PHILADELPHIA, PA — GSK plc (NYSE: GSK) said the U.S. Food and Drug Administration has expanded approval of its RSV vaccine AREXVY to include adults ages 18 to 49 who are at increased risk for lower respiratory tract disease caused by respiratory syncytial virus.
The decision broadens eligibility beyond prior approvals covering adults 60 and older and those ages 50 to 59 at elevated risk, allowing younger high-risk populations to receive the vaccine.
The company said the expanded indication addresses a population with measurable disease burden, including an estimated 17,000 hospitalizations, 277,000 emergency department visits, and 1.97 million outpatient visits annually among U.S. adults ages 18 to 49.
Most hospitalizations in that age group occur in individuals with underlying conditions such as chronic cardiopulmonary disease, kidney disease, obesity, or diabetes.
GSK Head of Vaccines and Infectious Diseases Research and Development Sanjay Gurunathan said the approval could help address unmet medical need among younger adults with risk factors.
“This age expansion can help address a significant medical need for adults in the United States at higher risk of severe RSV disease due to certain underlying conditions,” Gurunathan said.
The FDA’s decision was supported by data from a Phase IIIb trial evaluating immune response and safety in adults ages 18 to 49 compared with those 60 and older.
The study met its primary endpoint, demonstrating a non-inferior immune response in the younger cohort.
Participants included individuals with stable chronic conditions associated with increased RSV risk, and the trial enrolled 1,458 participants across 52 sites in six countries, including 16 in the United States.
Safety findings were consistent with earlier studies, with the most common adverse events including injection site pain, fatigue, muscle pain, headache, and joint pain, typically occurring within four days of vaccination and described as mild to moderate.
AREXVY contains a recombinant RSV glycoprotein F antigen stabilized in its prefusion form and is combined with GSK’s AS01E adjuvant system to enhance immune response.
The vaccine is indicated for prevention of RSV-related lower respiratory tract disease in adults 60 and older and adults 18 to 59 who are at increased risk.
The company said the vaccine is not approved for use in pregnant individuals and should be administered in accordance with official recommendations, noting that protective immune responses may not occur in all recipients.
Globally, AREXVY has been approved for adults 60 and older in about 70 countries and for at-risk adults ages 50 to 59 in more than 60 countries.
In the European Economic Area, the vaccine is approved for adults ages 18 and older.
GSK said it continues to pursue regulatory submissions in additional markets to expand availability.
More information, including prescribing details, is available at https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Arexvy/pdf/AREXVY.PDF.
RSV is a common respiratory virus that affects the lungs and breathing passages and is estimated to impact 64 million people globally each year.
In adults, particularly those with underlying health conditions or compromised immune systems, RSV can lead to severe complications including pneumonia, hospitalization, and death.
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