Preparing for vaccination

Most people in Australia receive vaccines in general practices, but they can also receive them in:

• local council clinics
• community centres
• pharmacies
• school-based immunisation programs
• travel medicine clinics
• public hospitals
• staff occupational health clinics
• aged care facilities
• Aboriginal medical services
• state mass vaccination clinics

State and territory legislation outlines who can access and administer vaccines.

All vaccines must be administered in accordance with the relevant legislation, best practice, and the guidelines and recommendations in this Handbook.

Also follow other relevant guidelines, such as National Vaccine Storage Guidelines: Strive for 5¹ and Australian Guidelines for the Prevention and Control of Infection in Healthcare.²

Immunisation providers need to comprehensively screen everyone who wants to be vaccinated.

Providers should:

• ensure that they have the right person to be vaccinated
• check which vaccine(s) are indicated, including any missed vaccine doses
• consider whether the person needs alternative or additional vaccines
• check whether there are any contraindications or precautions for the vaccines the person is receiving
• ensure that the person to be vaccinated is the appropriate age for the vaccines they are receiving
• check that the correct time interval has passed since the person received any previous vaccine(s) or blood products

Some people may need changes to the routinely recommended vaccines to:

• eliminate or minimise the risk of adverse events
• optimise their immune response
• protect a household contact against vaccine-preventable diseases

See Catch-up vaccination and relevant disease chapters for more details.

Spacing of different vaccines

If an individual needs to receive multiple vaccines, these can be given at the same visit or at separate visits with appropriate intervals between vaccines. In general:

• an inactivated vaccine can be given at any time before or after, or at the same time as, all other vaccines registered in Australia (see disease-specific chapters for exceptions). However, there may be some exceptions. For example, it is preferred that Fluad Quad and Shingrix are given a few days or more apart.
• a live parenteral vaccine can be given either at the same time as another live parenteral vaccine, or at least 4 weeks apart^3,4

Co-administration of combination vaccines containing the same antigen is not routinely recommended.

Steps for pre-vaccination screening

Follow the next 4 steps to complete the pre-vaccination screening process:

1. Complete the pre-vaccination screening checklist 

Give the pre-vaccination screening checklist to the person receiving the vaccine or their carer. Either print the checklist and hand it to the person or display the checklist in the clinic or surgery for easy reference.

Some of the questions in the checklist are deliberately non-specific. This is to elicit as much important information as possible. 

2. If possible, check prior immunisation history on the Australian Immunisation Register or in vaccine administration software

3. Consider occupational and lifestyle factors

If the person is an adult, ask them about any occupational and lifestyle factors that may influence their vaccination requirements. See Table. Catch-up schedule for people ≥10 years of age (for vaccines recommended on a population level) in Catch-up vaccination.

4. Consider actions for any conditions

If the person lists a condition or circumstance on the pre-vaccination screening checklist, see Table. Responses to conditions or circumstances identified through the pre-vaccination screening checklist. This lists the appropriate action to take, and a rationale.

5. Seek further advice

Where necessary, seek further advice from: 

• a specialist immunisation clinic
• a medical practitioner with expertise in vaccination
• the immunisation section in your state or territory health authority
• your local public health unit

Conditions or circumstances identified using the pre-vaccination screening checklist

Use Table. Responses to conditions or circumstances identified through the pre-vaccination screening checklist to decide what action to take if you have identified a condition or circumstance in the pre-vaccination screening checklist.

Only vaccines recommended on the National Immunisation Program schedule are included in this table. For information on other vaccines, see:

• the relevant disease chapter in this Handbook
• the vaccine product information

Contraindications to vaccination

Only 2 absolute contraindications apply to all vaccines:

• anaphylaxis following a previous dose of the relevant vaccine
• anaphylaxis following any component of the relevant vaccine (see Table. Components of vaccines used in Australia)

2 further contraindications apply to live vaccines (both parenteral and oral):

• People who are significantly immunocompromised should not receive live vaccines. This is regardless of whether the immunocompromising condition is caused by disease or treatment.
• Pregnant women should not receive live vaccines, in general. Women should be advised not to become pregnant within 28 days of receiving a live vaccine. See Table. Vaccines that are contraindicated in pregnancy: live attenuated vaccines in Vaccination for women who are planning pregnancy, pregnant or breastfeeding. 

