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GSK's hepatitis B vaccine, licensed in the United States since 1989 and prequalified by WHO for use in national programmes.
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.
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.Engerix-B (hepatitis B vaccine, recombinant) slips into a pocket on its target.
Licensed under BLA 103239 (FDA Purple Book) source
| Region | Year | Indication |
|---|---|---|
| US | 1989 | Hepatitis B vaccine (recombinant), BLA 103239 |
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Query for this drug: (TITLE:"Engerix-B" OR ABSTRACT:"Engerix-B" OR TITLE:"hepatitis B vaccine, recombinant" OR ABSTRACT:"hepatitis B vaccine, recombinant" OR TITLE:"Engerix" OR ABSTRACT:"Engerix" OR TITLE:"Engerix B" OR ABSTRACT:"Engerix 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 Engerix-B (hepatitis B vaccine, recombinant), not a curated reading list.
Shares Euvax B (hepatitis B vaccine, LG Chem), WHO list of prequalified vaccines, Hepatitis B birth-dose vaccination by country, Hepatitis B and C as cancer causes and the tags preventive-vaccine, hepatitis-b-vaccine.
Shares Euvax B (hepatitis B vaccine, LG Chem), WHO list of prequalified vaccines, Hepatitis B birth-dose vaccination by country, Hepatitis B and C as cancer causes and the tags preventive-vaccine, hepatitis-b-vaccine.
Shares Euvax B (hepatitis B vaccine, LG Chem), WHO list of prequalified vaccines, Hepatitis B birth-dose vaccination by country, Hepatitis B and C as cancer causes and the tags preventive-vaccine, hepatitis-b-vaccine.
Shares WHO list of prequalified vaccines, HPV & HBV vaccination and the tag preventive-vaccine.
Shares WHO list of prequalified vaccines, HPV & HBV vaccination and the tag preventive-vaccine.
Shares HPV & HBV vaccination and the tag preventive-vaccine.
Shares WHO list of prequalified vaccines, GSK, HPV & HBV vaccination.
Shares GSK, HPV & HBV vaccination.
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