New immunisation reference page: Moderna COVID-19 vaccine

Following the announcement by the Australian Government that 25 million doses (as well as additional variant specific versions) of Moderna's COVID-19 vaccine, Elasomeran, had been secured for the Australian population, this vaccine was last week granted provisional determination by the TGA.

Our new reference page explores the various clinical trials involving Elasomeran, as well as details the immunogenicity, efficacy and safety data available for this vaccine.

To read more follow the link below:

MVEC: Moderna COVID-19 vaccine


MVEC eLearning: Vaccines in Pregnancy

MVEC are excited to launch the next of our eLearning packages. Our eLearning packages are designed to allow immunisation providers to consolidate and evaluate their technical skills. Targeted resources are available to assist with our eLearning and a certificate of completion will be made available upon completion of the corresponding eLearning quiz.

Vaccines in Pregnancy has been designed to provide an overview of vaccines that are recommended in pregnancy, vaccines that are contraindicated in pregnancy and the process to follow if a contraindicated vaccine is inadvertently administered during pregnancy.

You can access Vaccines in Pregnancy via our MVEC Education Portal or via the following link:

MVEC eLearning: Vaccines in Pregnancy


TGA grants provisional determination for the Moderna COVID-19 vaccine, Elasomeran

The Therapeutic Goods Administration (TGA) has granted provisional determination to Moderna Australia Pty Ltd for their COVID-19 vaccine candidate, Elasomeran. It is being considered for use in those aged 12 years or older for active immunisation to prevent COVID-19 disease. It is an mRNA vaccine requiring two doses, given 28 days apart.

Granting provisional determination means that Moderna Australia Pty Ltd is now eligible to apply for provisional registration. Following the provisional pathway provides a formal and transparent mechanism for speeding up the registration of promising new medicines with preliminary clinical data.

Provisional determination is only granted once the TGA has considered all eligibility criteria, including evidence of a plan to submit comprehensive clinical data.

You can read the press release from the TGA below:

TGA grants provisional determination for the Moderna COVID-19 vaccine, Elasomeran

For more information on the process of COVID-19 vaccine provisional approval please refer to our reference page:

MVEC: Provisional registration of COVID-19 vaccine(s) in Australia


The Conversation: What’s Australia’s first local Pfizer-style COVID vaccine? And when might it be in our arms? An mRNA expert explains

A research team at Monash University are working on developing Australia’s first mRNA vaccine candidate, with phase 1 trials set to begin in October or November this year.

Although the vaccine under development works by the same principles as the Pfizer and Moderna vaccines by using a genetic code called RNA to spark the production of the coronavirus’s specific spike protein, there are key notable differences.

Firstly, the Monash mRNA vaccine directs cells to make a small part of the spike protein, the receptor binding domain. The receptor binding domain is the tip of the spike protein which is the part that is mutating to form new variants of COVID disease. Targeting this part of the spike protein allows variant-specific responses, for which there is a strong clinical need.

Secondly, existing vaccines are modelled on the original strain of the virus first detected in Wuhan, however, the Monash mRNA vaccine has since been changed to sequence the Beta strain – a strain which was first detected in South Africa for which vaccines created from the original variant are less effective.

This highlights the flexibility of mRNA vaccines with sequences being able to be changed and adapted to new variants that have emerged and that may emerge in the future.

Plans are underway for the vaccine to be developed locally, an important step in developing Australia’s capacity for mRNA vaccine production and the newly developing Australian RNA biotechnology sector overall.

To read more, follow the link below:
The Conversation: What’s Australia’s first local Pfizer-style COVID vaccine? And when might it be in our arms? An mRNA expert explains


Healthed Going Viral Podcast featuring A/Prof Nigel Crawford

Associate Professor Nigel Crawford is interviewed by Dr David Lim, GP and Medical Educator on Healthed Australia’s Going Viral podcast. In this podcast, Nigel discusses the clinical features of Thrombosis with thrombocytopenia syndrome (TTS) and provides an approach for diagnosing and managing it.

You can listen to the podcast here:

Healthed Australia: Going Viral Podcast Episode 157: AZ Clots – Are you missing it?

