Introduction

The purpose of the Immunisation Handbook 2020 (the Handbook) is to provide clinical guidelines for health professionals on the safest and most effective use of vaccines in their practice. These guidelines are based on the best scientific evidence available at the time of publication, from published and unpublished literature.

Changes to the Handbook since 2020

All chapters have been updated and revised since the 2017 edition (2nd edition, 2018). The following changes have been made.

• Changes have been made to the anaphylaxis and emergency management section (section 2.3.3) in chapter 2 ‘Processes for safe immunisation’ and Appendix A4.4 ‘Resuscitation requirements for all authorised vaccinators and pharmacy vaccinators’.
• Chapter 4 ‘Immunisation for special groups’ has been rearranged and updated. Tables 4.4–4.7 and 4.9 have been updated. Table 4.3 for vaccination of children diagnosed with a condition requiring immunosuppression and updated recommendations for use of meningococcal vaccines have been added.
• Chapter 5 ‘Coronavirus disease (COVID-19)’ has been added and continues to be updated.
• With the introduction of the 12-month immunisation event, the measles, mumps, rubella and pneumococcal chapters have been updated accordingly.
• Chapter 16 ‘Pneumococcal disease’ was updated, to reflect the introduction of a two-dose primary series of PCV10 and earlier booster at 12 months in July 2020. From December 2022, PCV13 replaced PCV10 on the routine Schedule.
• Chapter 13 ‘Meningococcal disease’ has been updated to include recommendations on the use of the recombinant group B meningococcal vaccine, MenB (Bexsero).
• Following discontinuation of Td vaccine (ADT-Booster), the tetanus and diphtheria chapters have been updated to include recommendations on Tdap for adults.
• MMR and varicella vaccines are recommended to be administered either intramuscularly or subcutaneously as indicated (see section 2.2.3).
• Changes have been made to the following vaccine abbreviations – Hib-PRP, MenACWY, MenC, MenB (see Commonly used abbreviations table).
• Changes to authorisation of vaccinators for fully authorised vaccinators, pharmacist vaccinators and supervised vaccinating health workers (VHW) (Appendix 4).
• Chapter 23. Inclusion of recombinant zoster vaccine (rZV) and discontinuation of live zoster vaccine.

The National Immunisation Schedule

The National Immunisation Schedule (the Schedule) is the series of publicly funded vaccines available in New Zealand (see Table 1). Some vaccines are also offered as part of an extended immunisation programme for targeted special groups in response to a recognised need (see Table 2). See also section 2.1.7 for a summary of the primary immunisation requirements for adults (funded) and other funded and unfunded recommendations for this age group.

On 1 July 2012, the management and purchasing of vaccines transferred from the Ministry of Health to PHARMAC. All publicly funded vaccines are now listed on PHARMAC’s Pharmaceutical Schedule, and the district health boards (DHBs) are responsible for funding these once PHARMAC has listed them.

PHARMAC considers medicine and vaccine funding applications from pharmaceutical suppliers, health professionals, consumer groups and patients. Usually, manufacturers/suppliers decide whether to make an application for funding. Normally this will follow registration and approval of the medicine or vaccine by Medsafe. PHARMAC will generally only consider an application for a medicine or vaccine to be funded once it has been registered and approved by Medsafe.

Following a vaccine funding application, PHARMAC will assess the vaccine, seek clinical input (for vaccines this may be from the immunisation subcommittee of the Pharmacology and Therapeutics Advisory Committee [PTAC] or from PTAC itself), and conduct an economic analysis. The recommendations from the immunisation subcommittee are then considered by PTAC, which will provide advice to PHARMAC. PHARMAC then decides what priority the application has for funding and consults with the Ministry of Health on capacity and implementation issues that may be associated with introducing a new vaccine. Depending on the outcome of that process, PHARMAC may then negotiate with the supplier. If an agreement is reached, PHARMAC will consult with the health sector on a funding proposal.

The Ministry of Health remains responsible for and manages the National Immunisation Programme, which:

• aims to prevent disease through vaccination and to achieve coverage that prevents outbreaks and epidemics
• is accountable for achieving the Immunisation Coverage targets
• monitors disease burden and those at risk
• provides guidance to the sector on immunisation, cold chain and resources
• ensures immunisation providers deliver services that meet the needs of their population
• implements the National Immunisation Schedule
• delivers trusted and effective vaccine programmes
• provides immunisation resources, including the Immunisation Handbook
• improves information and data systems
• manages the National Immunisation Register (NIR) and the Aotearoa Immunisation Register (AIR) (see section 2.3.5).

The Ministry of Health works with PHARMAC to ensure there is a strong link between vaccine purchasing decisions and the management and implementation of the National Immunisation Programme.

