Read this article to learn more about:
- hepatitis B
- introduction of the hexavalent vaccine into the routine childhood immunisation schedule
- implications for the neonatal selective immunisation programme for babies at risk of hepatitis B.
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In autumn 2017, a 6 in 1 DTaP/IPV/Hib/HepB combination vaccine will be offered to infants at 8, 12, and 16 weeks of age. This hexavalent vaccine, which will replace the pentavalent (5 in 1) vaccine currently offered, will not only protect infants against diphtheria, tetanus, pertussis, polio, and Hib disease, but also provide them with protection against hepatitis B. In this article, we describe the symptoms and prevalence of hepatitis B, provide information about the hexavalent vaccine, and discuss the continued importance of screening pregnant women for hepatitis B.
What is hepatitis B?
Hepatitis B is an infection of the liver caused by the hepatitis B virus (HBV). Most new infections with HBV are sub-clinical or may cause a flu-like illness with features such as weight loss, abdominal pain, nausea, vomiting, arthralgia, and jaundice. Acute HBV infection occasionally leads to sudden and severe hepatic necrosis, which can be fatal. 1 Chronic HBV infection can result in progressive liver disease, leading to cirrhosis in some patients and an increased risk of developing hepatocellular carcinoma. 1
The incubation period of HBV ranges from 40 to 160 days with an average of 60 to 90 days. 2 Diagnosis is usually made using serological tests that look for the presence of hepatitis B surface antigen (HBsAg). Among those patients who are HBsAg positive, those in whom hepatitis B e-antigen (HBeAg) is also detected are the most infectious. 1
Humans are the only known reservoir of HBV-transmission can occur through sexual intercourse, contaminated blood products, needlestick injuries, sharing of injecting equipment amongst drug users, and from mother to baby during or soon after childbirth. 3 Transmissibility of HBV varies depending on the infectivity of the carrier, for example, if the infected person has a high viral load or is also HBeAg positive. 1 Without timely intervention, the rate of perinatal transmission to neonates from HBV-infected mothers who are also HBeAg positive is 70%, compared with 10% for those who have HBV infection but are HBeAg negative. 1
Globally it has been estimated that 2 billion people have been infected with HBV with about 350 million having chronic infection. 1 The distribution of HBV infection varies from high prevalence areas (>8% infected) such as sub-Saharan Africa, most of Asia, and the Pacific islands, to areas of intermediate prevalence (2-8%) such as the Amazon, southern parts of Eastern and Central Europe, the Middle East, and the Indian sub-continent. 3 Low-prevalence (<2%) regions include most of Western Europe and North America. 3 In high prevalence areas, perinatal transmission from infected mother to baby around the time of delivery is the most important route of transmission. 3
In 1992, the World Health Assembly recommended that by 1997, every country should have a universal hepatitis B immunisation programme. 4 As the UK is a low prevalence and low incidence country for hepatitis B, 3 introducing a universal hepatitis B programme using a monovalent hepatitis B vaccine would not have been cost-effective. Infant combination hepatitis B vaccines (which also protect against diphtheria, tetanus, polio, pertussis, and Hib) are now available in the UK. 5 In 2014 the Joint Committee on Vaccination and Immunisation (JCVI) re-evaluated the benefits and cost-effectiveness of a universal hepatitis B infant immunisation programme in the UK and subsequently recommended the use of the hexavalent DTaP/IPV/Hib/HepB combination vaccine for all infants. 5
Implementation of a hepatitis B vaccine into the routine childhood immunisation schedule
From autumn 2017, Infanrix hexa ® (DTaP/IPV/Hib/HepB) will replace both Pediacel ® and Infanrix-IPV+Hib ® (DTaP/IPV+Hib) for primary baby immunisations. 6 The change in vaccine means that babies will be immunised against all the diseases the current pentavalent vaccine offers (diphtheria, tetanus, pertussis, polio, and Hib), with the addition of hepatitis B in the hexavalent vaccine.
