COVID-19 vaccines regulatory status

Before any COVID-19 vaccine is approved for use in Australia, it is subject to the well-established and rigorous evaluation processes of the Therapeutic Goods Administration (TGA), part of the Department of Health and Aged Care. The regulatory status of COVID-19 vaccines in Australia are listed below.

Provisionally approved vaccines and those granted full registration have undergone a thorough and independent review by the TGA and have met the high safety, efficacy and quality standards required for use in Australia. Further information about the provisional registration pathway and transitioning to full registration can be found below.

Provisional registration pathway and transition to full registration

All COVID-19 vaccine applications are treated with the greatest priority as part of the Department of Health and Aged Care's response to the pandemic. Under normal circumstances, the TGA's assessment (for both provisional and full registration) begins once all information to support registration is available. For COVID-19 vaccines, the TGA has agreed to accept rolling data to enable early evaluation of data as it comes to hand using the provisional pathway.

The TGA will only make a provisional registration decision for a vaccine once all required data relating to safety, quality and efficacy has been provided and assessed.

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. However, the timeframe for the evaluation of each vaccine will ultimately depend on when the complete data package is provided by sponsors.

Sponsors may apply to transition a provisional registration to full registration when there is more clinical data to confirm the safety of the vaccine.

Further information on the TGA's evaluation process for vaccines is available at COVID-19 vaccine approval process.

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 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.

Emergency use of vaccines in other countries

The TGA is aware that other countries may consider exercising emergency use provisions that allow access to unapproved vaccines prior to formal regulatory approval based on assessment of early safety and efficacy data. Exercising these provisions is a matter for those countries, taking into account the risks versus benefits in the context of the prevailing domestic pandemic situation.