LONDON (dpa-AFX) - GSK plc (GSK, GSK.L) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the expansion of the indication for its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine, Arexvy, to include all adults aged 18 years and older.
A final decision from the European Commission is expected in February 2026. If approved, this expanded indication would make Arexvy available to all adults 18+, broadening access beyond the current approvals.
Arexvy was the first RSV vaccine approved in Europe for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 and older, as well as those aged 50-59 at increased risk of RSV disease.
RSV is a common contagious virus affecting the lungs and breathing passages and impacts an estimated 64 million people of all ages globally every year. RSV can exacerbate certain medical conditions, and lead to severe illness resulting in hospitalisation and even death.
GSK is continuing to seek expanded indications for its RSV vaccine in other geographies including the US and Japan.
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