Hepatitis B vaccine - Hepatitis B vaccine information for health professionals
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Changes to the selective neonatal hepatitis B vaccination programme – Effective from 1 July 2025
The routine childhood immunisation schedule in Wales is changing in 2025 and 2026. These changes affect the selective neonatal vaccination programme for babies born to mothers with hepatitis B (HepB).
From 1 July 2025:
- the monovalent HepB dose offered at one year from the selective neonatal HepB programme schedule will be removed from the schedule.
From 1 January 2026:
- the addition of a (4th dose) of DTaP/IPV/Hib/HepB (hexavalent) vaccine at a new routine appointment at 18 months replaces the need to receive a dose of monovalent HepB vaccine at one year.
It is very important that babies eligible for the selective neonatal HepB schedule receive this 18-month dose.
For further details about these changes, see:
- Changes to routine childhood and selective neonatal hepatitis B vaccinations on the Welsh Government website (external site).
- Selective neonatal Hepatitis B immunisation pathway (effective 1 July 2025) on the Welsh Government website (external site).
Download the printable information sheet about these changes here:
About the vaccine
There are two classes of products which are available for immunisation against Hepatitis B. Hepatitis B immunoglobulin gives a temporary and passive immunity while waiting for the vaccine to respond and the Hepatitis B vaccine, which gives active immunity.
The Hepatitis B vaccine does not contain live organisms (it is inactivated) and cannot cause the disease. It is prepared from yeast cells and is manufactured by recombinant DNA technology.
Hepatitis B vaccination is offered to all babies born after 1 August 2017 as part of the NHS routine vaccination schedule (“6-in-1 vaccine”).
The complete routine immunisation schedule includes information about routine and non-routine vaccinations.
Immunisation for people at high risk of Hepatitis B
Hepatitis B vaccination in pregnancy
Hepatitis B infection in pregnant women may result in severe disease for the mother and chronic infection for the baby so it’s advised that hepatitis B vaccination should not be withheld from a pregnant woman if she is in a high-risk category.
There is no evidence of any risk from vaccinating pregnant or breastfeeding women against hepatitis B. As it is an inactivated (killed) vaccine, the risks to the unborn baby are likely to be negligible and the hepatitis B vaccine should be given where there is a definite risk of infection.
Babies born to mothers with Hepatitis B
During pregnancy, all women are offered screening for Hepatitis B. Babies born to mothers who, following screening, are found to be chronically infected with hepatitis B virus (HBV) or who have had acute hepatitis B during pregnancy are at risk of becoming infected with HBV. In addition to the routine hepatitis B vaccinations, babies born to mothers infected with hepatitis B need to be given extra doses of the hepatitis B vaccine at birth, 4 weeks and 1 year of age.
Some mothers infected with hepatitis B are considered especially high-risk because they are highly infectious. Babies born to these high-risk mothers should receive an injection of Hepatitis B immunoglobulin (HBIG) at birth. HBIG is made from blood and contains antibodies to hepatitis B. It gives fast protection but is not long lasting. They will also need a Hepatitis B vaccination to give them the longer-term protection.
All babies born to mothers infected with hepatitis B should have a blood test at 12 months of age to check if they have become infected with hepatitis B.
Hepatitis B vaccine for those considered ‘at-risk’
All those in high risk groups are also offered the hepatitis B vaccine. Some of these groups include individuals who:
- have chronic kidney disease (CKD stage 4 and 5, including haemodialysis) require Hepatitis B
- have chronic liver disease (for instance those who have severe liver disease, such as cirrhosis of any cause, or have milder liver disease and may share risk factors for acquiring hepatitis B infection, such as individuals with chronic hepatitis C)
- receive regular blood or blood products (for example individuals with haemophilia, thalassaemia, or other chronic anaemia) or carers who administer such products
- inject drugs
- are sexual partners, children, or other close family or household contacts of people who inject drugs (PWID)
- change sexual partners frequently, are men who have sex with men (MSM) or commercial sex workers
- are household, close family or sexual contacts of an individual with hepatitis B infection
- are members of a family adopting children from countries with a high or intermediate prevalence of hepatitis B
- are, or are close family member of or share a household with short-term foster carers who receive emergency placements
- are, or are close family member of or share a household with permanent foster carers who accept a child known to be hepatitis B infected
- are inmates of custodial institutions in the UK, including those on remand
- are resident in accommodation for those with learning disabilities
- are adults or children attending day care, schools, and centres for those with learning disabilities and based on local risk assessment, are at risk of percutaneous exposure (such as biting or being bitten) on a regular basis
- are solely at an occupational risk of hepatitis B exposure
- are travelling to high-risk countries
Summary of product characteristics
The Hepatitis B vaccine is given as a single or combined product:
- Monovalent hepatitis B (HepB):
- Information about Engerix B® 10micrograms/0.5ml on the EMC website (external site).
- Information about Engerix B® 20micrograms/1ml on the EMC website (external site).
- Information about HBvaxPRO® 5micrograms/0.5ml on the EMC website (external site).
- Information about HBvaxPRO® 10micrograms/1ml on the EMC website (external site).
- Combined hepatitis A and B vaccine (HeBHepA):
- Hexavalent hepatitis B:
- Hepatitis B for renal patients:
An appropriate vaccine product should be selected for the patient.
Schedule guidance in the Green Book, chapter 18 on the UK Government website (external site) supersedes the SmPC.
Guidance
Vaccination programme recommendations from the Joint Committee on Vaccination and Immunisation (JCVI) and Welsh Government policy can be found at the links below.
Joint Committee on Vaccination and Immunisation on the UK Government website (external site) – read JCVI publications and statements: search e.g., Hepatitis B.
Welsh Health Circulars and Welsh Government letters
- Eliminating hepatitis (B and C) as a public health threat: actions for 2022 to 2023 and 2023 to 2024 on the Welsh Government website (external site).
- Attaining the WHO targets for eliminating hepatitis (B and C) as a significant threat to public health on the Welsh Government website (external site).
- Introduction of the hexavalent (“6 in 1”) vaccine including hepatitis B into the routine immunisation schedule for babies born on or after 1 August 2017 on the Welsh Government website (external site).
- Change of vaccine for the routine primary infant immunisation on the Welsh Government website (external site).
Clinical resources and information
- Green Book, chapter 18, about hepatitis B on the UK Government website (external site).
- Hexavalent combination vaccine: programme guidance from UKHSA on the UK Government website (external site).
- Hepatitis B: vaccine recommendations during supply constraints on the UK Government website (external site).
Patient group directions (PGDs) and protocols
PGD templates for vaccines can be found on the patient group directions (PGDs) and protocols page (external site).
Further clinical resources and information
Data and surveillance
Vaccination surveillance information can be found on the pages below:
If considering this vaccine as a part of travel health protection, then see the Public Health Wales travel vaccination page.
Page last reviewed: 5th August 2025