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Dynavax's adjuvanted hepatitis B vaccine for adults, licensed in the United States in 2017 and in the European Union in 2021.
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".
Why 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).
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.
1.Heplisav-B (hepatitis B vaccine, recombinant, adjuvanted) slips into a pocket on its target.
Licensed under BLA 125428 (FDA Purple Book) source
Authorised (EMEA/H/C/005063) source
| Region | Year | Indication |
|---|---|---|
| US | 2017 | Hepatitis B vaccine (recombinant), adjuvanted, BLA 125428 |
| EU | 2021 | Active immunisation against hepatitis B in adults 18 and older (EMEA/H/C/005063) |
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Query for this drug: (TITLE:"Heplisav-B" OR ABSTRACT:"Heplisav-B" OR TITLE:"hepatitis B vaccine, recombinant, adjuvanted" OR ABSTRACT:"hepatitis B vaccine, recombinant, adjuvanted" OR TITLE:"Heplisav B" OR ABSTRACT:"Heplisav B") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Heplisav-B (hepatitis B vaccine, recombinant, adjuvanted), not a curated reading list.
Shares Engerix-B (hepatitis B vaccine, recombinant), Hepatitis B and C as cancer causes, HPV & HBV vaccination and the tags preventive-vaccine, hepatitis-b-vaccine.
Shares Engerix-B (hepatitis B vaccine, recombinant), Hepatitis B and C as cancer causes, HPV & HBV vaccination and the tags preventive-vaccine, hepatitis-b-vaccine.
Shares Hepatitis B and C as cancer causes, HPV & HBV vaccination and the tags preventive-vaccine, hepatitis-b-vaccine.
Shares Hepatitis B and C as cancer causes, HPV & HBV vaccination and the tags preventive-vaccine, hepatitis-b-vaccine.
Shares Hepatitis B and C as cancer causes, HPV & HBV vaccination and the tags preventive-vaccine, hepatitis-b-vaccine.
Shares Recombivax HB / HBVaxPro (hepatitis B vaccine, recombinant), Engerix-B (hepatitis B vaccine, recombinant), Hepatitis B and C as cancer causes, HPV & HBV vaccination.
Shares HPV & HBV vaccination and the tag preventive-vaccine.
Shares HPV & HBV vaccination and the tag preventive-vaccine.
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