The Therapeutic Goods Administration (TGA) has granted provisional determination to Biocelect Pty Ltd (on behalf of Novavax Inc.) for their COVID-19 vaccine candidate.
Granting provisional determination means that Biocelect (on behalf of Novavax) is now eligible to apply for provisional registration. Following the provisional pathway provides a formal and transparent mechanism for speeding up the registration of promising new medicines with preliminary clinical data.
Provisional determination is only granted once the TGA has considered all eligibility criteria, including evidence of a plan to submit comprehensive clinical data.
You can read the press release from the TGA below:
TGA grants additional provisional determination for a COVID-19 vaccine
For more information on the process of COVID-19 vaccine provisional approval please refer to our reference page:
MVEC: Provisional registration of COVID-19 vaccine(s) in Australia