Currently Enrolling Trials
Arexvy is specifically indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in individuals 60 years of age and older.
Arexvy is supplied as a suspension for intramuscular injection. It is administered as a single dose (0.5 mL).
Mechanism of Action
Arexvy contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK’s proprietary AS01E adjuvant. The vaccine induces an immune response against RSVpreF3 that protects against LRTD caused by RSV.
Adverse effects associated with the use of Arvexy may include, but are not limited to, the following:
- injection site pain
Clinical Trial Results
FDA approval was based AReSVi-006 (Adult Respiratory Syncytial Virus) phase 3 trial data. In the trial, the vaccine showed statistically significant and clinically meaningful overall efficacy of 82.6% against RSV-LRTD in adults aged 60 years and older, meeting the primary endpoint. In addition, efficacy was 94.6% in older adults with at least one underlying medical condition, including certain cardiorespiratory and endocrine-metabolic conditions. Efficacy against severe RSV-LRTD, defined as an RSV-associated LRTD episode preventing normal, everyday activities, was 94.1%.