TL/DR –
GSK has submitted an application to the US FDA to expand the indication of its respiratory syncytial virus (RSV) vaccine, Arexvy, to adults aged 18-49 who are at increased risk for severe RSV infection. The FDA has accepted the application for review, with a decision expected in H1 2026. This submission comes after a successful Phase IIIb trial showing positive immune response and safety outcomes in this population and aims to address the approximated 21 million U.S. adults under 50 with at least one risk factor for severe RSV infection.
US FDA to Review Extended Indication Application for GSK’s Respiratory Syncytial Virus Vaccine
GSK announced that the US FDA is reviewing an application to expand the use of its Arexvy (respiratory syncytial virus (RSV) vaccine, adjuvanted) for adults aged 18-49 at increased risk. Currently, Arexvy is approved for preventing lower respiratory tract disease (LRTD) due to RSV in adults aged 60 and above and those aged 50-59 years at increased risk.
RSV is a contagious virus affecting around 64 million individuals globally, including an estimated 21 million Americans under 50 with at least one risk factor for severe RSV infection, such as COPD, asthma, heart failure, and CHD. It can worsen existing medical conditions and cause severe illness that may lead to hospitalisation or death.
The FDA’s review is backed by positive Phase IIIb data demonstrating immune response and safety in the 18-49 age group at risk. These safety profiles align with results from the original phase III study that approved the vaccine’s use in the US. The FDA’s decision is expected in H1 2026. Moreover, GSK is also seeking expanded indications for the RSV vaccine in other regions such as Europe and Japan.
GSK’s RSV Vaccine
The RSV vaccine comprises a recombinant RSV glycoprotein F stabilized in prefusion conformation (RSVPreF3) with GSK’s proprietary AS01E adjuvant. It is approved for preventing RSV-LRTD in individuals 60 years and older and those aged 50-59 at increased risk in over 60 countries and 50 markets including the US, Japan, and Europe. Users must follow the official recommendations for the vaccine.
About NCT06389487 Trial
The NCT06389487 is a phase IIIb study that evaluated the immune response and safety of GSK’s RSV vaccine in adults aged 18-49 at increased risk compared to those aged 60 and above. The study involved 1,458 participants across 52 locations in six countries.
RSV in Adults
RSV impacts an estimated 64 million people globally every year. Adults with certain comorbidities, compromised immune systems, or advancing age are at higher risk of RSV disease, which can worsen conditions like COPD, asthma, and heart failure, leading to severe outcomes including pneumonia, hospitalisation, and death.
Forward-Looking Statements
GSK warns investors about forward-looking statements or projections and potential risks and uncertainties that may cause actual results to vary from projections. Refer to the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2024, and GSK’s Q1 Results for 2025.
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