Health regulatory agency approves vaccine for use in Australia

Australia’s Therapeutic Goods Administration (TGA) – the nation’s health regulatory agency – has provisionally approved the Oxford/AstraZeneca Covid-19 vaccine for use in Australia.

It has been provisionally approved in Australia for people 18 years and older and two doses will be required.

This registration means the AstraZeneca vaccine has met the TGA’s rigorous standards for safety, quality and efficacy.

The first priority groups can thus start receiving the vaccine, which began arriving in the country this week, in early March. The vaccine is being provided free to all Australian residents.

First batch of 142,000 doses arrived at Sydney airport

An initial batch of 142,000 doses arrived in Sydney from Europe at midday on Monday.

“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,” the Department of Health said in a statement released yesterday (Tuesday).

“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.”

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

Vaccine to be distributed through multiple locations

According to the department and the National Rollout Strategy, the vaccine will be distributed through multiple locations – including general practice clinics, GP respiratory clinics, vaccination clinics and pharmacies – 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.

Rolling out the Pfizer vaccine across the country has been described as the largest logistical challenge to face Australia since World War II. Around two million doses are scheduled to arrive before the end of March.