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V232 Current Process Hepatitis B Vaccine
V232 Current Process Hepatitis B Vaccine is a vaccine Biologic drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 3 development for Prevention of hepatitis B infection.
V232 Current Process Hepatitis B Vaccine stimulates the body's immune system to produce antibodies against the hepatitis B virus.
The V232 Current Process Hepatitis B Vaccine is used to prevent Hepatitis B and Hepatitis B Infection. It is a recombinant hepatitis B vaccine, as indicated by its listing on ClinicalTrials.gov.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable. -
Big-pharma sponsor
+3.0pp
Merck Sharp & Dohme LLC 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 | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | V232 Current Process Hepatitis B Vaccine |
|---|---|
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
This vaccine works by introducing a small, harmless piece of the hepatitis B virus to the body, which triggers an immune response and the production of antibodies that can recognize and neutralize the virus. The vaccine is administered in multiple doses to ensure long-term protection against hepatitis B infection.
Approved indications
- Prevention of hepatitis B infection
Common side effects
- Pain, redness, or swelling at the injection site
Key clinical trials
- A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057) (PHASE3)
- A Research Study to Test Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured With an Upgrade to the Production Process (V232-054) (PHASE3)
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:
- V232 Current Process Hepatitis B Vaccine CI brief — competitive landscape report
- V232 Current Process Hepatitis B Vaccine updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about V232 Current Process Hepatitis B Vaccine
What is V232 Current Process Hepatitis B Vaccine?
How does V232 Current Process Hepatitis B Vaccine work?
What is V232 Current Process Hepatitis B Vaccine used for?
Who makes V232 Current Process Hepatitis B Vaccine?
What drug class is V232 Current Process Hepatitis B Vaccine in?
What development phase is V232 Current Process Hepatitis B Vaccine in?
What are the side effects of V232 Current Process Hepatitis B Vaccine?
Related
- Drug class: All vaccine drugs
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Prevention of hepatitis B infection
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing