GSK plc (LSE/NYSE: GSK) has announced that the European Commission has authorized Arexvy, a recombinant adjuvanted respiratory syncytial virus (RSV) vaccine, for active immunization to prevent lower respiratory tract disease (LRTD) caused by RSV in adults aged 50-59 who are at increased risk. This marks an expansion of the vaccine’s approval in Europe, where it has been authorized since June 2023 for use in adults aged 60 and over for the prevention of RSV-LRTD.
Adults with underlying health conditions, such as chronic obstructive pulmonary disease (COPD), asthma, heart failure, and diabetes, are at a higher risk of severe outcomes from RSV infection compared to those without these conditions. RSV can worsen these underlying conditions, leading to complications like pneumonia, hospitalization, or even death.
There are approximately 65 million adults aged 50-59 in the European Union/European Economic Area, with an estimated 20 million of these individuals (around one-third) having at least one underlying medical condition that increases their risk of severe RSV disease.
Tony Wood, Chief Scientific Officer at GSK, commented, “The approval of Arexvy for this broader age group underscores the importance of extending the benefits of RSV immunization to adults aged 50-59 who are at increased risk. RSV can significantly impact the health of older adults, especially those with pre-existing conditions, which can also add pressure on healthcare systems. As we approach the RSV season, we are proud to be the first to offer a vaccine that can help protect more people in Europe from RSV-LRTD.”
The regulatory approval was based on positive results from a phase III trial that evaluated the immune response and safety of GSK’s RSV vaccine in adults aged 50-59, including those at higher risk of RSV-LRTD due to underlying medical conditions.
Professor Dr. Tino F. Schwarz from Klinikum Würzburg Mitte in Würzburg, Germany, highlighted the significance of the vaccine extension, stating, “Many patients in the 50-59 age group with certain underlying medical conditions are at increased risk for severe RSV infection. These patients are likely to benefit from the expanded age indication of the RSV vaccine, which could help reduce the burden of RSV-associated LRTDs. I hope that the NITAGs in Europe will quickly adapt the vaccination recommendations to include these patients.”
Beyond the approvals in Europe and the United States, GSK has also submitted regulatory applications to extend the vaccine’s use to at-risk adults aged 50-59 in Japan and other regions, with decisions currently under review. Further trials assessing the immunogenicity and safety of the vaccine in adults aged 18-49 at increased risk and immunocompromised adults aged 18 and older are expected to yield results later in 2024.
