GSK plc has received approval from the European Commission (EC) to expand the use of its Respiratory Syncytial Virus (RSV) vaccine, Arexvy, to adults aged 18 years and older. The decision broadens access to the vaccine across Europe, enabling countries to offer protection against RSV-related Lower Respiratory Tract Disease (LRTD) to all adults.

Arexvy was the first RSV vaccine authorised in the European Economic Area and was initially approved for adults aged 60 years and above, as well as individuals aged 50–59 who are at increased risk of RSV disease. The updated indication significantly expands eligibility and strengthens RSV prevention efforts among younger adult populations.

Commenting on the approval, Sanjay Gurunathan, Head of Vaccines and Infectious Diseases R&D at GSK, said, “The decision marks an important step in protecting adults against RSV, a potentially serious respiratory infection that can lead to hospitalisation and severe complications, particularly in people with underlying health conditions.”

In the European Union alone, an estimated 158,000 adults aged 18 years and older are hospitalised each year due to RSV infections. Adults admitted with RSV face a higher risk of severe outcomes, higher fatality rates and increased healthcare costs compared to children, while the overall disease burden is likely underreported due to limited routine testing.

Arexvy contains a recombinant RSV glycoprotein F antigen stabilised in the prefusion conformation (RSVPreF3), combined with GSK’s proprietary AS01E adjuvant system, which enhances immune response. As with all vaccines, protection may vary among individuals and use should follow official immunisation recommendations.

The vaccine is currently approved for adults aged 60 and above in more than 65 countries, and for individuals aged 50–59 at increased risk in over 60 countries, including the US and Japan. GSK is also pursuing expanded indications for Arexvy in additional markets, including the US and Japan.

RSV is a common and highly contagious virus that affects the lungs and respiratory tract, impacting an estimated 64 million people globally each year. Adults with chronic conditions, compromised immune systems or advanced age are at greater risk of severe disease, including pneumonia, hospitalisation and death.