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COVID-19 vaccine: Provisional registrations

15 August 2022

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.

Effective date Sponsor Name Type

a. 19 January 2022

b. 9 June 2022

c. 22 July 2022

Biocelect Pty Ltd on behalf of Novavax Inc

NUVAXOVID (NVX-CoV2373)

a. For individuals aged 18 years and over

b. Booster dose for individuals aged 18 years and over

c. For individuals aged 12 years and over

Protein vaccine

a. 9 August 2021

b. 3 September 2021

c. 7 December 2021

d. 17 February 2022

e. 19 July 2022

Moderna Australia Pty Ltd

SPIKEVAX (elasomeran)

a. For individuals aged 18 years and over

b. For individuals aged 12 years and over

c. Booster dose for individuals aged 18 years and over

d. For individuals aged 6 years and over

e. For individuals aged 6 months and over

mRNA
25 June 2021 Janssen-Cilag Pty Ltd

COVID-19 Vaccine Janssen

For individuals aged 18 years and over

Viral vector

a. 15 February 2021

b. 8 February 2022

AstraZeneca Pty Ltd

VAXZEVRIA (previously COVID-19 Vaccine AstraZeneca)

a. For individuals aged 18 years and over

b. Booster dose for individuals aged 18 years and over

Viral vector

a. 25 January 2021

b. 22 July 2021

c. 26 October 2021

d. 3 December 2021

e. 27 January 2022

f. 7 April 2022

Pfizer Australia Pty Ltd

COMIRNATY (tozinameran)

a. For individuals aged 16 years and over

b. For individuals aged 12 years and over

c. Booster dose for individuals aged 18 years and over

d. For individuals aged 5 years and over

e. Booster dose for individuals aged 16-17 years old

f. Booster dose for individuals aged 12-15 years old

mRNA

Consumer Medicine Information (CMI) for COVID-19 vaccines

The CMI for each vaccine is published and updated by the Australian sponsor. The CMI provides important information such as what you should know before you're given the vaccine, including if you are taking other medicines, potential side effects, and a list of both active and inactive ingredients.

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.

Labels for COVID-19 vaccines

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.