2. Processes for safe immunisation

All vaccines must always be stored and/or transported within the recommended temperature range of +2°C to +8°C. See the National Standards for Vaccine Storage and Transportation for Immunisation Providers 2017 (2nd edition) for detailed vaccine storage, transportation and destruction information.

The ‘cold chain’ is defined as ‘the system of transporting and storing vaccines within the recommended temperature range of +2°C to +8°C from the place of manufacture to the point of vaccine administration (the individual)’. The integrity of the cold chain is dependent not only on the equipment used for storage, transportation and monitoring but also on the people involved and the processes/practices they undertake.

What is informed consent?

Informed consent is a fundamental concept in the provision of health care services, including immunisation. It is based on ethical obligations that are supported by legal provisions (eg, the Health and Disability Commissioner Act 1994, Code of Health and Disability Services Consumers’ Rights 1996, Health Information Privacy Code 1994, Privacy Act 1993 and Privacy Amendment Act 2013).

Providing meaningful information to enable an informed choice and to seek informed consent is a duty that all health and disability providers must meet to uphold the rights of health and disability consumers. Informed consent includes the right to be honestly and openly informed about one’s personal health matters. The right to agree to treatment carries with it the right to refuse and withdraw from treatment.

Informed consent is also an external expression of a health care provider’s pivotal ethical duty to uphold and enhance their patient’s autonomy by respecting the patient’s personhood in every aspect of their relationship with that individual.

The informed consent process

Informed consent is a process whereby the individual or parent/guardian are appropriately informed in an environment and manner that are meaningful. Having been well informed, they are willing and able to agree to what is being suggested without coercion.

Regardless of age, an individual and/or their parent/guardian must be able to understand:

• that they have a choice
• why they are being offered the treatment/procedure
• what is involved in what they are being offered
• the probable benefits, risks, side-effects, failure rates and alternatives, and the risks and benefits of not receiving the treatment or procedure.

To make an informed choice and give informed consent for vaccination, the individual or parent/guardian needs to understand the benefits and risks of vaccination, including those to the child and community.

Consent for patients who are incompetent (individuals who do not have the capacity to consent) may be given by:

• a welfare guardian appointed under the Protection of Personal and Property Rights Act 1988
• an attorney under an activated enduring power of attorney in respect of care and welfare.

If there is no welfare guardian or attorney under an enduring power of attorney, treatment may be provided under Right 7(4) of the Code of Health and Disability Services Consumers’ Rights if:

• the treatment is in the best interests of the patient; and
• attempts have been made to find out what the patient would have wanted if s/he were competent; or
• if it is not possible to find out what the patient would have wanted, the views of people interested in the patient’s welfare have been considered.

The essential elements of the informed consent process are effective communication, full information and freely given competent consent. The specific rights in the Code of Health and Disability Services Consumers’ Rights that represent these three elements are:

• Right 5: Right to effective communication
• Right 6: Right to be fully informed
• Right 7: Right to make an informed choice and give informed consent.[1]

For example, section 7(1) of the Code states that ‘services may be provided to a consumer only if that consumer makes an informed choice and gives informed consent, except where any enactment, or the common law, or any other provision of the Code provides otherwise.’ Information on the Code of Health and Disability Services Consumers’ Rights can be found on the Health and Disability Commissioner’s website.

Health professionals have legal obligations to obtain informed consent prior to a procedure and prior to data collection (eg, data collected for the AIR). Unless there are specific legal exceptions to the need for consent, the health professional who acts without consent potentially faces the prospect of a civil claim for exemplary damages, criminal prosecution for assault (sections 190 and 196 of the Crimes Act 1961), complaints to the Health and Disability Commissioner and professional disciplining.

Ensuring that an individual has made an informed choice regarding treatment options has been included in the Health Practitioners Competence Assurance Act 2003. This Act ensures that health practitioners are, and remain, competent and safe to practise. For example, the Nursing Council of New Zealand competencies for the Registered Nurse Scope of Practice, Competency 2.4, ‘ensures the client has adequate explanation of the effects, consequences and alternatives of proposed treatment options’ (see the Nursing Council of New Zealand website). 

