The Pfizer COVID-19 vaccine has been provisionally approved for rollout in Australia, the Therapeutic Goods Administration (TGA) has confirmed.It is the first vaccine to receive regulatory approval in Australia.

The TGA decided that the Pfizer vaccine met the “high safety, efficacy and quality standards required for use in Australia”.

The TGA provisional approval is for people aged 16 and older. Two doses will be required – at least 21 days apart.

The vaccination roll-out is expected to begin in February. (AP)

A priority group of Australians are expected to now receive their first dose of the vaccine as soon as it can be received from Pfizer and the necessary checks are undertaken by the TGA, prior to its distribution.

When will the roll-out start?

The latest advice given to the Government from Pfizer is that shipping and the first vaccinations are expected to be in late February.

Prime Minister Scott Morrison said approval of the Pfizer vaccine this morning comes exactly one year after the first case of COVID-19 was detected in Australia.

“It is a year today since the first case of COVID-19 in Australia. What an extraordinary year it has been over these past 12 months,” Mr Morrison told reporters. 

“A year on from that fateful day, Australia, we know, has done better and managed this together, working together better than almost any other country in the world today.”

In a statement earlier, Mr Morrison said the TGA approval was an important step in the fight against COVID-19.

“I welcome the TGA’s approval of the Pfizer vaccine, with our own Australian experts finding it is safe, effective and of a high standard,” the Prime Minister said.

“Australians should take confidence in the thorough and careful approach taken by our world-class safety regulator.

“Our priority has always been to keep Australians safe and protect lives and livelihoods.  Today’s approval is another big step forward for our community, particularly in the protection of our most vulnerable people.”

Health Minister Greg Hunt has said Australia’s vaccine roll-out strategy is “on track” to be complete by October 2021. 

“This approval by the TGA is one of the earliest in the world for a full approval,” Mr Hunt said.  

“We know that the European Medicines Agency and the Swiss have already made such an approval but Australia is amongst the earliest.” 

How will the roll-out work?

Mr Hunt revealed further specifics of Australia’s roll-out plan, which will also include the AstraZeneca vaccine, expected to be available from late March.

From late February, 80,000 doses of the Pfizer vaccine will be available per week.

By late March, one million doses of the AstraZeneca will be available per week.

A nurse prepares a dose of Pfizer-BioNTech vaccine against the new coronavirus to be injected at the Andras Josa Teaching Hospital in Nyiregyhaza, Hungary, Sunday, Jan. 24, 2021. (Attila Balazs/MTI via AP) (AP)

Mr Hunt said Australia had secured 140 million doses of the vaccine, one of the highest per capita rates in the world.

In Australia the vaccine will be rolled out in five phases at more than 1000 vaccination administration sites.


People who need protection the most will get the vaccine first. This includes aged care and disability care residents and workers, frontline health care workers, and quarantine and border workers.

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