GSK has announced that the European Medicines Agency (EMA) is currently reviewing its application to expand the approved use of its respiratory syncytial virus (RSV) vaccine, Arexvy, to include adults aged 18 and older.
The move positions GSK to compete more effectively with other RSV vaccine makers, including Moderna’s recently approved mRESVIA and Pfizer’s Abrysvo. On Thursday, U.S. regulators authorised Moderna’s mRESVIA for at-risk adults between the ages of 18 and 59—broadening its eligible population beyond older adults.
RSV is a widespread seasonal virus that often causes cold-like symptoms but can result in severe illness such as pneumonia, particularly among infants and the elderly. Expanding access to effective vaccines is seen as critical in mitigating the virus’s health burden across different age groups.
Currently, Arexvy is approved in the European Union for adults aged 60 and above. It also holds authorisation for use in high-risk adults between 50 and 59. If granted, the new label expansion would significantly widen its reach and potential impact across the adult population.
The regulatory decision comes at a time when GSK is aiming to revitalise its vaccine sales. Arexvy generated £0.1 billion ($135.4 million) in revenue in the first quarter of 2025—a 57% year-on-year decline—falling short of expectations. The company had originally projected peak annual sales for the vaccine to reach £3 billion, but performance has lagged in recent quarters.
GSK stated that a final decision from the EMA on the expanded indication is expected in the first half of 2026.
