Particle.news

Download on the App Store

FDA Suspends Valneva’s Ixchiq Chikungunya Vaccine Over Safety Reports

The move follows fresh post‑marketing data that regulators say show the live vaccine can cause chikungunya‑like illness in some recipients.

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.