Health Affairs October 21, 2025
On August 22, 2025, the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) suspended the biologics license for IXCHIQ, a live-attenuated chikungunya vaccine, citing “serious safety concerns.” Manufactured by Valneva Austria GmbH, the vaccine was initially approved by the FDA in November 2023 via the accelerated approval program for therapies addressing serious conditions that can fill an unmet medical need based on a surrogate endpoint (i.e., a measure thought to predict clinical benefit).
Manufacturers receiving accelerated approval are required to conduct studies to confirm the anticipated clinical benefit. In Valneva’s case, it was required to conduct two post-market studies: 1) “a pragmatic randomized controlled trial to assess the effectiveness and safety of IXCHIQ vaccination in the...
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