GSK announces topline data on co-administration of Arexvy, Shingrix

GSK announced topline data from the phase 3 trial in adults 50 years and older evaluating the immunogenicity, reactogenicity and safety of Arexvy when co-administered with Shingrix, both AS01-adjuvanted vaccines. The data were presented as a late-breaking abstract at the European Geriatric Medicine Society, or EuGMS, Congress in Valencia, Spain. Shingrix is approved for the prevention of shingles in adults aged 50 years and older. Arexvy is approved for the prevention of lower respiratory tract disease caused by respiratory syncytial virus in individuals 60 years of age and older, as well as individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV. The data showed a non-inferior immune response when the vaccines were co-administered compared to when they were administered at separate visits. Co-administration was also well tolerated, with acceptable reactogenicity and safety profiles. In both groups, the most frequently reported adverse events were pain at the injection site, fatigue, and myalgia. The duration of solicited adverse events was comparable across the two groups. Results from this trial will be submitted for peer-reviewed scientific publication and will be used to support regulatory submissions to the FDA, the European Medicines Agency and other regulators.