GSK plc’s adjuvanted recombinant respiratory syncytial virus (RSV) vaccine, Arexvy, has received approval from the European Commission for use in all adults aged 18 years and older.
The vaccine was previously authorised in adults aged 60 and above, as well as in those aged 50–59 who are at increased risk for RSV-related disease. The updated approval now allows European countries to offer the vaccine to the entire adult population.
RSV is a contagious virus that affects the lungs and respiratory tract, causing lower respiratory tract disease (LRTD). In the European Union, an estimated 158,000 adults are hospitalised annually due to RSV infections. Hospitalised adults are at higher risk of severe complications, face increased treatment costs, and have a higher fatality rate compared to children. The true number of cases is likely underreported due to limited routine testing.
Arexvy contains a recombinant RSV glycoprotein F stabilised in the prefusion conformation (RSVPreF3) combined with GSK’s proprietary AS01E adjuvant. It is already approved in more than 65 countries for adults aged 60 and older and in over 60 countries for adults aged 50–59 with underlying medical conditions, including in the US and Japan.
Globally, RSV affects an estimated 64 million people annually, with adults at increased risk due to chronic conditions, immunocompromised status, or advanced age. RSV infection can worsen conditions such as COPD, asthma, and chronic heart failure, and may lead to severe outcomes including pneumonia, hospitalisation, and death.
The vaccine is intended for the prevention of RSV-LRTD in adults and should be used in accordance with official recommendations. While it provides protection against RSV, a full immune response may not occur in all individuals. GSK continues to pursue expanded indications for Arexvy in other regions, including the United States and Japan.
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