Australia Issued Provisional Determination for Pfizer's COVID-19 Vaccine

Australia’s Therapeutic Goods Administration (ATG) announced on October 14, 2020, Pfizer Australia Pty Ltd. has received provisional 'determination' for its COVID-19 vaccine candidate, BNT162b2. 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 full approval for inclusion in the Australian Register of Therapeutic Goods.