Chikungunya vaccine candidate receives FDA Fast Track Designation

In a follow-up on Valneva’s Chikungunya vaccine candidate, the France based biotech company announced Friday that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for VLA1553.

VLA1553 is a monovalent, single dose, live-attenuated vaccine candidate for protection against chikungunya.

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.”

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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.

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Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea and rash, potentially developing into long-term, serious health impairments.