The Pfizer/BioNTech COVID-19 vaccine has today been provisionally approved for use in Australia by the Therapeutic Goods Administration (TGA).
The TGA said following a thorough and independent review of Pfizer’s submission, it was decided the vaccine met the high safety, efficacy and quality standards required.
The provisional approval is for individuals 16 years of age and older. Two doses will be required, at least 21 days apart.
Australian 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,” the Prime Minister 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.”
The 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.
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.