Before any COVID-19 vaccine is approved for use in Australia, it will be subject to the well-established and rigorous assessment and approval processes of the Therapeutic Goods Administration (TGA), part of the Department of Health.
The TGA has received applications and is assessing data for the following COVID-19 vaccines. Further information about the provisional registration pathway and transitioning to full registration can be found below.
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Sponsor |
Vaccine Name |
Vaccine Type |
Application |
Regulatory status |
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AstraZeneca Pty Ltd |
VAXZEVRIA (ChAdOx1-S [recombinant]) (previously COVID-19 Vaccine AstraZeneca) |
Viral vector |
a. Vaccination for individuals aged 18 years and over. |
Provisionally approved on 15 February 2021 |
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b. Booster dose for individuals aged 18 years and over. |
Provisionally approved on 8 February 2022 |
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Biocelect Pty Ltd on behalf of Novavax Inc |
NUVAXOVID |
Protein vaccine |
a. Vaccination for individuals aged 18 years and over |
Provisionally approved on 19 January 2022 |
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b. Booster dose for individuals aged 18 years and over. |
Provisionally approved on 9 June 2022 |
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c. Vaccination for individuals aged 12-17 years. |
Provisionally approved on 22 July 2022 |
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Grand Pacific CRO Australia (on behalf of Medigen Vaccine Biologics Corp) |
MVC COVID-19 vaccine (MVC-COV1901) |
Protein subunit |
Vaccination for adults aged 18 years and older. |
Under evaluation for provisional registration |
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Graythan Regulatory Services Pty Ltd (on behalf of Vaxxinity Inc.) |
COSMOVAXX (S1-RBD-sFc Th/CTL Peptides) |
Multitope protein-peptide |
Booster dose for individuals aged 16 years and older |
Under evaluation for provisional registration |
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Janssen-Cilag Pty Ltd |
COVID-19 Vaccine Janssen |
Viral vector |
Vaccination for individuals aged 18 years and over. |
Provisionally approved on 25 June 2021 |
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Moderna Australia Pty Ltd |
SPIKEVAX (elasomeran) |
mRNA |
a. Vaccination for adults aged 18 years and over |
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b. Vaccination for individuals aged 12-17 years |
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c. Booster dose for individuals aged 18 years and over |
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d. Vaccination for individuals aged 6-11 years |
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e. Booster dose for individuals aged 12 years and over |
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f. Vaccination for individuals aged 6 months to less than 6 years |
Provisionally approved 19 July 2022 |
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Moderna Australia Pty Ltd |
SPIKEVAX Bivalent Original/Omicron (elasomeran/imelasomeran) (Previously SPIKEVAX Bivalent Zero/Omicron (elasomeran/elasomeran 0- omicron) |
mRNA |
Booster dose for adults aged 18 years and over |
Provisionally approved 29 August 2022 |
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Moderna Australia Pty Ltd |
SPIKEVAX Bivalent Original/Omicron BA.4‑5 (elasomeran/davesomeran) |
mRNA |
Booster dose for individuals 12 years of age and over. |
Provisionally approved on 17 February 2023 |
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Pfizer Australia Pty Ltd |
COMIRNATY - (tozinameran) |
mRNA |
a. Vaccination for individuals aged 16 years and over. |
Provisionally approved on 25 January 2021 |
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b. Booster dose for individuals aged 12-15 years and over. |
Provisionally approved on 22 July 2021 |
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c. Booster dose for individuals aged 18 years and over. |
Provisionally approved on 26 October 2021 |
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d. Vaccination for individuals aged 5-11 years. |
Provisionally approved on 3 December 2021 |
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e. Booster dose for individuals aged 16-17 years. |
Provisionally approved on 27 January 2022 |
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f. Booster dose for individuals aged 12-15 years. |
Provisionally approved on 7 April 2022 |
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g. Booster dose for individuals aged 5-11 years. |
Provisionally approved on 20 September 2022 |
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h. Vaccination for individuals aged 6 months to less than 5 years. |
Provisionally approved on 29 September 2022 |
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Pfizer Australia Pty Ltd |
COMIRNATY Original/Omicron BA.1 (tozinameran and riltozinameran) |
mRNA |
Booster dose for individuals aged 18 years and over under |
Provisionally approved on 27 October 2022 |
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Pfizer Australia Pty Ltd |
COMIRNATY BIVALENT Omicron BA.4/BA.5 COVID-19 VACCINE (tozinameran and famtozinameran) |
mRNA |
Booster dose for individuals 12 years of age and older |
Provisionally approved on 20 January 2023 |
Provisional registration pathway and transition to full registration
All COVID-19 vaccine applications are being treated with the greatest priority as part of the Department of Health and Aged Care's response to the pandemic. Under normal circumstances, the TGA's assessment (for both provisional and full registration) begins once all information to support registration is available. For COVID-19 vaccines, the TGA has agreed to accept rolling data to enable early evaluation of data as it comes to hand using the provisional pathway.
The TGA will only be in a position to make a provisional registration decision for a vaccine once all required data relating to safety, quality and efficacy has been provided and assessed.
With rolling submissions, collaboration with international regulators, and proactively working with sponsors, it is expected the evaluation of COVID-19 vaccines will be significantly expedited without compromising on our strict standards of safety, quality and efficacy. However, the timeframe for the evaluation of each vaccine will ultimately depend on when the complete data package is provided by sponsors.
Sponsors may apply to transition a provisional registration to full registration when there is more clinical data to confirm the safety of the vaccine.
Further information on the TGA's evaluation process for vaccines is available at: COVID-19 vaccine approval process.
Emergency use of vaccines in other countries
The TGA is aware that other countries may consider exercising emergency use provisions that allow access to unapproved vaccines prior to formal regulatory approval based on assessment of early safety and efficacy data. Exercising these provisions is a matter for those countries, taking into account the risks versus benefits in the context of the prevailing domestic pandemic situation.