Immunisation weekly update – 25 January 2022

TGA provisionally approves Novavax COVID-19 vaccine NUVAXOVID

Novavax COVID-19 vaccine, also known as Nuvaxovid (Biocelect Pty Ltd/Novavax Inc) has been provisionally approved by the TGA for use in a primary course of vaccination in people aged 18 years and older. Novavax COVID-19 vaccine is a spike protein-based vaccine. Each 0.5mL dose contains 5 micrograms of the of SARS-CoV-2 spike protein and 50 micrograms of Matrix-M as an adjuvant. 

• ATAGI recommends that Novavax COVID-19 vaccine can be used for the primary course of COVID-19 vaccination in people aged 18 or older.
• The recommended schedule for administration is 2 doses, a minimum of 3 weeks apart.
• Novavax COVID-19 vaccine is not currently recommended for use as a booster vaccine.

See the full list of recommendations: ATAGI statement on the use of Novavax COVID-19 vaccine (Nuvaxovid)

Information sheet: COVID-19 vaccination – Information on COVID-19 Nuvaxovid (Novavax) vaccine

AIR Reports: COVID-19 vaccination status (AIR042A) report

From 23 January 2022, enhancements to the Australian Immunisation Register (AIR) will enable practices to extract reports via AIR/PRODA login to assist them with monitoring a patient’s COVID-19 vaccination status including downloading a practice level report that will display:

• patients who have not yet received any doses of COVID-19 vaccine and/or
• patients that have had two doses and are eligible for a booster, and
• patients who are due or overdue for a booster.

General practices will be able to select an age range when running reports with the default age range for the report being 5 to 80 years old, noting there is no limitation on ages that can be selected.

The expansion of the report to those individuals who have only received one dose will be released at a later date.

Practices requiring assistance in accessing this report can contact immunisation@cesphn.com.au

Booster dose interval shortened to 3 months

From Friday 21 January, booster doses are available for those who completed their primary course of COVID-19 vaccination 3 or more months ago, using either the Comirnaty (Pfizer) or Spikevax (Moderna – half dose) vaccine for anyone aged 18 and older. Further information see Commonwealth: COVID-19 booster vaccine advice and NSW Health: Booster vaccination

Practices are reminded to take all opportunities to ensure vulnerable people and communities, including older people and residents of residential aged care facilities (RACFs), pregnant women, and immunocompromised individuals receive a booster dose, in line with ATAGI recommendations.

Dose intervals for vaccination of 5-11 year old children

ATAGI continues to recommend a 2 dose schedule for the 5-11 year old cohort of Comirnaty (Pfizer), 8 weeks apart. The interval can be shortened in special circumstances to a minimum of 3 weeks, for higher risk groups (such as those with medical risk factors for severe illness) in the context of ongoing community transmission. This also includes severely immunocompromised children aged 5-11 years, who are now recommended to have three doses as part of the primary vaccine course.

Third primary dose for immunocompromised children

ATAGI recommends that severely immunocompromised children aged 5-11 years receive a third primary dose of vaccine to optimise their protection, in line with advice for those aged 12 years and older. The 3^rd primary dose guidance has been updated to include children aged 5 years and older. The recommended interval for the 3rd primary dose is 2 to 6 months after the 2nd dose of vaccine.

Further information here: ATAGI – Provider guide to COVID-19 vaccination of people with immunocompromise

Vaccine exemption following COVID infection – 6 weeks or 6 months?

The Australian Technical and Advisory Group on Immunisation (ATAGI) continues to advise that previous infection is not a contraindication to vaccination and vaccination can occur following recovery of acute illness from COVID-19.

Following COVID infection, NSW Health provides all patients with a Medical Clearance Notice (via email/SMS). This letter provides patients with 6-week exemption to not be vaccinated for the purposes of the NSW Public Health Orders (like vaccine mandates for certain jobs). The patient is not required to go to the GP to seek medical exemption documents for these 6 weeks, they can use this NSW Health letter as evidence.

The ATAGI guidelines for Temporary Medical Exemption is a guideline for immunisation providers. This document outlines situations in which a temporary exemption of up to 4 months may be provided (previously 6 months). It states that an exemption can be provided to patient with: PCR-confirmed SARS-CoV-2 infection, where vaccination can be deferred until 4 months after the infection. This gives a framework for GPs to work within, and following clinical assessment, a GP can use clinical judgment to provide an exemption to a patient for a maximum duration of 4 months if the patient meets the criteria for exemption. This exemption needs to be documented on the Australian Immunisation Register (via online AIR site or the AIR form IM011) and patients are given a Proof of Medical Exemption.

To extend the NSW Health 6-week exemption, a patient needs to book in with a GP for an assessment to see if they qualify for further exemption. To meet the requirements for a temporary exemption of up to 4 months, a patient needs to have been infected with SARS-COV2 infection, AND have a non-permanent contraindication (see criteria on the IM011 form). The GP must clinically assess and determine if providing a temporary exemption to the patient is appropriate. Example for temporary exemption: if a patient has recovered from COVID infection, but symptoms continue to persist beyond 6 weeks (e.g.: long COVID). For patients where an exemption is clinically required for longer than 4 months, the GP can refer patients to an immunologist/specialist.

TGA COVID-19 vaccine weekly safety report 

A reminder the TGA provides a COVID-19 vaccine weekly safety report. To 16 January, TGA has received 54 adverse events reports since the roll out in the 5-11 year old age group. The most common reactions reported included vomiting, paleness, fainting, dizziness and headache. Evidence from clinical trials and real-world experience from overseas indicate that side effects most commonly seen in 5-11 year old were mild and temporary.  In the US, over 8 million doses of the vaccine have already been given to children aged 5-11, a review of their surveillance data published found that most side effects are mild.

Resources: How to report a suspected adverse event following immunisation in NSW.

Shingrix approved for use in people ages 18 year and over

The TGA has approved an expanded indication of the newest shingles vaccine, Shingrix, to prevent herpes zoster and postherpetic neuralgia in adults 18 years and older who are at increased risk of herpes zoster.

Until now, zoster vaccine has only been licensed in Australia for use in adults 50 years and older using either one of two vaccines. They are Shingrix (GlaxoSmithKline), an adjuvanted recombinant varicella zoster vaccine requiring two doses and Zostavax (Merck), a live attenuated single dose vaccine.

SHINGRIX is indicated for the prevention of herpes zoster (HZ) and post-herpetic neuralgia in:

1. adults 50 years of age or older;
2. adults 18 years of age or older at increased risk of HZ.

Shingrix Product Information 

Authorised nurse immunised courses accepted in states and territories

Authorised nurse immunised courses accepted in states and territories

This resource, updated 11 Jan 2022, lists the authorised nurse immuniser courses accepted by states and territories in Australia that should be used with the relevant state and territory legislation. 

NCIRS: COVID-19 FAQ

Reminder: The NCIRS COVID-19 FAQ and COVID-19 and children FAQ pages are regularly updated and are a helpful tool for providers and patients.

COVID-19 live stream update for GPs

Join the latest COVID-19 vaccine live stream update for GPs. The panel will provide latest key updates and answer participants’ questions live about the COVID-19 vaccine rollout.

Details: Thursday 27 January 2022, 11:30am (AEDT) | Click link to join

Catch up on previous webinars.