U.S. Markets closed

Novavax still plans to push RSV vaccine to market after failed trial

Sara Gilgore
Novavax still plans to push RSV vaccine to market after failed trial

It’s official: Novavax Inc. will have to complete another clinical trial for its respiratory syncytial virus vaccine candidate for infants, ResVax, lengthening its road to market by roughly three years following its failed phase 3 trial in March. The Gaithersburg biotech has received a letter from the Food and Drug Administration indicating another trial is required before it can earn clearance, said Novavax CEO Stanley Erck in an interview. “We are still heavily focused on RSV,” Erck said, adding: “Yes, it’s going to take a couple years longer and more money than we hoped." The news marks a pivotal moment for Novavax (NASDAQ: NVAX) as it works its way down the regulatory pathways in the U.S. and abroad after ResVax failed to prevent RSV in newborns through maternal immunizations at a high-enough rate in its late-stage trial.