GSK shares data for AREXVY, its RSV older adult vaccine

GSK announced new data from the AReSVi-006 or Adult Respiratory Syncytial Virus, phase III trial evaluating the efficacy of a single dose of AREXVY or respiratory syncytial virus vaccine, adjuvanted, against lower respiratory tract disease LRTD caused by respiratory syncytial virus RSV in adults aged 60 years and older over multiple RSV seasons and after annual revaccination. The vaccine efficacy is estimated using a Poisson model adjusted by age, region and season…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…”Safety and reactogenicity data were consistent with initial observations from the phase III program. The vaccine was generally well tolerated. The most frequently observed adverse events were injection site pain, fatigue, myalgia, headache, and arthralgia. These were generally mild to moderate and transient. GSK will present these data at the US Centers for Disease Control and Prevention’s CDC Advisory Committee on Immunization Practices 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 US product label. These data will be submitted to the US Food and Drug Administration and other regulators for review.