Development Phase
Phase 3 Clinical Trial
Primary Status
Platform Technology
Protein subunit (OspA)
Biologic Architecture
Target Indication
Lyme disease
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 | Phase 3 Date: H1 2026 field efficacy readout (company) |
| EMA (Europe) | Phase 3 Date: H1 2026 field efficacy readout (company) |
| Health Canada | Not Filed / Pre-submission |
| TGA (Australia) | Not Filed / Pre-submission |
Scientific Profile & Documentation
- Platform Architecture
- Protein subunit (OspA)
- Lead Developer
- Valneva / Pfizer
- Next Expected Milestone
- VALOR Phase 3 field efficacy results (company: H1 2026); BLA/MAA planned if positive
- Analyst & Development Notes
- Most advanced Lyme vaccine candidate in late clinical development; targets multiple prevalent Borrelia serotypes (company materials).
- Primary Source Documentation
- Valneva FY results disclosure (SEC 6-K summary path) →
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 VerificationPhase 3 Clinical Trial confirmed as of 2026-07-10.
-
Target MilestoneVALOR Phase 3 field efficacy results (company: H1 2026); BLA/MAA planned if positive
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.