Privacy and control over personal information

The right to authorise, or to exert some control over, the collection and disclosure of personal information about oneself is a right closely allied to that of consent to treatment and is also relevant to personal integrity and autonomy. The Health Information Privacy Code 1994 gives people the right to access, and seek correction of, health information about them (Rules 6 and 7). It also requires health agencies collecting identifiable information to be open about how and for what purpose that information will be stored, and who will be able to see it (Rule 3).

Parents and guardians have a similar right of access to information about their children under section 22F of the Health Act 1956. This right is limited in that access requests can be refused if providing the information would be contrary to the interests or wishes of the child.

Further information about privacy and health information can be found on the Privacy Commissioner’s website, or by calling the privacy enquiries line: 0800 803 909.

Immunisation consent in primary care

Parents should be prepared during the antenatal period for the choice they will have to make about their child’s vaccination. During the third trimester of pregnancy, the lead maternity carer must provide Ministry of Health information on immunisation and the AIR. This is a requirement under clause DA21(c) of the Primary Maternity Services Notice 2007, pursuant to section 88 of the New Zealand Public Health and Disability Act 2000.

Prior to immunisation with any vaccine, the vaccinator should ascertain if the vaccine recipient (child or adult) has a condition or circumstance which may influence whether a vaccine is given, deferred or contraindicated. Table 2.2 below provides a checklist of conditions or circumstances to screen for, along with the appropriate action to take and a rationale.

The vaccinator will also need to determine which vaccines are due, assess the vaccine recipient’s overall current vaccination status and address parental concerns. The vaccinator also needs to advise the individual/parent/guardian they will need to remain for 20 minutes post-vaccination. 

No individual should be denied vaccination without serious consideration of the consequences, both for the individual and for the community. Where there is any doubt, seek advice from the individual’s general practitioner (GP), a public health medicine specialist, medical officer of health, consultant paediatrician or IMAC.

See the relevant disease chapter section for more specific vaccine contraindications.

Conditions that are not contraindications to immunisation

The conditions in Table 2.3 are not contraindications to the immunisation of children and adults (see also section 3.1).

In general, follow the recommendations in the manufacturers’ data sheets.

Principles for spacing of doses of the same vaccine

The immune response to a series of vaccines depends on the time interval between doses. The general rule is for a minimum of four weeks between doses of a primary series; however, the immune response may be better with longer intervals. A repeat dose of the same vaccine given less than four weeks after the previous dose may result in a reduced immune response. Specific recommendations for a rapid schedule by the manufacturer may apply for some vaccines.

Generally, a minimum interval of four to six months between priming dose(s) and the booster dose allows affinity maturation of memory B cells, and thus higher secondary responses (see section 1.1).

It is not necessary to repeat a prior dose if the time elapsed between doses is more than the recommended interval.

Spacing of different vaccines

Two or more parenterally administered live vaccines may be given at the same visit; for example, MMR and VV. However, when given at different visits, a minimum interval of four weeks is recommended. This interval is to avoid the response to the second vaccine being diminished due to interference from the response to the first vaccine.

Note that no interval is required between administration of Bacillus Calmette–Guérin (BCG) and rotavirus vaccines.

Unless there is a specific recommendation against it, a subunit vaccine can be administered either simultaneously or at any time before or after a different subunit or live vaccine.

Concurrent administration of vaccines

Changing the timing of visits or increasing the number of visits to avoid multiple injections delays protection against potentially serious diseases and may also lead to incomplete immunisation. Best practice is to follow the Schedule.

The objective of a catch-up programme is to complete a course of vaccinations that provides adequate protection. Catch-up programmes should be based on documented evidence of previous vaccination (eg, the child’s Well Child Tamariki Ora My Health Book, AIR, or overseas immunisation records).

When children have missed vaccine doses, it is important to bring them up to date as quickly as possible. Where more than one vaccine is overdue, it is preferable to give as many as possible at the first visit. For children aged 12 months and older, MMR is the priority.

