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COVID-19 vaccines regulatory status
Before any COVID-19 vaccine is approved for use in Australia, it is subject to the well-established and rigorous evaluation processes of the Therapeutic Goods Administration (TGA), part of the Department of Health and Aged Care. The regulatory status of COVID-19 vaccines in Australia are listed below.
Provisionally approved vaccines and those granted full registration have undergone a thorough and independent review by the TGA and have met the high safety, efficacy and quality standards required for use in Australia. Further information about the provisional registration pathway and transitioning to full registration can be found below.
Sponsor | Vaccine Name | Vaccine Type | Application | Provisional status | Full registration |
---|---|---|---|---|---|
AstraZeneca Pty Ltd | VAXZEVRIA (ChAdOx1-S [recombinant]) (previously COVID-19 Vaccine AstraZeneca) | Viral vector | a. Vaccination for individuals aged 18 years and over | Product voluntarily cancelled by the sponsor on 23 April 2024 | |
b. Booster dose for individuals aged 18 years and over | Product voluntarily cancelled by the sponsor on 23 April 2024 | ||||
Biocelect Pty Ltd on behalf of Novavax Inc | NUVAXOVID (SARS-CoV-2 rS vaccine with Matrix-M1 adjuvant) | Protein vaccine | a. Vaccination for individuals aged 18 years and over | Provisionally approved 19 January 2022 | Full registration granted 26 October 2023 |
b. Booster dose for individuals aged 18 years and over | Provisionally approved 9 June 2022 | Full registration granted 26 October 2023 | |||
c. Vaccination for individuals aged 12-17 years | Provisionally approved 22 July 2022 | Full registration granted 26 October 2023 | |||
d. Booster dose for individuals aged 12-17 years | Full registration granted 31 January 2024 | ||||
Biocelect Pty Ltd on behalf of Novavax Inc | NUVAXOVID XBB.1.5 COVID-19 Vaccine | Protein vaccine | Vaccination for individuals aged 12 years and older | Application for full registration withdrawn by sponsor 21 May 2024. This is a decision of the sponsor. Questions about this withdrawal should be directed to the sponsor. | |
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| Protein subunit | Vaccination for adults aged 18 years and older | Application for provisional registration withdrawn 25 July 2023 | |
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 | |
Janssen-Cilag Pty Ltd | COVID-19 Vaccine Janssen (Ad26.COV2.S) | Viral vector | Vaccination for individuals aged 18 years and over | Product voluntarily cancelled by the sponsor on 28 August 2023 | |
Moderna Australia Pty Ltd | SPIKEVAX (elasomeran) | mRNA | a. Vaccination for adults aged 18 years and over | Provisionally approved 9 August 2021 | Full registration granted 21 April 2023 |
b. Vaccination for individuals aged 12-17 years | Provisionally approved 3 September 2021 | Full registration granted 21 April 2023 | |||
c. Booster dose for individuals aged 18 years and over | Provisionally approved 7 December 2021 | Full registration granted 21 April 2023 | |||
d. Vaccination for individuals aged 6-11 years | Provisionally approved 17 February 2022 | Full registration granted 21 April 2023 | |||
e. Booster dose for individuals aged 12 years and over | Provisionally approved 19 October 2022 | Full registration granted 21 April 2023 | |||
f. Vaccination for individuals aged 6 months to less than 6 years | Provisionally approved 19 July 2022 | Application to transition to full registration under evaluation. | |||
Moderna Australia Pty Ltd | 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 | Not applicable. Provisional registration lapsed 30 August 2024. |
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 17 February 2023 | Full registration granted 14 August 2023 |
Moderna Australia Pty Ltd | SPIKEVAX XBB.1.5 (andusomeran) | mRNA | For individuals aged 6 years and older | Full registration granted 06 October 2023 for individuals 12 years and older. | |
Moderna Australia Pty Ltd | SPIKEVAX JN.1 (SARS-CoV-2 JN.1 mRNA) | mRNA | For individuals aged 12 years and older | NA | Application for full registration under evaluation. |
Pfizer Australia Pty Ltd | COMIRNATY - (tozinameran) | mRNA | a. Vaccination for individuals aged 16 years and over | Provisionally approved 25 January 2021 | Full registration granted 13 July 2023 |
b. Booster dose for individuals aged 12-15 years | Provisionally approved 22 July 2021 | Full registration granted 13 July 2023 | |||
c. Booster dose for individuals aged 18 years and over | Provisionally approved 26 October 2021 | Full registration granted 13 July 2023 | |||
d. Vaccination for individuals aged 5-11 years | Provisionally approved 3 December 2021 | Full registration granted 13 July 2023 | |||
e. Booster dose for individuals aged 16-17 years | Provisionally approved 27 January 2022 | Full registration granted 13 July 2023 | |||
f. Booster dose for individuals aged 12-15 years | Provisionally approved 7 April 2022 | Full registration granted 13 July 2023 | |||
g. Booster dose for individuals aged 5-11 years | Provisionally approved 20 September 2022 | Full registration granted 13 July 2023 | |||
h. Vaccination for individuals aged 6 months to less than 5 years | Provisionally approved 29 September 2022 | Full registration granted 13 July 2023 | |||
Pfizer Australia Pty Ltd | COMIRNATY Original/Omicron BA.1 (tozinameran and riltozinameran) | mRNA | Booster dose for individuals aged 18 years and over | Provisionally approved 27 October 2022 | |
Pfizer Australia Pty Ltd | COMIRNATY OMICRON XBB.1.5 (raxtozinameran) | mRNA | For individuals aged 6 months and older | a. Full registration granted 06 October 2023 for individuals 5 years and older. b. Full registration granted 21 December 2023 for individuals 6 months to less than 5 years. | |
Pfizer Australia Pty Ltd | COMIRNATY ORIGINAL/OMICRON BA.4-5 (tozinameran/famtozinameran) | mRNA | a. Primary Vaccination series and booster dose for individuals 12 years of age and older | Provisionally approved 20 January 2023 | |
b. Primary vaccination series and booster dose for individuals aged 5-11 years | Provisionally approved 20 December 2023 | ||||
c. Primary vaccination series and booster dose for individuals aged 6 months to less than 5 years | Provisionally approved 9 May 2024 | ||||
Pfizer Australia Pty Ltd | COMIRNATY JN.1 (bretovameran) | mRNA | For individuals aged 6 months and older | NA | Application for full registration under evaluation. |
Provisional registration pathway and transition to full registration
All COVID-19 vaccine applications are 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 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.
Labels for COVID-19 vaccines
To enable timely distribution of COVID-19 vaccines, international labels will be used during the initial global rollout, including in Australia.
Some information typically present on the Australian label may be absent and/or modified on the international label, as well as additional information present that is not relevant to the Australian context.
Batch release assessment of COVID-19 vaccines
The TGA ensures there is an independent quality assessment of every batch of vaccine supplied in Australia. COVID-19 vaccines have a priority release schedule.
Learn more about the Batch release assessment of COVID-19 vaccines.
Post-approval changes
After the initial registration of a vaccine, the sponsor may request changes to the registration details, which require additional assessment and approval by the TGA.
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.