Australia’s vaccine agreements

Australia has entered into 4 separate agreements for the supply of COVID-19 vaccines, if they are proved to be safe and effective.

Australia has entered into 4 separate agreements for the supply of COVID-19 vaccines, if they are proved to be safe and effective.

The Australian Government has invested $363 million to support research and development, to contribute to the global effort to find successful vaccines and treatments to stop the spread of COVID-19.

The Australian Government has invested more than $3.3 billion through these 4 agreements, which will strengthen Australia's position to access safe and effective vaccines when they become available.

Pfizer/BioNTech

The Pfizer/BioNTech vaccine has been provisionally approved by the Therapeutic Goods Administration (TGA) for individuals 16 years and older.

Read the announcement about the provisional approval of the Pfizer/BioNTech COVID-19 vaccine.

Status

Type

Developer

Likely Doses*

Provisionally approved

 mRNA-based vaccine

Pfizer/BioNTech

2

Testing Process

All vaccines must pass different stages of research trials to prove they are safe and effective. Preclinical results in animal studies announced by Pfizer and BioNTech showed immunisation prevented infection with COVID-19 in the lungs and nose. These findings will be submitted to a research journal for peer review. Preliminary results of the Phase 1 clinical trial, published in the New England Journal of Medicine in October 2020, showed the vaccine generated a strong immune response. Early (Phase 1/2) human clinical trials are being completed in the United States, Germany and Japan. Large-scale human clinical trials (Phase 2/3), involving 44,000 participants, are underway in the United States, Germany, Argentina, Brazil and South Africa. The vaccine is being tested in adults 18-54 years of age, 55-85 years of age and adolescents 12-18 years of age. The Pfizer/BioNTech vaccine is the first COVID-19 vaccine to be tested in adolescents.

Doses for Australia

Before the Pfizer/BioNTech COVID-19 vaccine is approved for use in Australia it must pass the Therapeutic Goods Administration’s (TGA) rigorous assessment and approval processes. This includes assessment of its safety, quality and effectiveness. The TGA is actively monitoring COVID-19 vaccine development that is occurring both in Australia and around the world. In October 2020, the TGA granted a provisional determination to Pfizer for this vaccine candidate. This means that it is now eligible to apply for provisional registration on the Australian Register of Therapeutic Goods. If the Pfizer/BioNTech vaccine is successful:

  • 10 million doses will be available from early 2021
  • these doses will be manufactured offshore
  • Australia will have the option to purchase additional doses where supply is available.

University of Oxford/AstraZeneca

Status

Type

Developer

Likely Doses*

Phase 3 clinical trials

Viral vector vaccine

AstraZeneca

2

  • *Based on early trial results

The University of Oxford vaccine is one of the most progressed vaccines in development globally for Coronavirus (COVID-19). If it is proven to be safe and effective and is approved for use, it will be available in Australia from early 2021, as part of the Australian Government’s COVID-19 Vaccine and Treatment Strategy. In Australia, the vaccine would be manufactured by Australian-headquartered multinational biopharmaceutical company CSL in partnership with the developer, international pharmaceutical company AstraZeneca. The Oxford vaccine is one of nine vaccines supported by the Coalition for Epidemic Preparedness Innovations (CEPI), a global partnership to accelerate vaccine development.

Testing process

All vaccines must pass different stages of research trials to prove they are safe and effective. The CSIRO partnered with the CEPI to test the vaccine in pre-clinical (animal) trials in Australia. The Oxford vaccine has completed combined Phase 1 and 2 clinical trials, where it was tested in a small number of volunteers to show that it is safe. Trial results showed a strong antibody and T-cell response in participants. Larger combined Phase 2 and 3 clinical trials are now underway in the United Kingdom, United States, Brazil and South Africa.

Doses for Australia

Before the Oxford COVID-19 vaccine is approved for use in Australia it must pass the Therapeutic Goods Administration’s (TGA) rigorous assessment and approval processes. This includes assessment of its safety, quality and effectiveness. The TGA is actively monitoring COVID-19 vaccine development that is occurring both in Australia and around the world. In October 2020, the TGA granted a provisional determination to AstraZeneza for this vaccine candidate. This means that it is now eligible to apply for provisional registration on the Australian Register of Therapeutic Goods. If the Oxford vaccine is successful:

  • Australia has secured 53.8 million doses of this vaccine
  • 3.8 million doses will be delivered to Australia in early 2021
  • 50 million doses will be manufactured in Australia in monthly batches. CSL will manufacture these doses on behalf of AstraZeneca.

Novavax

Status  

Type  

Developer  

Likely Doses* 

Phase 3 clinical trials 

 Protein vaccine  

Novavax Inc.

