On May 3, the Food and Drug Administration (FDA) approved the first vaccine — Arexvy — for respiratory syncytial virus (RSV) to lower respiratory tract disease in people older than 60 years. This is the first RSV vaccine to be approved anywhere in the world.
The vaccine is manufactured by the company, GSK, and the FDA approval was based on a phase-3 trial carried out on nearly 25,000 participants. About 12,500 participants received one dose of the vaccine, while the remaining participants received a placebo. The trail showed that a single dose of the vaccine reduced the risk of people, older than 60 years, developing lower respiratory tract disease caused by the RSV virus by 82.6% and reduced the risk of developing severe disease by 94.1%.
The results were published in February in The New England Journal of Medicine.
