Wolfgang Bender, MD, PhD, chief medical officer of Valneva, commented, “Chikungunya is a growing threat with unpredictable outbreaks and a serious impact on public health. Infection with the virus can cause serious symptoms and complications. The fast track designation will allow us to work closely with the FDA and to accelerate our efforts to develop a one dose solution for the prevention of this spreading disease.”
Fast Track designation is granted by the FDA to products under development for serious conditions that have the potential to fulfill an unmet medical need. Fast Track is designed to facilitate the clinical development and expedite the review of new drugs and vaccines with the intention of accelerating the availability of promising products on the market.
Valneva will release VLA1553’s initial Phase 1 data in the coming weeks.