Immunisation: health professionals

Key updates:

• boosters for 12-15 year olds with chronic conditions
• expanded eligibility for fourth doses to anyone 16 years or older with a chronic condition, and
• simplification of CVAPs

Updates to mRNA COVID-19 vaccine dose intervals

• 8 weeks for Comirnaty (Pfizer 12 years +)
• 8 weeks for Spikevax (Moderna).

Updates to COVID-19 vaccination post infection.

• People who have had SARS-CoV-2 infection should receive a subsequent COVID-19 vaccine dose 3 months after confirmed infection.

Key updates:

• An additional “winter” booster dose of COVID-19 vaccine is approved for specific population groups who are at greatest risk of severe illness from COVID-19 and who have received their primary vaccination and first booster dose.

Key updates:

• Novavax COVID-19 vaccine approved as a booster dose for individuals aged 18 years and older if no other COVID-19 vaccine is considered suitable.

Key updates:

• Spikevax® - Moderna - COVID-19 Vaccine Administration Protocol age range eligibility now from 6 years and old.

Key updates:

• Novavax COVID-19 vaccine approved for use as primary course of COVID-19 vaccination in people aged 18 or older.
• Novavax COVID-19 vaccine is not currently approved for use as a booster.

Key updates:

• Revision of the interval to defer any due vaccinations following the onset of a SARS-CoV-2 infection from six months to up to four months.
• Revision of circumstances where the interval between dose 1 and dose 2 can be reduced in line with current ATAGI advice.
• CVAP Tozinameran [mRNA]) (Comirnaty®) for children aged 5-11 years: inclusion of the third primary dose for children with certain conditions or on therapies leading to severe immunocompromised.
• Vaxzevria® COVID-19 Vaccine – Astrazeneca and Elasomeran [mRNA-1273] - Spikevax® COVID-19 Vaccine – Moderna: Updating advice on co-administration of other vaccinations on the same day as Vaxzevria®  and Spikevax® vaccination.
• Vaxzevria® COVID-19 Vaccine – Astrazeneca and Elasomeran [mRNA-1273] - Spikevax® COVID-19 Vaccine – Moderna: Updating advice on frequency and use as a booster dose.

Key updates to version 21 of the COVID-19 Vaccine Administrative Protocol (CVAP) Tozinameran [mRNA]) Comirnaty ® COVID-19 Vaccine - Pfizer for persons aged 12 years and over:

• Revision of the recommended age to receive booster dose to 16 years and over
• Revision of the interval to defer any due vaccinations following the onset of a SARS-CoV-2 infection from six months to up to four months

• Clarify provision that a booster dose may be given at the interval specified in the most recent ATAGI recommendations on the interval for booster doses as published after the 23 December 2021.
• Update for booster dose for people with immunocompromise may be given at the interval specified in the most recent ATAGI recommendations in line with the timing for the general population as published after the 23 December 2021.

• Approval of Pfizer (Comirnaty®) Tozinameran [mRNA]) COVID-19 Vaccine – CHILDREN (5-11 years old) COVID-19 Vaccination Administration Protocol
• Amendment to booster dose availability for those persons eligible for boosters from 20 December 2021 to 3 January 2022 can now access the booster earlier than 5 months.
• Update to education requirements for Registered Nurses and Aboriginal Health Practitioners to reflect new courses
• Generic name change to Tozinameran [mRNA]) Comirnaty ® COVID-19 Vaccine  - Pfizer

Booster dose

• Approval of 5 month interval between the primary course of the COVID-19 vaccine and the booster dose.
• Approval for booster dose of Moderna Spikevax®  refer to COVID-19 Spikevax® Vaccination Administration Protocol (CVAP) for requirements.

• Approval of second doses of an alternative COVID-19 vaccine brand if the person is unable to access or not accepting the same brand as first dose of COVID-19 vaccine.
• Approval of the influenza vaccine and COVID-19 vaccine can be given at the same time.
• The eligible age for the Vaxzevria (AstraZeneca®) COVID-19 Vaccine is now 18 years and over.
• Updates to contraindications in relation to:
  • for people who have received an anti-SARS-CoV-2 monoclonal antibody or convalescent plasma should defer future doses of COVID-19 vaccine for at least 90 days.
  • other serious adverse events associated with COVID-19 vaccines.
  • people with SARS-CoV-2 infection can be vaccinated as soon as they have recovered from their acute illness or can defer vaccination for up to six months after onset of the SARS-CoV-2 infection.

