GSK shares ‘positive data’ for RSV vaccine for older adults

GSK plc announced new data from the AReSVi-006 phase III trial evaluating the efficacy of a single dose of Arexvy respiratory syncytial virus vaccine, adjuvanted, against lower respiratory tract disease caused by respiratory syncytial virus, or RSV, in adults aged 60 years and older over multiple RSV seasons and after annual revaccination. The results show that one dose of the vaccine is efficacious against RSV-LRTD and severe LRTD over two full RSV seasons, the company announced. Tony Wood, Chief Scientific Officer, GSK, said: “Our goal is to provide a high level of protection for older adults most at risk from RSV. These data show the efficacy of a single dose of our vaccine over two RSV seasons against RSV-LRTD, including in the populations most at risk due to age or underlying medical conditions. This reinforces our confidence in its potential to make a significant public health impact. We look forward to discussing these results with regulators and vaccine recommending bodies and to collecting more data from the ongoing clinical development program.” GSK will present these data at the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, or ACIP, meeting on June 21. Data from two influenza co-administration trials will also be presented, adding to the seasonal quadrivalent influenza vaccination co-administration data in the current U.S. product label. These data will be submitted to the U.S. Food and Drug Administration and other regulators for review.