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 2020, 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 2020 requires health agencies collecting identifiable information to be open about how and for what purpose that information will be used and who will be able to see it (Rule 3).  

In addition to providing information about collection by the vaccinating agency, people should be advised that vaccination information will be recorded in the Aotearoa Immunisation Register (AIR) maintained by Health New Zealand and directed to the online privacy statement for the AIR on the Health NZ website. This includes information on their choices with respect to control over their information. 

The Health Information Privacy Code 2020 also gives people the right to access, and seek correction of, health information about them (Rules 6 and 7). Parents and guardians have a similar right of access to information about their children. 

Further information about privacy and health information can be found on the Privacy Commissioner’s website. 

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.

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.

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 21) and varicella (see chapter 24).

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).

Figure 2.1: The cuddle position for infants

Figure 2.2: The infant lateral thigh injection site

Figure 2.3: The infant BCG vaccination site, and how to support the infant’s arm and hold the syringe

Figure 2.4: The BCG vaccine being slowly injected, and a white weal appearing as the needle is gradually withdrawn

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.

Figure 2.5: Cuddle positions for vastus lateralis or deltoid injections in children

Figure 2.6: The straddle position for vastus lateralis or deltoid injections in children

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).

Figure 2.7: Surface landmarks and structures potentially damaged by intramuscular injection in the upper limb

Figure 2.8: How to locate the deltoid site

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.

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 our new national register for vaccination activity that replaced both the National Immunisation Register (NIR), and the Covid Immunisation Register (CIR) in December 2023. The AIR:

• provides an accurate record of immunisation coverage rates both regionally and nationally – this information assists with 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
• enables health professionals to efficiently identify 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.

Individuals can choose to restrict access to their information in the AIR. This means they do not wish to share their information across providers, and so their full immunisation history will not be viewable via the AIR.

For more information on sign-up, programme updates and restricted access, 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)