The Therapeutic Goods Administration has approved the Pfizer/BioNTech COVID-19 vaccine in Australia, with the jab set to be rolled out by late February.
The Pfizer vaccine met strict standards for safety, quality and efficacy, and has been provisionally approved for Australians over 16.
Frontline hotel quarantine staff and health workers will be the first in line to receive the jab, followed by aged care employees, seniors and other vulnerable communities.
Two doses will be required – at least 21 days apart. The TGA said provisional approval of the vaccine is valid for two years.
'The TGA has granted provisional approval to Pfizer Australia Pty Ltd for its COVID-19 vaccine, COMIRNATY, making it the first COVID-19 vaccine to receive regulatory approval in Australia,' it said.
The Pfizer vaccine has met strict standards for safety, quality and efficacy, and has been provisionally approved for Australians over 16
Frontline hotel quarantine staff and health workers will be the first in line to receive the jab, followed by aged care employees, seniors and other vulnerable communities
'Following a thorough and independent review of Pfizer's submission, the TGA has decided that this vaccine meets the high safety, efficacy and quality standards required for use in Australia.'
Speaking to reporters on a year to the day since the first case of COVID-19 was diagnosed in Australia, Scott Morrison said Monday's approval was not an emergency, and all protocols had been followed.
'We remain on track to have those vaccines in Australia and ready to go from very small beginnings, I should stress - very small beginnings, starting small and we scale up.
'We are more looking at late February now than mid-February because of the challenges that we have seen in production and delivery.'
The Prime Minister said TGA experts found the vaccine to be safe, effective and of a high standard.
'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.'
Mr Morrison said it's more likely 4million people will be vaccinated by early April rather than late March as previously anticipated.
Scott Morrison said it's more likely 4million people will be vaccinated by early April rather than late March as previously anticipated
Health Minister Greg Hunt said that within the guidance the government has been provided, it's likely 80,000 doses will be given each week.
Mr Hunt said there is still no specific date set for the roll out in late February, but it would be dependent on shipping times.
'Those shipping times were provided last night, which means we are in a position to commence in late February and our guidance has always been for a window,' he said.
'Because of the global risk, we have to proceed with a safe, secure vaccine program but Australians can have confidence if the best regulator in the world approves the vaccine, it is safe and effective.
'The TGA has placed safety above all else.'
Chief Medical Officer Brendan Murphy said health authorities have got 'major logistics issues' vaccinating 26million people.
'The preparation that is going on for this vaccination journey is huge,' he said on Monday.
'We are ready to go. We are planning very exciting and very exciting that we have not had to do this in an emergency way because we have a crisis to deal with. We can do this in our normal safe Australian way.'
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.
Treasurer Josh Frydenberg insists Australia is still on track to receive the Pfizer COVID-19 vaccine from 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.
Mr Hunt believes new immunisation figures show Australians have faith in the TGA to provide expert advice and ensure the safety and efficacy of all vaccines provided to the community.
HealthMinister Greg Hunt said the world class regulators at the TGA have been working tirelessly to introduce a safe and effective COVID-19 vaccine in Australia
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
Immunisation rates for five-year-olds are now beyond the aspirational target of 95 per cent coverage, reaching 95.09 per cent in the December quarter of 2020 and exceeding the World Health Organisation estimated international average of 86 per cent.
'Reaching our target of 95 per cent supports herd immunity to stop the spread of vaccine-preventable diseases,' Mr Hunt said in a statement on Sunday.
'These figures show Australians have both the capacity and the will to lead the world in taking up COVID-19 vaccines, as they recognise how important vaccination is, and how it protects and saves lives.'
Aboriginal and Torres Strait Islander children at five years old have the highest rates of immunisation in the country at 97.25 per cent.