Overview
- Valneva withdrew its U.S. biologics license application and Investigational New Drug filing for Ixchiq after the FDA suspended the vaccine’s license in August 2025.
- The FDA placed the Ixchiq IND on clinical hold pending an investigation into a newly reported serious adverse event that occurred outside the United States.
- Valneva says the case involved a younger adult who received three vaccines concurrently, including Ixchiq, and the report was submitted to VAERS and other pharmacovigilance systems.
- The company states the event may be plausibly related to vaccination but causality has not been determined, and it is seeking more information to further characterize the case.
- Valneva reports no studies are currently vaccinating participants, plans to pursue post‑marketing clinical activities pending regulatory discussions, and is engaging authorities in regions where the vaccine is licensed.