{"entity":{"id":"twinrix","kind":"drug","name":"Twinrix / Ambirix (combined hepatitis A and B vaccine)","aka":["Ambirix","Twinrix Adult","Twinrix Paediatric","hepatitis A and B vaccine"],"tldr":"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.\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":"FDA Purple Book, October 2026 data download","url":"https://www.accessdata.fda.gov/drugsatfda_docs/PurpleBook/2026/purplebook-search-October-data-download.csv"},{"label":"EMA: Twinrix Adult (EPAR)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/twinrix-adult"},{"label":"EMA: Ambirix (EPAR)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ambirix"},{"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"],"cancers":[],"sections":["prevention"],"technologies":["hpv-vaccine"],"targets":[],"drugs":[],"companies":["gsk"],"institutions":[],"pathways":[],"terms":["hbv-hcv"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"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":[{"region":"EU","year":1996,"indication":"Twinrix Adult: non-immune adults and adolescents 16 and older at risk of hepatitis A and B (EMEA/H/C/000112)"},{"region":"US","year":2001,"indication":"Hepatitis A and hepatitis B (recombinant) vaccine, BLA 103850"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"1996-09-19","type":"approval","region":"EU","note":"Twinrix Adult authorised (EMEA/H/C/000112)","source":"https://www.ema.europa.eu/en/medicines/human/EPAR/twinrix-adult"},{"date":"2001-05-11","type":"approval","region":"US","note":"Licensed under BLA 103850 (FDA Purple Book)","source":"https://www.accessdata.fda.gov/drugsatfda_docs/PurpleBook/2026/purplebook-search-October-data-download.csv"},{"date":"2002-08-30","type":"approval","region":"EU","note":"Ambirix authorised (EMEA/H/C/000426)","source":"https://www.ema.europa.eu/en/medicines/human/EPAR/ambirix"}]},"route":"/drugs/twinrix/","neighbours":{"drug":[{"id":"engerix-b","kind":"drug","name":"Engerix-B (hepatitis B vaccine, recombinant)","route":"/drugs/engerix-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/"}]}}