Pfizer/BioNTech vaccine approved for rollout in Australia

The Therapeutic Goods Administration (TGA) has provisionally approved the Pfizer/BioNTech COVID-19 vaccine for use in Australia, after the vaccine met strict standards for safety, quality and efficacy. The approval is for individuals aged 16 years and older.

A priority group of Australians will 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. Shipping and the first vaccinations are expected to commence in late February; however, delays in shipping or production could postpone the vaccine rollout to early March. Two doses of the vaccine will be required, at least 21 days apart.

The rollout of the vaccine will begin across 30 to 50 hospital sites, with the priority groups determined based on the advice of the Australian Technical Advisory Group on Immunisation (ATAGI), which overseas Australia’s immunisation program.

In Australia, the vaccine will be rolled out in five phases and, over time, will involve more than 1000 vaccination administration sites. Once it is available, the first 1.4 million doses of the Pfizer vaccine will go to a priority group that includes quarantine and border workers, frontline health care worker subgroups, aged-care and disability-care staff, and aged-care and disability-care residents.

Up to 14.8 million doses will then be rolled out for other healthcare workers, and critical and high-risk workers, including defence, police, fire, emergency services and meat processing. Elderly adults aged 80 years and over, adults aged 70–79 years, and Aboriginal and Torres Strait Islander people aged over 55, will also receive the vaccination in this phase of the rollout. People aged 50 and above, and Aboriginal and Torres Strait Islanders aged 18–54 will receive the next 15.8 million doses, along with other critical and high-risk workers.

Prime Minister Scott Morrison welcomed the TGA’s approval of the vaccine and urged Australians to take confidence in the thorough and careful approach taken by the 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,” PM Morrison said.

Minister for Health Greg Hunt thanked all those involved in the development and assessment of the Pfizer/BioNTech COVID-19 vaccine, including the researchers and the medical experts at the TGA who worked tirelessly to introduce a safe 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. This approval and the upcoming rollout of the vaccine will play an important part in our ability to manage the pandemic in 2021,” Minister Hunt said.

Minister Hunt added that Australia’s vaccination program is based on the medical advice from the medical expert panel led by Professor Brendan Murphy. As a result, Australia has secured 140 million doses of the vaccine, one of the highest per capita rates in the world.

Head of the TGA, Adjunct Professor John Skerritt, said the TGA has been working non-stop to get the Pfizer vaccine assessed, while maintaining rigorous standards of safety, quality and efficacy. Adjunct Professor Skerritt thanked the TGA’s clinical and medical officers, scientists, pharmacists and experts in statistics, laboratory analysis and manufacturing assessment, who worked on assessing the vaccine.

“Our job is by no means done. In fact 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,” said Adjunct Professor Skerritt.

Minister Hunt noted that intense ongoing work will continue over the coming month, including batch testing of newly arrived doses, establishing cold storage facilities for the vaccine, training health providers to administer it, finalising distribution sites with states and territories, checking sites and protective equipment for safety, and scaling up systems for ongoing safety monitoring.

The Australian Government, states and territories, regulators and the health and medical sectors will work together to finalise arrangements under the Australian Vaccination Strategy.

Image credit: ©stock.adobe.com/au/Lakshmiprasad