GSK’s RSV Vaccine, Arexvy, Poised for Broader EU Approval

GSK plc (LSE/NYSE: GSK) is nearing an expansion of its respiratory syncytial virus (RSV) vaccine, Arexvy, following a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).

The recommendation supports extending the vaccine's use to all adults aged 18 and older.

The European Commission's final decision is anticipated in February 2026. If approved, this expanded indication would make Arexvy available to a significantly larger population, potentially impacting GSK's revenue stream in the coming years.

Currently, Arexvy is approved in Europe for adults aged 60 and older, as well as those aged 50-59 at increased risk of RSV disease. The potential expansion addresses a considerable health burden, as approximately 158,000 adults aged 18 and over are hospitalized annually in the EU due to RSV infections.

GSK's focus on innovation and expanding access to vaccines is a key driver of its growth strategy. The company's commitment to developing and commercializing vaccines for a wider range of adult populations is evident in its ongoing efforts to secure regulatory approvals in various geographies.

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

“GSK is dedicated to increasing access to our vaccines in broader adult populations and we continue to drive innovation to help make it easier for healthcare professionals to offer protection against severe RSV disease.”