The first RSV vaccines were approved by the FDA earlier this year.
Members of the CDC’s Advisory Committee for Immunization Practices (ACIP) have voted in favor of recommending recently approved respiratory syncytial virus (RSV) vaccines for use in adults aged 60 years and older after consulting with their health care provider.1 The first 2 RSV vaccines, from manufacturers GSK and Pfizer, were approved by the FDA earlier this year.2,3
Although some committee members were hoping for a broader recommendation, other members expressed concerns around a lack of data on vaccine effectiveness for adults over the age of 75 years as well as those in other high-risk groups.
Arexvy (respiratory syncytial virus vaccine, adjuvanted), manufactured by GSK, was approved by the FDA on May 3, 2023 to prevent lower respiratory tract disease caused by RSV in adults aged 60 years and older. The vaccine contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) in combination with GSK’s priority AS01E adjuvant.
FDA approval of Arexvy was based on data from AReSVi-006 (NCT04886596), a landmark phase 3 clinical trial. Trial results showed that the vaccine demonstrated both statistically significant and clinically meaningful overall efficacy against RSV-associated lower respiratory tract disease in adults aged 60 years and older, as well as efficacy in older adults with at least 1 underlying comorbid condition.
Additional studies of Arexvy evaluated the coadministration of Arexvy and an FDA-approved influenza vaccine; 2 participants developed acute disseminated encephalomyelitis and 1 developed Guillain-Barré syndrome. As a result, the FDA is requiring GSK to conduct postmarketing studies to evaluate the signals of serious risks for each of these conditions.
On June 1, the FDA approved Abrysvo, a bivalent RSV vaccine manufactured by Pfizer, also for the prevention of lower respiratory tract disease caused by RSV in adults aged 60 years and older. Approval for Abrysvo was based on data from the phase 3 RENOIR clinical trial (NCT05035212), a global, randomized, double-blind, placebo-controlled study evaluating the efficacy, immunogenicity, and safety of a single vaccine dose in older adults. Study participants—over 34,000 adults—were randomly assigned 1:1 to receive the bivalent RSVpreF vaccine 120 µg or placebo.
Interim results published in the New England Journal of Medicine demonstrated efficacy against RSV-associated lower respiratory tract illness with at least 2 or 3 signs and symptoms; the vaccine group had 1.19 RSV cases per 1000 person-years compared with 1.52 per 1000 person-years in the placebo group. Adverse event rates were similar through 1 month after injection in in each group.
RSV is a highly contagious respiratory disease with seasonal circulation. Transmission typically begins in the fall and peaks during the winter months. In older adults, RSV can cause lower respiratory tract infections, leading to life-threatening pneumonia and bronchiolitis. Data suggest that RSV is responsible for 14,000 deaths in adults aged 65 years and older.
In tems of pricing, GSK expects their vaccine to be priced between $200 and $295 per dose. suggested a range of $180 to $270 a dose, but could not guarantee that the final price would remain within that range.