If the vaccinator is uncertain about how to plan a catch-up programme, they should contact the local immunisation coordinator, IMAC, medical officer of health or public health service.

Once catch-up is achieved, vaccination for the child should continue as per the Schedule.

Vaccination of children with inadequate vaccination records

It is recommended that children without a documented history of vaccination have a full course of vaccinations appropriate for their age. It is preferable, and safe, for the individual to receive an unnecessary dose rather than to miss out a required dose(s) and not be fully protected.

Whenever adults are seen in general practice or by immunisation providers, there is an opportunity to ensure they have been adequately protected against the following diseases and have received at least a primary immunisation course as described in Table 2.4. If the requisite number of doses has not been received, catch-up vaccination is recommended and funded (see Appendix 2).

Women of childbearing age should know whether or not they are immune to measles (see chapter 12), rubella (see chapter 19) and varicella (see chapter 22).

Refer to the PHARMAC schedule for further details on vaccines funded for adults (available on the PHARMAC website). 

The WHO key recommendations for minimising pain and distress at the time of vaccination are:[3, 4]

• do not aspirate (draw back) when giving vaccines
• administer vaccines from the least to the most painful for all ages
• breastfeed before and during vaccine injection
• position (hold the infant/young child, individuals aged 3 years and older should sit up, parental presence)
• for infants, give oral rotavirus vaccine before injections (the vaccine contains sucrose that can reduce pain)
• use calming and supportive words at the time of vaccination; avoid language that increases anxiety
• provide appropriate distractions
• consider using topical anaesthetics (only if the cost is acceptable to the family).

See also section 2.3.2 and the IMAC factsheets Mitigating Vaccination Pain and Distress and Fear of Needles or Needle Phobia (available on the IMAC website).

Most Schedule vaccines are administered by intramuscular injection. The exceptions are IPV (IPOL; subcutaneously), BCG (intradermally) and rotavirus (oral). Live vaccines have previously been given via SC route and data sheets may still show this as an option, which can be helpful for those with bleeding disorders (see below).

Needle angle, gauge and length

Intramuscular injections should be administered at a 90-degree angle to the skin plane. The needle length used will be determined by the size of the limb and muscle bulk, whether the tissue is bunched or stretched and the vaccinator’s professional judgement. BCG vaccine (which can only be administered by authorised vaccinators with BCG endorsement) is given by intradermal injection. See Table 2.8. 

Infants aged under 6 months do not need to be grasped or restrained as firmly as toddlers or older children. At this age, excessive restraint increases their fear as well as muscle tautness. The recommended positioning for an infant is in a cuddle hold with parent/guardian, breastfeeding as appropriate. The cuddle position offers better psychological support and comfort for both the infant and the parent/guardian,[3] and the parent/guardian should be offered this position as a first choice (Figure 2.1).

If the parent/guardian is helping to hold the infant or child, ensure they understand what is expected of them and what will take place. Most vaccinators choose to quickly administer all the injections due and soothe the infant or child afterwards (see section 2.3.2 for soothing measures).

 

The choice between the two sites for IM injections from 12 months of age will be based on the vaccinator’s professional judgement, taking in account knowledge of the child and ease of restraint. Some vaccinators consider the vastus lateralis preferable for young children when the deltoid muscle bulk is small and because of the superficiality of the radial nerve. Discuss the options with the parent/guardian when making your decision. (See also ‘The 12- and 15-month immunisation events’ in section 2.2.7.)

The easiest and safest way to position and restrain a young child for a lateral thigh and/or deltoid injection is to sit the child sideways on their parent’s or guardian’s lap. The parent’s/guardian’s hand restrains the child’s outer arm and the child’s legs are either restrained between the parent’s/guardian’s legs or by placing a hand on the child’s outer knee or lower leg. Alternatively, the child may face their parent/guardian while straddling the parent’s/guardian’s legs (see Figure 2.5 and Figure 2.6). Keeping a firm hold will help to avoid needle scratches that can result if the child moves.

