COVID-19 Vaccine AstraZeneca receives provisional approval for use in Australia

COVID-19 Vaccine AstraZeneca has been granted provisional approval in Australia by the Therapeutic Goods Administration (TGA) for active immunisation of individuals ≥18 years old for the prevention COVID-19.

This approval marks an important milestone in AstraZeneca’s worldwide efforts against COVID-19, and its commitment to provide broad and equitable access globally, at no profit during the pandemic.

Liz Chatwin, Country President AstraZeneca Australia & New Zealand, said: “Today is a momentous day that brings months of hard work and collaboration between government, AstraZeneca and scientific experts on vaccination to fruition for the people of Australia.

“We are very proud that, through our partnership with University of Oxford, AstraZeneca is able to provide broad and equitable access to its COVID-19 vaccine at no profit during the pandemic, and that through the agreements made with the Australian Government and manufacturing partner CSL, we can make this vaccine available for use in Australia throughout the year.”

AstraZeneca has an agreement with the Australian Government  to supply millions of doses of the vaccine, with the bulk of this manufactured at CSL’s Melbourne facilities. Doses will be available for administration in Australia as swiftly as possible, in line with the government’s strategy.

The approval decision was based on a submission which included results of an interim analysis of the Phase III programme conducted by the University of Oxford and published in The Lancet on 8 December 2020. The vaccine is approved as a regimen of two standard doses given between four and 12 weeks apart, which was shown in the clinical trials to be well tolerated and effective at preventing symptomatic COVID-19, with no severe cases,  hospitalisations or deaths more than 14 days after the second dose.

The vaccine can be stored, transported and handled at normal refrigerated conditions (two -eight degrees Celsius) for up to six months.

Veeva ID: Z4-30880
Date of Preparation: February 2021