TGA grants provisional determination for COVID-19 vaccine

Australia’s Therapeutic Goods Administration (TGA), part of the Department of Health, has granted a provisional determination for UK drug major to AstraZeneca (LSE: AZN) in relation to its COVID-19 vaccine, ChAd0x1-S [recombinant]/AZD1222.

Granting of a provisional determination means that the TGA has made a decision that AstraZeneca is now eligible to apply for provisional registration for the vaccine in the Australian Register of Therapeutic Goods (ARTG). AstraZeneca is deveoping the vaccine in cooperation with Oxford University.

Provisional determination is the first step in the process and does not mean that an application has or will be made, or that the vaccine will be provisionally approved for inclusion in the ARTG.