The deltoid muscle is located in the lateral aspect of the upper arm. The entire deltoid muscle must be exposed to avoid the risk of radial nerve injury (an injection at the junction of the middle and upper thirds of the lateral aspect of the upper arm may damage the nerve) (see Figure 2.7).

 

When more than one vaccine is scheduled at the same visit, it is recommended that vaccinators give all the scheduled vaccines at that visit. This particularly applies to the 12- and 15-month events (see below), when three vaccines are scheduled.

Multiple vaccines should not be mixed in a single syringe unless specifically licensed and labelled for administration in one syringe. A different needle and syringe should be used for each injection.

The 12-month and 15-month immunisation events

MMR1, PCV and MenB are the vaccines are scheduled at the 12-month immunisation event. It is preferable to give vaccines into separate sites. If the deltoid bulk is considered insufficient for IM injection, then two injections can be given into one vastus lateralis (MMR and PCV), and the MenB given into the other leg. Local tenderness is a potential reaction to MenB, such that, if given in the vastus lateralis may temporarily affect the infant’s mobility.

Suggested options for 12-months immunisation are given below.

Sufficient deltoid mass:

1. MMR: IM left leg (vastus lateralis)
2. MenB: IM left arm (deltoid)
3. PCV: IM right leg (vastus lateralis)

Insufficient deltoid mass:

1. MMR: IM left leg (vastus lateralis)
2. PCV: IM left leg (vastus lateralis)
3. MenB: IM right leg (vastus lateralis)

To give two injections in the same limb, the vastus lateralis is preferred because of its greater muscle mass (see Figure 2.9). The injection sites should be on the long axis of the thigh and separated by at least 2 cm so that potential localised reactions will not overlap.

MMR2, varicella and Hib-PRP-T vaccines are scheduled at the 15-month event. When giving these vaccines, it is preferable to give one in each vastus lateralis and the third in the deltoid. When a fourth injection is required (eg, MenB catch-up), this should be given in the other deltoid.

The recommended vaccine administration sequence and location is:

1. Hib-PRP-T: IM in left leg (vastus lateralis)
2. Varicella: IM in left arm (deltoid)
3. MMR: IM in right leg (vastus lateralis).

If parents/guardians request to split the vaccines given at the 15-month event, then providers are advised to give MMR and VV at the first visit, followed by Hib-PRP-T at the second visit.

Note: there is a risk that the patient may not return for the second visit when the 15‑month vaccines are split.

If MMR and VV are not given at the same visit (concurrently), then there should be an interval of at least four weeks between them. This interval is to avoid the response to the second vaccine being diminished due to interference from the response to the first vaccine (see section 2.1.5).

Multiple injections in the same muscle

When two injections are to be given in the same limb, the vastus lateralis is preferred because of its greater muscle mass (see Figure 2.9). The injection sites should be on the long axis of the thigh and separated by at least 2 cm so that localised reactions will not overlap.

If multiple injections in the deltoid are required, the sites should be separated by at least 2 cm.[8]

Post-vaccination advice should be given both verbally and in writing. The advice should cover:

• which vaccines have been given and the injection sites, and whether the injections were IM or SC
• potential vaccine responses following immunisation (see Table 2.9) and what to do if these occur (eg, measures for relieving fever, when to seek medical advice)
• when the individual or parent/guardian should contact the vaccinator if they are worried or concerned
• contact phone numbers (including after-hours phone numbers).

The use of paracetamol (or ibuprofen) around the time of immunisation in anticipation of immunisation-related fever or localised pain occurring is only recommended routinely for infants and children aged under 2 years receiving MenB (Bexsero) vaccine. In this case, up to three doses of paracetamol (or ibuprofen) can be given prophylactically to reduce fever (see section ‎13.5.1). For immunisation events that do not include administration of MenB or for children over the age of two years receiving MenB, the use of paracetamol (or ibuprofen) around the time of immunisation in anticipation of immunisation-related fever or localised pain occurring is not generally recommended. However, use of these medicines is recommended if the child is distressed due to discomfort following immunisation.

Health care providers are encouraged to discuss with parents the possible immunisation responses and non-pharmaceutical management of fever or pain, as well as the role of medicines.

Fever

General fever-relieving measures include:

• giving extra fluids to drink (eg, more breastfeeds or water)
• reducing clothing if the baby is hot.

While a high fever alone does not need treatment, analgesics (paracetamol or ibuprofen) may be used for distress or pain in a febrile child.

Pain management and soothing measures

For breastfeeding infants, breastfeeding before, during and after the injection can provide comfort and pain relief.[3, 14]

Give the rotavirus vaccine 1–2 minutes before other immunisations; rotavirus vaccines contain sucrose that has been shown to reduce pain.[3, 14] The infant can then be breastfed (where possible) or held comfortably while the other immunisations are given.

For infants aged under 6 months, the 5 Ss (swaddling, side/stomach position, shushing, swinging and sucking) have been found to be effective for soothing and reducing pain after immunisations.[9]

Using age-appropriate distraction has been shown to reduce pain and distress.[3, 14] Examples include showing an interesting or musical toy to an infant, or encouraging an older child to blow using a windmill toy or bubbles. Electronic games/phone games can be useful for older children and teenagers. Do not rub the injection site after the injection, as it increases the risk of vaccine reactogenicity.

For infants and children, the use of a topical anaesthetic cream or patch has been found to be effective for immunisation pain management.[3, 14] Parents/guardians and those administering the vaccine should check the manufacturers’ recommendations before using topical anaesthetics. The correct dose for infants needs to be followed particularly carefully due to risk of methaemoglobinaemia. Topical anaesthetics may have a role in managing immunisation pain and anxiety, particularly for children who have had previous multiple medical interventions or needle phobias.

Following immunisation, if an infant or child is distressed by pain or swelling at the injection site, placing a cold, wet cloth on the area may help relieve the discomfort. Antipyretic analgesics (paracetamol or ibuprofen) may be used if the above measure does not relieve the child’s distress.

Anaphylaxis is a very rare,[10] unexpected and potentially fatal allergic reaction. It develops over several minutes and usually involves multiple body systems. Unconsciousness is rarely the sole manifestation and only occurs as a late event in severe cases. A strong central pulse (eg, carotid) is maintained during a faint (vasovagal syncope), but not in anaphylaxis.

In general, the more severe the reaction, the more rapid the onset. Most life-threatening adverse events begin within 10 minutes of vaccination. The intensity usually peaks at around one hour after onset. Symptoms limited to only one system can occur, leading to delay in diagnosis. Biphasic reactions, where symptoms recur 8 to 12 hours after onset of the original attack, and prolonged attacks lasting up to 48 hours have been described. All patients with anaphylaxis should be hospitalised. 

Signs of anaphylaxis

Anaphylaxis is a severe adverse event of rapid onset, characterised by circulatory collapse. In its less severe (and more common) form, the early signs are generalised erythema and urticaria with upper and/or lower respiratory tract obstruction. In more severe cases, limpness, pallor, loss of consciousness and hypotension become evident, in addition to the early signs. Vaccinators should be able to recognise all the signs and symptoms of anaphylaxis given in Table 2.10.

Accurate documentation, including information on the Aotearoa Immunisation Register (AIR), COVID-19 immunisation register (CIR), School-Based Vaccination System (SBVS) and practice management system (PMS), is essential. If the vaccinator has not kept accurate clinical records, it is difficult to prove what action/care was or was not taken/delivered if the patient notes are subject to legal scrutiny.

In addition to the information recorded on the AIR (see section 2.3.5), CIR, SBVS or PMS, information that should be collected in the patient’s clinical notes includes:

• confirmation that informed consent was given
• confirmation that the individual was observed for the recommended time and no adverse events occurred during the observation period (if an adverse event does occur, it is essential to document the action and treatment given and inform CARM – see section 1.6.3).

The vaccinator should also complete the relevant sections in the Well Child Tamariki Ora My Health Book and, where applicable, the child’s immunisation certificate (see Appendix 5), the Health New Zealand payment claim form (where applicable). If required, a manual vaccination recording form can be completed for entering into AIR as soon as is practical. 

