GSK plc (LSE:GSK) said on Friday that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a favourable opinion recommending that the use of its RSV vaccine, Arexvy, be extended to include all adults aged 18 years and above.

A final regulatory decision from the European Commission is anticipated in February 2026. Should approval be granted, Arexvy would become available for the prevention of RSV disease in the entire adult population aged 18 and over.

Arexvy was previously authorised in Europe as the first RSV vaccine for the prevention of lower respiratory tract disease caused by respiratory syncytial virus in adults aged 60 and older, as well as in individuals aged 50 to 59 who are considered at higher risk of severe RSV illness.

“Today’s positive CHMP opinion is an important step towards bringing more options to prevent severe RSV disease for adults in Europe,” said Sanjay Gurunathan, GSK Head of Vaccines and Infectious Diseases Research and Development.

Respiratory syncytial virus is a widespread and highly contagious virus that affects the lungs and airways, with an estimated 64 million infections worldwide each year. Within the European Union, RSV leads to an average of around 158,000 hospital admissions annually among adults aged 18 and above.

Adults admitted to hospital with RSV are more likely than children to experience serious complications, incur higher treatment costs, and face increased mortality rates. The actual scale of adult RSV infections may be higher than reported, as routine testing is not consistently performed.

Globally, the vaccine has already received approval in more than 65 countries for use in people aged 60 and over. It is also authorised in over 55 countries, including the United States, Japan and European markets, for individuals aged 50 to 59 who have certain underlying health conditions that increase their risk.

GSK said it continues to pursue broader regulatory approvals for Arexvy in additional markets, including the US and Japan.

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