A COVID-19 vaccine developed by pharmaceutical giant Pfizer has been provisionally approved for use in Australia today by the Therapeutic Goods Administration (TGA).
According to the TGA, the vaccine meets the high safety, efficacy and quality standards required for use in Australia.
The approval is for individuals 16 years of age and older, and two doses will be required - at least 21 days apart.
As such, the Australian Government will roll-out the vaccine into the community in stages - however, according to Prime Minister Scott Morrison, the timeline has been slightly delayed.
Because of manufacturing and production challenges the roll-out will commence in late-February, rather than mid-month as previously advised.
If there are delays in shipping or production, the possibility remains that commencement could be in early March, however guidance remains for late-February.
Nevertheless, the Government hopes to vaccine around 80,000 people per month.
The vaccine was approved through the regular channels, and not on an emergency basis as done in countries like the UK and the US where COVID-19 is still running rampant through communities.
However, it has received "provisional" approval by the TGA, meaning it is valid for two years and subject to strict conditions such as the requirement that Pfizer continue to provide information to the approvals body on longer term efficacy and safety from ongoing trials and post-market assessment.
"Australians can be confident that the TGA's review process of this vaccine was rigorous and of the highest standard," the TGA said.
"The TGA will continue to actively monitor the safety of the Pfizer vaccine both in Australia and overseas and will not hesitate to take action if safety concerns are identified."
PM Morrison said the TGA approval was an important step in the fight against COVID-19.
"I welcome the TGA's approval of the Pfizer vaccine, with our own Australian experts finding it is safe, effective and of a high standard," the Prime Minister said.
"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 protect lives and livelihoods. Today's approval is another big step forward for our community, particularly in the protection of our most vulnerable people."
News of the vaccine approval comes as Australia goes seven consecutive days of no community transmission of COVID-19.
There are currently no Australians on ventilation or in the ICU because of COVID-19 complications.
However, the situation is not the same overseas, with more than 25 million active cases in the world.
Just yesterday the US confirmed 173,067 new cases of COVID-19 and more than 3,000 deaths.
Meanwhile, 61,121 cases were confirmed in the UK yesterday, and 33,552 in Brazil.
In total there have been more than 99 million people infected with the coronavirus globally and more than 2 million have died.
Updated at 10.02am AEDT on 25 January 2021.
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