All articles tagged with #ixchiq
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.
The U.S. Food and Drug Administration (FDA) has approved Ixchiq, the first vaccine for chikungunya virus, a mosquito-borne disease. The vaccine is approved for individuals aged 18 and older who are at increased risk of exposure to the virus. Chikungunya is a global health threat with millions of reported cases in the past 15 years. The most common symptoms include fever and joint pain, and some individuals may experience prolonged joint pain. Ixchiq is administered as a single dose injection and contains a weakened version of the virus. The vaccine's safety was evaluated in clinical studies, and the most commonly reported side effects were headache, fatigue, and muscle pain. The FDA is requiring a postmarketing study to assess the risk of severe adverse reactions. The vaccine's effectiveness is based on immune response data, and confirmatory clinical studies will be conducted.