Valneva SE (VALN), a specialty vaccine company, announced that it has voluntarily withdrawn both the biologics license application (BLA) and Investigational New Drug (IND) application for its chikungunya vaccine, IXCHIQ, in the United States.
The decision follows the suspension of the vaccine's license by the U.S. Food and Drug Administration (FDA) in August 2025. Valneva had been awaiting further guidance on its formal response to the suspension but was recently informed that the FDA has placed the IND on clinical hold pending investigation of a newly reported foreign Serious Adverse Event (SAE).
Currently, no clinical studies involving IXCHIQ are actively vaccinating participants. Valneva stated that it intends to proceed with planned post-marketing clinical activities, subject to further discussions with regulatory authorities.
The SAE under investigation occurred outside the United States and involved a younger adult who received three concomitant vaccines, including IXCHIQ. According to the information available to Valneva, which has been submitted to the U.S. Vaccine Adverse Event Reporting System (VAERS) and other pharmacovigilance systems, the case may be plausibly related to IXCHIQ vaccination, though causality has not been determined. The company is actively seeking additional details to further characterize the case.
Further, Valneva emphasized its commitment to the highest safety standards and continues to engage proactively with health authorities in all territories where IXCHIQ is licensed, including Europe, Canada, the United Kingdom, and Brazil.
While the vaccine is currently targeted at travelers to regions where the chikungunya virus is endemic, such as tropical and subtropical areas in Asia, Africa, and the Americas, Valneva maintains that IXCHIQ's benefit-risk profile remains favorable for individuals living in endemic and outbreak settings. The company highlighted IXCHIQ's unique positioning as a highly durable single-shot vaccine.
Chikungunya virus (CHIKV) is a mosquito-borne viral disease spread by the bites of infected Aedes mosquitoes, which causes fever, severe joint and muscle pain, headache, nausea, fatigue, and rash. Joint pain is often debilitating and can persist for weeks to years.
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