Exception: With further advice, people with HIV who are mildly immunocompromised can receive MMR (measles-mumps-rubella), varicella and zoster vaccines. See Vaccination for people who are immunocompromised, and individual disease chapters.

Live viral vaccines are:

• Japanese encephalitis (Imojev) (parenteral)
• MMR (measles-mumps-rubella) (parenteral)
• MMRV (measles-mumps-rubella-varicella) (parenteral)
• rotavirus (oral)
• varicella (parenteral)
• yellow fever (parenteral)
• zoster (parenteral)

Live bacterial vaccines are:

• BCG (bacille Calmette–Guérin) (parenteral)
• Vaxchora cholera vaccine (oral)
• typhoid (oral)

See Infographic. Vaccination for women who are planning pregnancy, pregnant or breastfeeding

Components of immunisation products used in Australia

The way vaccines are manufactured can change over time. This means that the information in Table. Components of immunisation products used in Australia may change.

The Therapeutic Goods Administration provides the most current versions of the product information and consumer medicines information documents for vaccines and other medicines.

None of the vaccines listed on the National Immunisation Program contain thiomersal.

Please refer to the relevant disease-specific chapter in this Handbook for more information on any contraindications and precautions related to vaccine components.

False contraindications to vaccination

No-one should be denied the benefits of vaccination by withholding vaccines for inappropriate reasons.

Conditions listed in this section are not contraindications to vaccination. People with these conditions can receive all recommended vaccines:

• mild illness without fever (temperature <38.5°C)
• family history of any adverse events following immunisation
• history of convulsions
• treatment with antibiotics
• treatment with locally acting (inhaled or low-dose topical) steroids
• replacement corticosteroids
• asthma, eczema, atopy, hay fever or ‘snuffles’
• previous infection with the same pathogen
• prematurity — premature infants can receive vaccines if they are medically stable (see also Vaccination for preterm infants)
• history of neonatal jaundice
• low weight in an otherwise healthy child
• neurologic conditions, including cerebral palsy and Down syndrome
• contact with an infectious disease
• child’s mother is pregnant
• child to be vaccinated is being breastfed
• woman to be vaccinated is breastfeeding
• recent or imminent surgery (see Vaccination before or after anaesthesia or surgery)
• poorly documented vaccination history

Valid consent is the voluntary agreement by an individual to a proposed procedure, which is given after sufficient, appropriate and reliable information about the procedure, including the potential risks and benefits, has been conveyed to that individual.^8-12

As part of the consent procedure, people receiving vaccines and/or their parents or carers should be given sufficient information (preferably written) about the risks and benefits of each vaccine. This includes:¹³

• what adverse events are possible
• how common they are
• what they should do about them

Table. Side effects following immunisation for vaccines used in the National Immunisation Program schedule can be used to inform valid consent.

Criteria for valid consent

For consent to be legally valid, the following elements must be present:^12,14

1. It must be given by a person with legal capacity, and of sufficient intellectual capacity to understand the implications of receiving a vaccine.
2. It must be given voluntarily in the absence of undue pressure, coercion or manipulation.
3. It must cover the specific procedure that is to be performed.
4. It can only be given after the potential risks and benefits of the relevant vaccine, the risks of not having it, and any alternative options have been explained to the person.

The person must have the opportunity to seek more details or explanations about the vaccine or its administration.

The information must be provided in a language or by other means that the person can understand. Where appropriate, involve an interpreter or cultural support person.

Obtain consent before each vaccination, after establishing that there are no medical condition(s) that contraindicate vaccination. Consent can be verbal or written.

Consent on behalf of a child or an adolescent

In general, a parent or legal guardian of a child has the authority to consent to that child being vaccinated. 

Some Australian states and territories have legislation that addresses the issue of a child’s consent to medical treatment. Check with your state or territory health authority about these laws. 

The common law applies in the states and territories that do not have specific legislation relating to children’s consent to medical treatment. This common-law position is often referred to as Mature Minor or Gillick competence.

