Development Phase
Phase 2 Clinical Trial
Primary Status
Platform Technology
mRNA
Biologic Architecture
Target Indication
Mpox
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 | Not Filed / Pre-submission |
| EMA (Europe) | Not Filed / Pre-submission |
| Health Canada | Not Filed / Pre-submission |
| TGA (Australia) | Not Filed / Pre-submission |
Scientific Profile & Documentation
- Platform Architecture
- mRNA
- Lead Developer
- BioNTech SE
- Next Expected Milestone
- Primary completion (most advanced trial): 2027-06 (registry estimate)
- Analyst & Development Notes
- Auto-grouped from 1 ClinicalTrials.gov record(s) sharing intervention/sponsor. Phases and timelines are registry fields and may lag company disclosures.
- Primary Source Documentation
- ClinicalTrials.gov NCT07379580 →
Registered Clinical Trials & Studies
Direct registry links to active, completed, or pivotal registration studies across phases.
NCT07379580
Phase 2 Clinical Trial
A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA
Status: Active / Ongoing • Expected Readout: 2027-06
Milestone Overview
-
Stage VerificationPhase 2 Clinical Trial confirmed as of 2026-07-10.
-
Target MilestonePrimary completion (most advanced trial): 2027-06 (registry estimate)
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.