A booster dose of COVID-19 Vaccine approved for people aged 18 year who meet the eligibility criteria under the Australian Technical Advisory Group on Immunisations, including in pregnancy.

• Persons 18 years and over may access a booster dose of a COVID-19 vaccine in line with ATAGI recommendations 6 months after receiving a second dose, refer to the Australian Technical Advisory Group on Immunisation (ATAGI) recommendations on the use of a booster dose of COVID-19 vaccine.

Third primary dose of COVID-19 Vaccine approved for individuals who are severely immunocompromised.

• Persons 12 years and over with certain conditions or on therapies leading to severe immunocompromised as defined in the Eligibility Conditions at the Australian Government Department of Health website may access a third primary dose of a COVID-19 vaccine in line with ATAGI recommendations.
• Also refer to the Australian Government Department of Health website for Eligibility Declaration Form and Eligibility Declaration Information for the third primary dose for individuals who are severely immunocompromised.

Spikevax® COVID-19 Vaccine (Moderna) is now approved for use in Northern Territory

• Persons 12 years and over may now receive the Spikevax®COVID-19 Vaccine in accordance with the requirements of the Spikevax® COVID-19 Vaccine Administration Protocol.
• Persons aged 16 years and over with capacity must consent to receive the vaccine and a record kept by the health practitioner administering the vaccine.
• Parents of children aged 12-15 years must provide informed consent to the child receiving the vaccine and a record kept by the health practitioner administering the vaccine.
• Updated information on cardiac indications relevant to the Comirnaty® and Spikevax® COVID-19 Vaccines.

Update to Comirnaty® COVID-19 Vaccine

• Comirnaty® COVID-19 Vaccine is provisionally registered in people aged 12 years of age and older and is given in a two-dose schedule.
• mRNA vaccines (i.e., Comirnaty® or Spikevax® COVID-19 Vaccines) are the preferred vaccines over Vaxzevria® (formerly AstraZeneca) COVID-19 Vaccine in people aged under 60 years, and in pregnant women.
• Updated information on cardiac indications relevant to the Comirnaty® and Spikevax® COVID-19 Vaccines.

Spikevax® COVID-19 Vaccine (Moderna) is now approved for use in Northern Territory

• Persons 18 years and over may receive the Spikevax®COVID-19 Vaccine in accordance with the requirements of the new Spikevax® COVID-19 Vaccine Administration Protocol.

New name for Astrazeneca COVID-19 Vaccine

• All CVAPs have been updated to include the new name for Astrazeneca® COVID-19 VACCINE (ChAdOx1-S) solution for injections, which is now known as Vaxzevria® COVID-19 Vaccine (ChAdOx1-S) Solution for Injection.

Comirnaty (Pfizer) COVID-19 Vaccine:

• Children 12-15 years may receive the Pfizer vaccine in accordance with the requirements of the Comirnaty (Pfizer) COVID-19 Vaccine Administration Protocol.
• Parents of children aged 12-15 years must provide informed consent to the child receiving the vaccine and a record kept by the health practitioner administering the vaccine.

AstraZeneca COVID-19 Vaccine

• Individuals must meet the eligibility criteria under the National COVID-19 vaccination implementation phases specifically:
  • 60 years of age and older for first and second doses; or
  • 18 years of age and older for a second dose only

Comirnaty (Pfizer) COVID-19 Vaccine

• Change to allow children 12-15 years in priority categories to receive the vaccine. The priority categories for children 12-15 years include:
  • ATAGI recommended priority categories found in the ATAGI statement regarding vaccination of adolescents aged 12–15 years on the Federal Department of Health website.
  • children with rheumatic heart disease.
• Contraindications updated to include any person who has an episode of Rheumatic fever within the last 3 months or has current active inflammatory markers.
• Persons aged 16 years and over with capacity must consent to receive the vaccine and a record kept by the health practitioner administering the vaccine.
• Parents of children aged 12-15 years must provide informed consent to the child receiving the vaccine and a record kept by the health practitioner administering the vaccine.
• Precaution for persons with inflammatory cardiac illness eg. myocarditis, pericarditis, endocarditis within the last 6 months consultation with medical officer or cardiologist required before giving the vaccine.

