The authorization was announced today: exactly a year after the first case was confirmed in Australia.
The first vaccinations are expected in late February, although the government notes this could be early March if there are delays in shipping or production.
The TGA provisional approval is for individuals 16 years of age and older; with two doses administered at least 21 days apart. The provisional approval is valid for two years.
Prime Minister Scott Morrison said today's news 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.
“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.”
The vaccine, registered as COMIRNATY, will be rolled out in five phases over the coming months. This will start with up to 50 hospital sites, prioritizing quarantine and border workers; frontline health care workers; and aged care and disability residents and staff. Over time, Australia plans to have more than 1,000 vaccination sites.
The Pfizer/BioNTech vaccine is one of four supply agreements that Australia has made; although is also the smallest at 10 million doses. The others are with AstraZeneca (53.8 million doses expected ‘early 2021); Novavax (51 million doses ‘during 2021’) and through COVAX.
Australia had also hoped to source 51 million doses through a homegrown vaccine from the University of Queensland / CSL, but development of this candidate was halted in December after it triggered false positives on some HIV tests in Phase 1 trials.