TGA provisionally approves AstraZeneca COVID-19 vaccine for use in Australia

The Therapeutic Goods Administration (TGA) has provisionally approved the Oxford/AstraZeneca COVID-19 vaccine for use in Australia.

Date published:
Audience:
General public

The Therapeutic Goods Administration (TGA) has provisionally approved the Oxford/AstraZeneca COVID-19 vaccine for use in Australia.

The first priority groups in Australia can start receiving this vaccine in early March.

This registration means the AstraZeneca vaccine has met the TGA’s rigorous standards for safety, quality and efficacy, and will be provided for free to all Australian residents.

It has been provisionally approved in Australia for people 18 years and older.

Two doses will be required.

The TGA, from a regulatory perspective, has reviewed all the available evidence and determined that the AstraZeneca vaccine can be safely administered 4-12 weeks apart.

Drawing on the advice of the TGA and also from the implementation of the program internationally, our Australian Technical Advisory Group on Immunisation has determined that to create the very best immune response, ensure the most effective clinical protection and maximise broader community coverage, the vaccine should be administered 12 weeks apart.

The approval is subject to strict conditions, and AstraZeneca will be required to continue providing information to the TGA on the safety, efficacy and quality of the vaccine.

The AstraZeneca vaccine will be distributed through many more locations, including general practice clinics, GP respiratory clinics, vaccination clinics and pharmacies.

The National Rollout Strategy details how the vaccine will be distributed more widely over the coming months.  

The next steps in the process will include batch testing of all doses, establishing cold storage facilities for the vaccine, training health providers to administer it, and finalising distribution sites.

This Australian Government has several agreements for the supply of COVID-19 vaccines in place.

Read the announcement here

Learn more about the Oxford/AstraZeneca vaccine here.

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