respiratory tract. Due to age-related decline in immunity and underlying diseases, elderly people are at high risk of developing severe RSV-related illnesses. RSV can exacerbate conditions such as chronic obstructive pulmonary disease (COPD), asthma, and chronic heart failure, potentially leading to pneumonia, hospitalization, or even death. In industrialized countries, RSV causes over 420,000 hospitalizations and 290,000 deaths annually. Adults with underlying diseases experience higher rates of outpatient visits and hospitalizations, indicating a significant unmet clinical need.

The approval was primarily based on key data from the Phase III trial RENOIR (NCT05035212) for the prevention of RSV infection in individuals aged 60 years and older. The study included approximately 37,000 participants. Analysis showed that the vaccine efficacy (against RSV-related lower respiratory tract disease, defined as having at least two symptoms) reached 66.7%, with an efficacy against severe disease (defined as having at least three symptoms) of 85.7%. Additionally, the vaccine demonstrated good tolerability and safety.

Notably, the BLA for PF-06928316, intended for active immunization of pregnant women to prevent RSV-related lower respiratory tract disease in infants from birth up to 6 months of age, was accepted by the FDA on February 21, 2023, with a PDUFA date set for August 2023.

On May 8, Pfizer registered a new Phase III clinical trial (MONET) in the hope of expanding the use of RSVpreF vaccine to adult patients at high risk of severe RSV.

On May 4, GSK's RSV vaccine GSK3844766A (RSVPreF3 OA) was approved by the FDA for marketing, becoming the first vaccine used to prevent lower respiratory tract diseases caused by RSV infection in adults over 60 years old. The results of a pivotal Phase III AReSVi-006 study involving 25,000 patients showed that the overall vaccine efficacy against RSV-LRTD was 82.6%, achieving the primary endpoint. The efficacy in preventing severe RSV-LRTD was 94.1%. Among individuals with underlying comorbidities, the vaccine efficacy was 94.6%, with 93.8% observed in the 70-79 age group. Additionally, the vaccine demonstrated consistent efficacy in preventing LRTD caused by both RSV-A and RSV-B infections, at 84.6% and 80.9%, respectively.

Overall, Pfizer's key clinical trials for PF-06928316 are very comprehensive, aiming to cover application scenarios for all age groups. Facing the challenge from GSK, which has taken the lead in launching the world’s first RSV vaccine for the elderly, Pfizer's differentiated strategy might help it secure a sufficient market share.

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