Saint Herblain (France), August 25, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the United States Food and Drug Administration (FDA) has suspended the license for IXCHIQ®, citing four new reports of serious adverse events (SAEs) consistent with chikungunya-like illness. The suspension of the license is effective immediately and requires Valneva to stop shipping and selling of IXCHIQ® in the United States.
The suspension follows the FDA’s decision on August 6, 2025[1] to remove its recommended pause[2] in the use of IXCHIQ® in individuals 60 years of age and older based on a thorough investigation of reported SAEs, primarily among elderly individuals with multiple underlying health conditions.
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