COVID-19 vaccination clinical information


The information on this page will assist health professionals delivering the COVID-19 Vaccination Program in South Australia. Information contained in these documents is correct at the time of release. As information is continually evolving some documents will be updated if related information and recommendations change in the future.

Advice from ATAGI

The Australian Technical Advisory Group on Immunisation (ATAGI) advises the Minister of Health on the immunisation programs and provides clinical guidance on the vaccines available in Australia.

Regularly updated ATAGI statements can be found here:

Children aged 5 to 11

Children aged 5 to 11 can get their paediatric Pfizer COVID-19 vaccine at most SA Health vaccination clinics (including some mobile clinics), selected general practices, GP respiratory clinics and pharmacies.

Children aged 6 to 11 can get their reduced dose of Moderna COVID-19 vaccine at participating GPs and selected pharmacies.

Vaccinating children aged 5 to 11 against COVID-19 decreases spread of the virus to all age groups. It also reduces the child’s risk of rare but serious complications, such as multi-system inflammatory syndrome, and post-COVID-19 condition (long COVID).

The paediatric Pfizer COVID-19 vaccine is recommended for children aged 5 to 11 and is one third of the dose given to those aged 12 and over.

The Moderna COVID-19 vaccine is available at a reduced dose for people aged 6 to 11 which is half the dose given to those aged 12 and over.

The paediatric Pfizer and reduced dose of Moderna COVID-19 vaccines should be given in two doses, 8 weeks apart. This can be reduced to a minimum of three weeks for Pfizer and four weeks for Moderna in special circumstances.

For more information:



Medically at-risk children aged 5 to 17

It is important that children with an underlying medical condition access COVID-19 vaccination as soon as possible to significantly reduce their risk of COVID-19 infection, illness or hospitalisation.

If the child is medically stable, they can receive their vaccine at an SA Health vaccination clinic, or participating GP, respiratory clinic or pharmacy.

If the child has a medical at-risk condition (see list below) and is medically unstable, they should be referred for assessment at the Specialist Immunisation Service at the Women’s and Children’s Hospital.

Referrals can also be made if the child has an eligible condition and the parent or legal guardian is hesitant and requires further counselling that cannot be provided by their vaccine provider, GP or specialist.

Referrals are made by faxing a referral letter to 08 8161 9295.

Medical at-risk conditions

Immunology/Infectious Diseases

  • Primary Immune Deficiency
  • HIV/Acquired Immune Deficiency

Neurology

  • Severe epilepsy
  • Neuromuscular dystrophy
  • Demyelinating condition
  • Severe Cerebral Palsy
  • Severe neurocognitive disability

Respiratory

  • Chronic lung disease
  • Cystic fibrosis
  • Severe asthma (defined as required for high dose inhaled steroids, long term oral steroids, biologics, PICU admission, frequent (> 4) hospital admission
  • Condition requiring airway intervention – tracheostomy, BiPap, home oxygen

Haematology/Oncology

  • Haematological Malignancy
  • Non-haematological malignancy
  • Post Stem cell Transplant

Gastroenterology

  • Inflammatory bowel disease
  • Chronic liver disease
  • Short gut syndrome

Rheumatology

  • Juvenile idiopathic arthritis
  • Systemic lupus erythematosus
  • Juvenile dermatomyositis
  • Chronic inflammatory condition requiring immunosuppression or immunomodulatory therapy

Endocrine

  • Type I Diabetes

Renal

  • Chronic renal failure (eGFR <44L/min)

Cardiology

  • Complex congenital heart disease
  • Cardiomyopathy
  • Valvular heart disease
  • Pulmonary hypertension

Disability

  • NDIS participant

Other

  • Congenital or genetic condition with significant impairment requiring frequent assistance with activities of daily living
  • Eating disorder
  • Severe Obesity (BMI ≥ 120% of the 95% percentile for age or absolute BMI ≥ 35 kg/m2 whichever is lower BMI > 95th percentile)
  • Traumatic brain and/or spinal cord injury
  • Severe mental health condition (which impacts on their ability to comply with public health measures)
  • Solid organ transplant recipients
  • Children/ Adolescents with complex and/or chronic disease
  • For other conditions which do not fall under a preceding category, please detail why the child is at increased risk

Medically at-risk adults

The South Australian COVID-19 Specialist Immunisation Clinic (SACSIC) provides specialist services for adults identified as at risk for adverse events following immunisation (AEFI) or those who experience AEFIs in the context of a COVID-19 vaccine.

