The nation’s medical regulator the Therapeutic Goods Administration has approved Pfizer’s COVID-19 vaccine for use in Australia.
The decision paves the way for the rollout, scheduled to start in late February, despite global supply issues faced by vaccination producers.
Prime Minister Scott Morrison said these problems were already having an impact on Australian supply, though the program was still on track to launch within the stated goal of mid-to-late February.
“We’re more looking at late February than mid-February now because of the challenges we have seen in the production and delivery for both AZ [AstraZeneca] and Pfizer around the world,” he said.
The TGA said following a thorough and independent review of Pfizer’s submission, it was decided the vaccine met the high safety, efficacy and quality standards required.
It is the first COVID-19 jab to be approved for use in Australia.
The approval is on a provisional basis, meaning it is valid for two years.
It allows the vaccine to be supplied in Australia for people aged 16 and older. Two doses will be required at least 21 days apart.
Mr Morrison welcomed the decision.
“Australians should take confidence in the thorough and careful approach taken by our world-class safety regulator,” he said.
“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.”
Health Minister Greg Hunt said the rollout would start with 80,000 jabs per week, “if not more”.
The Government was expecting to be briefed by Pfizer on supply beyond March in mid-February.
Health Department Secretary Brendan Murphy said Australia faced “major logistics issues” vaccinating the entire Australian population.
The Pfizer vaccine needs to be stored at minus-70 degrees Celsius.