Also known as: Arexvy
Arexvy is an adjuvanted respiratory syncytial virus (RSV) vaccine used for active immunization against RSV-associated lower respiratory tract disease in eligible adults. It was first approved in the U.S. in 2023 and has subsequently expanded to include adults 18 through 59 years at increased risk. The product is administered as a single intramuscular dose after reconstitution.
The FDA has expanded approval of GSK's Arexvy RSV vaccine to include adults aged 18 to 49 years at increased risk for lower respiratory tract disease, based on phase 3b trial data showing noninferior immune response.
GSK's RSV vaccine Arexvy received expanded FDA approval to cover all high-risk adults, adding approximately 21 million Americans under 50 to the eligible population and matching competitor approvals from Pfizer and Moderna.
New real-world effectiveness data presented at RSVVW'26 demonstrate that GSK's Arexvy RSV vaccine was associated with a 75.6% reduction in RSV-related hospitalizations among adults aged 60 and older, with exploratory findings suggesting potential benefits for cardiovascular and respiratory complications.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06843317 |
Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults |
RECRUITING | PHASE1 |
| NCT06194318 |
First-in-human Safety and Immunogenicity Study of SCB-1019 and SCB-1019T in Healthy Adults |
COMPLETED | PHASE1 |