Referral process and criteria

All referrals to the South Australian COVID-19 Specialist Immunisation Clinic must be forwarded via fax or email using the SACSIC Referral Form (PDF 47KB). Criteria for referral are listed on the form.

Further information is available at:

Immunocompromised people

ATAGI recommends a third dose of COVID-19 vaccine as part of the primary course for people aged 5 and over who are severely immunocompromised. The third dose is intended to maximise the level of immune response to as close as possible to the general population. The third dose is given two months after the second dose.

Antibody testing is not recommended to assess for immunity to SARS-CoV-2 following COVID-19 vaccination, including in immunocompromised individuals after a second or third dose.

A booster dose of is recommended for those aged 16 years and older, given three months after the third primary dose.

The additional winter dose can be given to eligible individuals provided that four months has passed since their first booster dose AND three months has passed since a positive test result, if the individual had confirmed SARS-CoV-2 since their booster dose.

Eligibility

For a list of eligible conditions, see ATAGI recommendations on the use of a third primary dose of COVID-19 vaccine in individuals who are severely immunocompromised.

An individual with an unlisted condition should only be considered for a third dose where the treating physician has assessed the patient as having a similar level of severe immunocompromise to the eligible conditions.

Preferred vaccine types for third dose

  • Children 5 to 11: paediatric Pfizer vaccine
  • Children 6 to 11: paediatric Pfizer vaccine or a half dose of the Moderna vaccine
  • People 12 to 17: Pfizer or Moderna vaccine
  • People 18 and over Pfizer or Moderna vaccine

Possible alternative vaccine types for third dose

  • Novavax can be used as a third dose in those aged 18 or over, noting there is very limited data on its efficacy in people with immunocompromise
  • AstraZeneca can be used as a third dose in those aged 18 and over if AstraZeneca was given for the first two doses AND there are no contraindications or precautions for use, OR if a significant adverse reaction occurred after previous doses of other vaccine types contraindicating their further use, and the benefits of AstraZeneca vaccination outweigh the risks.

Recommended interval

The recommended interval for the third dose is two months after the second dose of vaccine. A minimum interval of four weeks may be considered in exceptional circumstances (e.g. anticipated intensification of immunosuppression or outbreaks). People who had a second dose more than six months ago should receive a third dose as soon as possible.

Scheduled doses for severely immunocompromised people

  • A three dose primary course for all those aged 5 years and older.
  • The third primary dose is recommended to be given two months after the second primary dose.
  • A booster dose is recommended for those aged 12 years and older, recommended to be given three months after the third primary dose.
  • An additional winter dose is recommended for those aged 16 years and older, given four months or longer after the first booster dose or from three months after a confirmed SARS-CoV-2 infection, if infection occurred since the first COVID-19 booster dose.

Proof of eligibility

Patients attending a pharmacy or SA Health site will need to show evidence of their eligibility for a third dose as outlined in the Commonwealth eligibility declaration form.

Evidence can be provided in one of the following ways:

  1. A letter from a GP or other treating specialist confirming the individual is severely immunocompromised (as per guidelines).
  2. Another medical document dated within the last 5 years which shows the individual is severely immunocompromised (as per guidelines), such as a:
    • patient medical summary from clinical records or My Health Record printed by treating GP’s practice
    • chronic disease care plan from treating GP
    • discharge summary from a hospital or other medical facility
    • named prescription for a medication prescribed to treat relevant conditions or procedures outlined in the guideline.
  1. A condition-specific identifier that the patient has been issued.
  2. An Eligibility Declaration Form completed by the patient, legal guardian or substitute decision maker (if unable provide any of the above evidence of eligibility).

