GSK’s RSV Vaccine Arexvy Gains Positive CHMP Approval for Adults 18+

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GSK’s RSV Vaccine Arexvy Gains Positive CHMP Approval for Adults 18+

GSK plc announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive recommendation for the expansion of its RSV vaccine, Arexvy, to include all adults aged 18 years and older. The final decision by the European Commission is expected in February 2026.

Importance of Arexvy’s Approval for Adults

Currently, Arexvy is approved for preventing lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 60 and older. It is also available for individuals aged 50-59 who are at increased risk for RSV due to underlying medical conditions.

Hospitalizations: In the European Union, approximately 158,000 adults over 18 are hospitalized each year due to RSV-related illnesses.
Global Impact: RSV affects an estimated 64 million individuals of all ages worldwide annually.

Sanjay Gurunathan, GSK’s Head of Vaccines and Infectious Diseases Research and Development, emphasized that this positive CHMP opinion is a significant step toward providing more preventive options against severe RSV disease for adults in Europe.

Health Risks Associated with RSV

RSV is a highly contagious virus impacting the lungs and respiratory system. It can exacerbate conditions like COPD, asthma, and chronic heart failure. For adults, the risks associated with RSV include:

Higher likelihood of severe complications.
Increased treatment costs.
Higher fatality rates than children.

Despite this, the number of hospitalizations among adults may be underestimated due to a lack of routine testing.

Future Plans for GSK’s RSV Vaccine

GSK is actively pursuing expanded indications for Arexvy in other countries, including the United States and Japan. The vaccine features an adjuvanted recombinant form of the RSV glycoprotein F, targeting enhanced immunity against severe disease.

As the landscape for adult vaccinations evolves, GSK remains committed to increasing access and driving innovation in RSV prevention.