The French biotech firm Valneva has announced the permanent withdrawal of its chikungunya vaccine, Ixchiq, from the United States. This strategic exit follows an expanded investigation by federal health regulators into the product’s safety profile.
Regulatory hurdles and safety concerns The voluntary withdrawal follows a marketing suspension issued by the U.S. FDA in August 2024. The agency’s intervention was prompted by reports of over 20 serious adverse events and one death from encephalitis directly linked to the vaccine.
The situation intensified recently when the FDA placed a clinical hold on the development program to investigate a new serious adverse event involving a young adult outside the U.S. While definitive causality remains unproven, Valneva noted the case is “plausibly related” to the vaccination.
Market implications and strategic shift
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U.S. Landscape: With Ixchiq’s departure, Bavarian Nordic’s Vimkunya remains the sole chikungunya vaccine available to American consumers. Valneva clarified that this withdrawal is “permanent,” with no current plans to reintroduce the shot even after completing post-marketing studies.
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Global Operations: The vaccine remains licensed in other territories, including Europe, the UK, Canada, and Brazil. Valneva maintains that the benefit-risk profile stays favorable for populations living in endemic regions.
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Corporate Outlook: The company stated that the U.S. withdrawal will not impact its workforce or 2025 financial projections, as sales expectations had already been adjusted following the August suspension.
Valneva is now pivoting its focus toward its Lyme disease vaccine candidate (VLA15), partnered with Pfizer, which is nearing a crucial Phase 3 data readout.