{"entity":{"id":"prehevbrio","kind":"drug","name":"PreHevbrio / PreHevbri (hepatitis B vaccine, adults, withdrawn)","aka":["PreHevbri"],"tldr":"VBI Vaccines' adult hepatitis B vaccine, licensed in the United States in 2021 and the European Union in 2022, and no longer marketed in either.","summary":"The FDA Purple Book lists Prehevbrio under BLA 125737 (VBI Vaccines (Delaware), Inc.), licensed on 30 November 2021 as 10 micrograms per millilitre, with a marketing status of discontinued in its October 2026 edition. The EMA authorised PreHevbri (EMEA/H/C/005466, VBI Vaccines B.V.) on 25 April 2022 for active immunisation against hepatitis B in adults; the EMA medicines report of 4 November 2026 gives its status as withdrawn.\n\nWhy it is a cancer vaccine: WHO estimates that hepatitis B caused 1.1 million deaths in 2024, mostly from cirrhosis and hepatocellular carcinoma (primary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after birth (within 24 hours), followed by two or three further doses (WHO fact sheet, 28 July 2026).","status":"withdrawn","asOf":"2026-11-04","links":[{"label":"FDA Purple Book, October 2026 data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: PreHevbri (EPAR)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/prehevbri"},{"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":["heplisav-b","engerix-b"],"cancers":[],"sections":["prevention"],"technologies":["hpv-vaccine"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["hbv-hcv"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"PreHevbrio","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":2021,"indication":"Hepatitis B vaccine (recombinant), BLA 125737; discontinued"},{"region":"EU","year":2022,"indication":"Active immunisation against hepatitis B in adults (EMEA/H/C/005466); withdrawn"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2021-11-30","type":"approval","region":"US","note":"Licensed under BLA 125737 (FDA Purple Book)","source":"https://www.accessdata.fda.gov/drugsatfda_docs/PurpleBook/2026/purplebook-search-October-data-download.csv"},{"date":"2022-04-25","type":"approval","region":"EU","note":"Authorised (EMEA/H/C/005466)","source":"https://www.ema.europa.eu/en/medicines/human/EPAR/prehevbri"}]},"route":"/drugs/prehevbrio/","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/"}],"term":[{"id":"hbv-hcv","kind":"term","name":"Hepatitis B and C as cancer causes","route":"/terms/hbv-hcv/"}]}}