Hepatitis B Vaccine

Key vaccine facts

This vaccine gives protection against the hepatitis B virus, which is a major cause of serious liver disease, including liver cancer and cirrhosis (scarring of the liver, which prevents the liver from working properly).

The individual hepatitis B vaccine can be given at the same time as other vaccines such as the pneumococcal conjugate vaccine (PCV), hepatitis A, measles, mumps and rubella (MMR), pre-school booster and other travel vaccines. But the vaccines should be given at separate sites, preferably in a different arm or leg.

The vaccine does not contain any live viruses, and cannot cause hepatitis B disease.

Since the disease is so serious, the World Health Organization has said that all babies in the world should be protected by hepatitis B vaccination. In the UK all babies are now offered the combination 6-in-1 vaccine which contains hepatitis B vaccine, as well as vaccines against five other serious diseases.

Who should have the vaccine

The individual (monovalent) hepatitis B vaccine continues to be given to those in the UK at high risk of hepatitis B disease. The way the hepatitis B virus is transmitted - through contaminated blood and other bodily fluids, such as semen and vaginal fluids - means that some people are at greater risk of contracting hepatitis B than others. This includes:

babies born to mothers with hepatitis B infection.
babies born to a hepatitis B negative woman, but known to be going home to a household with another hepatitis B infected person.
people with chronic (long-term) liver disease or kidney conditions
people with blood disorders such as haemophilia, who receive blood products
close family contacts of someone with chronic hepatitis B infection
foster carers and people adopting children from countries where there is a high risk of hepatitis B infection
people who inject drugs
people who change sexual partners frequently
prisoners
people with learning disabilities who live in residential accommodation
healthcare workers and other staff in healthcare settings who may come into direct contact with blood or blood products
workers in other settings who may be at risk of injury from needles, or at risk of being deliberately injured or bitten by patients.

The hepatitis B vaccine may also be recommended as a travel vaccine for travel to some parts of the world.

Safety and side effects

All vaccines go through rigorous testing and regulatory processes that can take up to 15 years to ensure they are safe and effective. Like all medicines, vaccines can cause side effects, but not everyone experiences these.

Several different makes of hepatitis B vaccine are used in the UK. For full information about the specific side effects for the vaccine you are offered, ask for the patient information leaflet for the vaccine. Side effects reported for hepatitis B vaccines in general are listed below.

Very common - affecting more than 1 in 10 people at each dose:

headache
pain, redness and hardness at the injection site
feeling tired or irritable
loss of appetite

Common - affecting up to 1 in 10 people at each dose:

high temperature (fever) above 37.5 degrees
feeling sick or being sick
diarrhoea or pain in the stomach
swelling, bruising or itching at the injection site
generally feeling unwell

Uncommon - affecting up to 1 in 100 people at each dose:

feeling dizzy
aching muscles
flu-like symptoms

Rare - affecting up to 1 in 1000 people at each dose:

low blood pressure
joint pain (arthralgia)
hives, rash or itchiness
pins and needles (paraesthesia)
swollen glands in the neck, armpit or groin (lymphadenopathy)

More serious side effects are very rare (affecting fewer than 1 in 10,000 people at each dose). You should consult your doctor if you or your child experiences suspected serious side effects after vaccination. This is mainly to check that it is the vaccine causing the symptoms, and not some unrelated disease.

As with any vaccine, medicine or food, there is a very small chance of a severe allergic reaction - anaphylaxis. Anaphylaxis is different from less severe allergic reactions because it causes life-threatening breathing and/or circulation problems. It is always extremely serious but can be treated with adrenaline. Health care workers who give vaccines know how to do this. In the UK between 1997 and 2003 there were a total of 130 reports of anaphylaxis following ALL immunisations. During this six year period, around 117 million doses of vaccines were given in the UK. This means that the overall rate of anaphylaxis is around 1 in 900,000.

More information on side effects

If you are concerned about any reactions that occur after vaccination, consult your doctor. In the UK you can report suspected vaccine side effects to the Medicines and Healthcare products Regulatory Agency (MHRA) through the Yellow Card Scheme . You can also contact the MHRA to ask for data on Yellow Card reports for individual vaccines . See more information on the Yellow Card scheme and monitoring of vaccine safety.

