Overview

• The suspension takes effect immediately and requires Valneva to stop shipping and selling IXCHIQ in the United States.
• Updated monitoring identified four additional serious adverse events consistent with chikungunya‑like illness, three in people aged 70–82 and one in a 55‑year‑old, including one brief hospitalization with recovery.
• All newly reported cases were outside the United States and remain under investigation, with no definitive causal link established.
• The move reverses an August 6 FDA step that had allowed restricted use in higher‑risk older adults after labeling added warnings about rare severe reactions.
• Valneva said it will maintain access in other licensed regions, kept 2025 revenue guidance after €7.5 million in first‑half IXCHIQ sales, and saw its shares drop over 26% as global agencies flag rising chikungunya risk.