THE Therapeutic Goods Administration (TGA) has granted a provisional determination to Biocelect Pty Ltd on behalf of Novavax Inc, for the COVID-19 vaccine, NVX-CoV2373.
The move means the vaccine is now eligible to apply for provisional registration for inclusion on the Australian Register of Therapeutic Goods.
Similar determinations have been issued in relation to the AstraZeneca/Oxford (PD 12 Oct 2020), Pfizer/BioNTech and Janssen Cilag (PD 19 Nov 2020) vaccine.
The TGA said in making the decision to grant the provisional determination, it had 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.
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