Changes to the National Immunisation Schedule since 2020

Table 1 shows the 2020 National Immunisation Schedule, and Table 2 shows the vaccines funded for special groups at higher risk of some diseases.

Changes to vaccine funding since 2020 are as follows.

• From 2020, the quadrivalent inactivated influenza vaccine (Afluria Quad; see chapter 11 ‘Influenza’) will be the Schedule vaccine for eligible individuals, including pregnant women and adults aged 65 years and older.
• An immunisation event has been introduced at age 12 months. This enables two doses of MMR to be given in the second year of life, replacing the MMR dose that was previously given at age 4 years.
• From 1 December 2022, PCV13 (Prevenar 13) replaces PCV10 (Synflorix) given at age 6 weeks, 5 months and 12 months. The extended immunisation programme for targeted special groups (using PCV13 and 23PPV) remains unchanged.
• DTaP-IPV (Infanrix-IPV) will continue to be given age 4 years.
• mRNA-CV (Comirnaty) is available as 30 µg dose for all adolescents and adults aged from 12 years, and two paediatric formulations are available – 10 µg dose is available for children aged 5 to 11 years and a 3 µg dose is available for certain children aged from 6 months to 4 years at increased risk of severe COVID-19. Also available rCV is from the age of 12 years (primary course only for 12–17 years) in New Zealand as part of the COVID-19 pandemic response. Booster doses of mRNA-CV are available from age 16 years at least three months after completion of primary course. Booster doses of rCV are available from the age 18 years given at least six months after completion of primary course.
• Tdap (Boostrix) replaced Td at the 45-year and 65-year events and for tetanus-prone wounds.

Table 1: National Immunisation Schedule, commencing 1 October 2020 (revised 1 December 2022)

Antigen(s)	DTaP-IPV-HepB/Hib	PCV13	RV1	MMR	Hib-PRP-T	VV	DTaP-IPV	Tdap	HPV9	Influenza	rZV
Brand	Infanrix-hexa	Prevenar 13	Rotarix	Priorix	Hiberix	Varivax	Infanrix-IPV	Boostrix	Gardasil9	Afluria Quad	Shingrix
Manufacturer	GSK	Pfizer	GSK	GSK	GSK	GSK	GSK	GSK	Seqirus/MSD	Seqirus	GSK
Pregnancy								●a		●
6 weeks	●	●	●
3 months	●		●
5 months	●	●
12 months		●		●
15 months				●	●	●b
4 years							●
11 or 12 yearsc								●	● 2 dosesc
45 years								●d
65 years								●		● annually	● 2 doses

All individuals aged from 5 years are eligible to receive two doses of a COVID-19 vaccine. Additional doses and booster doses are also available to different groups (see Chapter 5).

Changes to extended immunisation programme for special groups

Vaccines funded for special groups are described in Table 2 below. Changes to existing programmes since 2020 are as follows.

1. Tdap vaccine funding for pregnant women was extended in 2019, it is now recommended to be given from 16 weeks’ gestation of every pregnancy, preferably in the second trimester. (Funded when given any time in the second or third trimester.)
2. A single dose of Tdap is funded for parents or primary caregivers of infants admitted to a neonatal intensive care unit or special care baby unit for more than 3 days, who had not been exposed to maternal vaccination at least 14 days prior to birth.
3. A single dose of meningococcal ACWY vaccine (MenACWY) is funded for individuals aged between 13 and 25 years entering or in their first year of living in boarding school hostels, tertiary education halls of residence, military barracks, or prisons.
4. Meningococcal B vaccine (MenB), MenACWY and meningococcal C vaccine (MenC) are funded for certain special groups at increased risk of meningococcal disease, including those who have previously had meningococcal disease of any group.
5. In addition to two primary doses and a booster dose recommended routinely from age 16 years, a third primary dose of mRNA-CV (30 µg or 10 µg, as age appropriate) given at least eight weeks after first two primary doses is recommended for certain individuals aged from 5 years who are severely immunocompromised (or where indicated, rCV from age 18 years). Those eligible for a third primary dose aged from 16 years are also eligible for a second booster dose, given at least six months after their first booster. Other groups with increased risk of severe breakthrough COVID-19 are also eligible to a second booster dose.

Table 2: Extended immunisation programme for special groups – vaccines funded in addition to the routine schedule
Note: Vaccinators are advised to regularly check the Pharmaceutical Schedule and any online updates for changes to funding decisions for special groups. See also chapter 4 ‘Immunisation of special groups’.

