The Therapeutic Goods Administration has provisionally approved the Pfizer/BioNTech COVID-19 vaccine for use in Australia
“Following a thorough and independent review of Pfizer’s submission, the TGA has decided that this vaccine meets the high safety, efficacy and quality standards required for use in Australia,” the TGA said in a statement Monday.
“COMIRNATY is provisionally approved and included in the Australian Register of Therapeutic Goods (ARTG) for active immunisation to prevent coronavirus disease 2019 (COVID-19), caused by SARS-CoV-2, in individuals 16 years of age and older.
“Provisional approval of this vaccine is valid for two years and means it can now be legally supplied in Australia.
“The approval is subject to certain strict conditions, such as the requirement for Pfizer to continue providing information to the TGA on longer term efficacy and safety from ongoing clinical trials and post-market assessment.
“COMIRNATY has been shown to prevent COVID-19 however it is not yet known whether it prevents transmission or asymptomatic disease.”
Two doses will be required – at least 21 days apart.
A priority group of Australians are expected to now receive their first dose of the vaccine as soon as it can be received from Pfizer and the necessary checks are undertaken by the TGA, prior to its distribution, the Federal Government said.
The latest advice given to the Government from Pfizer is that shipping and the first vaccinations are expected to be in late February. Final dates will be confirmed by Pfizer shortly and are subject to shipping and distribution.
If there are delays in shipping or production, the possibility remains that commencement could be in early March, however guidance remains for late February.
Prime Minister Scott Morrison said the TGA approval is 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.”
Minister for Health Greg Hunt said that Australia’s vaccination program has been based on the medical advice from the medical expert panel led by Professor Brendan Murphy.
“We will continue to review the medical advice and monitor and adapt to developments around the world,” Minister Hunt said.
In Australia the vaccine will be rolled out in five phases over the coming months and, over time, will involve more than 1,000 vaccination administration sites.
Head of the TGA, Adjunct Professor John Skerritt said the TGA has 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.
He noted that the monitoring of vaccine safety post-approval is an important part of the regulatory review of vaccines.
“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.
“We will also continue our work on the regulatory review for potential approval of other vaccines, notably the AstraZeneca and Novavax vaccines, as well as vaccines delivered through the COVAX facility.”
The rollout is set to begin across 30 to 50 hospital sites, and people who need protection the most will get the vaccine first. This includes aged care and disability care residents and workers, frontline health care workers, and quarantine and border workers.