Australia’s therapeutic goods regulator determined that it met strict standards for safety, quality and efficacy, the federal government said on Monday.
The TGA’s provisional approval is for people aged over 16, and a priority group of Australians would receive their first of two doses of the vaccine once received from the drugmaker, the government added.
Vaccination of priority groups is expected to begin in late February, at 80,000 doses per week.
Two doses will be required – at least 21 days apart, a government statement said. Australia will administer both doses of the vaccine at the recommended time.
“You don’t start what you can’t finish, and finishing the job involves two doses,” said Prime Minister Scott Morrison, adding a digital system would ensure people get two doses.
He cautioned there are limitations to what the vaccines can do and that the rollout would not mean border restrictions would be lifted.
Quarantine and border personnel, frontline health workers, some First Nations Australians, aged care and disability staff and residents will be the first group to receive vaccines.
The vaccine will not be mandatory.
Department of Health Secretary Brendan Murphy praised Australia for finally getting to this “special day”.
“This is a very special day for Australia,” the former Chief Medical Officer said at a press conference on Monday.
“We are in this wonderful position of still having no community transmission and yet we have approved, through our normal, proper processes, the first vaccine.
“We can now get that vaccine shipped to Australia, do the batch testing and start our vaccination program, according to our schedule.”
Is this approval and “emergency” approval?
In the US, the Food and Drug Administration worked rapidly to issue an emergency use authorisation for Pfizer’s COVID-19 vaccine, but the PM said this isn’t the case in Australia.
Both Morrison and Professor Murphy said the TGA’s approval was a “formal” one and not “emergency”.
Where are Indigenous Australians in the queue?
“They have been specifically contemplated,” Health Minister Greg Hunt said.
“Indigenous Australians over 55 years of age will be in phase 1(b) again on medical advice, and Indigenous Australians under 55 years of age but over 16 will be in what is known as phase 2(a).”
Can pregnant women have the vaccine?
While the US and UK have different recommendations about pregnant women taking the vaccine, Professor Murphy said Australia would seek more advice from the ATARGI (Australian Technical Advisory Group on Immunisation) on this matter.
“There is no data on theoretically the risk of this vaccine, Pfizer or AstraZeneca, on pregnancy is probably very low,” he said.
What about the other vaccines?
Australia expects to have the capacity to produce the AstraZeneca vaccine onshore starting late March.
With files from Reuters.