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Ixchiq FDA Approval History

FDA Approved: Yes (Discontinued) (First approved November 9, 2023)
Brand name: Ixchiq
Generic name: chikungunya vaccine, live
Dosage form: Injection
Previous Name: VLA1553
Company: Valneva USA, Inc.
Treatment for: Chikungunya Disease Prevention

Last updated by Judith Stewart, BPharm on Aug 26, 2025.

Ixchiq (chikungunya vaccine, live) is a live-attenuated, single dose vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV.

On August 22, 2025, the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) announced the suspension of the biologics license for Valneva’s live-attenuated Ixchiq vaccine. This vaccine was initially approved by the FDA under the accelerated approval pathway in November of 2023 for the prevention of disease caused by the chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV.

The decision was based on serious safety concerns related to the vaccine, which appeared to be causing chikungunya-like illness in vaccine recipients. There had been one death from encephalitis directly attributable to the vaccine (CSF PCR was + for the vaccine strain of the virus) and over 20 reported serious adverse events that were consistent with chikungunya-like illness. Reported serious adverse events have included 21 hospitalizations and 3 deaths. Furthermore, the clinical benefit of the vaccine has not yet been verified in confirmatory clinical studies.

CBER’s benefit-risk analysis broadly shows the vaccine does not have benefits outweighing risks, under most plausible scenarios. For these reasons, CBER believes this vaccine is not safe and that continued administration to the public would pose a danger to health.

Development timeline for Ixchiq

DateArticle
Aug 25, 2025Valneva Announces FDA’s Decision to Suspend License of Chikungunya Vaccine Ixchiq In the U.S.
Nov 10, 2023Approval FDA Approves Ixchiq (Chikungunya Vaccine, Live) for the Prevention of Disease Caused by Chikungunya Virus
Aug 14, 2023Valneva Announces PDUFA Date Extension for Chikungunya Virus Vaccine Candidate
Jun 13, 2023Valneva Announces Publication of its Chikungunya Vaccine Candidate Phase 3 Data in The Lancet
Dec 23, 2022Valneva Completes BLA Submission to U.S. FDA for its Single-Shot Chikungunya Vaccine Candidate
May 25, 2022Valneva Successfully Completes Lot-to-Lot Consistency Trial for its Single-Shot Chikungunya Vaccine Candidate
Aug  5, 2021Valneva Announces Positive Phase 3 Pivotal Results for its Single-Shot Chikungunya Vaccine Candidate
Jul  7, 2021Valneva Awarded FDA Breakthrough Designation for its Single-Shot Chikungunya Vaccine Candidate
Dec 21, 2018Valneva Awarded FDA Fast Track Designation for Chikungunya Vaccine Candidate

Further information

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