From 1 July 2024, there will be a brand change on the National Schedule from Hiberix to Act-HIB.  This will be a ‘soft change’, meaning Hiberix supply will be exhausted before Act-HIB comes into the supply chain.

Hiberix is delivered as part of the National Immunisation Schedule at 15 months to booster Hib protection delivered in the first year of life as part of Infanrix-hexa vaccine.

Hiberix is licensed and funded for use in infants and children 2 months to 5 years of age to receive catch-up doses.

Hiberix is also funded for children aged 5 years or older and adults with a medical condition that increases their risk of invasive Hib disease AND is listed on the Pharmaceutical Schedule. It is used out of licensure in children 5 years of age and over and adults as there is no alternative vaccine available in New Zealand for these age groups. No safety concerns are expected for use in older age groups.

Children under 2 years with invasive Hib disease do not always produce protective antibodies and therefore should be considered susceptible and receive a complete course of Hib vaccination as soon as possible during convalescence.

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Special groups

An additional dose of Hiberix is funded (as appropriate) for (re-)immunisation of individuals:

• cochlear implant (pre- or post-)
• functional asplenia
• post-chemotherapy
• post-haematopoietic stem cell transplantation
• pre- or post-solid organ transplantation
• pre- or post-splenectomy
• renal dialysis
• severely immunosuppressive regimen

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Catch-up doses

In children 12 months to 5 years of age a single dose of Hib vaccine is required, regardless of doses given in the first year of life.

For children under 5 years of age, refer to Appendix 2 Planning immunisation catch-ups in the current Immunisation Handbook.

For older children and adults with an eligible medical condition, missed doses of Hiberix can be given at any time.

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Storage and preparation

Store vaccine and diluent as per cold chain between 2°C to 8°C.

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Administration

Hiberix can be administered concurrently with other vaccines, including all National Immunisation Schedule vaccines. Separate syringes and different injection sites should be used.

Intramuscular injection is the preferred method of administration.

More than 20 years of studies and safety monitoring have shown that Hib vaccines have excellent safety profiles. No serious reactions to this vaccine have been identified.

Administration of Hiberix should be postponed in individuals suffering from a fever over 38°C. The presence of a minor infection is not a reason to delay immunisation.

Hiberix should not be given to:

• Anyone with severe allergy (anaphylaxis) to a previous dose of this vaccine or other Hib containing vaccine, or a component of the vaccine.

Advice should be sought for the following groups:

• Those with bleeding disorders, such as haemophilia. The vaccine should be administered in accordance with the haematologist’s instructions. It may, in this situation only, be given subcutaneously

Hiberix vaccine contains a polysaccharide from the outside of the Hib bacterium conjugated to tetanus toxoid protein.

Around 95% of invasive Hib disease was caused by Haemophilus influenzae type b prior to the introduction of the vaccine. The remainder of invasive Hib disease is caused by a further five encapsulated (typeable) serotypes and unencapsulated (non-typeable) serotype for which there are currently no vaccines. Since introduction in1994, Hib conjugate vaccines have been highly successful in reducing Hib disease in young children. Prior to the introduction of Hib vaccines on the New Zealand National Immunisation Schedule, there were approximately 150 infant cases per 100,000 people. This incidence fell dramatically to around 0.2 cases per 100,000 within a year following introduction of the Hib vaccine. In 2015, there were just three laboratory confirmed cases, all of which were in unvaccinated children under 5 years of age.

Clinical efficacy of Hiberix has been estimated to be 95-100% and more than 95% of infants will produce protective antibody after the primary series.

• Carter P, Turner N, Poole T et al. 2012 Antigen Review for the New Zealand National Immunisation Schedule: Haemophilus influenzae type B. Ministry of Health 2012. Available from: https://researchspace.auckland.ac.nz/handle/2292/47683
• Ezeanolue E, Harriman K, Hunter P, Kroger A, Pellegrini C. Centers for Disease Control and Prevention. General Recommendations on Immunization Recommendations of the Advisory Committee on Immunization Practices (ACIP);[updated 2020 July 27; cited 2020 September 28]. Available from: https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.pdf
• Centers for Disease Control and Prevention (CDC). Haemophilus influenzae type B. Epidemiology and Prevention of Vaccine-Preventable Diseases, 13th Edition. [reviewed 2019 April 15; cited 2020 September 28] Available from: https://www.cdc.gov/pinkbook/hcp/table-of-contents/index.html?CDC_AAref_Val=https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/hib.pdf
• ESR. Surveillance Report Notifiable diseases in New Zealand 2015. Available from: https://researchspace.auckland.ac.nz/handle/2292/47683
• Health New Zealand | Te Whatu Ora, Immunisation handbook [Internet]. Available from: https://www.tewhatuora.govt.nz/for-health-professionals/clinical-guidance/immunisation-handbook