TGA Provisional Approval of Moderna COVID-19 vaccine to include 12-17 years age group

On September 4 2021, the Therapeutic Goods Administration (TGA) granted provisional approval to Moderna Australia Pty Ltd for its COVID-19 vaccine—Spikevax (elasomeran) to include the 12-17 years age group. This decision follows the provisional approval granted by the TGA to Spikevax on 9 August 2021 for use in individuals aged 18 years and older.

To find out more information, please refer to our dedicated MVEC Moderna COVID-19 vaccination page in the link below:

MVEC Moderna COVID-19 vaccination page


New immunisation reference page: Immune thrombocytopenia (ITP)

Immune thrombocytopenia, also previously known as idiopathic thrombocytopenia purpura (ITP), is an uncommon autoimmune condition in which the body’s own immune system attacks platelets (the cells found in the blood which normally help the blood to clot).

Our new reference page discusses the background of ITP, including presentation of the condition and the association between ITP and MMR vaccines. Our page also answers questions around ITP and COVID-19 vaccines, including whether or not COVID-19 vaccines should be administered to people with a history of ITP.

To read more follow the link below:
MVEC: Immune thrombocytopenia (ITP)


A recording of the 30th August CVU mini is now available

Thank you to all who attended our recent CVU miniseries event Matters of the heart: Myocarditis and pericarditis associated with COVID-19 mRNA vaccination on 30th August 2021.

This interactive webinar took an in-depth look at an important vaccine safety signal associated with COVID-19 mRNA vaccines (Pfizer and Moderna).

A recording of this event is now available via our education portal.

To access this recording please follow the link below:

CVU mini - 30th August 2021


The Age: ‘The moment you walk in through those doors your healing starts’: Victoria leading the race on Indigenous vaccination

Data released by the federal government has highlighted the widening gap between fully vaccinated Indigenous Australians and the overall population, and the direct impact COVID-19 will have on First Nations people if Australia eases restrictions once 70 or 80 per cent of adults are vaccinated.

Historically, Australia’s Aboriginal community has been heavily impacted by the effects of widespread viral infections such as measles, smallpox and the Spanish Flu and this article highlights the impact low COVID-19 vaccination rates could have on our First Nations people.

Despite the slow rollout, Victoria is leading the way in terms of vaccination rates amongst the Indigenous population with 43% of people fully vaccinated against COVID-19, more than double that of the non-Indigenous population in Victoria at 26%.

According to Jeroen Weimar, the COVID-19 response commander in Victoria, the states’ success with facilitating a competent roll out initiative amongst the Indigenous communities can be attributed to joint efforts and strong partnerships.

To read the article in full, please click on the link below.
The Age: ‘The moment you walk in through those doors your healing starts’: Victoria leading the race on Indigenous vaccination


ABC News US: FDA-approved Pfizer vaccine not OK for off-label use in kids, official says

The U.S. Food and Drug Administration (FDA) have issued advice following full approval of the Pfizer COVID-19 vaccine for people aged 16 an older that it should not be given to young children as off-label use.

Pfizer's COVID-19 vaccine was authorised for use in children ages 12 to 15 in May by the FDA, meeting all the criteria to amend the EUA and with 100% effectiveness in children ages 12-15. Additionally, the Moderna and Johnson & Johnson vaccines are both available in the U.S. for anyone 18 years and older, with Moderna still awaiting a decision for approval on emergency use authorisation with the FDA.

Pfizer vaccine safety data on 5–11-year-olds is due to be submitted by the end of September, with Moderna due to report in the middle of fall. Clinical trials are still ongoing, however, it is expected that the first vaccine shots for children ages 5-11 could happen by the end of 2021, or early 2022. In order to detect the rarest of side-effects before the roll out begins across the U.S., the FDA have advised that the trials will need to expand the pool of volunteers.

To read the article in full, please click on the link below
ABC News US: FDA-approved Pfizer vaccine not OK for off-label use in kids, official says


MVEC animation: Myocarditis, pericarditis and COVID-19 vaccines

MVEC have created a new animation to help explain myocarditis and pericarditis which have been reported in a small number of individuals who have received mRNA COVID-19 vaccines Comirnaty™ and Moderna.

To view the animation and to find out more information, please refer to our myocarditis, pericarditis following COVID-19 mRNA vaccines immunisation reference page:
MVEC animation: Myocarditis and pericarditis following COVID-19 mRNA vaccines


Federal Government Announces No Fault COVID-19 Indemnity Scheme

Federal Health Minister Greg Hunt has announced the details of the no fault COVID-19 Vaccine Claim Scheme following extensive consultation with the peak medical, healthcare, business and insurance sectors to ensure a comprehensive National Scheme.

The purpose of the Scheme will be to provide Australians with quick access to compensation for COVID-19 claims related to the administration of a Therapeutic Goods Administration approved COVID-19 vaccine delivered through a Commonwealth Government approved program.

From 6 September Australians who suffer injury and loss of income due to their COVID-19 vaccine will be able to register their intent to claim from the COVID-19 vaccine claims scheme webpage.

To read more, follow the link below:
Federal Government Announcement: No Fault COVID-19 Indemnity Scheme


ATAGI recommendations on the use of COVID-19 vaccines in all young adolescents in Australia

The Australian Technical Advisory Group on Immunisation (ATAGI) has released recommendations on the use of COVID-19 vaccines in all young adolescents in Australia.

The advice recommends children aged 12-15 be vaccinated against COVID-19 using Comirnaty (Pfizer).

A summary of ATAGI recommendations includes:

  • Vaccination against COVID-19 is recommended for all individuals from 12 years of age, extending the current recommendation for those aged 16 years and older.
  • A two-dose schedule using Comirnaty (Pfizer), the only vaccine currently registered for use in Australia in this age group, is recommended.
  • Recommendations on the use of Spikevax (Moderna) for adolescents will be finalised following the decision on provisional registration of Spikevax (Moderna) in this age group.

To read the statement in full, please click the link below:
ATAGI recommendations on the use of COVID-19 vaccines in all young adolescents in Australia


MCRI's Professor Fiona Russell joins ABC Q+A host, Virgina Trioli tonight at 8:30pm AEST

MCRI's Professor Fiona Russell joins ABC Q+A host, Virginia Trioli, tonight at 8:30pm AEST for an important discussion around the COVID-19 Delta variant, lockdowns and their impact on children, teens and young people.

For more details, please click on the link below:
ABC Q+A


CVU mini event 30th August 2021 - Reminder to register

A reminder to register for our next Clinical Vaccinology Update (CVU) mini event: Matters of the heart: Myocarditis and pericarditis associated with COVID-19 mRNA vaccination on Monday 30th August 2021, at 7pm AEST.

To view the full program and to register for this event, please visit our Events page.

A recording of Matters of the heart: Myocarditis and pericarditis associated with COVID-19 mRNA vaccination will be available on our Education Portal following the event.


About MVEC

The Melbourne Vaccine Education Centre (MVEC) is an educational website, developed with the aim of providing up-to-date immunisation information for both healthcare professionals and members of the public. We are based at Murdoch Children’s Research Institute (MCRI), a research organisation, and are affiliated with SAEFVIC (Surveillance of Adverse Events Following Vaccination in the Community), the Victorian Vaccine Safety Service.