The Therapeutic Goods Administration has approved the Oxford University-developed AstraZeneca coronavirus vaccine for use in Australia.
Much of Australia's vaccine rollout strategy hinged on the AstraZeneca vaccine being approved, as millions of doses are being manufactured locally in Melbourne by CSL.
It comes after the TGA approved the Pfizer-BioNTech vaccine last month.
In a statement, the TGA said it had approved the AstraZeneca vaccine for people aged over 18 years.
The regulator 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.
Australia has secured 53.8 million doses of the AstraZeneca vaccine.
"The vaccine has met requirements for standards, for safety, quality, and efficacy, and will be provided free to Australians," Prime Minister Scott Morrison said on Tuesday.
"It means that Australia now has two safe and effective COVID-19 vaccines available. Initial supply into Australia will be imported from overseas. And in the coming months, the AstraZeneca vaccine will be manufactured here in Australia," Mr Morrison said.
Health Minister Greg Hunt told reporters he was pleased AstraZeneca has been "cleared for lift-off".
"The AstraZeneca vaccine, on current advice, we hope and expect that it should be able to commence, subject to shipping confirmation, in early March, if not earlier," Mr Hunt said.
The AstraZeneca vaccine will initially be imported, with CSL later ramping up production of the locally-made version of the vaccine to 1 million doses a month.
John Skerritt, the head of the TGA, said the recommendation was for a 12 week gap between the first and second dose.
But he said the vaccine was proven effective with the second jab given in a time frame between four to 12 weeks.
That is in contrast to a three week recommended gap between the first and second jab for the Pfizer vaccine.
With AAP.
People in Australia must stay at least 1.5 metres away from others. Check your jurisdiction's restrictions on gathering limits.
If you are experiencing cold or flu symptoms, stay home and arrange a test by calling your doctor or contact the Coronavirus Health Information Hotline on 1800 020 080. News and information is available in 63 languages at .
Please check the relevant guidelines for your state or territory: , , , , , , , .
