# Recombivax HB / HBVaxPro (hepatitis B vaccine, recombinant)

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

## TL;DR

Merck's hepatitis B vaccine, sold as Recombivax HB in the United States since 1986 and as HBVaxPro in the European Union since 2001.

## Summary

Recombivax HB is Merck's recombinant hepatitis B vaccine. The FDA Purple Book lists it under BLA 101066 (Merck Sharp & Dohme), first licensed on 23 July 1986, in strengths of 5 micrograms per 0.5 millilitre, 10 micrograms per millilitre and 40 micrograms per millilitre, with pre-filled syringes added in 1996. In the European Union the same company's vaccine is HBVaxPro (EMEA/H/C/000373, Merck Sharp & Dohme B.V.), authorised on 27 April 2001; the EMA indication for the 5-microgram presentation covers individuals from birth through 15 years of age considered at risk of exposure to hepatitis B virus.

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: HBVaxPro; Recombivax
- Tags: preventive-vaccine; hepatitis-b-vaccine
- Brand: Recombivax HB
- 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: US 1986: Hepatitis B vaccine (recombinant), BLA 101066; EU 2001: HBVaxPro: active immunisation against hepatitis B virus infection (EMEA/H/C/000373)

## Sources

- FDA Purple Book, October 2026 data download: https://www.accessdata.fda.gov/drugsatfda_docs/PurpleBook/2026/purplebook-search-October-data-download.csv
- EMA: HBVaxPro (EPAR): https://www.ema.europa.eu/en/medicines/human/EPAR/hbvaxpro
- 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/), [Heplisav-B (hepatitis B vaccine, recombinant, adjuvanted)](https://onco.cc/drugs/heplisav-b/)
- fronts: [Prevention & Risk](https://onco.cc/fronts/prevention/)
- technologies: [HPV & HBV vaccination](https://onco.cc/technologies/hpv-vaccine/)
- companies: [Merck & Co. (MSD)](https://onco.cc/companies/merck/)
- terms: [Hepatitis B and C as cancer causes](https://onco.cc/terms/hbv-hcv/), [Hepatitis B birth-dose vaccination by country](https://onco.cc/terms/hepatitis-b-birth-dose-programmes/)

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