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mRNA-1083 Composition 2 Dose B
mRNA-1083 Composition 2 Dose B is a Biologic drug developed by ModernaTX, Inc.. It is currently in Phase 2 development.
mRNA-1083 Composition 2 Dose B is a vaccine intervention being studied in a clinical trial for SARS-CoV-2 and Influenza conditions. It is part of a Phase 1/2 study evaluating the safety, reactogenicity, and immunogenicity of mRNA-based Influenza and SARS-CoV-2 vaccines in healthy adults.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
ModernaTX, Inc. is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | mRNA-1083 Composition 2 Dose B |
|---|---|
| Sponsor | ModernaTX, Inc. |
| Modality | Biologic |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Study of mRNA-based Influenza and SARS-CoV-2 (COVID-19) Multi-component Vaccines in Healthy Adults (PHASE1, PHASE2)
- A Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (Influenza and COVID-19) Vaccine in Adults ≥18 to <65 Years of Age (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- mRNA-1083 Composition 2 Dose B CI brief — competitive landscape report
- mRNA-1083 Composition 2 Dose B updates RSS · CI watch RSS
- ModernaTX, Inc. portfolio CI
Frequently asked questions about mRNA-1083 Composition 2 Dose B
What is mRNA-1083 Composition 2 Dose B?
Who makes mRNA-1083 Composition 2 Dose B?
What development phase is mRNA-1083 Composition 2 Dose B in?
Related
- Manufacturer: ModernaTX, Inc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing