Development Phase
Approved / Licensed
Primary Status
Platform Technology
Licensed biologic (see FDA product page)
Biologic Architecture
Target Indication
Mpox / Smallpox
Pathogen / Antigen
Last Verified
2026-07-10
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: see FDA pageFrom FDA public vaccines/biologics approval materials |
| EMA (Europe) | Not Filed / Pre-submission |
| Health Canada | Not Filed / Pre-submission |
| TGA (Australia) | Not Filed / Pre-submission |
Scientific Profile & Documentation
- Platform Architecture
- Licensed biologic (see FDA product page)
- Lead Developer
- See FDA listing
- Next Expected Milestone
- US-licensed — see product label / ACIP for use; further supplements may expand indication
- Analyst & Development Notes
- FDA CBER licensed / approved vaccine (regulator-confirmed US listing). From FDA Vaccines Licensed for Use in the United States listing. May also have later supplements (strain updates, age expansions); see product page.
- Primary Source Documentation
- FDA — Smallpox and Monkeypox Vaccine, Live, Non-Replicating →
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 2026-07-10.
-
Target MilestoneUS-licensed — see product label / ACIP for use; further supplements may expand indication
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.