Indemnity insurance

All vaccinators should carry indemnity insurance. Most employers have indemnity cover, but vaccinators do not have an automatic right to claim under that cover. Indemnity insurance should cover vaccinators/health professionals for disciplinary proceedings, coroners’ inquiries, and claims of negligence or error that may lead to injury, death or damage.

The Aotearoa Immunisation Register (AIR) is an information system that replaced both the National Immunisation Register (NIR), and the Covid Immunisation Register (CIR) in December 2023. The AIR:

• provides a more accurate record of immunisation coverage rates regionally and nationally – this information assists with better programme planning to improve coverage rates and identify areas with lower immunisation rates
• collects information about the Schedule, and some targeted programmes (eg, Tdap during pregnancy, BCG vaccine)
• collects information about influenza immunisations and high-risk adolescent and adult immunisations (since July 2014)
• enables health professionals to identify quickly and easily which vaccines an individual has received (especially if they have moved areas or changed health care providers) and any that are due or may have been missed
• enables individuals to have an accurate, up-to-date record of their immunisation history.

For more information on sign-up and programme updates, please refer to the Aotearoa Immunisation Register website.

1. Health and Disability Commissioner. Code of Health and Disability Services Consumers’ Rights [updated July 2012]; URL: https://www.hdc.org.nz/your-rights/the-code-and-your-rights/. (accessed 8 May 2020)
2. Lee J, Robinson JL ,Spady DW. Frequency of apnea, bradycardia, and desaturations following first diphtheria-tetanus-pertussis-inactivated polio-Haemophilus influenzae type B immunization in hospitalized preterm infants. BMC Pediatrics, 2006. 6(6): p. 20.
3. World Health Organization. 2015. Report to SAGE on Reducing Pain and Distress at the Time of Vaccination (ed.). URL: https://www.who.int/immunization/sage/meetings/2015/april/1_SAGE_latest_pain_guidelines_March_24_Final.pdf (accessed 8 May 2020)
4. Poland GA, Borrud A, Jacobson RM, et al. Determination of deltoid fat pad thickness. Implications for needle length in adult immunization. JAMA, 1997. 277(21): p. 1709-11.
5. Koster MP, Stellato N, Kohn N, et al. Needle length for immunization of early adolescents as determined by ultrasound. Pediatrics, 2009. 124(2): p. 667-72.
6. Knuf M, Zepp F, Meyer CU, et al. Safety, immunogenicity and immediate pain of intramuscular versus subcutaneous administration of a measles-mumps-rubella-varicella vaccine to children aged 11-21 months. European Journal of Pediatrics, 2010. 169(8): p. 925-33.
7. Cook IF. An evidence based protocol for the prevention of upper arm injury related to vaccine administration (UAIRVA). Hum Vaccin, 2011. 7(8): p. 845-8.
8. Centers for Disease Control and Prevention. 2015. Vaccine Administration. in Epidemiology and Prevention of Vaccine-Preventable Diseases  (The Pink Book) Hamborsky J, Kroger A,Wolfe S (eds). Washington DC.  URL: https://www.cdc.gov/vaccines/pubs/pinkbook/vac-admin.html. (accessed 3 July 2020)
9. Harrington JW, Logan S, Harwell C, et al. Effective analgesia using physical interventions for infant immunizations. Pediatrics, 2012. 129(5): p. 815-22.
10. Bohlke K, Davis RL, Marcy SM, et al. Risk of anaphylaxis after vaccination of children and adolescents. Pediatrics, 2003. 112(4): p. 815-20.
11. World Health Organization. 2019. Immunization Stress-related Response. A manual for program managers and health professionals to prevent, identify and respond to stress-related responses following immunization. (ed.), Geneva: World Health Organization. URL: https://www.who.int/publications-detail/978-92-4-151594-8 (accessed 07 May 2020)
12. Australian Technical Advisory Group on Immunisation (ATAGI). 2018. After vaccination. in Australian Immunisation Handbook. Canberra.  URL: https://immunisationhandbook.health.gov.au. (accessed 3 July 2020)