(Adds details of rollout, prime minister's comment)
SYDNEY, Jan 25 (Reuters) - Australia's medical regulator has approved the Pfizer/BioNTech COVID-19 vaccine for use under a formal process, one of the first countries to complete a comprehensive approval, Prime Minister Scott Morrison said on Monday.
The vaccine had been provisionally approved by the Therapeutic Goods Administration's (TGA) for Australians aged 16 years and over, Morrison told reporters, noting it was a year since the first coronavirus case was detected in the country.
Vaccination of priority groups is expected to begin in late February, at 80,000 doses per week, Health Minister Greg Hunt told reporters.
Two doses will be required – at least 21 days apart, a government statement said. Australia will administer both doses of the vaccine at the recommended time.
"You don't start what you can't finish, and finishing the job involves two doses," said Morrison, adding a digital system would ensure people get two doses.
He cautioned there are limitations to what the vaccines can do and that the rollout would not mean border restrictions would be lifted. Quarantine and border personnel, frontline health workers, aged care and disability staff and residents will be the first group to receive vaccines. Australia expects to have the capacity to produce the AstraZeneca vaccine onshore starting late March.
"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," Morrison said in a statement.
(Reporting by Kirsty Needham and Byron Kaye; editing by Diane Craft and Sam Holmes)