The Therapeutic Goods Administration has ticked off on the vaccine after it met strict standards around safety, quality and efficacy.
Two doses at least 21 days apart will be required, with a priority group expected to receive the vaccine as soon as it arrives in Australia.
The Morrison Government is confident that is on track for late February, but has conceded there is a possibility a delay in shipping or production could push it to early March.
Prime Minister Scott Morrison said the approval was an important step in the fight against coronavirus.
“Australians should take confidence in the thorough and careful approach taken by our world-class safety regulator,” he said on Monday.
“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 rollout will begin across 30 to 50 hospital sites covering aged care and disability residents and workers, frontline healthcare workers, as well as quarantine and border workers.
It will then expand to 1000 vaccine administration sites as the five-phase rollout widens across the population.
TGA boss John Skerritt said the regulator’s job was far from finished.
“The monitoring of vaccine safety post-approval is an important part of the regulatory review of vaccines,” he said.
“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.”
Regulatory review for the AstraZeneca and Novavax vaccines is ongoing.
Monday marks one year since the first coronavirus case was diagnosed in Australia, which has since had more than 28,700 cases and 909 deaths.
In stark contrast, there have been 25 million cases in the US alone and in excess of 400,000 deaths.