Development Phase
Approved / Licensed
Primary Status
Platform Technology
See FDA product page / label
Biologic Architecture
Target Indication
Chikungunya
Pathogen / Antigen
Last Verified
2026-08-01
Tier 1 Multi-Source Checked
Multi-Jurisdiction Regulatory Status
Official licensing, rolling submissions, or authorization status tracked across major health authorities.
| Regulatory Authority | Status & Details |
|---|---|
| US FDA | Approved / Authorized Date: 2023-11-09FDA accelerated approval for individuals 18+ at high risk of chikungunya virus exposure |
| EMA (Europe) | Approved / Authorized Date: 2024-06-28EMA approved for active immunization of individuals 18+ |
| Health Canada | Approved / Authorized Date: 2024-06-14Health Canada approved |
| TGA (Australia) | Under Regulatory Review Date: 2024-09-01TGA submission under evaluation |
Scientific Profile & Documentation
- Platform Architecture
- See FDA product page / label
- Lead Developer
- Valneva Austria GmbH
- Next Expected Milestone
- Post-marketing safety surveillance; adolescent trial data readout
- Analyst & Development Notes
- FDA CBER licensed / approved vaccine (regulator-confirmed US listing). First chikungunya vaccine licensed in US; later subject to post-approval safety actions — verify current FDA status. May also have later supplements (strain updates, age expansions); see product page. Check live FDA communications for current license status (post-approval actions possible).
- Primary Source Documentation
- FDA — IXCHIQ →
Registered Clinical Trials & Studies
Direct registry links to active, completed, or pivotal registration studies across phases.
No primary ClinicalTrials.gov record linked directly. Study data tracked via regulatory submission filings and peer-reviewed releases.
Milestone Overview
-
Stage VerificationApproved / Licensed confirmed as of 2026-08-01.
-
Target MilestonePost-marketing safety surveillance; adolescent trial data readout
Vaccine Data Navigator Candidate Profile Registry:
This candidate profile is indexed across all clinical development levels (Preclinical through Phase 1–3, Regulatory Filing, and Licensure) from primary registry databases (ClinicalTrials.gov, WHO ICTRP, FDA CBER, EMA, Health Canada, TGA Australia). Data are updated continuously to track global biologic and vaccine pipelines.