Appendix 4: Authorisation and criteria of vaccinators

See note 5 on authorised vaccinators

A person may be authorised under regulation 44A(2) of the Medicines Regulations 1984 by the Director-General of Health or the National Medical Officer of Health to administer a vaccine for the purposes of an approved immunisation programme.[6]

Regulation 44A(2) stipulates that the person seeking approval must apply in writing to the Director-General or a medical officer of health and provide documentary evidence that they:

• can carry out basic emergency techniques including resuscitation and the treatment of anaphylaxis
• have knowledge of the safe and effective handling of immunisation products and equipment
• can demonstrate clinical interpersonal skills
• have knowledge of the relevant diseases and vaccines to be able to explain the vaccination to the individual, parent or guardian who is to consent to the vaccination on behalf of the individual, to ensure that the individual or parent or guardian of the individual can give informed consent to the vaccination.

The usual protocol requires fully authorised vaccinator applications to be submitted to a medical officer of health in the applicant’s local region. Authorisation given under Regulation 44A(2) is valid for a period of two years from the date of authorisation and is subject to such conditions as the Director-General or the National Medical Officer of Health thinks fit. During the early stages of the COVID-19 response, the Director of Public Health, in their capacity as a National Medical Officer of Health, authorised all authorised vaccinators and provisional authorised vaccinators to provide National Immunisation Schedule and funded vaccinations (as noted in their authorisation) for those at increased risk of vaccine-preventable disease (as identified in this Immunisation Handbook). This meant they did not need to apply for authorisation in different PHU areas. This remains in effect until 1 June 2024. See Section A4.1.5 Process when a vaccinator is new to the health district in which they intend to practise.

Successful applicants will be authorised to administer either all or specific vaccines depending on the training they have completed (see Table A4.1). Details of the training they must complete is set out in section A4.1.2.

Assessment requirements

To become an authorised vaccinator or pharmacist/intern pharmacist vaccinator, all applicants must first meet the following HNZ | TWO requirements.

1. Demonstrate that within the preceding 24 months they have attended, completed and passed a Vaccinator Foundation Course (VFC) and have received the associated certificate. The VFC must meet the current Vaccinator Foundation Course Standards (published by IMAC) and the course should consist of:
   • a minimum of 16 hours’ educational input
   • a written open-book assessment (minimum one-hour duration), which may be oral at the facilitator’s discretion.
2. Undergo an independent clinical assessment by an immunisation coordinator or an approved assessor (as agreed by the Medical Officer of Health).[7] Information about the practice environment, including cold chain and emergency management processes, will be collected at the time of the clinical assessment. When a vaccinator is expecting to provide vaccines to infants and young children under 3 years of age, their clinical assessment must include the vaccination of at least one child aged under 2 years using the vastus lateralis injection site. 
3. Have evidence that they hold a current practising certificate from their registration authority (eg, Nursing Council of New Zealand, Pharmacy Council of New Zealand, Paramedic Council). 
4. Have a current cardiopulmonary resuscitation (CPR) certificate (see section A4.4 for details).

Completion of authorisation

Fully authorised vaccinator applicants

Authorised vaccinator applicants [8] who have successfully completed their clinical assessment will then need to apply for authorisation under Regulation 44A(2) by submitting an application, including the documentation described above, to a medical officer of health. Generally, this will be their local Medical Officer of Health, but in some instances, this authorisation may be given by a national Medical Officer of Health.

Pharmacist vaccinator applicants

Pharmacists and intern pharmacists who have met the assessment requirements detailed above and should notify the Pharmaceutical Society (PSNZ) by an email containing the following information:

1. full name
2. membership number
3. name of the pharmacy or pharmacies which vaccinations will be provided from, or if the pharmacist is a locum
4. date of the course (or update course)
5. date of their clinical assessment.

Copies of the vaccination certificate or resuscitation certificates are not required. Emails should be sent to p.society@psnz.org.nz and need to include ‘pharmacist vaccinator’ in the subject line.

For audit purposes, it is recommended that all pharmacist vaccinators keep a copy of the record of their vaccinator training and other relevant documentation in a file at their current place of work.

Authorisation of fully authorised vaccinators is valid for two years from the date of the authorisation approval letter from the Medical Officer of Health. To maintain status as an authorised vaccinator, authorisation must be renewed two yearly. To be authorised, the vaccinator must meet the requirements specified below.

To renew their vaccinator status, vaccinators are required to:

1. during the past two years or within a month of expiry of status, have completed a vaccinator update course that meets the current Vaccinator Update Course Standards[9]
2. have a summary of their immunisation practice over the past 12 months. The summary should include type of immunisation practice as a vaccinator (eg, general practice, occupational health, pharmacy etc); types of vaccinations given (eg, intramuscular, subcutaneous, intradermal); and other responsibilities related to immunisation (eg, cold chain-designated person, etc)
3. have evidence of a current practising certificate
4. have evidence of a current CPR certificate (see section A4.4 for details).

