GSK announces EMA CHMP recommended expanding approval of RSV vaccine

GSK announced that the European Medicines Agency’s, EMA, Committee for Medicinal Products for Human Use, CHMP, has recommended expanding the approval of GSK‘s respiratory syncytial virus, RSV, vaccine for the prevention of lower respiratory tract disease, LRTD, caused by RSV from adults aged 60 and above to include adults aged 50-59 years at increased risk for RSV disease. Today’s positive opinion is the first time that an indication for adults aged 50-59 has been recommended by CHMP for a RSV vaccine, one of the final steps prior to the extension of the marketing authorisation by the European Commission. The European Commission’s final decision is expected by September 2024. GSK’s RSV vaccine was approved by the US FDA for adults aged 50-59 at increased risk on 7 June 2024. GSK has also filed regulatory submissions to expand the use of its RSV vaccine to adults aged 50-59 at increased risk in Japan and other geographies with regulatory decisions undergoing review.