The European Commission has granted approval to GSK's (NYSE:GSK) Arexvy, a vaccine against respiratory syncytial virus (RSV), to now include adults aged 50-59 who are at high risk of severe disease.
This follows its prior approval for use in adults aged 60 and over.
Tony Wood, GSK’s Chief Scientific Officer, welcomed the decision, stating, "Today's approval reflects the importance of broadening the benefits of RSV immunization to adults aged 50-59 who are at increased risk. As we enter the RSV season, we are pleased to be the first to deliver a vaccine to help protect more people in Europe from RSV-LRTD."
Professor Dr. Tino F. Schwarz from Klinikum Würzburg Mitte emphasized the health benefits this expansion could bring, noting that, "these patients are likely to benefit from the extension of the age indication of the RSV vaccine, helping to reduce the burden of disease of RSV-associated LRTDs."
In addition to the US and European approvals, GSK has also filed regulatory submissions to extend the use of this vaccine to adults aged 50-59 at increased risk, including in Japan and other geographies with regulatory decisions undergoing review.