The FDA has expanded the approved age indication of GSK’s RSV vaccine Arexvy to adults aged 18–49 who are at increased risk for RSV-related lower respiratory tract disease.
Written By: Samiksha Jadhav BPharm
Reviewed By: Pharmacally Editorial Team
The US Food and Drug Administration (FDA) has expanded the approved age indication of GSK’s RSV vaccine Arexvy to include adults aged 18 to 49 years who are at increased risk for lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV).
The vaccine was previously approved in the United States for the prevention of RSV-related LRTD in adults aged 60 years and older, and in adults aged 50–59 years with certain underlying risk factors.
According to GSK, the expanded indication aims to address the unmet medical need among younger adults who face a higher risk of severe RSV disease due to chronic health conditions. The vaccine is not indicated for use during pregnancy.
Sanjay Gurunathan, Head of Vaccines and Infectious Diseases Research and Development at GSK, said the decision supports the company’s strategy to broaden RSV prevention in adult populations. He noted that expanding eligibility could help protect vulnerable individuals and reduce pressure on healthcare systems during RSV seasons.
RSV continues to impose a significant burden on younger adults in the United States. Each year, RSV infection in adults aged 18–49 is associated with approximately 17,000 hospitalisations, 277,000 emergency department visits, and nearly 2 million outpatient visits. Most severe cases occur in individuals with chronic conditions such as cardiopulmonary disease, kidney disease, obesity, or diabetes, which increase the risk of serious RSV complications.
The FDA’s decision was supported by results from the Phase IIIb trial (NCT06389487), which evaluated immune responses and safety in adults aged 18–49 at increased risk for RSV-related LRTD. The study showed that the immune response in this group was non-inferior to that observed in adults aged 60 years and older following a single dose of the vaccine.
Evidence of vaccine efficacy had previously been demonstrated in the Phase III AReSVi-006 trial (NCT04886596), which formed the basis of the original regulatory approvals.
Safety findings in the Phase IIIb trial were consistent with the broader clinical development programme. The most commonly reported adverse reactions included injection-site pain, fatigue, myalgia, headache, and arthralgia, typically occurring within four days after vaccination and generally mild to moderate in severity.
Arexvy contains a recombinant RSV glycoprotein F antigen stabilised in the prefusion conformation (RSVPreF3) combined with GSK’s AS01E adjuvant system, designed to enhance the immune response. The vaccine is currently approved in 70 countries for adults aged 60 years and older, and in more than 60 countries for adults aged 50–59 at increased risk. In the European Economic Area, the vaccine is authorised for adults aged 18 years and older.
Respiratory syncytial virus is a highly contagious respiratory pathogen that infects an estimated 64 million people worldwide each year. While often associated with infants, RSV can also cause severe disease in adults, particularly those with weakened immunity or chronic health conditions. In vulnerable populations, infection can lead to pneumonia, hospitalisation, and increased mortality, highlighting the need for expanded preventive strategies.
GSK said it continues to pursue additional regulatory submissions globally to broaden access to its RSV vaccine and support long-term growth in adult immunisation programs.
References
GSK’s RSV vaccine, Arexvy, approved in US for expanded age indication in adults aged 18–49 years at increased risk, 13 March 2026, GSK’s RSV vaccine, Arexvy, approved in US for expanded age indication in adults aged 18–49 years at increased risk | GSK
A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and Above, ClinicalTrials.gov ID NCT06389487, https://clinicaltrials.gov/study/NCT06389487
Efficacy Study of GSK’s Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above, ClinicalTrials.gov ID NCT04886596, https://clinicaltrials.gov/study/NCT04886596
About the Writer
Samiksha Vikram Jadhav is a B.Pharm graduate with a strong academic foundation in pharmaceutical sciences, pharmacology, and drug development. She has a keen interest in healthcare advancements, clinical research, medical writing, and emerging therapies. Her work focuses on presenting developments in the pharmaceutical and healthcare sectors through clear and accurate scientific communication.