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.
Dr Murphy added while the vaccine was approved people aged 16 and above, “a very careful clinical decision” will need to be made about whether it will be given to those who are old and frail.
“The risks versus the benefits of the vaccination need to be considered,” he said.
Norway reported some deaths among very old recipients of the vaccine last week.
The vaccine was designed to reduce the negative health impacts of COVID-19, but Dr Murphy warned that it was not clear yet whether the vaccine would reduce transmission rates.
“We don’t yet know how effective they are at preventing the transmission of the virus,” he said, though noted it “stands to reason” that vaccines will also reduce the spread.
COVID-19 vaccine not mandatory
The Government wants to start rolling out the vaccine in February, prioritising groups such as quarantine and healthcare workers and Australians in aged care homes.
The vaccine will not be mandatory, even for staff in aged care homes.
Mr Hunt said the TGA “placed safety above all else”.
“The TGA’s processes are, I believe, the best in the world, and we have ensured that they are thorough,” he said.
“This approval and the upcoming rollout of the vaccine will play an important part in our ability to manage the pandemic in 2021.”
The TGA says it will continue to monitor the safety of the Pfizer vaccine in Australia and overseas, and “will not hesitate to take action if safety concerns are identified”.
Australia has purchased 10 million doses of the vaccine.