# Hepatitis B Vaccine (rDNA), Serum Institute of India

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

## TL;DR

The Serum Institute of India's hepatitis B vaccine, prequalified by WHO since 2004 in adult and paediatric presentations.

## Summary

WHO's list of prequalified vaccines carries Hepatitis B Vaccine (rDNA) from the Serum Institute of India Pvt. Ltd. (regulated by India's Central Drugs Standard Control Organization) in adult and paediatric presentations, in one-dose ampoules or vials and ten-dose vials, prequalified on 12 November 2004.

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: Serum Institute hepatitis B vaccine
- Tags: preventive-vaccine; hepatitis-b-vaccine
- Brand: Hepatitis B Vaccine (rDNA)
- 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: WHO 2004: WHO prequalification, hepatitis B vaccine (adult and paediatric)

## Sources

- WHO list of prequalified vaccines (CSV export): https://extranet.who.int/prequal/vaccines/prequalified/export?page&_format=csv
- WHO fact sheet: hepatitis B (28 July 2026): https://www.who.int/news-room/fact-sheets/detail/hepatitis-b

## Connected records

- drugs: [BEVAC hepatitis B vaccine (Biological E)](https://onco.cc/drugs/bevac/), [Euvax B (hepatitis B vaccine, LG Chem)](https://onco.cc/drugs/euvax-b/), [Heberbiovac HB (hepatitis B vaccine, Cuba)](https://onco.cc/drugs/heberbiovac-hb/)
- collections: [WHO list of prequalified vaccines](https://onco.cc/collections/who-prequalified-vaccines/)
- fronts: [Prevention & Risk](https://onco.cc/fronts/prevention/)
- technologies: [HPV & HBV vaccination](https://onco.cc/technologies/hpv-vaccine/)
- companies: [Serum Institute of India](https://onco.cc/companies/serum-institute-of-india/)
- 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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