GSK shares new data for RSV vaccine Arexvy
GSK announced positive results from its phase 3 trial which assessed the immune response and safety of Arexvy, its respiratory syncytial virus (RSV) vaccine, adjuvanted, in adults aged 50 to 59 including those at an increased risk of RSV lower respiratory tract disease (LRTD) due to underlying conditions.
The results are expected to be presented at the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) meeting this month.
The vaccine is already approved in the US for the prevention of RSV-LRTD in adults over the age of 60, as well as being approved in Europe, Japan and various other countries.
The trials demonstrated an immune response in patients of this age group at an increased risk of RSV due to underlying conditions, that was non-inferior to the response observed in adults over the age of 60. Safety and reactogenicity data also remained consistent with results from the initial phase 3 programme. Common adverse events included pain, fatigue and headache, most of which were transient and mild in intensity.
Tony Wood, GSK’s chief scientific officer, commented: “This trial reinforces our confidence in our RSV vaccine’s ability to help protect adults aged 50 to 59 at increased risk for RSV-LRTD. We will submit these data for regulatory review as quickly as possible with the goal of offering adults in this age group the option of a vaccine for the first time.”
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