Overview
- U.S. regulators suspended Ixchiq’s license effective immediately, ordering Valneva to stop shipping and selling the shot in the United States.
- The FDA cited more than 20 reports of chikungunya‑like illness, about 21 hospitalizations and three deaths, including an encephalitis death the agency deemed directly attributable to the vaccine.
- CBER concluded the risks now outweigh the benefits and said the vaccine poses a danger to health, with the office indicating it intends to propose a full market withdrawal.
- Recent reports included four new serious cases outside the U.S., three in adults aged 70–82 and one in a 55‑year‑old; testing in the encephalitis case matched the vaccine strain.
- Valneva said it will investigate and keep supplying countries where Ixchiq remains licensed, left its 2025 guidance unchanged for now, saw shares fall roughly 25–26%, and Bavarian Nordic’s Vimkunya now stands as the only chikungunya vaccine approved in the U.S.