COVID-19 vaccines regulatory status

TGA evaluates COVID-19 vaccines before they're approved for use in Australia.

Provisionally approved vaccines and those granted full registration have undergone a thorough and independent review by the TGA. They meet high safety, efficacy and quality standards required for use in Australia.

Provisional registration pathway and transition to full registration

To make the provisional pathway work, the TGA has agreed to accept rolling data for COVID-19 vaccines.

It's only after all the safety, efficacy, and quality data are in that the TGA will make a provisional registration decision.

With rolling submissions, collaboration with international regulators, and proactively working with sponsors, it is expected the evaluation of COVID-19 vaccines will be significantly expedited without compromising on our strict standards of safety, quality and efficacy. 

Each vaccine will be evaluated when sponsors provide the complete data package.

Vaccine sponsors can switch from provisional to full registration when they have more clinical data.

Labels for COVID-19 vaccines

As part of the initial global rollout, international labels are used.

There may be some information missing or modified on the international label. This might be information not relevant to the Australian label.

Batch release assessment of COVID-19 vaccines

Every batch of vaccine supplied in Australia gets an independent quality assessment. COVID-19 vaccines have a priority release schedule. See Batch release assessment of COVID-19 vaccines.

Post-approval changes

Vaccine sponsors can request changes to registration details after initial registration. Sponsors will need additional assessment and approval.