Novavax begins Phase 3 trial for RSV vaccine

Clinical-stage biopharmaceutical company Novavax said Monday it has started a Phase 3 clinical trial of its vaccine for the protection against respiratory syncytial virus (RSV) in older adults.

RSV is a widespread disease that causes respiratory tract infections and affects approximately 2.5 million older adults in the United States each year. It is responsible for 14,000 deaths and 177,000 hospitalizations annually among adults older than 65.

Novavax's Phase 3 study, known as the Resolve trial, will access the efficacy of the RSV F-protein nanoparticle vaccine in the prevention of moderate to severe lower respiratory tract disease caused by RSV. More than 11,000 older adults throughout the country are participating in the randomized study.

“We have taken advice and recommendations from the FDA (Food and Drug Administration), along with numerous key opinion leaders and clinical experts, to design the Resolve trial to align with and build on the strength of our previous clinical results,” Novavax President and CEO Stanley Erck said. "The Resolve trial takes Novavax one step closer to bringing this important vaccine to licensure, years ahead of other RSV vaccine development efforts.”

Novavax released the results of its Phase 2 trial in August, which showed the vaccine to be statistically significantly effective in preventing all symptoms of RSV disease, including lower respiratory tract infections, in older adults.