{"entity":{"id":"fendrix","kind":"drug","name":"Fendrix (hepatitis B vaccine, adjuvanted, for kidney failure)","aka":[],"tldr":"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.\n\nWhy 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).","status":"approved","asOf":"2026-11-04","links":[{"label":"EMA: Fendrix (EPAR)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/fendrix"},{"label":"WHO fact sheet: hepatitis B (28 July 2026)","url":"https://www.who.int/news-room/fact-sheets/detail/hepatitis-b"}],"tags":["preventive-vaccine","hepatitis-b-vaccine"],"related":["engerix-b","heplisav-b"],"cancers":[],"sections":["prevention"],"technologies":["hpv-vaccine"],"targets":[],"drugs":[],"companies":["gsk"],"institutions":[],"pathways":[],"terms":["hbv-hcv"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"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":[{"region":"EU","year":2005,"indication":"Hepatitis B immunisation for patients aged 15 and older with renal insufficiency, including pre-haemodialysis and haemodialysis (EMEA/H/C/000550)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2005-02-02","type":"approval","region":"EU","note":"Authorised (EMEA/H/C/000550)","source":"https://www.ema.europa.eu/en/medicines/human/EPAR/fendrix"}]},"route":"/drugs/fendrix/","neighbours":{"drug":[{"id":"engerix-b","kind":"drug","name":"Engerix-B (hepatitis B vaccine, recombinant)","route":"/drugs/engerix-b/"},{"id":"heplisav-b","kind":"drug","name":"Heplisav-B (hepatitis B vaccine, recombinant, adjuvanted)","route":"/drugs/heplisav-b/"}],"section":[{"id":"prevention","kind":"section","name":"Prevention & Risk","route":"/fronts/prevention/"}],"technology":[{"id":"hpv-vaccine","kind":"technology","name":"HPV & HBV vaccination","route":"/technologies/hpv-vaccine/"}],"company":[{"id":"gsk","kind":"company","name":"GSK","route":"/companies/gsk/"}],"term":[{"id":"hbv-hcv","kind":"term","name":"Hepatitis B and C as cancer causes","route":"/terms/hbv-hcv/"}]}}