Introducing the 6-in-1 vaccine into the UK was part of a global strategy to eliminate the hepatitis B virus worldwide. Hepatitis B infection can result in serious liver problems, including scarring and cancer and can be fatal. As the disease is so serious, the World Health Organization has said that all babies should be vaccinated against it.
The 6-in-1 vaccines in use in the UK are not new. Infanrix hexa was licensed in Europe in 2000 and since then over 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.
Vaxelis was licensed in 2016. The UK Health Security Agency considers Infanrix hexa or Vaxelis interchangeable, although it recommends that the same brand is given for all three doses, if possible. A key difference is how they are supplied. Vaxelis is supplied in a pre-filled syringe, while Infanrix hexa needs mixing.
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 for pertussis was introduced in the UK in 1990, and has led to a drop in the number of cases.
Components of the 6-in-1
The 6-in-1 vaccine is sometimes referred to as DTaP/Hib/HepB/IPV, which stands for ‘Diphtheria, Tetanus, acellular Pertussis, Hib, Hepatitis B and Inactivated Polio Vaccine’.
'Acellular' means that the pertussis vaccine (the aP in DTaP) does not contain any whole pertussis bacteria. It contains just three proteins from the surface of the pertussis bacteria.
These produce a good immune response by themselves. This greatly reduces the chance of serious side effects, such as high temperatures, screaming episodes, and hypotonic-hyporesponsive episodes (HHE). See section above for more on possible side-effects.
The 6-in-1 vaccine also includes inactivated polio virus (IPV). This means the virus has been killed (inactivated) and cannot cause polio. This was a very small risk with the live, oral polio vaccine (OPV) used in the UK until 2004.
The Hib part of the 6-in-1 is known as a conjugate vaccine. Sugars (polysaccharides) 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. See our page on 'Types of vaccine' for more information on conjugate vaccines.
The brand names of the 6-in-1 vaccines used in the UK are Infanrix hexa and Vaxelis. These vaccines contain far fewer components that make the immune system produce antibodies to protect people against the disease. This means the vaccines are less likely to cause side effects. Please see the patient information leaflets for more information. Infantrix hexa and Vaxelis patient information leaflets.
How well does the vaccine work?
Before the introduction of vaccines, thousands of babies and children in the UK died from these diseases annually. This dropped to almost no deaths following the introduction of vaccination. Evidence shows that the 6-in-1 vaccine is very effective.
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 in which Oxford Vaccine Group is a partner.
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.
People who travel to counties where tetanus may be more of a risk than in the UK may also be recommended a booster.
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.
Hepatitis B vaccination for babies born to mothers who have hepatitis B infection or are at high risk
Babies born to mothers who are infected with hepatitis B are at high risk of becoming infected 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.
There is a special hepatitis B screening programme in place in the UK for pregnant women and an immunisation programme for babies who are identified as being at risk. When the 6-in-1 vaccine was introduced, the immunisation programme changed slightly.
Most babies born to mothers with hepatitis B infection 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.
If a baby is born to a hepatitis B negative woman but known to be going home to a household with another hepatitis B infected person and at immediate risk of infection, a single dose of a monovalent hepatitis B vaccine should be offered before the baby is discharged from hospital. The baby should then continue on the routine childhood schedule that starts at 8 weeks.
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. Specific hepatitis B immunoglobulin (HBIG) is made from the plasma of people who have been immunised against hepatitis B and screened for other blood-borne infections, including HIV and hepatitis C.
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.