The expanded approval means Arexvy is now indicated for all adults aged 60 and older, and adults aged 18–59 at increased risk for LRTD caused by RSV.
RT’s Three Key Takeaways:
- FDA Expands RSV Vaccine Eligibility: The FDA expanded approval of Arexvy to include adults aged 18–49 who are at increased risk of severe disease from Respiratory syncytial virus.
- Targets Younger High-Risk Adults: This update builds on prior approvals for older adults and aims to protect younger individuals with conditions such as chronic heart or lung disease, obesity, or diabetes—groups that account for many RSV-related hospitalizations.
- Supported by Clinical Trial Data: The decision was based on Phase III trial results showing a comparable immune response to older adults, with a consistent safety profile including common side effects like injection site pain, fatigue, and headache.
The US FDA has expanded the approved age indication of Arexvy (RSV vaccine, [adjuvanted]) to adults aged 18 to 49 years at increased risk for lower respiratory tract disease (LRTD) caused by RSV, according to manufacturer GSK.
Arexvy was previously approved in the US for the prevention of RSV-related LRTD in adults aged 60 and older, and adults aged 50–59 at increased risk for LRTD caused by RSV. This vaccine is not for use in pregnant individuals, the company says.
“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.
The annual RSV burden among US adults aged 18–49 years is about 17,000 hospitalizations, 277,000 emergency department admissions, and 1.97 million outpatient visits.2† Most hospitalizations in younger adults occur in those with chronic medical conditions which place them at increased risk for severe RSV disease (e.g. chronic cardiopulmonary, kidney or renal disease, obesity and diabetes).2†
The FDA’s decision was supported by data from a Phase IIIb trial (NCT06389487) demonstrating a non-inferior immune response compared to adults aged 60 years and above.3 Vaccine efficacy was demonstrated in the earlier Phase III trial (NCT04886596).4 The safety profile was consistent with findings from the broader Phase III program that supported the initial US approval, with the most common adverse events being injection site pain, fatigue, myalgia, headache, and arthralgia within four days of vaccination.3
GSK continues to advance regulatory submissions for its RSV vaccine across multiple geographies to expand availability and support long-term growth objectives.
Respiratory Syncytial Virus vaccine (adjuvanted) contains recombinant RSV glycoprotein F stabilised in the prefusion conformation (RSVPreF3). This antigen is combined with GSK’s proprietary AS01E adjuvant before administration.
The use of this vaccine should be in accordance with official recommendations. As with any vaccine, a protective immune response may not be elicited in all vaccinees.
The vaccine has been approved for the prevention of RSV-LRTD in individuals 60 years of age and older in 70 countries. In addition, it is approved for use in individuals aged 50–59 who are at increased risk due to certain underlying medical conditions in more than 60 countries. In the European Economic Area it is approved for adults aged 18 years and older.
The GSK proprietary AS01 adjuvant system contains STIMULON QS-21 adjuvant licensed from Antigenics LLC, a wholly owned subsidiary of Agenus Inc. STIMULON is a trademark of SaponiQx Inc., a subsidiary of Agenus.
References: See https://www.gsk.com/en-gb/media/press-releases/gsk-s-rsv-vaccine-arexvy-approved-in-us-for-expanded-age-indication-in-adults-aged-18-49-years-at-increased-risk/
Image: Arexvy RSV vaccine GSK https://www.businesswire.com/news/home/20230503005829/en/US-FDA-Approves-GSK%E2%80%99s-AREXVY-the-World%E2%80%99s-First-Respiratory-Syncytial-Virus-RSV-Vaccine-for-Older-Adults
