Valneva Withdraws Chikungunya Vaccine IXCHIQ Applications In U.S. Amid FDA Suspension

Core Viewpoint - Valneva SE has voluntarily withdrawn its biologics license application and Investigational New Drug application for its chikungunya vaccine, IXCHIQ, in the United States due to regulatory challenges and safety investigations [1][2]. Regulatory Actions - The U.S. FDA suspended the vaccine's license in August 2025, leading Valneva to await further guidance on its response [2]. - The FDA has placed the IND on clinical hold pending an investigation into a newly reported foreign Serious Adverse Event (SAE) [2]. Clinical Studies and Safety - Currently, no clinical studies involving IXCHIQ are actively vaccinating participants [3]. - Valneva intends to proceed with planned post-marketing clinical activities, subject to discussions with regulatory authorities [3]. Serious Adverse Event Investigation - The SAE under investigation occurred outside the U.S. and involved a younger adult who received three concomitant vaccines, including IXCHIQ [4]. - The case may be plausibly related to IXCHIQ vaccination, although causality has not been determined [4]. - The company is actively seeking additional details to further characterize the case [4]. Commitment to Safety - Valneva emphasizes its commitment to the highest safety standards and continues to engage proactively with authorities in all territories where IXCHIQ is licensed, including Europe, Canada, the United Kingdom, and Brazil [5]. Vaccine Target and Profile - IXCHIQ is targeted at travelers to regions where the chikungunya virus is endemic, such as tropical and subtropical areas in Asia, Africa, and the Americas [6]. - Valneva maintains that IXCHIQ's benefit-risk profile remains favorable for individuals living in endemic and outbreak settings, highlighting its unique positioning as a highly durable single-shot vaccine [6].