Yesterday (1/20), Novavax received provisional determination from Australia’s Therapeutic Goods Administration for its COVID-19 vaccine, marking the first steps in gaining provisional approval. Australia’s provisional approval pathway allows for drug therapies (or vaccines) to enter the Australian market so long as preliminary clinical data is provided. The provisional determination means now that the sponsor may apply for provisional registration with the TGA; if the vaccine moves forward to gain provisional approval, Australian citizens can be expected to receive first doses of the vaccine in the first half of 2021.

Read more here.

More on: