# Twinrix / Ambirix (combined hepatitis A and B vaccine)

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

## TL;DR

GSK's combined vaccine against hepatitis A and hepatitis B, licensed in the European Union since 1996 and the United States since 2001; the hepatitis B part is what protects against liver cancer.

## Summary

The FDA Purple Book lists Twinrix (Hepatitis A & Hepatitis B (Recombinant) Vaccine) under BLA 103850 (GlaxoSmithKline Biologicals), licensed on 11 May 2001. The EMA medicines report lists three GSK products with the same two active substances (inactivated hepatitis A virus and hepatitis B surface antigen): Twinrix Adult (EMEA/H/C/000112, authorised 19 September 1996) for non-immune adults and adolescents from 16 at risk of both infections; Twinrix Paediatric (EMEA/H/C/000129, 10 February 1997) for ages 1 to 15; and Ambirix (EMEA/H/C/000426, 30 August 2002), a two-dose course for ages 1 to 15 that the EMA says should be used only when the risk of hepatitis B during the course is relatively low, because protection may not be obtained until after the second dose.

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: Ambirix; Twinrix Adult; Twinrix Paediatric; hepatitis A and B vaccine
- Tags: preventive-vaccine; hepatitis-b-vaccine
- Brand: Twinrix
- Modality: Prophylactic vaccine (inactivated hepatitis A virus with recombinant hepatitis B surface antigen)
- 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: EU 1996: Twinrix Adult: non-immune adults and adolescents 16 and older at risk of hepatitis A and B (EMEA/H/C/000112); US 2001: Hepatitis A and hepatitis B (recombinant) vaccine, BLA 103850

## Sources

- FDA Purple Book, October 2026 data download: https://www.accessdata.fda.gov/drugsatfda_docs/PurpleBook/2026/purplebook-search-October-data-download.csv
- EMA: Twinrix Adult (EPAR): https://www.ema.europa.eu/en/medicines/human/EPAR/twinrix-adult
- EMA: Ambirix (EPAR): https://www.ema.europa.eu/en/medicines/human/EPAR/ambirix
- WHO fact sheet: hepatitis B (28 July 2026): https://www.who.int/news-room/fact-sheets/detail/hepatitis-b

## Connected records

- drugs: [Engerix-B (hepatitis B vaccine, recombinant)](https://onco.cc/drugs/engerix-b/)
- 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/)

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