{"entity":{"id":"heplisav-b","kind":"drug","name":"Heplisav-B (hepatitis B vaccine, recombinant, adjuvanted)","aka":["Heplisav B"],"tldr":"Dynavax's adjuvanted hepatitis B vaccine for adults, licensed in the United States in 2017 and in the European Union in 2021.","summary":"Heplisav-B is Dynavax's adjuvanted recombinant hepatitis B vaccine. The FDA Purple Book lists it under BLA 125428 (Dynavax Technologies Corporation), licensed on 9 November 2017, as 20 micrograms per 0.5 millilitre in a single-dose vial. The EMA authorised Heplisav B (EMEA/H/C/005063, Dynavax GmbH) on 18 February 2021 \"for the active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older\".\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: Heplisav B (EPAR)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/heplisav-b"},{"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","recombivax-hb","fendrix","prehevbrio"],"cancers":[],"sections":["prevention"],"technologies":["hpv-vaccine"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["hbv-hcv"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Heplisav-B","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":"US","year":2017,"indication":"Hepatitis B vaccine (recombinant), adjuvanted, BLA 125428"},{"region":"EU","year":2021,"indication":"Active immunisation against hepatitis B in adults 18 and older (EMEA/H/C/005063)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2017-11-09","type":"approval","region":"US","note":"Licensed under BLA 125428 (FDA Purple Book)","source":"https://www.accessdata.fda.gov/drugsatfda_docs/PurpleBook/2026/purplebook-search-October-data-download.csv"},{"date":"2021-02-18","type":"approval","region":"EU","note":"Authorised (EMEA/H/C/005063)","source":"https://www.ema.europa.eu/en/medicines/human/EPAR/heplisav-b"}]},"route":"/drugs/heplisav-b/","neighbours":{"drug":[{"id":"engerix-b","kind":"drug","name":"Engerix-B (hepatitis B vaccine, recombinant)","route":"/drugs/engerix-b/"},{"id":"fendrix","kind":"drug","name":"Fendrix (hepatitis B vaccine, adjuvanted, for kidney failure)","route":"/drugs/fendrix/"},{"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/"}],"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/"}],"term":[{"id":"hbv-hcv","kind":"term","name":"Hepatitis B and C as cancer causes","route":"/terms/hbv-hcv/"}]}}