You are here
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.
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.