The Therapeutic Goods Administration (TGA) has confirmed that the COVID-19 Pfizer vaccine has been provisionally approved for rollout in Australia.
The Pfizer coronavirus vaccine has been provisionally approved for use in Australia with the first jabs set for late February.
This makes Pfizer the first vaccine to receive regulatory approval in Australia and the news comes exactly one year after the first case of COVID-19 was detected in Australia.
The Therapeutic Goods Administration has ticked off on the vaccine after it met strict standards around safety, quality, and efficacy.
Prime Minister Scott Morrison said the approval was an important step in the fight against coronavirus.
“Australians should take confidence in the thorough and careful approach taken by our world-class safety regulator,” he said on Monday.
“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.”
Prime Minister Scott Morrison
The TGA provisional approval is for people aged 16 and older and the vaccine requires two doses at least 21 days apart.
The rollout will begin as soon as it arrives in Australia and will be given to 30 to 50 hospital sites covering aged care and disability residents and workers, frontline healthcare workers, as well as quarantine and border workers.
It will then expand to 1000 vaccine administration sites as the five-phase rollout widens across the population.
TGA boss John Skerritt said the regulator’s job was far from finished.
“The monitoring of vaccine safety post-approval is an important part of the regulatory review of vaccines,” he said.
“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.”
TGA boss John Skerritt
Regulatory review for the AstraZeneca and Novavax vaccines is ongoing. However, the AstraZeneca vaccine is estimated to be available for Australians from late March.
The Prime Minister recently stated that the government has a “target” of having four million people vaccinated by the end of March.
Once these vaccinations are rolled out globally, travel should, theoretically, restart safely and efficiently.
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