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Active-controlled vaccine B
Active-controlled vaccine B is a Biologic drug developed by Sinovac Biotech Co., Ltd. It is currently in Phase 1 development.
Active-controlled vaccine B, also known as mRNA-1608, is being studied in clinical trials for various conditions including metastatic melanoma, genital herpes, hepatitis B, and varicella-zoster virus.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Active-controlled vaccine B |
|---|---|
| Sponsor | Sinovac Biotech Co., Ltd |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Safety, Tolerability and Immunogenicity of a Maternal Respiratory Syncytial Virus (RSV) Vaccine (MKK900) in Healthy Adult Women (PHASE1)
- Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in BCG Vaccinated Volunteers (PHASE1, PHASE2)
- Dose-Ranging Study to Evaluate a 25-Valent Pneumococcal Conjugate Vaccine (PHASE2)
- Interpersonal Communication Training and Vaccination Workflow Training Alone and in Combination to Improve Communication and Recommendations About HPV Vaccination in Pharmacies, IMPACT HPV Trial (NA)
- Evaluating the Safety and Immunogenicity of MTBVAC (PHASE2)
- Precision Medicine Approach for Early Dementia & Mild Cognitive Impairment (PHASE3)
- A Phase I/II, Dose-finding Study to Assess the Safety, Reactogenicity, and Immunogenicity of a Broadly Protective Sarbecovirus Vaccine (GBP511) in Healthy Adults. (PHASE1, PHASE2)
- Study to Evaluate the Safety and Immunogenicity of a Lyophilized Herpes Zoster Virus mRNA Vaccine (PHASE1, 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:
- Active-controlled vaccine B CI brief — competitive landscape report
- Active-controlled vaccine B updates RSS · CI watch RSS
- Sinovac Biotech Co., Ltd portfolio CI
Frequently asked questions about Active-controlled vaccine B
What is Active-controlled vaccine B?
Who makes Active-controlled vaccine B?
What development phase is Active-controlled vaccine B in?
Related
- Manufacturer: Sinovac Biotech Co., Ltd — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing