European Commission authorises expanded age indication for GSK’s Arexvy: The first respiratory syncytial virus vaccine for adults aged 50-59 at increased risk

GSK plc announced that the European Commission has approved Arexvy (a recombinant adjuvanted RSV vaccine) for preventing lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 50-59 at increased risk. The vaccine was previously approved in June 2023 for those aged 60 and older.

Adults with conditions like chronic obstructive pulmonary disease (COPD), asthma, heart failure, and diabetes are at higher risk for severe RSV outcomes, which can lead to pneumonia, hospitalization, or death. With approximately 20 million adults in the EU/EEA aged 50-59 having such conditions, this approval aims to extend RSV protection to this vulnerable group.

The decision was supported by positive Phase III trial results showing the vaccine's efficacy and safety in this age group. GSK is also seeking approval in other regions and plans to report on trials for younger and immunocompromised adults later in 2024.