# Fendrix (hepatitis B vaccine, adjuvanted, for kidney failure)

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

## TL;DR

GSK's adjuvanted hepatitis B vaccine for people from 15 years of age whose kidneys are failing, including people on dialysis, authorised in the European Union since 2005.

## Summary

Fendrix (EMEA/H/C/000550, GlaxoSmithKline Biologicals S.A.) was authorised by the EMA on 2 February 2005. Its EMA indication reads: "Fendrix is indicated in adolescents and adults from the age of 15 years onwards for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes for patients with renal insufficiency (including pre-haemodialysis and haemodialysis patients)." It is not in the FDA Purple Book.

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
- Tags: preventive-vaccine; hepatitis-b-vaccine
- Brand: Fendrix
- Modality: Prophylactic vaccine (recombinant, adjuvanted)
- 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 2005: Hepatitis B immunisation for patients aged 15 and older with renal insufficiency, including pre-haemodialysis and haemodialysis (EMEA/H/C/000550)

## Sources

- EMA: Fendrix (EPAR): https://www.ema.europa.eu/en/medicines/human/EPAR/fendrix
- 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/), [Heplisav-B (hepatitis B vaccine, recombinant, adjuvanted)](https://onco.cc/drugs/heplisav-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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