AstraZeneca COVID-19 Vaccine

• Inclusion of prior assessment requirements for persons with specific allergies.
• Change to Drug Interactions to recommend an interval of 7 days between COVID 19 vaccine and other vaccines including influenza.

Comirnaty (Pfizer) COVID-19 Vaccine

• Pregnant women (category B1 - limited experience in humans, animal studies do not indicate harmful effects).
• Change to contraindications to replace “hypersensivity” to “anaphylaxis” in relation to the active substance or to any of the excipients (including Polyethylene Glycol).
• Inclusion of prior assessment requirements for persons with specific allergies.
• Change to Drug Interactions to recommend an interval of 7 days between COVID 19 vaccine and other vaccines including influenza.

The CVAPs have been updated in response to recent advice provided by the Australian Technical Advisory Group on Immunisation. Changes include:

COVID-19 Vaccine AstraZeneca

• Change in inclusion criteria to people aged 60 years and above
• Inclusion of pregnancy under contraindications
• Addition of web-link to health provider resources

Comirnaty vaccine

• Change in Inclusion criteria to include pregnancy
• Inclusion of COVID-19 vaccination decision guide for women who are pregnant, breastfeeding or planning pregnancy
• Addition of web-link to health provider resources

The CVAPS have been updated in response to recent advice provided by the Australian Technical Advisory Group on Immunisation. Changes include:

COMIRNATY COVID-19 Vaccine Pfizer:

• reduction of interval to 7 days for other vaccines
• inclusion of 4 clotting disorders as precautions and need for medical consult prior to administration which may be undertaken via telephone
• no change in pregnancy – needs referral to medical officer.

COVID-19 Vaccine AstraZeneca:

• reduction of interval to 7 days for other vaccines
• inclusion of 4 clotting disorders as contraindications
• further doses of COVID-19 Vaccine AstraZeneca are contraindicated in people who develop thrombosis with thrombocytopenia after their first dose
• no change in pregnancy – needs referral to medical officer.

For more information please read the joint statement from ATAGI and THANZ on Thrombosis with Thrombocytopenia Syndrome (TTS) and the use of COVID-19 Vaccine AstraZeneca and the Clinical guidance on use of COVID-19 vaccine in Australia on the Federal Department of Health web site.

COMIRNATY COVID-19 Vaccine Pfizer:

• Change the cold storage temperature requirements following advice from Therapeutic Goods Administration to allow more flexible storage. For further information, go to the TGA website.

COVID-19 Vaccine AstraZeneca:

• Revision of age covered by the protocol to 30 years and above as People between 18 and 29 years of age as risks due to thrombosis with thrombocytopenia are likely to be higher than benefits from reduction in COVID disease complications.
• Requirement for explicit informed consent to be documented in clinical record for people aged between the age of 30 and 50 years as this vaccine can be used in adults aged under 50 years where the benefits clearly outweigh the risk for that individual and the person has made an informed decision based on an understanding of the risks and benefits.
• Record any vaccine administration issues in clinical incident management system.

COMIRNATY COVID-19 Vaccine Pfizer:

• Change the age covered by the protocol to 16 years and above
• Record any vaccine administration issues in clinical incident management system.

As for all vaccines, including COVID-19 vaccines, health care providers should be alert for persistent, unexpected and/or severe adverse events following immunisation in their patients, particularly those that occur 1–2 weeks after vaccination. For more information please read ATAGI reinforce recommendations on use of COVID-19 vaccines following review of vaccine safety data and benefits on the Federal Department of Health web site.

The COVID-19 vaccine protocols (CVAPs) for COVID-19 vaccine AstraZeneca and COMIRNATY COVID-19 vaccine Pfizer have been updated to reflect the advice provided by the Australian Technical Advisory Group for Immunisations. Out of an abundance of caution they are recommending that vaccination with any COVID-19 vaccine should be deferred for people who have a history of the following rare conditions:

• People with a confirmed medical history of CVST, and/or
• people with a confirmed medical history of heparin induced thrombocytopenia (HIT). HIT is an immune-mediated complication of treatment with heparin that affects platelet function. A HIT-like mechanism is being investigated as a potential, but unconfirmed, pathway to CVST post COVID-19 vaccination.

This is until further information from ongoing investigations in Europe is available and is only a precautionary measure.

As for all vaccines, including COVID-19 vaccines, health care providers should be alert for persistent, unexpected and/or severe adverse events following immunisation in their patients, particularly those that occur 1 to 2 weeks after vaccination.