Following a thorough and independent review, the TGA has decided that the following vaccines meet the high safety, efficacy and quality standards required for use in Australia. Learn more about the COVID-19 vaccine approval process.
|
Sponsor |
Vaccine Name |
Vaccine Type |
Effective date |
Application |
|
AstraZeneca Pty Ltd |
Viral vector |
a. 15 February 2021 |
For individuals aged 18 years and over |
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|
b. 8 February 2022 |
Booster dose for individuals aged 18 years and over |
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Biocelect Pty Ltd on behalf of Novavax Inc |
|
Protein vaccine |
a. 19 January 2022 |
For individuals aged 18 years and over |
|
b. 9 June 2022 |
Booster dose for individuals aged 18 years and over |
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c. 22 July 2022 |
For individuals aged 12 years and over |
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Janssen-Cilag Pty Ltd |
|
Viral vector |
25 June 2021 |
For individuals aged 18 years and over |
|
Moderna Australia Pty Ltd |
mRNA |
a. 9 August 2021 |
For individuals aged 18 years and over |
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b. 3 September 2021 |
For individuals aged 12 years and over |
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c. 7 December 2021 |
Booster dose for individuals aged 18 years and over |
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d. 17 February 2022 |
For individuals aged 6 years and over |
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e. 19 July 2022 |
For individuals aged 6 months and over |
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f. 19 October 2022 |
Booster dose for individuals aged 12 years and over |
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|
Moderna Australia Pty Ltd |
mRNA |
29 August 2022 |
Booster dose for individuals aged 18 years and over |
|
|
Moderna Australia Pty Ltd |
SPIKEVAX Bivalent Original/Omicron BA.4-5 (elasomeran/davesomeran) |
mRNA |
17 February 2023 |
Booster dose for individuals 12 years of age and older |
|
Pfizer Australia Pty Ltd |
|
mRNA |
a. 25 January 2021 |
For individuals aged 16 years and over |
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b. 22 July 2021 |
For individuals aged 12 years and over |
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c. 26 October 2021 |
Booster dose for individuals aged 18 years and over |
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d. 3 December 2021 |
For individuals aged 5 years and over |
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e. 27 January 2022 |
Booster dose for individuals aged 16-17 years old |
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f. 7 April 2022 |
Booster dose for individuals aged 12-15 years old |
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g. 20 September 2022 |
Booster dose for individuals aged 5-11 years old |
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h. 29 September 2022 |
For individuals aged 6 months and over |
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Pfizer Australia Pty Ltd |
COMIRNATY Original/Omicron BA.1 (tozinameran and riltozinameran) |
mRNA |
27 October 2022 |
Booster dose for individuals aged 18 years and over |
|
Pfizer Australia Pty Ltd |
COMIRNATY BIVALENT Omicron BA.4/BA.5 COVID-19 VACCINE (tozinameran and famtozinameran) |
mRNA |
20 January 2023 |
For individuals aged 12 years and over |
Labels for 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 will 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.