Australia's medical regulator has approved the Pfizer coronavirus vaccine for provisional use, with the first doses set to be rolled out late next month.
The Therapeutic Goods Administration (TGA) said on Monday it had cleared Pfizer's Comirnaty vaccine for Australians over the age of 16 after it met strict standards around safety, quality and efficacy.
"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.
Provisional approval of the vaccine is valid for two years. Two doses are required at least 21 days apart, with aged care and disability residents and workers, frontline healthcare staff as well as quarantine and border workers at the front of the queue.
Prime Minister Scott Morrison said the approval marked a big step forward in Australia's virus response, noting it was provisional under the normal processes of the TGA and not an emergency approval.
Pfizer's COVID-19 vaccine is the first to be approved for use in Australia. Source: AAP
“We are one of the first countries in the handful of countries to have gone through that comprehensive and thorough process here in Australia to ensure the approval of that vaccine,” he told reporters on Monday.
"Australians should take confidence in the thorough and careful approach taken by our world-class safety regulator.
"Our priority has always been to keep Australians safe and to 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 government's vaccine program is now slated to start in late February - instead of the middle of the month due to international shipment or production delays - and end in October.
"We are looking at late February now, rather than mid-February because of the challenges that we have seen in the production and delivery for both AstraZeneca and Pfizer around the world," Mr Morrison said. "You will be aware of the situation and the pressures that we are seeing globally."
Despite this, Health Minister Greg Hunt said the government remains "on track".
About 80,000 doses will be administered each week during the initial phase, though Mr Hunt said that number could be higher.
That rate will then be increased to about one million doses per week once the vaccine can be manufactured in Australia.
“Around August last year, we took the decision that we didn’t want to be in a situation where we were completely reliant on the production of vaccines overseas," Mr Morrison said.
"We took the decision, we put the arrangements in place to ensure we would be able to produce our own vaccine here in Australia and that is happening now."
He said the federal government had "paid a premium" and was involved in the development of vaccine production in Melbourne.
Opposition leader Anthony Albanese on Monday questioned whether the federal government is on track to meet its commitment of vaccinating four million people by the end of March.
“We will be holding [Prime Minister Scott Morrison] to account on that, because it appears that that is going the way of the commitment that all Australians who were stranded overseas would be home by Christmas,” he said.
“If the Morrison government had secured the Pfizer deal before other countries had secured one billion doses of their own, maybe the government would have more than one in five Australians being looked after by this vaccine.”
Health Secretary Brendan Murphy said authorities had been closely monitoring the situation in Norway,
"The TGA advice - and we have been concerned about this - for the very elderly and frail will need a very careful clinical decision," he said.
A World Health Organization expert panel found no evidence the vaccine had contributed to the deaths.
TGA boss John Skerritt said the regulator would continue to monitor and review the safety of the vaccine.
"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," he said.
Meanwhile, regulatory review for the AstraZeneca and Novavax vaccines is ongoing.
Monday marks , 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.
Mr Morrison reiterated the vaccine rollout is not a "silver bullet", and that it would not immediately lead to a relaxation of restrictions on international travel, masks and social distancing.
With AAP.
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