GSK RSV vaccine accepted for regulatory review by EMA for adults 50-59

GSK plc announced that the European Medicines Agency, or EMA, has accepted the company’s regulatory application to expand the use of its adjuvanted recombinant respiratory syncytial virus, or RSV, vaccine to adults aged 50-59 who are at increased risk for RSV disease. If accepted, GSK‘s RSV vaccine would be the first vaccine available to help protect this population. Arexvy is currently approved in Europe in adults aged 60 and over for the prevention of lower respiratory tract disease caused by RSV. “GSK is the first company to file for regulatory approval to extend RSV vaccination to help protect adults aged 50 to 59 at increased risk for RSV disease due to underlying medical conditions. A European regulatory decision is anticipated in H2 2024,” the company stated.