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COVID-19 vaccines undergoing evaluation

25 November 2021

Before any COVID-19 vaccine is approved for use in Australia, it will be subject to the well-established and rigorous assessment and approval processes of the Therapeutic Goods Administration (TGA), part of the Department of Health.

The TGA has received applications and is assessing preliminary data for the following COVID-19 vaccines using the provisional pathway and rolling review procedures.

Sponsor Name Type Further information Regulatory status
Moderna Australia Pty Ltd SPIKEVAX (elasomeran) mRNA Provisional Determination Notice
  1. Provisionally approved on 9 August 2021 for adults aged 18 years and over.
  2. Provisionally approved on 3 September 2021 for individuals aged 12-17 years.
  3. Booster dose under evaluation.
  4. Application for use in individuals <12 years of age under evaluation.
Biocelect Pty Ltd on behalf of Novavax Inc NVX-CoV2373 Protein vaccine Provisional determination notice Under evaluation
Janssen-Cilag Pty Ltd COVID-19 Vaccine Janssen Viral vector Provisional determination notice

Provisionally approved on 25 June 2021 for individuals aged 18 years and over.

Pfizer Australia Pty Ltd COMIRNATY - BNT162b2 [mRNA] mRNA Provisional determination notice
  1. Provisionally approved on 25 January 2021 for individuals aged 16 years and over.
  2. Provisionally approved on 22 July 2021 for individuals aged 12-15 years and over.
  3. Booster dose provisionally approved on 26 October 2021 for individuals aged 18 years and over.
  4. Under evaluation for individuals aged 5-11 years.
AstraZeneca Pty Ltd VAXZEVRIA (previously COVID-19 Vaccine AstraZeneca) Viral vector Provisional determination notice
  1. Provisionally approved on 15 February 2021 for individuals aged 18 years and over.
  2. Booster dose under evaluation.

All COVID-19 vaccine applications are being treated with the greatest priority as part of the Department of Health's response to the pandemic. Under normal circumstances, TGA's assessment (for both provisional and general 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.

Many of the large-scale clinical trials that will provide evidence of safety and effectiveness are still progressing and these results will be provided to the TGA as they become available. The TGA will also evaluate quality data (such as how the vaccines are manufactured).

The TGA will only be in a position to 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. We have not yet received a full data package from any company.

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

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.