The Pfizer COVID-19 vaccine has been granted provisional approval by the Therapeutic Goods Administration (TGA).
The federal government has confirmed the first vaccines were expected in late February, though they could be pushed back to early March if there were delays to shipping or production.
Provisional approval has been granted for Australians over 16. The vaccine will be administered in two doses, at least 21 days apart.
Prime Minister Scott Morrison said the TGA’s approval was a pivotal step in protecting Australians from the pandemic.
“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,” he 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.”
Health Minister Greg Hunt said the TGA had been working around the clock to expedite approval.
“The TGA’s processes are, I believe, the best in the world and we have ensured that they are thorough,” Mr Hunt said.
“The TGA has placed safety above all else.”
The Pfizer vaccine had a 95 per cent efficacy, and was considered the world’s most effective protection against COVID-19.