For certain procedures, including vaccination, a child or adolescent may be determined to be mature enough to understand the proposed procedure, and the risks and benefits associated with it. These young people may have the capacity to consent under certain circumstances.^8,11 

If a child or adolescent refuses a vaccination that a parent or guardian has given consent for, respect the child’s or adolescent’s wishes, and inform the parent or guardian.⁸

Consent on behalf of an adult lacking capacity

Carefully assess an adult’s capacity to give valid consent to vaccination. If the adult lacks capacity, refer to relevant state and territory laws for obtaining consent from a substitute decision-maker. For example, this may occur for influenza vaccination of an elderly person with dementia.

See the enduring guardianship legislation in your state or territory for more details.

Resources to help communicate the risks and benefits of vaccines

Use plain language when communicating information about vaccines and their use. The person to be vaccinated (or their parent or guardian) must:^15,16

• be encouraged to ask for more details
• have enough time to decide whether to consent

Provide printed information to supplement any verbal explanations.¹⁷ Table. Comparison of the effects of diseases and the side effects of NIP vaccines provides some basic information to communicate the risks and benefits of vaccination.

More details about vaccines and their use are available from:

• the Australian Government Department of Health website on immunisation, which includes information on immunisation throughout life and vaccine-preventable diseases
• the National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases website, which includes fact sheets about specific vaccines, vaccine-preventable diseases and vaccine safety. The website also hosts an online decision aid to help people decide whether to receive MMR vaccine.

Evidence of consent

General practice or public immunisation clinics

People can give consent either in writing or verbally, according to the protocols of the health facility. All consent must meet the criteria for valid consent. 

Document evidence of verbal consent in the clinical records. 
For electronic medical records, include a typed record of verbal consent in the person’s file, or scan a copy of written consent into the file.

If the practice or clinic routinely follows a standard procedure, show that the provider followed the procedure by using a stamp, a sticker or the provider’s signature.

People need to give explicit verbal consent before receiving any vaccine, even if they gave written consent at previous vaccination encounters for the same vaccine. Document verbal consent in the person’s file each time they give it.

School-based vaccination programs

Consent is required to provide individual vaccines or a vaccine course through school-based vaccination programs.

In school-based, and other large-scale, vaccination programs, the parent or guardian usually does not attend with the child on the day they receive the vaccine. Written consent from the parent or guardian is desirable in these circumstances. 

If the parent or guardian cannot provide written consent, or if they need further clarification, they can give verbal consent to the immunisation provider by telephone. Clearly document this on the child’s consent form.

In some states and territories, older adolescents may be able to provide their own consent for vaccinations offered through school-based vaccination programs. See Consent on behalf of a child or an adolescent. 

Consent requirements and vaccines offered in these programs vary between jurisdictions. See your state or territory school-based vaccination program guidelines for more details.

Always follow the standard principles of infection prevention and control during vaccination to prevent the transmission of infectious organisms.

These principles include recommendations for:

• routine hand hygiene
• using personal protective equipment, as appropriate
• handling and disposing of sharps
• routine cleaning of the work environment

See the National Health and Medical Research Council Australian Guidelines for the Prevention and Control of Infection in Healthcare.²

All immunisation providers must be familiar with, and adhere to, the National Health and Medical Research Council Australian Guidelines for the Prevention and Control of Infection in Healthcare.²

If a person is exposed to blood or body fluids, follow appropriate guidelines for post-exposure prophylaxis.

Depending on the vaccine(s) being administered, and the age and size of the person to be vaccinated, decide on the appropriate injection site and route, and the injection equipment required (for example, syringe size, needle length and gauge). 

The equipment needed will depend on whether the vaccine is: 

• a reconstituted vaccine
• a vaccine from an ampoule or vial
• a vaccine in a pre-filled syringe

Use a new, sterile, disposable syringe and needle for each injection, unless the vaccine is in a pre-filled syringe.

