Arexvy (respiratory syncytial virus vaccine, adjuvanted) is now available for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older.
The Food and Drug Administration (FDA) approved Arexvy in May 2023 based on data from the phase 3 AReSVi 006 trial (ClinicalTrials.gov Identifier: NCT04886596), which included approximately 25,000 adults 60 years of age and older. The efficacy of Arexvy in the prevention of a first episode of confirmed RSV-A and/or B-associated LRTD during the first season was the study’s primary endpoint.
Compared with placebo, Arexvy significantly reduced the risk of developing RSV-associated LRTD by 82.6% (96.95% CI, 57.9-94.1) in individuals 60 years of age and older and by 84.4% (95% CI, 46.9-97.0) in participants 70 years of age and older. Due to the low number of cases in patients 80 years of age and older, vaccine efficacy in this population could not be concluded.
The vaccine was generally well tolerated with the most commonly reported adverse events being injection site pain, fatigue, myalgia, headache, and arthralgia. There was also no interference in immune response when Arexvy was administered with Fluarix Quadrivalent.
Arexvy is supplied as 2 components: a single-dose vial of lyophilized antigen component (powder) and a single-dose vial of adjuvant suspension component (liquid) (packaged without syringes or needles). Following reconstitution, the vaccine should be administered by intramuscular injection. A single dose after reconstitution is 0.5mL.
Rob Truckenmiller, Senior Vice President, Head of US Vaccines, GSK, said: “We are excited to announce that Arexvy is now available to older adults in major retail pharmacies across the US ahead of this year’s RSV season. As the makers of the first FDA-approved RSV vaccine for older adults, we’re hopeful that RSV vaccines, like Arexvy, will help reduce the considerable clinical, economic, and human impact that RSV has on older adults and our public health system.”
