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COVID-19 vaccine: Provisional registrations

26 March 2021

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
25 January 2021 Pfizer Australia Pty Ltd COMIRNATY - BNT162b2 [mRNA] mRNA
15 February 2021 AstraZeneca Pty Ltd COVID-19 Vaccine AstraZeneca Viral vector

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.

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.