Valneva has voluntarily withdrawn its US regulatory applications for its chikungunya vaccine, IXCHIQ, after the FDA suspended the license and placed the program on clinical hold pending investigation of a newly reported serious adverse event.
Valneva SE announced that it has withdrawn both the Biologics License Application (BLA) and Investigational New Drug (IND) application for its chikungunya vaccine, IXCHIQ, in the US. The decision follows the
The FDA’s latest action was prompted by a newly reported foreign Serious Adverse Event (SAE) involving a younger adult who received 3 vaccines at the same time, including IXCHIQ. While the case may be plausibly related to the chikungunya vaccine, Valneva emphasized that causality has not yet been established. The company has submitted all available information to the US Vaccine Adverse Event Reporting System (VAERS) and other global pharmacovigilance systems, and it continues to seek additional details to better understand the incident.
At present, no clinical studies involving IXCHIQ are actively vaccinating participants in the US. Despite the regulatory pause, Valneva plans to proceed with its post-marketing clinical activities, subject to discussions with relevant health authorities. These efforts are intended to further evaluate the vaccine’s safety and performance while maintaining alignment with regulatory expectations.
Valneva reiterated its commitment to maintaining the highest safety standards and confirmed ongoing engagement with regulators in all regions where IXCHIQ is currently licensed, including Europe, Canada, the United Kingdom, and Brazil. In these markets, the vaccine remains authorized for use in individuals at risk of chikungunya infection, particularly travelers to endemic regions such as tropical and subtropical areas of Asia, Africa, and the Americas.
Valneva withdrew its IXCHIQ BLA and IND after the FDA suspended the license and placed the program on clinical hold due to a reported SAE.
The adverse event occurred outside the US and involved multiple vaccines; causality has not yet been determined.
IXCHIQ remains licensed in several regions, with Valneva maintaining confidence in its benefit-risk profile for endemic and outbreak settings.
Chikungunya is a mosquito-borne viral disease that can cause severe joint pain, fever, and long-term disability. While the virus is most prevalent in endemic and outbreak-prone regions, international travel has increased the risk of exposure for non-residents as well. Valneva continues to believe that IXCHIQ® offers a favorable benefit-risk profile, especially for people living in endemic areas where the disease burden is highest.
The company highlighted the potential advantages of IXCHIQ® as a highly durable, single-shot vaccine, which could play an important role in outbreak response and long-term prevention strategies. However, the U.S. withdrawal reflects Valneva’s cautious approach in the face of regulatory uncertainty and ongoing safety evaluations.
As investigations continue, the future of IXCHIQ in the U.S. will depend on the outcome of the FDA’s review and the availability of additional safety data. For now, Valneva’s focus remains on transparency, regulatory collaboration, and ensuring patient safety across all markets.