The change from a pentavalent to hexavalent vaccine does not affect the timing of the routine childhood immunisation schedule. Infanrix hexa ® (DTaP/IPV/Hib/HepB) will be offered to all babies born on or after 1 August 2017 from late September/early October 2017 at 8, 12, and 16 weeks of age. 6 Table 1 below outlines the routine childhood immunisation schedule and the associated vaccines following the introduction of hexavalent vaccine.
Table 1: Routine childhood immunisation schedule following the introduction of Infanrix hexa®6
Safety and efficacy of Infanrix hexa®
Infanrix hexa ® is not a new vaccine, it was first licensed for use in Europe in October 2000. 7 It is licensed for use in 97 other countries across the world including Canada, Australia, and New Zealand-approximately 150 million doses have been given to infants across the world. 7
The safety profile of Infanrix hexa ® is good, common adverse events experienced are mild to moderate and are the same as those experienced following administration of pentavalent Pediacel ® and Infanrix ® -IPV+Hib vaccines. 8 These include redness, swelling, and tenderness at the injection site, and fever, irritability, loss of appetite, diarrhoea, and vomiting. 9
Results from clinical trials show that nearly all infants given the three dose primary vaccination course of Infanrix hexa ® at 2, 3, and 4 months of age develop protective levels of antibodies against diphtheria (100%), tetanus (100%), pertussis (100%), hepatitis B (99.5%), polio (97.8-100%), and Hib (96.4%). 9
Implications for the neonatal selective immunisation programme for babies at risk of hepatitis B
In 1998, the National Screening Committee recommended that all pregnant women should be screened for HBV in each pregnancy. 10 The aim of the screening programme is to identify pregnant women who are infected with HBV so that babies born to them, who are at increased risk of acquiring HBV around the time of delivery, can be immunised from birth. 11
While the introduction of hexavalent vaccine will provide recipients with protection from future exposure to hepatitis B, since the routine schedule does not commence until 8 weeks of age, it will not provide the critical early protection required by those babies already exposed to hepatitis B at birth. For this reason women should still be offered screening for hepatitis B in each pregnancy. Babies born to women who are found to be infected with HBV, who are at increased risk of acquiring the virus from their mother, should receive an accelerated course of hepatitis B vaccine starting at birth. 6 Such babies should receive a dose of monovalent hepatitis B vaccine at birth and if indicated, also given hepatitis B immunoglobulin (HBIG). These babies will also require a dose of monovalent hepatitis B vaccine at 4 weeks of age. 2,6,7
Babies born after 1 August 2017, however, should receive Infanrix hexa ® (DTaP/IPV/Hib/HepB) at 8 weeks of age, instead of a dose of monovalent hepatitis B vaccine. They should then receive Infanrix hexa ® (DTaP/IPV/Hib/HepB) again at 12 and 16 weeks. 6 Table 2 below sets out the different hepatitis B immunisation schedule for babies born to hepatitis B positive mothers, compared with the routine programme.
At 1 year of age, babies born to hepatitis B positive mothers will still require a dose of monovalent hepatitis B vaccine and a blood test (HBsAg) to exclude infection. 6 However, such babies will no longer need a dose of monovalent hepatitis B vaccine with their pre-school boosters. 6
Table 2: Hepatitis B in the Immunisation schedule for routine childhood and selective neonatal hepatitis B programmes following the introduction of Infanrix hexa®6
Vaccine ordering and stock management
In preparation for the switch over in late September/early October 2017, Infanrix hexa ® (DTaP/IPV/Hib/HBV) will be made available to order via ImmForm from 1 September 2017. Prior to the changeover, immunisers should aim to run down their stocks of Pediacel ® and Infanrix-IPV+Hib ® (DTaP/IPV+Hib) and only hold what is required to complete courses of vaccine for babies born before 1 August 2017. Infanrix hexa ® (DTaP/IPV/Hib/HBV) should only be administered to babies born before 1 August 2017 if there is no pentavalent vaccine held locally and no further supplies are available through ImmForm. 6 Vaccination should not be delayed in order to obtain the pentavalent vaccine.
