TGA gives Pfizer COVID vaccine provisional determination

Regulatory NewsRegulatory News | 14 October 2020 |  By 

Another vaccine against SARS-CoV-2, the virus that causes the novel coronavirus, has received provisional determination from Australia’s Therapeutic Goods Administration (TGA). Pfizer, doing business in Australia as Pfizer Australia Pty Ltd, received the determination on 14 October for its messenger ribonucleic acid (mRNA) COVID-19 vaccine candidate, BNT162b2.
The decision comes after a 9 October decision by TGA to grant provisional determination to AstraZeneca’s recombinant chimpanzee adenovirus vector vaccine ChAdOx1-S. (Related: TGA moves AstraZeneca's vaccine on first step toward approval, Regulatory Focus 9 October 2020)
This first step from Australia’s regulatory authority means that a second vaccine is now set along the path toward approval in Australia; the next step is that Pfizer may now apply for provisional approval.
TGA’s provisional regulatory pathway gives sponsors an accelerated, but still “formal and transparent,” mechanism to speed up registration of medicines and vaccines the agency deems promising, using more preliminary clinical data than would be required for a full approval for inclusion in the Australian Register of Therapeutic Goods (ARTG), explained the agency in announcing the determination for Pfizer's vaccine candidate.
The decision to approve any vaccine through the provisional pathway will involve weighing the sponsor’s plan for submission of a comprehensive suite of clinical data and the gravity of the coronavirus pandemic, as well as other factors, said TGA.


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