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COVID-19 vaccine: Provisional registrations
8 June 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 |
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.
- CMI for Pfizer COMIRNATY COVID-19 vaccine (click the "I accept" button)
- CMI for AstraZeneca COVID-19 vaccine
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.