Ingredients

There are several different hepatitis B vaccines used in the UK. Apart from the active ingredients (antigens) that produce the immune response for hepatitis B, these vaccines contain water and very small amounts of other added ingredients. Many of these are already found naturally in the body or food. For the full information about ingredients of the specific vaccine you are offered, ask for the patient information leaflet.

Apart from the active ingredients (the antigens), hepatitis B vaccines contain very small amounts of this added ingredient:

a luminium, which strengthens and lengthens the immune response to the vaccine

Hepatitis B vaccines may also contain tiny traces of products used during the manufacturing process:

yeast proteins from the yeast that is used to grow the hepatitis B proteins for the vaccine. A tiny quantity may remain in the vaccine, but there is no evidence that this can cause allergic reactions.
formaldehyde, used to inactivate (kill) the hepatitis B viruses used in the vaccine
sodium chloride (salt) and other salts based on sodium and potassium, used as acidity regulators
sodium borate (borax), used as an acidity regulator

Growing the active ingredients for the vaccines:

hepatitis B vaccines contain one of the proteins from the surface of the hepatitis B virus (hep B surface antigen, or HBsAg). This protein is made by inserting the genetic code into yeast cells, which removes any risk of viral DNA getting into the final product. This process is called recombinant DNA technology.

Latex may be used in the packaging of some of the hepatitis B vaccines.

More information about the vaccine

The hepatitis B vaccine can be given either as a single vaccine (monovalent), or in combination with the hepatitis A vaccine (bivalent combination), or as part of the 6-in-1 vaccine (hexavalent).

There are currently five different hepatitis monovalent products on the market, for adults and children. Different products can be used to complete a course of vaccinations.

One of these products – Fendrix – is specifically for adults and young people aged 15 and over with poor kidney function (renal insufficiency). In addition, HBvaxPRO40 can be given to people who are already undergoing dialysis and those who will need dialysis in future.

Please refer to the patient information leaflets for more details:

There are three products of the combined hepatitis A and B vaccine available. Again, please read the patient information leaflets for more detail.

Finally there are two products of the 6-in-1 hexavalent vaccine used in the UK. You can find out more here.

Pre and post exposure prevention

As well as preventing hepatitis B infection before exposure, through the production of antibodies, the hepatitis B vaccine is very effective at preventing infection after a person has been exposed to the virus. Ideally, vaccination should start within 24 hours of exposure. However, it can still work up to a week after exposure.

For pre-exposure prevention, three doses of vaccine are required. This is the same for post-exposure prevention, although these are given in an accelerated schedule.

Where required, post-exposure doses are given as soon as possible after exposure, then at one month and two months. Some people, depending on their particular circumstances, such as occupation, risk of continued exposure and hepatitis B antibody levels may need a reinforcing dose of vaccine 12 months after their initial exposure, and again five years later. For more detail, please refer to Chapter 18 of the Green Book.

Hepatitis B immunoglobulin

Specific hepatitis B immunoglobulin (HBIG), made from the plasma of people who have been immunised and screened for other infections, such as HIV, can also give protection against hepatitis B infection after accidental inoculation, or contamination with blood infected with hepatitis B. This protection is immediate, but temporary. Babies born to mothers who are thought to be particularly infectious may be given hepatitis B immunoglobulin alongside vaccination, so a baby is protected while they develop active immunity from vaccination.

The hepatitis B vaccine is given either as a single (monovalent) vaccine, or in combination with the hepatitis A vaccine (bivalent combination).

Babies born to a mother with hepatitis B

Most babies born to mothers with hepatitis B will receive a total of six vaccines to protect against hepatitis B between birth and 12 months of age. Three of these vaccines are given as part of the routine 6-in-1 schedule at 8, 12 and 16 weeks of age. Additional individual hepatitis B vaccines (called monovalent) are also given straight after the baby is born, again at 4 weeks old and at 12 months old.Babies who are born to women with high levels of infection may also given an injection of hepatitis B immunoglobulin at birth. This provides immediate, temporary protection while the baby develops immunity through the other hepatitis B vaccines. At one year of age, when a baby has had all the vaccines, they will be tested to make sure they are not infected with hepatitis B.