Explore licensed vaccines, adverse event reporting data, and history for this disease.
- Phase 1
- Phase 2
- Phase 3
- Filed
- Approved
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: 2026-08-05From FDA public vaccines/biologics approval materials |
| EMA (Europe) | Not Filed / Pre-submission |
| Health Canada | Not Filed / Pre-submission |
| TGA (Australia) | Not Filed / Pre-submission |
Progress and adoption outlook
Where this candidate sits on a fixed development ladder, and when a licence and a routine-use recommendation could follow in each jurisdiction, as scenario bands. Input grade: Regulator-confirmed status date in at least one jurisdiction.
- Preclinical
- Phase 1
- Phase 1/2
- Phase 2
- Phase 2/3
- Phase 3
- Submitted to a regulator
- Under regulatory review
- Approved / authorised
- Recommended for routine use
Current position: Approved / authorised
| Jurisdiction | Status in the record | Submission | Regulator decision | Earliest routine use |
|---|---|---|---|---|
| United StatesFDA (CBER) · ACIP (CDC) | approved (2026-08-05, regulator confirmed) | — | 2026-082026-08 to 2026-08 | 2026-11— to 2027-04 |
| European UnionEMA (CHMP) and European Commission · national bodies (STIKO, HAS, Folkhälsomyndigheten and others) | no jurisdiction-specific filing known | 2026-102026-10 to 2026-10 | 2027-122027-07 to 2028-06 | 2028-062027-08 to 2029-12 |
| CanadaHealth Canada · NACI | no jurisdiction-specific filing known | 2026-102026-10 to 2026-10 | 2027-082027-04 to 2028-01 | 2027-122027-05 to 2029-01 |
| United KingdomMHRA · JCVI | no jurisdiction-specific filing known | The MHRA 150-day national assessment and International Recognition Procedure pages could not be fetched on 2026-10-24; no target is used. | ||
| AustraliaTGA · ATAGI | no jurisdiction-specific filing known | TGA registration-timeframe pages timed out on 2026-10-24; no target is used. | ||
| JapanPMDA / MHLW · MHLW immunisation subcommittee | no jurisdiction-specific filing known | PMDA English pages reached on 2026-10-24 state that target review times exist but give no figure. | ||
| WHO prequalificationWHO Prequalification · SAGE | no jurisdiction-specific filing known | WHO prequalification procedure pages returned 404/500 on 2026-10-24; no target is used. | ||
Each window shows the typical scenario with the fast-to-slow band beneath it (year-month). Bands come from the parameters on the outlook model page; they are not forecasts.
Scientific Profile & Documentation
- Platform Architecture
- Licensed biologic (see FDA product page)
- Lead Developer
- ModernaTX, Inc.
- 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). Listed in 2026 biological approvals materials. May also have later supplements (strain updates, age expansions); see product page.
- Primary Source Documentation
- FDA — MFLUSIVA Influenza Vaccine, mRNA →
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 2026-10-31.
-
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.