In order to avoid vaccine wastage following the introduction of Infanrix hexa ®, any remaining stocks of Pediacel ® and Infanrix-IPV+Hib ® (DTaP/IPV+Hib) should be used to complete courses of immunisation for babies born before 1 August 2017. If stocks of these vaccines still remain, as a temporary measure they can be used for pre-school boosting at the age of 3 years and 4 months. 6
Once these stocks are used up, pre-school boosting should revert back to Repevax ® (dTaP/IPV).
The introduction of a vaccine which combines DTaP/IPV/Hib and HepB means that infants can be provided with protection against six harmful diseases at the very earliest opportunity in a single injection. Extensive experience of using this hexavalent vaccine across the world for a number of years has shown it to be safe and effective. Further information about the hexavalent vaccine programme is available in the updated Green Book Hepatitis B chapter and on the Public Health England (PHE) immunisation webpage ( www.gov.uk/government/collections/immunisation) in the following documents:
- The hexavalent DTaP/IPV/Hib/HepB combination vaccine-Information for healthcare practitioners about the inclusion of hepatitis B vaccine in the routine infant immunisation programme
- The hexavalent DTaP/IPV/Hib/HepB combination vaccine-Information for healthcare practitioners about the neonatal selective immunisation programme for babies at risk of hepatitis B
1. Klevens M, Lavanchy D, Spradling P. Hepatitis, viral. In: Heymann DL, editor. Control of communicable diseases manual, 19th edition. Washington DC: American Public Health Association, 2008: 284-293.
2. Public Health England (PHE), Department of Health. Hepatitis B. The Green Book, Chapter 18. PHE, 2017. Available at: www.gov.uk/government/publications/hepatitis-b-the-green-book-chapter-18 (accessed 14 August 2017).
3. Hawker J, Begg N, Blair I et al. Hepatitis B. In: Communicable disease control and health protection handbook, 3rd edition. Oxford: Wiley-Blackwell, 2012: 129-133.
4. Van Damme P, Kane M, Meheuson A. Integration of hepatitis B vaccination into national immunisation programmes. BMJ 1997; 314: 1033.
5. Joint Committee on Vaccination and Immunisation (JCVI). Minutes of the meeting held on 1 October 2014. Available at: app.box.com/s/iddfb4ppwkmtjusir2tc/file/22846051967
6. Public Health England (PHE). Vaccine update-issue 261, April 2017. PHE, 2017. Available at: www.gov.uk/government/publications/vaccine-update-issue-261-april-2017 (accessed 14 August 2017).
7. Public Health England. The hexavalent DTaP/IPV/Hib/HepB combination vaccine-Information for healthcare practitioners about the inclusion of hepatitis B vaccine in the routine infant immunisation programme. PHE, 2017. Available at: www.gov.uk/government/publications/hexavalent-combination-vaccine-programme-guidance (accessed 14 August 2017).
8. Dhilllon S. DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™): a review of its use as a primary and booster vaccination. Drugs 2010; 70 (8): 1021-1058.
9. GlaxoSmithKline UK. Summary of product characteristics-Infanrix hexa, powder and suspension for suspension for injection. Electronic Medicines Compendium, 2017. www.medicines.org.uk/emc/medicine/33313 (accessed 14 August 2017).
10. Winyard G. Health service circular-screening of pregnant women for hepatitis B and immunisation of babies at risk. NHS Executive, 1998. Available at: webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4011840.pdf
11. NHS Infectious Diseases in Pregnancy Screening Programme team. NHS Infectious Diseases in Pregnancy Screening Programme handbook-2016 to 2017. London: Public Health England, 2016. Available at: www.gov.uk/government/uploads/system/uploads/attachment_data/file/542492/NHS_IDPS_Programme_Handbook_2016_to_2017.pdf
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