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 later 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.”
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.