Global biopharma giant GSK has announced a major expansion of its Respiratory Syncytial Virus (RSV) vaccine Arexvy, with the US FDA now approving use for adults aged 18–49 at increased risk for lower respiratory tract disease (LRTD) caused by RSV.

 

Previously, Arexvy was authorized for adults 60 and older, and for those 50–59 with heightened risk. The vaccine remains not for use in pregnant individuals.

 

“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, and help ease pressure on the healthcare system,” said Sanjay Gurunathan, GSK Head of Vaccines and Infectious Diseases Research and Development. “We are proud of this latest step in our strategy to bring RSV prevention to broader adult populations.”

 

RSV poses a substantial burden on younger adults, causing roughly 17,000 hospitalizations, 277,000 emergency department visits, and 1.97 million outpatient visits annually in the 18–49 age group. Hospitalizations are mostly seen in adults with chronic conditions such as cardiopulmonary disease, kidney disease, obesity, or diabetes.

 

The FDA’s approval was backed by data from a Phase IIIb trial showing a non-inferior immune response compared with adults aged 60 and older. Earlier Phase III results had already demonstrated vaccine efficacy. The safety profile remains consistent with prior studies, with the most common side effects being injection site pain, fatigue, myalgia, headache, and arthralgia occurring within four days of vaccination.

 

Arexvy contains recombinant RSV glycoprotein F stabilized in prefusion form (RSVPreF3), combined with GSK’s proprietary AS01E adjuvant. The vaccine has already been approved in 70 countries for adults 60+, and in over 60 countries for adults 50–59 at increased risk. In the European Economic Area, it is approved for all adults 18 and older.