Vaccine	Individuals eligible for funded vaccine
Haemophilus influenzae type b (Hib-PRP-T) (chapter 7)	For (re)vaccination of patients who are: post-haematopoietic stem cell transplant (HSCT) or chemotherapy pre- or post-splenectomy or with functional asplenia pre- or post-solid organ transplant pre- or post-cochlear implants undergoing renal dialysis and other severely immunosuppressive regimens For use in testing for primary immune deficiencya
Hepatitis A (HepA) (chapter 8)	Transplant patients Children with chronic liver disease Close contacts of hepatitis A cases
Hepatitis B (HepB) (chapter 9)	Household or sexual contacts of patients with acute or chronic hepatitis B virus (HBV) infection Babies of mothers with chronic HBV infection need both hepatitis B vaccine (HepB) and hepatitis B immunoglobulin (HBIG) at birth Children aged under 18 years who have not achieved positive serology and who require additional vaccination HIV-positive patients Hepatitis C-positive patients Following non-consensual sexual intercourse Prior to any planned immunosuppressionb Patients following immunosuppressionb Solid organ transplant patients, including liver or kidney transplant Post-HSCT patients Following needle-stick injury Dialysis patients
Human papillomavirus (HPV) (chapter 10)	People aged 9 to 26 years inclusive who are: confirmed with HIV infection transplant (including stem cell) patients post-chemotherapy
Annual influenza vaccine (chapter 11)	Patients aged 6 months to <65 years who: have any of the following cardiovascular diseases: ischaemic heart disease congestive heart failure rheumatic heart disease congenital heart disease cerebrovascular disease have either of the following chronic respiratory diseases: asthma, if on a regular preventative therapy other chronic respiratory disease with impaired lung function have diabetes have chronic renal disease have any cancer, excluding basal and squamous skin cancers if not invasive have any of the following other conditions: autoimmune disease immune suppression or immune deficiency HIV transplant recipients neuromuscular and central nervous system diseases/disorders haemoglobinopathies are children on long-term aspirin have a cochlear implant errors of metabolism at risk of major metabolic decompensation pre- and post-splenectomy Down syndrome are pregnant are children aged 4 years and under who have been hospitalised for respiratory illness or have a history of significant respiratory illness, including children age under 5 who were hospitalised with measles are patients who are compulsorily detained long-term in a forensic unit within a DHB hospitalc all children aged 3–12 yearsd
Measles, mumps and rubella (MMR) (chapters 12, 14 and 19)	(Re)vaccination of patients prior to planned or following immunosuppressionb
Meningococcal C conjugate vaccine (MenC), quadrivalent meningococcal conjugate vaccine (MenACWY) and meningococcal B vaccine (MenB) (chapter 13)	Pre- and post-splenectomy or with functional or anatomical asplenia HIV Complement deficiency (acquired or inherited) Pre- or post-solid organ transplant Close contacts of meningococcal case HSCT (bone marrow transplant) patients Prior to any planned immunosuppressionb Following immunosuppressionb Individuals who have had previous meningococcal disease (any group) MenACWY only: Individuals aged between 13 and 25 years entering or in their first year of living in boarding school hostels, tertiary education halls of residence, military barracks, or prisons.
Pertussis-containing vaccines (chapter 15)	Pregnant women – recommended to be given from 16 weeks’ gestation of every pregnancy, preferably in the second trimester. (Funded when given any time in second or third trimester) Tdap is funded for parents or primary caregivers of infants admitted to a neonatal intensive care unit or special care baby unit for more than 3 days, who had not been exposed to maternal vaccination at least 14 days prior to birth (Re)vaccination of patients who are: post-HSCT or chemotherapy pre- or post-splenectomy pre- or post-solid organ transplant undergoing renal dialysis or other severely immunosuppressive regimens
13-valent pneumococcal conjugate vaccine (PCV13) and 23‑valent pneumococcal polysaccharide vaccine (23PPV) (chapter 16)	For (re)vaccination of high-risk children, PCV13 for patients aged under 5 years and 23PPV for patients aged under 18 years: prior to planned or on immunosuppressive therapy or radiotherapy (vaccinate when there is expected to be a sufficient immune response) with primary immune deficiencies with HIV infection with renal failure or nephrotic syndrome who are immune-suppressed following organ transplantation (including HSCT) with cochlear implants or intracranial shunts with cerebrospinal fluid leak receiving corticosteroid therapy for more than 2 weeks, and who are on an equivalent daily dosage of prednisone of 2 mg/kg per day or greater, or children who weigh more than 10 kg on a total daily dosage of 20 mg or greater with chronic pulmonary disease (including asthma treated with high-dose corticosteroid therapy) preterm infants, born before 28 weeks’ gestation with cardiac disease, with cyanosis or failure with diabetes with Down syndrome who are pre- or post-splenectomy, or with functional asplenia PCV13 and 23PPV for (re)vaccination of patients aged 5 years and older: with HIV pre- or post-HSCTd or chemotherapye pre- or post-splenectomy or with functional asplenia pre- or post-solid organ transplant undergoing renal dialysis with complement deficiency (acquired or inherited) with cochlear implants with primary immune deficiency PCV13 and 23PPV for use in testing for primary immune deficiency.a
Inactivated polio vaccine (IPV) (chapter 17)	(Re)vaccination of patients prior to planned or following immunosuppressionb
Tetanus, diphtheria and pertussis (Tdap) (chapter 20)	(Re)vaccination of patients prior to planned or following immunosuppressionb Boosting of patients with tetanus-prone wounds For use in testing for primary immune deficiencya
Bacillus Calmette–Guérin (BCG) (chapter 21)	For infants at increased risk of tuberculosis (TB): living in a house or family with a person with current or past history of TB; or having one or more household members or carers who within the last 5 years lived in a country with a rate of TB ≥40 per 100,000 for 6 months or longer; or who, during their first 5 years, will be living 3 months or longer in a country with a rate of TB ≥40 per 100,000
Varicella vaccine (VV) (chapter 22)	Non-immune patients: with chronic liver disease who may in future be candidates for transplantation with deteriorating renal function before transplantation prior to solid organ transplant prior to any planned immunosuppressionb for post-exposure prophylaxis of immune-competent hospital in-patients Patients at least 2 years after bone marrow transplantation, on advice of their specialist Patients at least 6 months after completion of chemotherapy, on advice of their specialist HIV-positive patients with mild or moderate immunosuppression who are non-immune to varicella, on advice of their HIV specialist Patients with inborn errors of metabolism at risk of major metabolic decompensation, with no clinical history of varicella Household contacts of paediatric patients who are immunocompromised, or undergoing a procedure leading to immunocompromise, where the household contact has no clinical history of varicella Household contacts of adult patients who have no clinical history of varicella and who are severely immunocompromised or undergoing a procedure leading to immunocompromise, where the household contact has no clinical history of varicella

