# PreHevbrio / PreHevbri (hepatitis B vaccine, adults, withdrawn)

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

## TL;DR

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for active immunisation against hepatitis B in adults; the EMA medicines report of 4 November 2026 gives its status as withdrawn.

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- Status: withdrawn
- Last checked: 2026-11-04
- Also known as: PreHevbri
- Tags: preventive-vaccine; hepatitis-b-vaccine
- 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: US 2021: Hepatitis B vaccine (recombinant), BLA 125737; discontinued; EU 2022: Active immunisation against hepatitis B in adults (EMEA/H/C/005466); withdrawn

## Sources

- FDA Purple Book, October 2026 data download: https://www.accessdata.fda.gov/drugsatfda_docs/PurpleBook/2026/purplebook-search-October-data-download.csv
- EMA: PreHevbri (EPAR): https://www.ema.europa.eu/en/medicines/human/EPAR/prehevbri
- 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/)
- terms: [Hepatitis B and C as cancer causes](https://onco.cc/terms/hbv-hcv/)

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