The Therapeutic Goods Administration has approved the AstraZeneca vaccine for use in Australia.
The regulator has approved the jab for people aged 18 and over but says the decision to immunise those aged over 65 should be made on a case-by-case basis.
It says there are no safety concerns for people aged over 65 but there is not enough data to determine the efficacy for people in that age group.
"Australians can be confident that the TGA's review process of this vaccine was rigorous and of the highest standard," the TGA said in a statement on Tuesday.
"The decision to provisionally approve the vaccine was also informed by expert advice."
Initial supplies of the AstraZeneca vaccine will be imported into Australia from overseas before doses are manufactured locally.
The provisional approval is valid for two years and means the vaccine can now be legally supplied in Australia.
The first jabs of the Pfizer vaccine will be administered from Monday after a shipment of 142,000 doses landed in Australia.
Prime Minister Scott Morrison said Australia was one of the few countries which could produce its own coronavirus vaccine.
"It means that Australia now has two safe and effective COVID-19 vaccines available," he told reporters in Canberra.
Most opinion polls show about four in five Australians are willing to be vaccinated but there remains lingering trepidation about the vaccines among pockets of people.
Mr Morrison called for all Australians to listen to official medical advice.
"We have the best medical experts in the world. They are the ones who are making decisions about what is safe to take and whether it will be effective," he said.
"The same experts that you've trusted with your own children are the same people that you can trust when it comes to this vaccine."
Mr Morrison said he was entrusting experts with the health and safety of his family, including his mother and mother-in-law.
Hotel quarantine remains the subject of national debate after two billionaire businessmen offered to run regional isolation centres in Victoria and Queensland.
Lindsay Fox, who owns Avalon Airport near Geelong, is negotiating with the federal and state government over plans to house 1000 international arrivals.
Victorian Premier Daniel Andrews is looking at building a quarantine facility either at Avalon or Tullamarine Airport.
John Wagner wants to develop a purpose-built quarantine facility at Toowoomba's Wellcamp Airport.
The proposals are in response to hotel quarantine breaches triggering snap lockdowns in Melbourne, Brisbane, Perth and Adelaide.
Deputy Labor leader Richard Marles, who includes Avalon in his electorate, believes the idea is worth considering.
"There's a lot of land there, it is isolated, there would be the ability for people to come directly off a plane and go into a facility," he told reporters.
He said quarantine was a federal responsibility, which the Morrison government needed to grab control of.
"The extent to which the federal government has sought to duck-shove this and put it in the purview of the states beggars belief," Mr Marles said.
Victoria recorded two cases of local transmission on Tuesday, the fourth day of a five-day lockdown.
Australian Associated Press
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