Patients are not required to provide any medical or other details about their condition to their vaccination provider.

Booster doses

A booster dose enhances and extends protection from the primary course and helps prevent spread of the virus.

Currently, booster doses are available to everyone 16 years and over who have completed their primary course of COVID-19 vaccinations at least three months ago,

ATAGI also recommends that a first booster dose of Pfizer COVID-19 vaccine may be given to the following adolescents aged 12-15 years who have completed a primary course of vaccination 3 or more months ago:

  • those who are severely immunocompromised
  • those who have a disability with significant or complex health needs
  • those who have complex and/or multiple health conditions that increase the risk of severe COVID-19

ATAGI does not currently recommend booster doses for people aged 5 to 11.

Vaccine type

  • Eligible people aged 12-15 can have Pfizer as a booster dose.
  • People aged 16 to 17 can have the Pfizer vaccine as a booster dose.
  • People aged 18 and over can have Pfizer vaccine or a reduced dose of Moderna vaccine as a booster dose.
  • Novavax COVID-19 vaccine can be used as a booster dose in an individual aged 18 or older if no other COVID-19 brand is suitable for the individual.
  • AstraZeneca is no longer recommended for use as the booster dose for people who received a primary vaccination course of the AstraZeneca COVID-19 vaccine, although it can still be used for this purpose if these individuals have a medical contraindication to receiving Pfizer and/or Moderna vaccines or decline receiving an mRNA vaccine as a booster dose.

Winter dose

In addition to the first booster dose a winter dose of COVID-19 vaccine is recommended to increase vaccine protection for selected population groups at greatest risk of severe illness from COVID-19 who have completed their primary course and received a booster dose. These groups are:

The additional winter dose can be given to eligible individuals provided that four months has passed since their first booster dose AND three months has passed since a positive test result, if the individual had confirmed SARS-CoV-2 since their booster dose.

For more information see:

Vaccination following COVID-19 infection

  • Past infection with SARS-CoV-2 is not a contraindication to vaccination. This includes children with a past history of paediatric inflammatory multisystem syndrome or long COVID. Individuals who have prolonged symptoms from COVID-19 can be vaccinated on a case-by case basis.
  • A standard two dose schedule should be used unless the individual meets the criteria for severe immunocompromise and a third dose is recommended.
  • It is now recommended that all people should wait for 3 months after confirmed SARS-CoV-2 COVID-19 infection before they receive their next COVID-19 vaccine dose.
  • The next scheduled dose should then be given as soon as possible after this time.
  • Serological testing or other testing to detect current or previous infection with SARS-CoV-2 before vaccination is neither necessary nor recommended.

Vaccination exemptions

A person must meet certain eligibility requirements in order to obtain an exemption from COVID-19 vaccination. Criteria are listed in the ATAGI Expanded Guidance on temporary medical exemptions for COVID-19 vaccines.

Temporary medical exemption of up to 4 months may be granted from the date of testing positive to COVID-19.

Applying for an exemption

  1. For healthcare setting workers required to be vaccinated against COVID-19 under the South Australian Public Health Act, 2011:
    1. Medical practitioner writes a medical certificate clearly outlining the individual’s reason for medical exemption in line with the Australian Technical Advisory Group on Immunisation (ATAGI) COVID-19 vaccine exemptions guidelines.
    2. Medical practitioner completes SA Health Chief Public Health Officer Immunisation Exemption Application Form on behalf of the individual (who may be a worker, volunteer or visitor, depending on the specific Direction).
    3. The individual emails the medical certificate and immunisation. exemption application form to Health.NJNPExemptions@sa.gov.au
    4. Application for exemption is considered by the South Australian Chief Public Health Officer (CPHO).
    5. If approved, the CPHO provides a signed exemption letter that can be submitted to the individual’s employer, or the manager of the site which a volunteer or visitor seeks to enter.