 


PHN Webinar: Primary care identification and management of thrombosis with thrombocytopenia syndrome (TTS)

The PHN will be hosting a webinar for GPs on Wednesday 30 June featuring a panel of expert speakers including MVEC’s  A/Prof Nigel Crawford. The topic for the webinar is Primary care identification and management of thrombosis with thrombocytopenia syndrome (TTS) and will cover:

  • pathogenesis
  • latest incidence rates in age groups
  • incidence of different TTS clinical types
  • presentation and identification
  • GP management guidelines.

Further information and details on registration can be found via the link below:

PHN Webinar: Primary care identification and management of thrombosis with thrombocytopenia syndrome (TTS)


RACGP: Government announces new vaccine counselling MBS item number

Federal Health Minister Greg Hunt has announced the introduction of a newly-created MBS item in response to rising vaccine hesitancy related to widespread reporting the rare condition, thrombosis with thrombocytopenia syndrome, following receipt of the COVID-19 AstraZeneca vaccine. The new Medicare item, known as the Level B equivalent, will provide patients over 50 with a $38.75 rebate when receiving COVID vaccine counselling from their GP.

The introduction of this scheme will allow more time for GPs to address patient concerns and provide support in making informed decisions seen as crucial to boosting vaccination rates.

To read more, follow the link below:
RACGP: Government announces new vaccine counselling MBS item number


ATAGI statement on revised recommendations on the use of COVID-19 Vaccine AstraZeneca, 17 June 2021

ATAGI has revised the recommendations for COVID-19 vaccination within Australia.

Due to a higher risk and severity of thrombosis with thrombycytopenia syndrome (TTS) related to the use of COVID-19 AstraZeneca, Comirnaty™ is now the preferred COVID-19 vaccine for individuals aged 16-59 years. Due to the risk of severe outcomes related to COVID-19 disease for individuals aged 60 years and over, the benefits of vaccination in preventing disease outweighs the risk of developing TTS.

Individuals aged less than 60 years who have received their first dose of COVID-19 AstraZeneca without any serious adverse events (eg. anaphylaxis or TTS) should continue to receive their second dose.

For more information please refer to the link below:

ATAGI statement on revised recommendations on the use of COVID-19 Vaccine AstraZeneca, 17 June 2021

 

 


New immunisation reference page: COVID-19 mixed vaccine schedules

With the emergence of variant COVID-19 strains, global vaccine supply issues, and the need to rapidly immunise the population, a number of clinical trials are investigating the option of “mixed schedules”. Mixed schedules have been used previously in other vaccination strategies and involve the administration of different vaccine brands to complete a vaccine course.

Our new reference page explores the clinical trials underway which aim to determine the safety of mixed scheduling, the immunogenicity, as well as the recommendations for intervals between doses.

Due to a lack of available data, mixed vaccine schedules are not currently approved in Australia however are in use in Canada and across Europe.

To read more, follow the link below:

MVEC: COVID-19 mixed vaccine schedules

 


The New York Times: A Multibillion-Dollar Plan to End Polio, and Soon

The Global Polio Eradication Initiative has announced a $5.1 billion plan to eradicate polio globally by 2026. In August 2021, African countries were declared free of wild polio, leaving Afghanistan and Pakistan as the only remaining countries with endemic disease. Due to inadequate funding and a lack of political commitment, there has previously been limited success in trying to achieve a polio-free world. The coronavirus pandemic has added further challenges, bringing some polio vaccination programs to a halt.

The new initiative is set to focus on two key goals: integrating polio vaccination programs with other health care initiatives and focusing on areas with chronically low immunisation rates. The plan also ensures vaccine supply and outlines a communication strategy to increase vaccine acceptance. In addition to this, a new oral vaccine has been introduced and is thought to minimise the risk of vaccine-induced polio.

A key focus of the polio eradication program will be on immunising hard-to-reach communities, and training older female health workers, who are more successful in persuading caregivers to vaccinate their children. In order to reinstate polio eradication as a priority, even with competing health challenges in these cash poor countries, experts believe that programs designed to crush polio can also be used to help manage COVID-19 and other diseases.

To read more, follow the link below:
The New York Times: A Multibillion-Dollar Plan to End Polio, and Soon