Eligibility for publicly funded vaccines

Only vaccines given according to the Schedule are available free of charge, unless there is a specific funded programme in response to a recognised need (see Table 2). The immunisation benefit is paid by DHBs to providers for the administration of:

• all childhood Schedule vaccines
• influenza vaccine to eligible children and adults (ie, those at higher risk of disease)
• rZV to individuals aged 65 years
• tetanus-diphtheria-pertussis (Tdap) boosters given at ages 45 and 65 years (now funded)
• hepatitis A, hepatitis B, Hib-PRP-T, human papillomavirus (HPV), inactivated polio vaccine (IPV), MMR, meningococcal conjugate, pertussis, pneumococcal conjugate and/or polysaccharide, and varicella vaccines only, for eligible children and adults (ie, at higher risk of disease) as part of an extended immunisation programme for special groups.

The Health and Disability Services Eligibility Direction 2011 (the Eligibility Direction) issued by the Minister of Health sets out the eligibility criteria for publicly funded health and disability services in New Zealand. Only people who meet the eligibility criteria defined in the Eligibility Direction can receive publicly funded (ie, free or subsidised) health and disability services.

Regardless of their immigration and citizenship status, all children aged under 18 years are eligible to receive Schedule vaccines, and providers can claim the immunisation benefit for administering the vaccines. All children are also eligible for Well Child Tamariki Ora services.

Non-residents who were aged under 18 years when they commenced HPV vaccination are currently funded to complete the course, even if they are aged 18 years or older when they complete it.

Further information on eligibility can be found on the Ministry of Health website.

As part of the COVID-19 pandemic response the preferred vaccine, mRNA-CV, is available for certain children aged 6 months to 4 years, all children aged from 5 years and all adults in New Zealand, regardless of eligibility for publicly funded health and disability services. An additional vaccine, rCV, is also available for individuals aged 12 years or over, if indicated or for personal choice. Access to these vaccines will be granted through a defined Ministry of Health vaccine rollout plan.

Notifiable diseases

All diseases preventable by vaccines on the Schedule (or as part of a targeted programme) are notifiable, except for HPV, seasonal influenza, rotavirus, varicella and herpes zoster.

Note: Rotavirus infections presenting as gastroenteritis are notifiable as acute gastroenteritis.

Notification processes, and the diseases to which they relate, have been updated in the Health Act and supporting Health (Infectious and Notifiable Diseases) Regulations 2016. See the Ministry of Health’s 2017 document Guidance on Infectious Disease Management under the Health Act 1956 for an explanation, as well as the processes and forms for notifiable diseases.

The case definitions used by the medical officer of health to classify the notified case for surveillance purposes (and to assist in identifying appropriate prevention and control activities) and the laboratory tests required to confirm the diagnosis can be found in the Communicable Disease Control Manual. For the most up-to-date information, refer to the online version.