GSK’s respiratory syncytial virus (RSV) vaccine Arexvy has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the prevention of lower respiratory tract disease caused by RSV in adults aged 18 years and older.
The opinion covers all adults, including those with underlying medical conditions that increase the risk of severe RSV disease, and will now be reviewed by the European Commission for a final, EU-wide marketing authorisation decision.
Arexvy is a recombinant RSV prefusion F protein–based vaccine formulated with GSK’s proprietary AS01 adjuvant system, which is designed to enhance immune responses in adult populations. The CHMP’s recommendation is based on data from GSK’s clinical development programme assessing the vaccine’s efficacy, immunogenicity and safety in adults across age groups, including individuals at increased risk of severe RSV outcomes.
RSV is recognised as a significant cause of lower respiratory tract disease in adults, not only in older populations but also in adults with underlying health conditions, where infection can lead to serious respiratory complications.
The positive CHMP opinion reflects the public health need for broader adult protection against RSV and supports expansion of the vaccine’s use beyond previously approved age groups. Following the CHMP recommendation, the European Commission will issue a legally binding decision applicable across all EU member states.
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