Valneva SE announced on August 25, 2025, that the United States Food and Drug Administration (FDA) suspended the license for its chikungunya vaccine, IXCHIQ®, with immediate effect. This decision requires Valneva to cease shipping and selling IXCHIQ® in the United States.
The suspension follows four new reports of serious adverse events (SAEs) consistent with chikungunya-like illness, which occurred outside the United States. Three of these cases involved individuals aged 70 to 82 years, including one hospitalization, and the fourth case was in a 55-year-old individual.
This sudden decision by the FDA comes despite the agency's removal of a recommended pause on IXCHIQ® use in individuals 60 years and older just weeks prior. Valneva is evaluating the potential financial impact of a permanent withdrawal of the U.S. license and is investigating the cases, while remaining committed to providing IXCHIQ® in other licensed countries.
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