Pfizer and BioNTech's Covid-19 vaccine has been provisionally approved for individuals aged 16 years and above
Pfizer and BioNTech's Covid-19 vaccine will be delivered initially at up to 50 hospital sites across Australia. (Credit: Wilfried Pohnke from Pixabay.)
The Therapeutic Goods Administration (TGA), the regulatory body for therapeutic goods in Australia, has provisionally approved the Covid-19 vaccine of Pfizer and BioNTech for use in Australia.
The vaccine, which met the country’s strict standards for safety, quality and efficacy, has been provisionally approved for individuals aged 16 years and above.
With the approval in place, a priority group in the country will now get their first dose next month. TGA stated that two doses will be required, administered at least 21 days apart.
The approval of the Covid-19 vaccine is subject to stringent conditions, and Pfizer will be required to continue providing information to the regulator on the safety, efficacy and quality of the vaccine.
Prime Minister Scott Morrison said the TGA’s approval was an important step in the fight against Covid-19.
The Prime Minister said: “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.
“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.”
The Pfizer vaccine will be delivered initially at up to 50 hospital sites across Australia, where people who require protection the most will receive the vaccine first.
It will be rolled out in five phases in the coming months and will involve more than 1,000 vaccination administration sites.
The priority groups have been decided based on the suggestions from the Australian Technical Advisory Group on Immunisation (ATAGI).
Australian Minister for Health Greg Hunt said: “Australia’s high bar has been met; the vaccine has been approved as effective in stopping severe disease.
“I thank all those involved in the development and assessment of this Covid-19 vaccine, including the researchers, Pfizer, BioNTech and the medical experts at the TGA who have worked around the clock and over Christmas.
“This approval and the upcoming roll out of the vaccine will play an important part in our ability to manage the pandemic in 2021.”
In December 2020, Pfizer and BioNTech secured Health Canada’s approval for the emergency use of their Covid-19 vaccine.