The US FDA has granted approval for the first respiratory syncytial virus (RSV) vaccine to be marketed under the name of Arexvy. It is indicated for use in older adults, ≥60 years, to prevent lower respiratory tract disease caused by RSV.1 Arexvy is an adjuvanted RSV prefusion F protein-based vaccine.

“RSV is a highly contagious virus”, notes the FDA. It causes infections of the airways and lungs. The infection is seasonal, typically starting during the fall and peaking in the winter.

The approval was granted based on the results of the ongoing phase III AReSVi-006 (Adult Respiratory Syncytial Virus) trial involving nearly 25,000 persons aged 60 years and older. The trial examined the safety and effectiveness of a single dose of the vaccine compared to placebo. Administration of the vaccine reduced the risk of RSV-associated lower respiratory tract disease by 82.6%. The risk of developing severe infection also declined by 94.1%. The trial will continue for three seasons for RSV infections to assess efficacy and safety of a repeat dose of the vaccine. These data are from the first RSV season of the study.  

Injection site pain, headache, muscle pain, fatigue, and joint stiffness/pain were the most frequently occurring side effects. Ten patients in the vaccine group suffered atrial fibrillation vs 4 in the placebo group.

Reference

FDA News Release. https://www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine. May 3, 2023. Accessed on: May 4, 2023.