{"entity":{"id":"engerix-b","kind":"drug","name":"Engerix-B (hepatitis B vaccine, recombinant)","aka":["Engerix","Engerix B"],"tldr":"GSK's hepatitis B vaccine, licensed in the United States since 1989 and prequalified by WHO for use in national programmes.","summary":"Engerix-B is GSK's recombinant hepatitis B vaccine. The FDA Purple Book lists it under BLA 103239 (GlaxoSmithKline Biologicals), licensed on 28 August 1989, as a 20-microgram-per-millilitre and a 10-microgram-per-0.5-millilitre intramuscular injection in pre-filled syringes and single-dose vials, prescription only. WHO's list of prequalified vaccines carries it as \"Engerix\" (GlaxoSmithKline Biologicals SA, regulated by Belgium's Federal Agency for Medicines and Health Products) in one-, ten- and twenty-dose vials, with a prequalification date of 1 January 1987, which is how the list records it.\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":"WHO list of prequalified vaccines (CSV export)","url":"https://extranet.who.int/prequal/vaccines/prequalified/export?page&_format=csv"},{"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":["twinrix","recombivax-hb","heplisav-b","who-prequalified-vaccines"],"cancers":[],"sections":["prevention"],"technologies":["hpv-vaccine"],"targets":[],"drugs":[],"companies":["gsk"],"institutions":[],"pathways":[],"terms":["hbv-hcv"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Engerix-B","modality":"Prophylactic vaccine (recombinant)","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":"US","year":1989,"indication":"Hepatitis B vaccine (recombinant), BLA 103239"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"1989-08-28","type":"approval","region":"US","note":"Licensed under BLA 103239 (FDA Purple Book)","source":"https://www.accessdata.fda.gov/drugsatfda_docs/PurpleBook/2026/purplebook-search-October-data-download.csv"}]},"route":"/drugs/engerix-b/","neighbours":{"drug":[{"id":"euvax-b","kind":"drug","name":"Euvax B (hepatitis B vaccine, LG Chem)","route":"/drugs/euvax-b/"},{"id":"fendrix","kind":"drug","name":"Fendrix (hepatitis B vaccine, adjuvanted, for kidney failure)","route":"/drugs/fendrix/"},{"id":"heplisav-b","kind":"drug","name":"Heplisav-B (hepatitis B vaccine, recombinant, adjuvanted)","route":"/drugs/heplisav-b/"},{"id":"prehevbrio","kind":"drug","name":"PreHevbrio / PreHevbri (hepatitis B vaccine, adults, withdrawn)","route":"/drugs/prehevbrio/"},{"id":"recombivax-hb","kind":"drug","name":"Recombivax HB / HBVaxPro (hepatitis B vaccine, recombinant)","route":"/drugs/recombivax-hb/"},{"id":"twinrix","kind":"drug","name":"Twinrix / Ambirix (combined hepatitis A and B vaccine)","route":"/drugs/twinrix/"}],"collection":[{"id":"who-prequalified-vaccines","kind":"collection","name":"WHO list of prequalified vaccines","route":"/collections/who-prequalified-vaccines/"}],"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/"},{"id":"hepatitis-b-birth-dose-programmes","kind":"term","name":"Hepatitis B birth-dose vaccination by country","route":"/terms/hepatitis-b-birth-dose-programmes/"}]}}