The Pfizer/BioNTech COVID-19 vaccine has been granted provisional approval for use in Australia by the Therapeutic Goods Administration.
The administration said on Monday that after an independent review, the vaccine had met high safety standards.
The vaccine has been approved for people older than 16, with two doses required at least three weeks apart.
The federal government said the first vaccines were expected to be administered in late February.
If there are delays, the vaccine could be rolled out in March, but the government has stressed advice from Pfizer that a February rollout was likely.
A final date has yet to be confirmed due to production delays at the vaccine's European manufacturing plant as it ramps up production on the vaccine.
A priority group of Australians are expected to receive the first doses of the vaccine as soon it arrives in the country.
Group 1A for the vaccine rollout includes quarantine and border workers, frontline healthcare workers, aged-care staff, aged-care residents and disability care staff and residents.
It's estimated up to 1.4 million doses will be required for the first stage of the vaccine rollout.
Prime Minister Scott Morrison said the approval by the administration was a critical step forward.
"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," Mr Morrison 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."
The vaccine rollout will start across up to 50 hospital sites across the country.
The vaccine will be rolled out in five stages in coming months and will have 1000 vaccination sites operational.
Health Minister Greg Hunt welcomed the news of the TGA's approval.
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"Australia's high bar has been met; the vaccine has been approved as effective in stopping severe disease," Mr Hunt said.
"I thank all those involved in the development and assessment of this COVID-19 vaccine, including the researchers, Pfizer, BioNTech and the medical experts at the TGA who have worked around the clock and over Christmas.
"This approval and the upcoming roll out of the vaccine will play an important part in our ability to manage the pandemic in 2021."
The head of the TGA, Adjunct Professor John Skerritt, said work had been non-stop in carrying out tests for the vaccine to meet approval standards.
"We're thrilled to have this product pass the rigorous regulatory process and receive provisional approval," he said.
"Our job is by no means done. In fact the monitoring of vaccine safety post-approval is an important part of the regulatory review of vaccines.
"We now check the individual batches of vaccines that are destined for Australians while closely monitoring the safety and efficacy of the vaccine as it is rolled out."
- With The Canberra Times