A Pfizer COVID-19 vaccine has received Governmental approval for nation-wide release in Australia.
Australian regulatory authority The Therapeutic Goods Administration (TGA) has granted provisional approval for COMIRNATY, a COVID-19 vaccine from pharmaceutical giant Pfizer.
The TGA said the green light was handed following a thorough and independent review of Pfizer’s submission.
The vaccine, which has been approved for individuals 16 years of age and older, is currently expected to begin a rollout in late February. There remains, however, the possibility of an early March commencement with production and shipping delays.
The Government said the vaccine, set to be provided for free to all Australian residents, will not be mandatory.
Prime Minister Scott Morrison has welcomed the TGA’s decision, calling it a big step forward in the fight against the pandemic.
“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,” Mr Morrison 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.”
“The TGA has placed safety above all else,” said Minister for Health Greg Hunt.
“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.”
The Government is hoping to have around 80,000 people vaccinated every month. The vaccination includes two doses to be taken 21 days apart.
Mr Hunt said 140 million doses of the vaccine have been secured for Australia – one of the highest quantities per capita in the world.
The rollout will be aimed at 30 – 50 hospital sites and will focus on high-risk individuals, including those in aged care, as well as workers in disability care, frontline health care, quarantine and border.
1,000 vaccination administration sites will be used as the Federal Government rolls out a five-phase plan, stages ranging from immunising those in high-priority groups to those under the age of 16 – “if recommended.”
The provisional approval of a COVID-19 vaccine comes as Australia hits seven days of no locally transmitted cases. There are, at the time of writing, an estimated 135 active cases in the country.
Overseas, the situation remains much more dire. The World Health Organisation reports that there have been over 97 million cases worldwide and 2.1 million deaths.