Instead of applying for exemption, individuals with evidence of two TGA-approved COVID-19 vaccinations who develop confirmed COVID-19 are able to provide their employer with this evidence. This is valid for 4 months from the date of their first positive COVID test or their second TGA-approved COVID-19 vaccination, whichever is later.

For individuals required to be vaccinated as a condition of their employment set by their employer, or for any other activity where vaccination is required e.g. a COVID management plan or event

    1. Medical practitioner completes online Australian Immunisation Register (AIR) - immunisation medical exemption form for workers with medical contraindication to COVID-19 vaccination including, possible deferral of up to 4 months from date of testing positive to COVID-19.
    2. Medical practitioner submits completed form to AIR via PRODA account.
    3. Medical practitioner records vaccine exemption due to a medical contraindication online through the AIR site. Vaccine exemptions recorded on the AIR site are processed immediately.
    4. The individual downloads their COVID-19 digital certificate from Medicare online account through myGov to submit to an employer or event manager. The certificate lists the duration of the medical exemption as a ‘valid to’ date. Alternatively, an individual can ask the medical practitioner to print the certificate from the AIR website.

Vaccine information

Pfizer (COMIRNATY) COVID-19 vaccine

Moderna (Spikevax) COVID-19 vaccine

AstraZeneca (Vaxzevria) COVID-19 vaccine

Novavax (Nuvaxovid) COVID-19 vaccine

Reporting immunisation program errors

Immunisation program errors are a type of medication incident and include errors relating to:

  • the type or formulation of vaccine used, including where a contraindication exists or the vaccine is not approved for the age group of the recipient
  • incorrect vaccine preparation, dosage, dosage interval or administration route/site
  • use of vaccines which have expired or were incorrectly stored e.g. cold chain breach.

Some error types may occur secondary to inaccurate patient information (e.g. age, date of birth or previous vaccinations) being provided in the absence of access the Australian Immunisation Register, such as when internet access is temporarily unavailable.

All COVID-19 immunisation program errors must be reported as follows:

AND

Program Error mitigation resources:

Mandatory reporting of adverse reactions

As of 13 April 2021, an adverse event following immunisation (AEFI) is a notifiable condition in South Australia pursuant to section 63(2) of the South Australian Public Health Act 2011.

Medical practitioners, pathology services and authorised health practitioners under the Vaccine Administration Code are legally required to notify SA Health if a serious or unexpected AEFI occurs.
The South Australian Vaccine Safety Surveillance System (SAVSS) monitors AEFI for South Australia.

Information from AEFI reports received by SA Health are sent to the Therapeutic Goods Administration (TGA).

Health professionals are required to:

Be alert for any persistent, unexpected or severe AEFI, related to any vaccine.

How to notify

Notify serious or unexpected AEFI, or any AEFI which results in healthcare attendance to SA Health:

  • Complete an online Vaccine Reaction Report Form and a lodgement number will be issued following submission. An option to receive confirmation and lodgement number via email is available. You can also print a copy of your report.

OR

  • Call the SA Health COVID-19 Clinical Advisory Service between 8.30 am – 5.00 pm, Monday to Friday on 1300 232 272. Serious AEFI related to COVID vaccines can also be reported on this number outside of business hours.

Vaccine safety surveillance

AusVaxSafety is the national system for monitoring vaccine safety in Australia and will actively follow up people who have registered and have received a COVID-19 vaccine by sending them an SMS or email with a short survey that asks if they experienced an AEFI.

Cold chain management

COVID-19 vaccines have specific storage requirements. Further information is available at:

In the event of a cold chain breach affecting COVID-19 vaccines:

AND

Contact the SA Health COVID-19 Clinical Advisory Service on 1300 232 272 for further information.

Health workforce training

To ensure the health workforce is competent in the safe management and administration of COVID-19 vaccines, health practitioners must undertake specific mandatory training prior to ordering or administering any COVID-19 vaccinations.

For further information visit the Immunisation provider training and education page.

Resources for COVID-19 vaccine providers