GSK's Arexvy Gets the Green Light in Europe: First-Ever RSV Vaccine in Europe for Older Adults

The European Commission has approved GSK plc's GSK Arexvy (respiratory syncytial virus vaccine, adjuvanted) for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. 

Last month, the FDA approved the vaccine, making it the first RSV vaccine for older adults to be approved worldwide.

RSV is a common, contagious respiratory virus that leads to over 270,000 hospitalizations and approximately 20,000 in-hospital deaths each year in adults aged 60 years and over in Europe.

This is the first time an RSV vaccine for older adults has been granted European Marketing Authorization. The first launches are planned for the 2023/2024 RSV season, which typically starts in the autumn.

Efforts to develop an effective RSV vaccine have been impeded since the virus's initial discovery in 1956 due to the intricate molecular composition of the virus and the safety concerns associated with previous vaccine attempts.

The company does not expect a significant rollout in Europe this year, GSK's chief commercial officer Luke Miels told Reuters last month.

Pfizer Inc PFE and GSK are running a tight race to tap into the RSV vaccine market. Analysts say the market is estimated to be over $5 billion and could exceed $10 billion by 2030.

Price Action: GSK shares are up 0.17% at $34.67 during the premarket session on the last check Wednesday.