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FDA Suspends Valneva’s Ixchiq Chikungunya Vaccine in the U.S. After New Serious Adverse Reports

The agency said the vaccine’s risks outweigh its benefits under plausible scenarios.

Overview

  • Valneva said the suspension takes effect immediately and halts all Ixchiq shipments and sales in the United States.
  • The newly reported U.S. cases involve four recipients ages 55 to 82, which the company described as comparable to previously known events.
  • During a major spring outbreak in La Réunion, about twenty serious adverse events were recorded among older vaccine recipients and one death was deemed very likely linked.
  • Regulatory positions now diverge as the European Union reauthorized the shot in July after earlier age-based limits, while France had restricted use in seniors.
  • Valneva is evaluating potential financial impacts of a prolonged U.S. withdrawal as some researchers voice concern about a broader shift toward vaccine skepticism under Health Secretary Robert Kennedy Jr.