Gloves and protective eyewear are not routinely recommended for immunisation providers. However, the person administering the vaccine should wear gloves and eyewear if they are at risk of coming into contact with body fluids or if they have open lesions on their hands.¹⁸

Equipment may include:

• medical waste (sharps) container that meets Australian standards — always keep sharps containers out of the reach of children
• vaccine, plus diluent if the vaccine needs reconstitution
• 2 or 3 mL syringe (unless the vaccine is in a pre-filled syringe)
• appropriate drawing-up needle — 19 or 21 gauge needle, if required, to draw up through the rubber bung and to reconstitute the vaccine
• appropriate injecting needle — see Table. Recommended needle size, length and angle for administering vaccines in Administration of vaccines
• clean cottonwool and hypoallergenic tape or latex-free bandaid to apply to the injection site after vaccination
• age appropriate distraction tools i.e. rattle, VR goggles, tablets

Additional PPE may be recommended, such as masks, shields, gowns, based on current national and jurisdictional specific advice for preventing the spread of infectious diseases such as COVID-19.

Preparing an anaphylaxis response kit

Before each vaccination session, check that you have the protocols, equipment and medicines to manage anaphylaxis. Always keep an anaphylaxis response kit on hand. This kit should contain:

• adrenaline 1:1000 (at least 3 ampoules — check expiry dates)
• at least three drawing-up needles
• at least three syringes and 25 mm needles (22 or 23 gauge) for intramuscular injection. Syringes may be 1, 2, or 3mL syringes
• cottonwool swabs
• pen and paper to record the time the adrenaline was administered
• laminated copy of Table. Doses of intramuscular 1:1000 adrenaline for anaphylaxis in After vaccination
• laminated copy of Table. Recognising and treating anaphylaxis

See Preparing an anaphylaxis response kit.

See Adverse events following immunisation in After vaccination for details on recognising and treating adverse events following immunisation. In particular, see Using adrenaline and Using adrenaline autoinjectors in that section.

The cold chain is the system of transporting and storing vaccines within the temperature range of +2°C to +8°C from the place of manufacture to the point of administration.¹ This is essential for maintaining vaccine potency and vaccine effectiveness. 

The cold chain needs to be maintained, not only for vaccines provided as part of the National Immunisation Program but also for vaccines that a person buys from a pharmacist with a prescription. In these cases, both the doctor issuing the prescription and the pharmacist dispensing the vaccine must tell the person how and why to maintain the cold chain for the vaccine they have bought.

Some vaccines are transported and stored frozen; manufacturer’s instructions must be followed for transport, storage and defrosting processes.

All immunisation providers must be familiar with, and adhere to, the latest edition of National Vaccine Storage Guidelines: Strive for 5.¹

National Vaccine Storage Guidelines: Strive for 5¹ contains specific details on setting up the infrastructure for a vaccination service. All immunisation providers should refer to these guidelines to ensure that satisfactory equipment and procedures are in place before they start vaccination services

The guidelines also provide instructions on how best to transport vaccines from the main storage facility to outreach or external clinics. 

Purpose-built vaccine refrigerators are preferred for storing vaccines. Domestic refrigerators are not designed for the special temperature needs of vaccine storage. 

Cold chain breaches

Despite best practices, cold chain breaches sometimes occur. It is important to report any cold chain breaches so that people can be revaccinated or unused vaccines can be recalled, if required.

Do not discard or use any vaccines that have been exposed to temperatures below +2°C or above +8°C without obtaining further advice. Isolate the vaccines and contact your state or territory health authority for advice on National Immunisation Program vaccines, and the manufacturer/supplier for privately purchased vaccines. Recommendations for discarding vaccines may differ between health authorities and manufacturers.

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10. Rogers v Whitaker. Australian Law Reports (1992) 109 ALR 625 at 633.
11. Gulam H. Consent: tips for health care professionals. Australian Nursing Journal 2004;12:17-9.
12. Kerridge I, Lowe M, Stewart C. Ethics and law for the health professions. 4th ed. Sydney: The Federation Press; 2013.
13. Leask J, Braunack-Mayer A, Kerridge I. Consent and public engagement in an era of expanded childhood immunisation. Journal of Paediatrics and Child Health 2011;47:603-7.
14. Staunton P, Chiarella M. Law for nurses and midwives. 7th ed. Sydney: Elsevier/Churchill Livingstone; 2013.
15. Bird S. Discussing benefits and risks with patients. PSA testing. Australian Family Physician 2004;33:266-7.
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