IXCHIQ
STN: 125777
Proper Name: Chikungunya Vaccine, Live
Tradename: IXCHIQ
Manufacturer: Valneva Austria GmbH
Indication:
- For the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at high risk of exposure to CHIKV.
Product Information
- Package Insert - IXCHIQ
- Demographic Subgroup Information – Chikungunya Vaccine, Live (IXCHIQ)
Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
Latest Safety Information
- FDA Suspends the Biologics License for IXCHIQ Vaccine
August 22, 2025 - FDA Removes Recommended Pause in Use and Approves Required Updated Labeling
August 6, 2025 - FDA and CDC Recommend Pause in Use of Ixchiq (Chikungunya Vaccine, Live) in Individuals 60 Years of Age and Older While Postmarketing Safety Reports are Investigated
May 9, 2025
Supporting Documents
- January 29, 2026 Voluntary Revocation of Biologics License Application Letter - IXCHIQ
- Suspension Memo of Biologics License 1909 - IXCHIQ
- August 22, 2025 Suspension Letter - IXCHIQ
- August 6, 2025 Approval Letter - IXCHIQ
- December 8, 2023 Summary Basis for Regulatory Action - IXCHIQ
- November 9, 2023 Approval Letter - IXCHIQ
- Approval History, Letters, Reviews, and Related Documents - IXCHIQ