Valneva Withdraws U.S. Authorization Requests for Its Chikungunya Vaccine

License Suspension and Withdrawal Decision

Valneva reported that it made this decision following the suspension of its IXCHIQ vaccine license by the U.S. Food and Drug Administration (FDA) in August 2025. The company had been awaiting further information from the FDA regarding this suspension after having formally responded. The company was recently informed of a new decision by the U.S. agency to also suspend the clinical trial authorization (IND), pending information related to a new serious adverse event reported abroad. Valneva clarified that no clinical studies involving active administration of the IXCHIQ vaccine are currently underway. However, the laboratory plans to initiate the planned post-marketing clinical activities, subject to further discussions with the relevant regulatory authorities.

Reported Serious Adverse Event

According to the statement, the serious adverse event was reported outside the United States and involved a young adult who had received three different vaccines concurrently, including IXCHIQ. Based on the information available, which has been submitted to the U.S. Vaccine Adverse Event Reporting System (VAERS) and all pharmacovigilance systems in accordance with the product's license, the event could be related to vaccination with IXCHIQ, but causality has not yet been determined, according to the company. The company indicates that it is actively seeking additional data to better analyze this event. Valneva remains committed to adhering to the strictest safety standards and to proactively communicating with health authorities in all territories where IXCHIQ is approved, including Europe, Canada, the United Kingdom, and Brazil.

Vaccine Use and Market Potential

According to the laboratory, while IXCHIQ is currently intended primarily for travelers going to regions where the virus is endemic, including tropical and subtropical areas of Asia, Africa, and the Americas, as well as for individuals for whom vaccination is medically justified, Valneva continues to believe that the benefit-risk profile of IXCHIQ remains favorable for populations living in endemic areas or in epidemic situations. In these contexts, IXCHIQ could stand out as a single-dose vaccine offering lasting protection, the group indicates. The vaccine remains marketed in several territories where it has been authorized. The company continues to assess the global potential of the product based on medical needs and commercial attractiveness.