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Valneva Announces FDA’s Decision to Suspend License of Chikungunya Vaccine IXCHIQ® in the U.S.
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
About this update from Valneva Se
[{"type":"image","alt":"VALNEVA","displaySize":"","headline":null,"caption":"VALNEVA","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":44,"url":"https://media.zenfs.com/en/globenewswire.com/29df7eb71c048b91fe66a95a1cd8b1d6"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/9l2h5dKc1PlSY26lXUAWsA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTYyO2NmPXdlYnA-/https://media.zenfs.com/en/globenewswire.com/29df7eb71c048b91fe66a95a1cd8b1d6","width":300,"height":44}},"lazy":false},{"type":"text","content":"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.","length":469,"tagName":"p"},{"type":"text","content":"The suspension follows the FDA’s decision on August 6, 20251 to remove its recommended pause2 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. The sudden subsequent decision to suspend IXCHIQ® is based on updated VAERS data (Vaccine Adverse Event Reporting System), which now includes four additional SAEs that occurred outside the United States. Of the four reported cases, three occurred in individuals aged 70 to 82 years, including one hospitalization of an 82-year-old individual who was discharged after two days; the remaining case occurred in a 55-year-old individual. Valneva believes all cases describe symptoms consistent with those previously reported during clinical trials and post marketing experience, particularly among the elderly individuals for whom the vaccine’s Prescribing Information (PI) includes warnings and precautions. Valneva is continuing to investigate these cases in detail and if warranted will pursue further steps in connection with FDA’s decision in accordance with applicable statutory procedures.","length":1181,"tagName":"p"},{"type":"text","content":"Valneva is committed to upholding the highest safety standards and will continue to engage proactively ...