Fully authorised vaccinators

To continue vaccinating, fully authorised vaccinators need to apply for renewal of their authorisation to their local Medical Officer of Health and submit all relevant documentation (ie, immunisation update, CPR certificates and immunisation summary), prior to the expiry of their authorised vaccinator status.

Pharmacist vaccinators and intern pharmacist vaccinators

Prior to the expiry of their pharmacist vaccinator status (two-yearly, on the anniversary of their vaccinator foundation course), pharmacist vaccinators should notify PSNZ when they have completed the HNZ | TWO requirements specified above.

If it is less than five years since the vaccinator attended and completed an approved vaccinator course (ie, initial VFC or subsequent approved vaccinator update)

When a vaccinator has not achieved or maintained their vaccinator status, they must:

1. have a clinical assessment by an immunisation coordinator or approved assessor, completed within three months prior to application for authorisation/reauthorisation. If vaccinator status expired by less than one month, a clinical assessment is not required
2. have completed a vaccinator update course that meets the current Vaccinator Update Course Standards in the last two years
3. have a summary of their immunisation practice over the past 12 months or intended area of practice. The summary should include type of immunisation practice as a vaccinator (eg, general practice, occupational health, pharmacy, etc); types of vaccinations given (eg, intramuscular, subcutaneous, intradermal); and other responsibilities related to immunisation (eg, cold chain-designated person)
4. have evidence of a current practising certificate
5. have evidence of a current CPR certificate (see section A4.4 for details).

If it is five or more years since the applicant completed an approved vaccinator training and they have not achieved or maintained their vaccinator status

If it is more than five years since the applicant completed their initial VFC or subsequent approved vaccinator update, they will be required to attend and pass another VFC. This is because there will have been significant developments in vaccination delivery in the intervening interval.

See section A4.1.2 Process for full authorisation for vaccinators and pharmacist vaccinators.

Currently in place is provision for fully authorised vaccinators to be covered to work nationally until 1 June 2024. However, if a fully authorised vaccinator wishes to practise outside of the health district and/or public health area they were initially authorised for, they must advise the local Medical Officer of Health for the new area, and send through a copy of their current authorisation.

Pharmacist and intern pharmacist vaccinators are required to advise the local immunisation coordinator of their intention to set up a new pharmacist vaccinator service; this is to ensure that the coordinator is aware of which pharmacies require three-yearly spatial logging of the refrigerator. Where a vaccination service is already being offered this is not required.

All BCG vaccinators are fully authorised vaccinators with BCG endorsement. They are authorised by the local Medical Officer of Health as described below.

New BCG vaccinators and gazetted BCG vaccinators seeking regional BCG endorsement

To be endorsed as a BCG vaccinator, the applicant needs to:

1. complete an approved VFC
2. be nominated by their employer to become a BCG vaccinator
3. successfully complete a-approved online BCG vaccination course
4. complete under clinical supervision a minimum of five BCG vaccinations (using a standing order or prescription)
5. successfully complete a BCG clinical assessment by an approved BCG assessor
6. apply to the Medical Officer of Health for BCG endorsement approval, providing documented evidence of these requirements.

If a BCG vaccinator needs to administer additional Schedule vaccines, they will need to undertake a clinical assessment appropriate for the age group they will be vaccinating. Standing orders or prescriptions are required for the clinical assessment process.

For more information, see Health New Zealand | Te Whatu Ora webpage BCG vaccine and vaccinator endorsement. 

Process for two-yearly renewal of BCG vaccinator status

To renew BCG endorsement, vaccinators must apply to their local Medical Officer of Health prior to the expiry date and provide documented evidence that they:

1. are a current authorised vaccinator, and
2. have completed an online vaccination course that includes an update on BCG.
3. A BCG vaccinator who also holds full authorisation will need to complete a standard vaccinator update course, in addition the BCG update.

Note: BCG vaccinators must complete a BCG Vaccinator Update course every two years. This online course is available as part of IMAC education.

Provisional authorised vaccinators and provisional authorised pharmacist vaccinators, like fully authorised vaccinators, are authorised under regulation 44A(2). Regulation 44A(2) stipulates that the person seeking approval must apply in writing to the Director-General or the national Medical Officer of Health and provide documentary evidence that they:

1. can carry out basic emergency techniques, resuscitation, and the treatment of anaphylaxis
2. have knowledge of the safe and effective handling of immunisation products and equipment
3. can demonstrate clinical interpersonal skills
4. have knowledge of the relevant diseases and vaccines to be able to explain the vaccination to the individual, parent or guardian of the individual who is to consent to the vaccination on behalf of the individual, to ensure that the individual or parent or guardian of the individual can give informed consent to the vaccination.

Provisional authorised vaccinators and provisional authorised pharmacist vaccinators are only able to be authorised to administer influenza, MMR and COVID-19 vaccines (these are the only vaccines covered by the Provisional Vaccination Foundation Course and the COVID-19 Vaccine Education Course that these vaccinators complete). See Table A4.3.

