Novavax COVID vaccine takes first step toward Australian approval

Regulatory NewsRegulatory News | 20 January 2021 |  By 

Australia’s Therapeutic Goods Administration (TGA) has given a provisional determination to the COVID-19 vaccine being developed by Novavax. This first step means only that the sponsor can apply for provisional registration with TGA, clearing the path for submission of clinical data that may meet criteria for provisional approval.
The Australian provisional approval pathway allows drugs or vaccines to enter the market with “preliminary clinical data,” without the submission of a comprehensive data package, while still allowing for transparency and a formal review process, wrote the regulator.
“Provisional determination is the first step in the process and does not mean that an application has or will be made, or that the vaccine will be provisionally approved,” noted TGA.
If the vaccine receives provisional approval, Australians may receive the first doses of vaccine during the first half of 2021. The Australian government is anticipating a total of 51 million doses in 2021; full vaccination is expected to entail a two-dose regimen.
The protein vaccine is currently in phase 3 clinical trials, and is one of nine vaccines being developed with partial support from the global Coalition for Epidemic Preparedness Innovations.
Australia also has agreements in place for vaccines developed by Pfizer-BioNTech, the University of Oxford-AstraZeneca, and through the global vaccine alliance’s COVAX Facility. The latter agreement gives potential access to nine vaccine candidates; TGA has already given provisional determination to the Pfizer-BioNTech and AstraZeneca-University of Oxford vaccine candidates as well.


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Tags: coronavirus, TGA

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