After meeting strict standards for safety, efficacy and quality, the Therapeutic Goods Administration (TGA) has provisionally approved the Pfizer COVID-19 vaccine for use in Australia.
The TGA’s provisional approval, the first granted to a COVID-19 vaccine in Australia, is for people aged 16 and older. Two doses will be required – at least 21 days apart.
The first Pfizer vaccinations are expected to be rolled out in late February, with a priority group of Australians including aged care and disability care staff and residents, frontline healthcare workers and quarantine and border workers, able to access the first 1.4 million doses.
At this stage, it will not be mandatory for aged care residents and staff to be vaccinated against COVID-19.
In Australia, the vaccine will be rolled out across five phases over coming months and, eventually, involve more than 1,000 vaccination administration sites.
After the first priority group of Australians, the next 14.8 million doses will go to elderly adults aged 70 and over, other healthcare workers, Aboriginal and Torres Strait Islander people aged over 55, younger adults with underlying medical conditions, including those with a disability, and high risk workers including police and firefighters.
The priority groups were determined following advice from the Australian Technical Advisory Group on Immunisation (ATAGI), which oversees Australia’s immunisation program.
In a statement today, Prime Minister Scott Morrison said the TGA approval marked an important first step in the nation’s fight against COVID-19.
“Australians should take confidence in the thorough and careful approach taken by our world-class safety regulator,” he said.
“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.”
Provisional approval of the Pfizer vaccine is valid for two years, subject to strict conditions such as the company continuing to provide information to the TGA about longer term efficacy and safety from ongoing clinical trials and post-market assessment.
Head of the TGA, Adjunct Professor John Skerritt, said the regulator had been working non-stop to get the Pfizer vaccine assessed and were pleased to have it pass the rigorous regulatory process.
“Our job is by no means done,” he said.
“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.”
Further information about the Australian Government’s COVID-19 Vaccine National Rollout Strategy can be found here
