All articles tagged with #chikungunya vaccine
The FDA has suspended the biologics license for Ixchiq, a live-attenuated chikungunya vaccine by Valneva, due to serious safety concerns including reports of chikungunya-like illness in some recipients, following its accelerated approval less than two years ago.
The U.S. Food and Drug Administration (FDA) has granted approval to Valneva SE for IXCHIQ®, the world's first chikungunya vaccine. The single-dose, live-attenuated vaccine is indicated for individuals aged 18 and older who are at increased risk of exposure to the chikungunya virus. The approval is based on accelerated approval, contingent upon verification of clinical benefit in confirmatory studies. Valneva plans to monetize the Priority Review Voucher received from the FDA to support its research and development programs.