The Pfizer/BioNTech COVID-19 vaccine has been provisionally approved by the Therapeutic Goods Administration (TGA) for use in Australia.
In a statement, TGA said the provisional approval was for individuals 16 years of age and older. Two doses would be required, at least 21 days apart.
Head of TGA, John Skerritt (pictured) said the Administration’s staff had been working non-stop to get the Pfizer vaccine assessed, while maintaining the most rigorous standards of safety, quality and efficacy.
“I would like to thank our clinical and medical officers, scientists, pharmacists and experts in statistics, laboratory analysis and manufacturing assessment who have worked tirelessly on assessing this vaccine,” Adjunct Professor Skerritt said.
The latest advice given to the Government from Pfizer is that the first vaccinations are expected to be delivered in late February.
Prime Minister, Scott Morrison said 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,” Mr Morrison said.
“Australians should take confidence in the thorough and careful approach taken by our world-class safety regulator.”
Minister for Health, Greg Hunt said TGA had been working tirelessly to introduce a safe and effective COVID-19 vaccine in Australia.
“The TGA’s processes are, I believe, the best in the world and we have ensured that they are thorough.” Mr Hunt said.
“Australia’s high bar has been met; the vaccine has been approved as effective in stopping severe disease.”
He said the approval and the upcoming roll out of the vaccine would play an important part in Australia’s ability to manage the pandemic in 2021.
“Australia’s vaccination program has been based on the medical advice from the medical expert panel led by Professor Brendan Murphy. As a result we are in the fortunate position of having secured 140 million doses of vaccine, one of the highest per capita rates in the world,” Mr Hunt said.
He said people who needed protection the most would get the vaccine first.
This included aged care and disability care residents and workers, front-line health care workers and quarantine and border workers.
“The priority groups have been determined based on the advice of the Australian Technical Advisory Group on Immunisation which oversees Australia’s highly successful immunisation program,” Mr Hunt said.
Further information about the COVID-19 Vaccine National Roll Out Strategy can be found on the Department of Health website at this PS News link.
