# Heplisav-B (hepatitis B vaccine, recombinant, adjuvanted)

Source: https://onco.cc/drugs/heplisav-b/  
OnCo record `heplisav-b` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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".

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).

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-11-04
- Also known as: Heplisav B
- Tags: preventive-vaccine; hepatitis-b-vaccine
- 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: 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)

## Sources

- FDA Purple Book, October 2026 data download: https://www.accessdata.fda.gov/drugsatfda_docs/PurpleBook/2026/purplebook-search-October-data-download.csv
- EMA: Heplisav B (EPAR): https://www.ema.europa.eu/en/medicines/human/EPAR/heplisav-b
- WHO fact sheet: hepatitis B (28 July 2026): https://www.who.int/news-room/fact-sheets/detail/hepatitis-b

## Connected records

- drugs: [Engerix-B (hepatitis B vaccine, recombinant)](https://onco.cc/drugs/engerix-b/), [Fendrix (hepatitis B vaccine, adjuvanted, for kidney failure)](https://onco.cc/drugs/fendrix/), [PreHevbrio / PreHevbri (hepatitis B vaccine, adults, withdrawn)](https://onco.cc/drugs/prehevbrio/), [Recombivax HB / HBVaxPro (hepatitis B vaccine, recombinant)](https://onco.cc/drugs/recombivax-hb/)
- fronts: [Prevention & Risk](https://onco.cc/fronts/prevention/)
- technologies: [HPV & HBV vaccination](https://onco.cc/technologies/hpv-vaccine/)
- terms: [Hepatitis B and C as cancer causes](https://onco.cc/terms/hbv-hcv/)

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