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hepatitis B vaccines
hepatitis B vaccines is a Vaccine Biologic drug developed by National Heart, Lung, and Blood Institute (NHLBI). It is currently in Phase 3 development.
Stimulates the immune system to produce antibodies against hepatitis B surface antigen (HBsAg), providing protection against hepatitis B virus infection.
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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).
| 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 | hepatitis B vaccines |
|---|---|
| Sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
| Drug class | Vaccine |
| Modality | Biologic |
| Phase | Phase 3 |
Mechanism of action
The vaccine contains recombinant hepatitis B surface antigen that triggers an immune response. When administered, it prompts the body to produce antibodies against HBsAg without causing disease. These antibodies remain in the bloodstream and provide immunity against future hepatitis B virus exposure.
Approved indications
Common side effects
Key clinical trials
- Evaluation of Patients With Liver Disease
- ImPrEP LEN Brasil: Twice-Yearly Lenacapavir for HIV Prevention (NA)
- Oral-Periodontal Evaluation and Assessment of Oral Fluid Biomarkers in Patients With Hepatitis B+D
- Fungal Infection Susceptibility
- Withdrawal of Therapy After Long-Term Antiviral Treatment for Chronic Hepatitis B
- Evaluation of Patient Care Support for Cirrhosis and/or Liver Transplants
- Study of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants With Both Chronic Hepatitis B and HIV (PHASE2)
- The Mechanistic Biology of Primary Immunodeficiency Disorders
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:
- hepatitis B vaccines CI brief — competitive landscape report
- hepatitis B vaccines updates RSS · CI watch RSS
- National Heart, Lung, and Blood Institute (NHLBI) portfolio CI
Frequently asked questions about hepatitis B vaccines
What is hepatitis B vaccines?
How does hepatitis B vaccines work?
Who makes hepatitis B vaccines?
What drug class is hepatitis B vaccines in?
What development phase is hepatitis B vaccines in?
Related
- Drug class: All Vaccine drugs
- Manufacturer: National Heart, Lung, and Blood Institute (NHLBI) — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing