Valneva Withdraws U.S. Regulatory Filings For IXCHIQ Chikungunya Vaccine, Halts U.S. Development Following FDA Safety Review

Valneva has announced its decision to voluntarily withdraw both the Biologics License Application (BLA) and Investigational New Drug (IND) application for its chikungunya vaccine, IXCHIQ®, in the United States. This move follows the FDA’s suspension of the vaccine’s license in August 2025 and a subsequent decision to place the IND on clinical hold after a newly reported serious adverse event (SAE) outside the U.S. Valneva said it had been awaiting further clarity from the FDA before taking this step.

The reported SAE involved a younger adult who received three vaccines simultaneously, including IXCHIQ®. While the case may plausibly be linked to the chikungunya vaccine, no definitive causal relationship has been established. Valneva has submitted all available information to the U.S. Vaccine Adverse Event Reporting System (VAERS) and other global pharmacovigilance systems and is actively working to gather additional details to better understand the event.

Currently, there are no ongoing clinical trials actively vaccinating participants with IXCHIQ® in the U.S. Despite the FDA actions, Valneva plans to proceed with its post-marketing clinical activities, subject to further discussions with regulatory authorities. The company continues to emphasize its commitment to patient safety and regulatory transparency.

Outside the United States, Valneva remains engaged with health authorities in regions where IXCHIQ® is approved, including Europe, Canada, the U.K., and Brazil. The company maintains that the vaccine’s benefit-risk profile remains favorable, particularly for individuals living in or traveling to chikungunya-endemic or outbreak regions, where a single-dose, durable vaccine could play a critical public health role.