{"entity":{"id":"recombivax-hb","kind":"drug","name":"Recombivax HB / HBVaxPro (hepatitis B vaccine, recombinant)","aka":["HBVaxPro","Recombivax"],"tldr":"Merck's hepatitis B vaccine, sold as Recombivax HB in the United States since 1986 and as HBVaxPro in the European Union since 2001.","summary":"Recombivax HB is Merck's recombinant hepatitis B vaccine. The FDA Purple Book lists it under BLA 101066 (Merck Sharp & Dohme), first licensed on 23 July 1986, in strengths of 5 micrograms per 0.5 millilitre, 10 micrograms per millilitre and 40 micrograms per millilitre, with pre-filled syringes added in 1996. In the European Union the same company's vaccine is HBVaxPro (EMEA/H/C/000373, Merck Sharp & Dohme B.V.), authorised on 27 April 2001; the EMA indication for the 5-microgram presentation covers individuals from birth through 15 years of age considered at risk of exposure to hepatitis B virus.\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: HBVaxPro (EPAR)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/hbvaxpro"},{"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":["merck"],"institutions":[],"pathways":[],"terms":["hbv-hcv"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Recombivax HB","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":1986,"indication":"Hepatitis B vaccine (recombinant), BLA 101066"},{"region":"EU","year":2001,"indication":"HBVaxPro: active immunisation against hepatitis B virus infection (EMEA/H/C/000373)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"1986-07-23","type":"approval","region":"US","note":"Licensed under BLA 101066 (FDA Purple Book)","source":"https://www.accessdata.fda.gov/drugsatfda_docs/PurpleBook/2026/purplebook-search-October-data-download.csv"},{"date":"2001-04-27","type":"approval","region":"EU","note":"HBVaxPro authorised (EMEA/H/C/000373)","source":"https://www.ema.europa.eu/en/medicines/human/EPAR/hbvaxpro"}]},"route":"/drugs/recombivax-hb/","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":"merck","kind":"company","name":"Merck & Co. (MSD)","route":"/companies/merck/"}],"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/"}]}}