The first respiratory syncytial virus (RSV) vaccine, adjuvanted, Arexvy, has been launched by GSK for preventing lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV).
The RSV virus is a common, contagious respiratory illness that is potentially serious.
An estimated 14,000 deaths among adults 65 years and older are caused by it in the US each year, with approximately 177,000 hospitalizations.
The majority of RSV hospitalizations occur in older adults with underlying medical conditions such as diabetes and chronic heart and lung disease.
The FDA approval was based on GSK's landmark pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial results.
This study showed 82.6% overall efficacy against RSV-LRTD in adults over 60 years of age, meeting the primary endpoint.
Efficacy was also 94.6% in older adults with underlying health conditions, such as cardiorespiratory disease and metabolic syndrome.
An RSV-associated LRTD episode that prevents normal, everyday activities was 94.1% effective. Overall, the vaccine was well tolerated with an acceptable safety profile.
The frequently reported expected side effects included mild to moderate and temporary symptoms such as pain at the injection site, fatigue, muscle pain, headaches, and joint pain.