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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.
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).
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.
1.Fendrix (hepatitis B vaccine, adjuvanted, for kidney failure) slips into a pocket on its target.
Authorised (EMEA/H/C/000550) source
| Region | Year | Indication |
|---|---|---|
| EU | 2005 | Hepatitis B immunisation for patients aged 15 and older with renal insufficiency, including pre-haemodialysis and haemodialysis (EMEA/H/C/000550) |
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Query for this drug: (TITLE:"Fendrix" OR ABSTRACT:"Fendrix" OR TITLE:"hepatitis B vaccine, adjuvanted, for kidney failure" OR ABSTRACT:"hepatitis B vaccine, adjuvanted, for kidney failure") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Fendrix (hepatitis B vaccine, adjuvanted, for kidney failure), not a curated reading list.
Shares Heplisav-B (hepatitis B vaccine, recombinant, adjuvanted), Engerix-B (hepatitis B vaccine, recombinant), Hepatitis B and C as cancer causes, HPV & HBV vaccination and the tags preventive-vaccine, hepatitis-b-vaccine.
Shares Engerix-B (hepatitis B vaccine, recombinant), Hepatitis B and C as cancer causes, GSK, HPV & HBV vaccination and the tags preventive-vaccine, hepatitis-b-vaccine.
Shares Heplisav-B (hepatitis B vaccine, recombinant, adjuvanted), Engerix-B (hepatitis B vaccine, recombinant), Hepatitis B and C as cancer causes, HPV & HBV vaccination and the tags preventive-vaccine, hepatitis-b-vaccine.
Shares Engerix-B (hepatitis B vaccine, recombinant), Hepatitis B and C as cancer causes, HPV & HBV vaccination and the tags preventive-vaccine, hepatitis-b-vaccine.
Shares Hepatitis B and C as cancer causes, HPV & HBV vaccination and the tags preventive-vaccine, hepatitis-b-vaccine.
Shares Hepatitis B and C as cancer causes, HPV & HBV vaccination and the tags preventive-vaccine, hepatitis-b-vaccine.
Shares Hepatitis B and C as cancer causes, HPV & HBV vaccination and the tags preventive-vaccine, hepatitis-b-vaccine.
Shares HPV & HBV vaccination and the tag preventive-vaccine.
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