# Engerix-B (hepatitis B vaccine, recombinant)

Source: https://onco.cc/drugs/engerix-b/  
OnCo record `engerix-b` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

GSK's hepatitis B vaccine, licensed in the United States since 1989 and prequalified by WHO for use in national programmes.

## Summary

Engerix-B is GSK's recombinant hepatitis B vaccine. The FDA Purple Book lists it under BLA 103239 (GlaxoSmithKline Biologicals), licensed on 28 August 1989, as a 20-microgram-per-millilitre and a 10-microgram-per-0.5-millilitre intramuscular injection in pre-filled syringes and single-dose vials, prescription only. WHO's list of prequalified vaccines carries it as "Engerix" (GlaxoSmithKline Biologicals SA, regulated by Belgium's Federal Agency for Medicines and Health Products) in one-, ten- and twenty-dose vials, with a prequalification date of 1 January 1987, which is how the list records it.

Why it is a cancer vaccine: WHO estimates that hepatitis B caused 1.1 million deaths in 2024, mostly from cirrhosis and hepatocellular carcinoma (primary liver cancer), and that infection in infancy and early childhood becomes chronic in about 95% of cases. WHO recommends that all babies receive the vaccine as soon as possible after birth (within 24 hours), followed by two or three further doses (WHO fact sheet, 28 July 2026).

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-11-04
- Also known as: Engerix; Engerix B
- Tags: preventive-vaccine; hepatitis-b-vaccine
- Brand: Engerix-B
- Modality: Prophylactic vaccine (recombinant)
- Mechanism: Recombinant hepatitis B surface antigen (the active substance the regulators name) trains the immune system to make antibodies against hepatitis B virus, preventing the infection that can lead to liver cancer.
- Approvals: US 1989: Hepatitis B vaccine (recombinant), BLA 103239

## Sources

- FDA Purple Book, October 2026 data download: https://www.accessdata.fda.gov/drugsatfda_docs/PurpleBook/2026/purplebook-search-October-data-download.csv
- WHO list of prequalified vaccines (CSV export): https://extranet.who.int/prequal/vaccines/prequalified/export?page&_format=csv
- WHO fact sheet: hepatitis B (28 July 2026): https://www.who.int/news-room/fact-sheets/detail/hepatitis-b

## Connected records

- drugs: [Euvax B (hepatitis B vaccine, LG Chem)](https://onco.cc/drugs/euvax-b/), [Fendrix (hepatitis B vaccine, adjuvanted, for kidney failure)](https://onco.cc/drugs/fendrix/), [Heplisav-B (hepatitis B vaccine, recombinant, adjuvanted)](https://onco.cc/drugs/heplisav-b/), [PreHevbrio / PreHevbri (hepatitis B vaccine, adults, withdrawn)](https://onco.cc/drugs/prehevbrio/), [Recombivax HB / HBVaxPro (hepatitis B vaccine, recombinant)](https://onco.cc/drugs/recombivax-hb/), [Twinrix / Ambirix (combined hepatitis A and B vaccine)](https://onco.cc/drugs/twinrix/)
- collections: [WHO list of prequalified vaccines](https://onco.cc/collections/who-prequalified-vaccines/)
- fronts: [Prevention & Risk](https://onco.cc/fronts/prevention/)
- technologies: [HPV & HBV vaccination](https://onco.cc/technologies/hpv-vaccine/)
- companies: [GSK](https://onco.cc/companies/gsk/)
- terms: [Hepatitis B and C as cancer causes](https://onco.cc/terms/hbv-hcv/), [Hepatitis B birth-dose vaccination by country](https://onco.cc/terms/hepatitis-b-birth-dose-programmes/)

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JSON: https://onco.cc/api/v1/entities/engerix-b.json