6-in-1 Vaccine

The impact of vaccination

The table below shows the average number of deaths in the UK each year, before and after introduction of a vaccine:

Disease Before After
Diphtheria 3500 0
Tetanus 200 0
Pertussis 1000 3
Polio 200 0
Hib Disease 60 0
TOTAL 4960 3

Source: Public Health England and the Health Protection Agency archive

Key vaccine facts

The 6-in-1 vaccine used in the UK gives protection against these six serious diseases: diphtheria, tetanus, whooping cough (pertussis), polio, Hib disease (Haemophilus influenzae type b) and hepatitis B. Before vaccines existed, these diseases used to kill thousands of children in the UK every year, as the table above shows. The vaccine has a good safety record and offers very good protection against all six diseases.

The 6-in-1 vaccine replaces the 5-in-1 vaccine for all UK babies on or after 1st August 2017. Babies born before 1st August 2017 received the 5-in-1 vaccine, but it is no longer routinely used in the UK.

In the UK the 6-in-1 vaccine is given at 2, 3 and 4 months. The repeated doses are needed to give a good immune response in most children. The vaccine can safely be given at the same time as other vaccines in the schedule (see the full UK routine schedule for details of the other vaccines). It is a combination vaccine, which reduces the number of injections a child needs. Read more about combination vaccines and multiple vaccinations and why these are not a risk to your baby's immune system.

The 6-in-1 vaccine used in the UK does not contain any live bacteria or viruses, and cannot cause any of the diseases it protects against.

The brand name of the 6-in-1 vaccine used in the UK is Infanrix Hexa (see the Patient Information Leaflet ). This vaccine contains just 10 components (the active ingredients that make the immune system produce antibodies to protect you against the disease). A similar vaccine used until 2004 contained more than 3,000 proteins among its components. This means that the current vaccine is less likely to cause side effects. See 'More information' below.

Who should have the vaccine?

Almost all babies can receive the 6-in-1 vaccine. However, there are some cases in which a baby should not have the vaccine:

  • If they have a fever at the time of vaccination
  • If they have signs of a neurological problem that is getting worse, including poorly controlled epilepsy
  • If they are allergic to the vaccine or any of its ingredients

Ask your GP, nurse or health visitor for advice if your child has a history of fits (febrile seizures) or has suffered a fit within 72 hours of a previous dose of the 6-in-1 vaccine.

There are special recommendations for babies born to mothers who are infected with hepatitis B. See 'More Information' below.>

Ingredients

The 6-in-1 vaccine used in the UK is called Infanrix Hexa. Apart from the active ingredients (the antigens), it contains very small amounts of these ingredients:

  • Aluminium, which strengthens and lengthens the immune response to the vaccine
  • Lactose and Medium 199 (containing amino acids, mineral salts and vitamins), both used as stabilisers
  • Sodium chloride (salt)

The vaccine may also contain traces of these products used during the manufacturing process:

  • Formaldehyde, an organic compound used to inactivate (kill) the viruses used in the vaccine
  • Yeast proteins from the yeast 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.
  • Antibiotics (neomycin and polymixin), used to stop bacteria growing and contaminating the vaccine

The Hib part of the 6-in-1 is a conjugate vaccine. Sugars are taken from the capsule around the Hib bacteria and joined to a non-toxic protein from tetanus. The protein helps to stimulate the immune system in a broader way to respond well to the vaccine. This gives a better immune response in individuals of all ages.

The polio part of the vaccine is grown in the laboratory using animal cell-lines. See more information on animal cell-lines in vaccine production.

The hepatitis B proteins for the vaccine are grown in yeast cells. This process is called recombinant DNA technology.

Other brands of the 6-in-1 vaccine used in other countries may contain different ingredients. If you are not in the UK, ask for the Patient Information leaflet for the vaccine you are offered.

Side effects

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

  • redness, pain and/or swelling at the injection site. This is more common at the second and third dose.
  • raised temperature (fever). This is more common at the second and third dose.
  • irritability
  • loss of appetite
  • vomiting
  • abnormal crying

Many of these symptoms can be relieved by giving paracetamol (Calpol) if your child is over 2 months, or ibuprofen if your child is over 3 months and weighs more than 5kg (see NHS Choices for more advice on giving painkillers to babies and children).

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

  • diarrhoea
  • bruising or bleeding at the injection site
  • a small, painless lump at the injection site. This usually disappears and is not serious.

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

  • unusual high-pitched screaming, and episodes during which the child may become blue, pale and/or limp (hypotonic-hyporesponsive episodes, or HHE)

Very rare (affecting fewer than 1 in 10,000 people at each dose):

  • fits (also called febrile convulsions or febrile seizures)

You should consult your doctor if your child experiences fits or HHE episodes after vaccination. This is mainly to check that it is the vaccine causing the symptoms, and not some unrelated disease. Symptoms such as fits can be very worrying for parents, but there is no evidence of long-term effects. Children can normally safely receive vaccines in the future. For more information on febrile seizures generally, see NHS Choices .

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 serious but can be treated with adrenaline. In the UK between 1997 and 2003 there were a total of 130 reports of anaphylaxis following ALL immunisations, but all of these people survived. Around 117 million doses of vaccines were given in the UK during this period, making the overall rate around 1 in 900,000. Depending on the cause of the reaction, and following expert guidance, the person may be able to have vaccinations in the future.

