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TGA grants provisional determination to Vaxine Pty Ltd for its COVID-19 recombinant protein vaccine

20 December 2021

The Therapeutic Goods Administration (TGA), part of the Department of Health, has granted provisional determination to Vaxine Pty Ltd in relation to its COVID-19 vaccine: Recombinant CoV-2-S-ΔTM protein with Advax-CpG55.2 (active ingredient name and tradename to be confirmed).

This recombinant (genetically engineered) protein vaccine will be considered for active immunisation to prevent COVID-19 caused by SARS-CoV-2. If approved, a complete course of the Recombinant CoV-2-S-ΔTM protein with Advax-CpG55.2 vaccine is potentially two doses given as an intramuscular injection 3 weeks apart.

Protein vaccines use a non-infectious component of the coronavirus. This protein is found on the surface of the virus and is manufactured in a laboratory, in the case of this product using insect cells. When the vaccine enters the body, immune cells recognise the vaccine protein as foreign and launch an immune response against it.

The granting of a provisional determination means that the TGA has made a decision that Vaxine Pty Ltd is now eligible to apply for provisional registration for the vaccine in the Australian Register of Therapeutic Goods (ARTG).

Provisional determination is the first step in the provisional registration process. Importantly, registration and supply in Australia will only commence should the vaccine be approved as safe and effective by the TGA.

In making its decision to grant Vaxine Pty Ltd a provisional determination, the TGA considered all eligibility criteria, including factors such as the evidence of a plan to submit comprehensive clinical data and the seriousness of the current COVID-19 pandemic.