2

Novavax is developing a vaccine for Coronavirus (COVID-19). If the vaccine is proven to be safe and effective and is approved for use, it will be available in Australia as early as the first half of 2021 as part of the Australian Government’s COVID-19 Vaccine and Treatment Strategy. It is expected that 51 million doses will be made available in Australia during 2021, which will supply enough doses to cover Australia’s whole population. Doses for Australia will be manufactured in several locations across Europe. The Novavax vaccine is one of nine vaccines supported by the Coalition for Epidemic Preparedness Innovations, a global partnership to accelerate vaccine development.

Testing process

All vaccines must pass different stages of research trials to prove they are safe and effective. The results of first-in-human (Phase 1) part of the clinical trial, published in the New England Journal of Medicine in September 2020, showed the vaccine generated a strong immune response and had a favourable safety profile in its limited trial participants. Phase 1/2 clinical trials are currently being conducted in Australia and the United States. Large-scale Phase 3 clinical trials are currently underway in the United Kingdom (UK) involving up to 15,000 volunteers. More large-scale clinical trials are planned for other countries in late 2020 and early 2021. The vaccine is being tested in adults 18-84 years of age in different populations, people living with HIV, and those with other chronic conditions.

Doses for Australia

Before the Novavax COVID-19 vaccine is approved for use in Australia, it must pass the Therapeutic Goods Administration’s (TGA) rigorous assessment and approval processes. This includes assessment of its safety, quality and effectiveness. The TGA is actively monitoring COVID-19 vaccine development that is occurring both in Australia and around the world. If the Novavax vaccine is successful it is expected:

  • 51 million doses will be made available in Australia during 2021

COVAX Facility

The Australian Government has joined the COVAX Facility as part of a global effort to support rapid, fair and equitable access to COVID-19 vaccines. This participation enables us to purchase vaccine doses for Australia as they become available. Currently 188 countries around the world have entered into the COVAX Facility. The participation of countries like Australia means the facility can invest in a diverse portfolio of potential COVID-19 vaccines and support vaccine manufacturers. It is aiming to mobilise 2 billion doses for the world by the end of 2021, addressing the acute phase of the pandemic. COVAX is coordinated by Gavi with help from member countries, the Coalition for Epidemic Preparedness Innovations (CEPI), the World Health Organization, and UNICEF.

Australia’s commitments to the COVAX Facility

The Australian Government has made 2 financial commitments to Gavi’s COVAX Facility for the supply of safe and effective COVID-19 vaccines:

  • An upfront payment of $123.2 million to allow the purchase of over 25,000,000 doses of COVID-19 vaccines for the Australian population. This would be sufficient for 50 percent of the population to receive a 2 dose regimen.
  • A further $80 million to support vaccine access for up to 94 lower-income countries through the Facility’s Advanced Market Commitment.

Doses for Australia

Before any vaccines will be made available, they must be approved for use in Australia. This includes the Therapeutic Goods Administration’s (TGA) rigorous assessment and approval processes for safety, quality and effectiveness. The TGA is actively monitoring COVID-19 vaccine development that is occurring both in Australia and around the world.

Potential COVAX Facility vaccines The following 9 vaccine candidates are in various clinical trial stages and, if found successful, will be included in the COVAX Facility.

Developer Type Status
AstraZeneca / University of Oxford Viral vector vaccine Phase 3 clinical trials
Novavax Protein subunit vaccine Phase 3 clinical trials
Moderna mRNA based vaccine Phase 3 clinical trials
CureVac mRNA based vaccine Phase 2 clinical trials
Sanofi / GSK Protein subunit vaccine  Phase 1/2 clinical trials
Inovio DNA based vaccine Ph Phase 1/2 clinical trials
Clover Biopharmaceuticals / GSK / Dynavax Protein subunit vaccine Phase 1 clinical trials
Institut Pasteur / Merck / Themis Viral vector vaccine Phase 1 clinical trials
University of Hong Kong Viral vector vaccine Preclinical

Supporting our region

Access to safe and effective vaccines will play a critical role in the economic recovery of our region from this pandemic. Supporting our regional neighbours to access doses will progress health outcomes, and help open up movement of people and goods. This will enable economic recovery and longer-term resilience of the Pacific and South East Asia.

Other agreements

The Australian Government supported the University of Queensland’s research into a possible COVID-19 vaccine. This vaccine has undergone phase 1 clinical trials, however will not be proceeding to phase 3.

National coronavirus and COVID-19 vaccine helpline

If you need information about COVID-19, COVID-19 vaccines or help with the COVIDSafe app, call the telephone number listed below. This number operates 24 hours a day, 7 days a week.

View contact

Last updated: 
22 February 2021

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