GSK PLC, the London-based pharmaceutical giant, announced today that its respiratory syncytial virus (RSV) vaccine, Arexvy, has been accepted for regulatory review by the European Medicines Agency (EMA) to expand its use to adults aged 18 years and older.
This development marks a significant step forward for the vaccine, which is already a pioneering treatment in the fight against RSV, a common contagious virus impacting an estimated 64 million people globally each year.
Arexvy holds the distinction of being the first RSV vaccine approved in the European Economic Area for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 and older, as well as for those aged 50 to 59 who are at increased risk due to underlying medical conditions. RSV can exacerbate certain health issues, leading to severe illness, hospitalization, and even death, making the potential expansion of Arexvy’s application a critical advancement in public health.
The EMA is expected to deliver a regulatory decision on this expanded use in the first half of 2026, according to GSK. If approved, Arexvy would become available to a much broader adult population across Europe, addressing a significant unmet need for RSV prevention among younger adults. GSK is also actively pursuing expanded indications for Arexvy in other key markets, including the United States and Japan, signaling a global push to combat the virus.
The vaccine itself, an adjuvanted recombinant formulation containing RSV glycoprotein F stabilized in the prefusion conformation (RSVPreF3) combined with GSK’s proprietary AS01E adjuvant, has been approved in over 60 countries for older adults and in more than 50 markets for at-risk individuals aged 50-59. Despite its proven efficacy, GSK notes that, as with any vaccine, a protective immune response may not be elicited in all recipients.
This regulatory milestone comes as GSK’s shares traded slightly lower at 1,544.50 pence in London on Friday morning, against a backdrop of a 0.6% decline in the wider FTSE 100 index. As the review process unfolds, GSK continues to position itself at the forefront of RSV prevention, potentially transforming the landscape of respiratory health across Europe and beyond.