To achieve provisional authorised vaccinator or provisional authorised pharmacist vaccinator status, HNZ | TWO requires vaccinators to:

1. complete the online Provisional Vaccinator Foundation Course (including learning assessment and webinar)
2. successfully complete a peer assessment of clinical practice
3. hold a current New Zealand Annual Practising Certificate
4. final year students completing a degree within a relevant field of study to provide proof of enrolment and student identification
5. have evidence of current CPR certificate (see section A4.4 for details)
6. submitted a completed application for authorisation as a provisional authorised vaccinator to the Ministry of Health
7. on receipt of written authorisation from a medical officer of health, provisional authorised vaccinators send copy of authorisation and peer assessment to the local immunisation coordinator.

Provisional authorised vaccinators who wish to continue to vaccinate after expiration of their authorisation will be required to transition to become a fully authorised vaccinator or pharmacist vaccinator. More information is available from the IMAC education website.

A person may be authorised by the Director-General of Health or a National Medical Officer of Health to prepare and administer a vaccine without a prescription. An authorised vaccinating health worker must, at all times while performing the tasks authorised under regulation 44AA, work under the clinical supervision and direction of a suitably qualified health practitioner.

Regulation 44AA(3) stipulates that the person must apply to the Director-General of Health or a National Medical Officer of Health and provide documentary evidence that they:

1. have successfully completed training as approved by the Director-General
2. can carry out basic emergency techniques, including resuscitation and the treatment of anaphylaxis and
3. have knowledge of the safe handling of immunisation products and equipment.

The VHW role is authorised in stages.

• Stage One vaccinators can administer specific vaccines to a limited age range:
  • mRNA-CV (30 µg) and influenza vaccine to those aged 12 and over
  • and/or Tdap and HPV9 to those aged 11 and over.
• Stage Two vaccinators can prepare and administer influenza and MMR vaccine and administer prepared mRNA-CV (10 µg) to children from age 5 years. There is an optional extension of training to allow them to prepare multidose vials of mRNA-CV.

Further detail is provided at Vaccinating workforce.

Stage One

Vaccinating health workers are not required to be registered health care professionals, but to complete Stage One authorisation they are required to apply to the Health NZ VHW authorisation portal and provide the following evidence:

1. course completion certificate(s) for Vaccinating Health Worker Stage 1 core course and vaccines specific course(s)
2. completed practical assessment from the IMAC Training and Competency Workbook
3. a current CPR certificate in basic life support (anaphylaxis management is covered through Ministry-approved IMAC training for all vaccinators).

Once authorisation is accepted a letter will be issued stipulating which vaccines they can administer under supervision.

Stage Two

For further authorisation as a Stage Two Vaccinating Health Worker, all applicants must meet the following Ministry of Health requirements for stage two. Stage Two VHWs may prepare and administer certain vaccines to children aged from 5 years under the clinical supervision and direction of a qualified health professional. There is the option to extend skills by completing then mRNA-CV multidose vial preparation training and authorisation.

To be granted Vaccinating Health Worker Stage 2 status, it is expected all applicants have completed core in-house training for Stage 1 and have completed at least 25 vaccination events over the previous 8 weeks and have been authorised for VHW Stage One – four vaccines.

Applicants are required to apply to the Health NZ VHW authorisation portal and provide the following evidence:

1. Vaccinating Health Worker Stage 2 course certificate
2. Completed practical assessment from the IMAC Training and Competency Workbook. Only the completed checklists and signed declaration are required to be submitted, the workbook should be retained by the applicant.
3. To apply for authorisation for preparation of Covid-19 multi-dose vials the signed checklists for mRNA-CV (30 µg), mRNA-CV (15/15 µg), mRNA-CV (10 µg) must be submitted along with the completed declaration.
4. The second-checker course certificate
5. A current CPR certificate in basic life support (anaphylaxis management is covered through Ministry-approved training for all vaccinators) is required for each application for authorisation.

Note: VHW Stage 2 preparation training is not required for pharmacy technicians as this is already covered in their scope of practice.

Authorisation of a vaccinating health worker (VHW) is valid for two years from the date of the authorisation from the National Medical Officer of Health. To maintain status as an authorised VHW, authorisation must be renewed two yearly and the vaccinator must meet the requirements specified below.

To renew their vaccinator status, vaccinators are required:

1. during the past two years or within a month of expiry date on authorisation letter, have completed a Vaccinating Health Worker update course that meets the current Vaccinator Update Course Standards [10]
2. to provide a summary of their immunisation practice over the past 12 months. The summary should include type of immunisation practice as a vaccinator (eg, general practice, pharmacy etc); and other responsibilities related to immunisation (eg, cold chain-designated person, etc)
3. to have evidence of a current CPR certificate (see section A4.4 for details).
4. to submit this evidence to receive updated authorisation letter.