Last reviewed 2026-05-26 · How we verify

Sci-B-Vac-Lot A

VBI Vaccines Inc. · Phase 3 active Biologic ✓ Verified May 2026

Sci-B-Vac-Lot A is a Recombinant hepatitis B vaccine Biologic drug developed by VBI Vaccines Inc.. It is currently in Phase 3 development for Prevention of hepatitis B infection in adults and adolescents. Also known as: Sci-B-Vac, 3-antigen HepB Vaccine, Bio-Hep-B.

Sci-B-Vac is a recombinant hepatitis B vaccine designed to provide improved immunogenicity and broader protection against hepatitis B virus variants.

Sci-B-Vac-Lot A is a vaccine used to study and prevent Hepatitis B. It is being compared to Engerix-B in a clinical trial to assess its safety and efficacy in healthy adults.

Likelihood of approval

59.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	Sci-B-Vac-Lot A
Also known as	Sci-B-Vac, 3-antigen HepB Vaccine, Bio-Hep-B
Sponsor	VBI Vaccines Inc.
Drug class	Recombinant hepatitis B vaccine
Target	Hepatitis B surface antigen (HBsAg)
Modality	Biologic
Therapeutic area	Immunology / Infectious Disease
Phase	Phase 3

Mechanism of action

Sci-B-Vac uses recombinant DNA technology to express hepatitis B surface antigen (HBsAg) in yeast, similar to other HBV vaccines, but with formulation and antigen design optimizations intended to enhance immune response. The vaccine stimulates both humoral and cellular immunity to prevent hepatitis B infection and its sequelae.

Approved indications

Prevention of hepatitis B infection in adults and adolescents

Common side effects

Injection site pain or erythema
Fatigue
Headache
Myalgia

Key clinical trials

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:

Sci-B-Vac-Lot A CI brief — competitive landscape report
Sci-B-Vac-Lot A updates RSS · CI watch RSS
VBI Vaccines Inc. portfolio CI

Frequently asked questions about Sci-B-Vac-Lot A

What is Sci-B-Vac-Lot A?

Sci-B-Vac-Lot A is a Recombinant hepatitis B vaccine drug developed by VBI Vaccines Inc., indicated for Prevention of hepatitis B infection in adults and adolescents.

How does Sci-B-Vac-Lot A work?

Sci-B-Vac is a recombinant hepatitis B vaccine designed to provide improved immunogenicity and broader protection against hepatitis B virus variants.

What is Sci-B-Vac-Lot A used for?

Sci-B-Vac-Lot A is indicated for Prevention of hepatitis B infection in adults and adolescents.

Who makes Sci-B-Vac-Lot A?

Sci-B-Vac-Lot A is developed by VBI Vaccines Inc. (see full VBI Vaccines Inc. pipeline at /company/vbi-vaccines-inc).

Is Sci-B-Vac-Lot A also known as anything else?

Sci-B-Vac-Lot A is also known as Sci-B-Vac, 3-antigen HepB Vaccine, Bio-Hep-B.

What drug class is Sci-B-Vac-Lot A in?

Sci-B-Vac-Lot A belongs to the Recombinant hepatitis B vaccine class. See all Recombinant hepatitis B vaccine drugs at /class/recombinant-hepatitis-b-vaccine.

What development phase is Sci-B-Vac-Lot A in?

Sci-B-Vac-Lot A is in Phase 3.

What are the side effects of Sci-B-Vac-Lot A?

Common side effects of Sci-B-Vac-Lot A include Injection site pain or erythema, Fatigue, Headache, Myalgia.

What does Sci-B-Vac-Lot A target?

Sci-B-Vac-Lot A targets Hepatitis B surface antigen (HBsAg) and is a Recombinant hepatitis B vaccine.

Drug class: All Recombinant hepatitis B vaccine drugs
Target: All drugs targeting Hepatitis B surface antigen (HBsAg)
Manufacturer: VBI Vaccines Inc. — full pipeline
Therapeutic area: All drugs in Immunology / Infectious Disease
Indication: Drugs for Prevention of hepatitis B infection in adults and adolescents
Also known as: Sci-B-Vac, 3-antigen HepB Vaccine, Bio-Hep-B

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing