Explore licensed vaccines, adverse event reporting data, and history for this disease.
Multi-Jurisdiction Regulatory Status
Official licensing, rolling submissions, or authorization status tracked across major health authorities.
| Regulatory Authority | Status & Details |
|---|---|
| US FDA | Under Regulatory Review Date: 2024-10-15BLA submitted to FDA following positive Phase 3 immunogenicity data vs separate flu & COVID vaccines |
| EMA (Europe) | Under Regulatory Review Date: 2024-11-01EMA regulatory submission planned/under review |
| Health Canada | Not Filed / Pre-submission Date: 2025-02-01Filing anticipated |
| TGA (Australia) | Not Filed / Pre-submission Date: 2025-03-01Filing anticipated |
Scientific Profile & Documentation
- Platform Architecture
- mRNA
- Lead Developer
- Moderna
- Next Expected Milestone
- FDA target PDUFA action date and ACIP review for 2025-2026 respiratory season
- Analyst & Development Notes
- Illustrates multi-jurisdiction status: filed/under review in some regions while US pathway was withdrawn pending refiling.
- Primary Source Documentation
- Moderna Analyst Day / pipeline disclosures →
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
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Stage VerificationRegulatory Submission Filed confirmed as of 2026-08-01.
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Target MilestoneFDA target PDUFA action date and ACIP review for 2025-2026 respiratory season
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.