Reactions listed under ‘possible side effects’ or ‘adverse events’ on vaccine product information sheets may not all be directly linked to the vaccine. See Vaccine side effects and adverse reactions for more information on why this is the case.

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 view data on Yellow Card reports for individual products . See more information on the Yellow Card scheme and monitoring of vaccine safety.

More information about the vaccine

In 2017 the UK decided to replace the 5-in-1 vaccine with a 6-in-1 vaccine. The 5-in-1 vaccine protected against diphtheria, tetanus, whooping cough (pertussis), polio and Hib disease (Haemophilus influenzae type b). The 6-in-1 vaccine also gives protection against hepatitis B, a cause of serious liver disease which can be fatal.

The 6-in-1 vaccine is not new. It was licensed in Europe in 2000, and since then about 150 million doses have been given in 97 countries in Europe and across the world, including Canada, Australia and New Zealand. The vaccine used in the UK is licensed for children from 6 weeks to 10 years old.

Since hepatitis B is so serious, the World Health Organization has said that all babies in the world should be protected by hepatitis B vaccination. Introducing the 6-in-1 vaccine into the UK is part of a global strategy to eliminate the virus worldwide. See the Public Health England statement for more information.

The 6-in-1 vaccine includes the acellular pertussis vaccine. 'Acellular' means that it does not contain any whole pertussis bacteria. It contains just three proteins from the surface of the pertussis bacteria, which produce a good immune response by themselves. This greatly reduces the chance of serious side effects such as high temperatures, screaming episodes, and HHE (see the section on side effects above). The whole cell (wP) vaccine used in the UK until 2004 contained whole killed pertussis bacteria. These contained thousands of antigens (the proteins and sugars that stimulate the immune system) and had a greater risk of side effects.

The 6-in-1 vaccine also includes inactivated polio virus (IPV). As this is inactivated (killed), it cannot cause polio (which was a very small risk with the live, oral polio vaccine used in the UK until 2004).

Different countries have decided on different schedules for the 6-in-1 vaccine. In the UK, the three doses are given as close together as possible to give babies early protection from pertussis (whooping cough). This disease can be particularly severe in very young babies, so the earlier they are protected the better. This 'accelerated' programme was introduced in the UK in 1990, and led to a drop in the number of pertussis cases.

The immunisation rate in the UK for three doses of the 5-in-1 vaccine has been around 94% since 2001, just below the World Health Organization target of 95%. However, rates have been lower than 94% in some areas of the UK. For example, in London in 2014 the coverage rate was around 90%, and in some parts of London the rate was below 75%.

Hepatitis B vaccination for babies born to mothers who have hepatitis B infection

Babies born to mothers who are infected with hepatitis B are at high risk of becoming infected themselves during birth. Infection in this way leads to long-term chronic infection in 90% of cases, and puts the child at risk of serious liver disease later in life. Since 1998 the UK has had a hepatitis B screening programme for pregnant women, and an immunisation programme for babies who are identified as being at risk.

This programme will continue, but it is changing slightly as a result of the introduction of the 6-in-1 vaccine. Babies born on or after 1st August 2017 to mothers with hepatitis B infection will still receive two doses of the individual (monovalent) hepatitis B vaccine, one immediately after birth and one at 4 weeks of age. Babies born to women who are thought to be particularly infectious may also be given hepatitis B immunoglobulin at birth. This provides immediate, temporary protection while the baby develops their own immunity through vaccination. Babies in this group will then follow the routine schedule and receive three doses of the 6-in-1 vaccine at 2 months, 3 months and 4 months of age. At one year of age they will receive another dose of the individual hepatitis B vaccine, and they will also be tested to make sure they are not infected with hepatitis B.

Does the vaccine work?

Diphtheria: A study carried on a large-scale diphtheria outbreak in Russia in the 1990s showed that three doses of diphtheria-containing vaccine were 97% effective against diphtheria.

Pertussis (whooping cough): Studies have shown that the acellular pertussis vaccine in the 6-in-1 has 80-95% effectiveness , but it is thought that protection may wane relatively quickly. This is an area of ongoing research, for example through the 'Periscope' project which Oxford Vaccine Group is taking part in.

Hib disease: Original studies done in the UK in the early 1990s showed that 90 to 99% of children developed protective levels of antibodies following three doses of Hib vaccine.

Polio: Studies carried out during polio epidemics show that the inactivated polio vaccine in the 6-in-1 is over 90% effective against paralytic polio.

Tetanus: Five doses of tetanus vaccine at the recommended intervals (three doses of the 6-in-1, plus the Pre-School booster and the Teenage booster) give up to 100% protection against tetanus. However, protection can wane over time. A tetanus booster may be recommended for adults who have an injury and are not sure about their tetanus vaccination history, or for travellers to countries where tetanus may be more of a risk.

Hepatitis B: The World Health Organization states that the hepatitis B vaccine is 95% effective in preventing infection and the development of chronic disease and liver cancer due to hepatitis B. Protection lasts at least 20 years and is probably lifelong.

Page last updated: 
Friday, June 29, 2018

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