Australia – Novavax COVID vaccine takes first step toward Australian approval

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…