25 January, 2021
THERAPEUTIC GOODS ADMINISTRATION APPROVES PFIZER VACCINE
The Therapeutic Goods Administration (TGA) has provisionally approved the Pfizer/BioNTech COVID-19 vaccine for use in Australia.
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 vaccine will be provided free to Australians, with a priority group of Australians expected to receive their first dose of the COVID-19 vaccine in late February and early March.
Federal Leichhardt MP Warren Entsch said this news would add further confidence to Australia’s vaccine strategy.
“This is an important moment for the people of Cairns, Cape York and Torres Strait and for the entire nation,” Mr Entsch said.
“The approval of the Pfizer/BioNTech vaccine comes after rigorous and independent assessment by the TGA, which shows it meets Australian standards for safety, quality and efficacy.”
Prime Minister Scott 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,” 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.”
Federal Health Minister Greg Hunt said the-world class regulators at the TGA have 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.” Minister Hunt said.
“The TGA has placed safety above all else.
“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.”
Mr Hunt said 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,” he said.
“We will continue to review the medical advice and monitor and adapt to developments around the world.”
The Australian Government continues to work with Pfizer on the final date of delivery of vaccines, noting that Pfizer has experienced some temporary production delays from its European manufacturing plant as it ramps up production to meet extraordinary global demand.
The government’s latest advice remains that the first doses of Pfizer are expected to arrive and be rolled out in late February. Final dates will be confirmed by Pfizer shortly and are subject to shipping and distribution.
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.
The Australian Government, states and territories, regulators and the health and medical sectors are working together to finalise arrangements under the Australian Vaccination Strategy and detailed roll out plans.
As the rollout begins across 30-50 hospital sites, 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.
The priority groups have been determined based on the advice of the Australian Technical Advisory Group on Immunisation (ATAGI) which oversees Australia’s highly successful immunisation program.