Australia: Australia approves Pfizer vaccine - millions of doses soon to arrive

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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.

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'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.

a couple of people that are talking to each other: The Pfizer vaccine has met strict standards for safety, quality and efficacy, and has been provisionally approved for Australians over 16 © Provided by Daily Mail The Pfizer vaccine has met strict standards for safety, quality and efficacy, and has been provisionally approved for Australians over 16 a person in a blue shirt: 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 © Provided by Daily Mail 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.'

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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.

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a woman talking on a cell phone: Scott Morrison said it's more likely 4million people will be vaccinated by early April rather than late March as previously anticipated © Provided by Daily Mail Scott Morrison said it's more likely 4million people will be vaccinated by early April rather than late March as previously anticipated

AUSTRALIA'S COVID-19 VACCINE ROLLOUT PHASESTITL

Phase 1a (up to 1.4 million doses)

Quarantine and border workers

Frontline healthcare worker

Aged care and disability care staff

Aged care and disability care residents

Phase 1b (up to 14.8 million doses)

Elderly adults aged 80 years and over

Elderly adults aged 70-79 years

Other health care workers

Aboriginal and Torres Strait Islander people over 55

Younger adults with an underlying medical condition, including those with a disability

Critical and high-risk workers including defence, police, fire, emergency services and meat processing

Phase 2a (up to 15.8 million doses)

Adults aged 60-69 years

Adults aged 50-59 years

Aboriginal and Torres Strait Islander people 18-54

Other critical and high-risk workers

Phase 2b (up to 16 million doses)

Balance of adult population

Catch up any unvaccinated Australians from previous phases

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Phase 3 (up to 13.6 million doses)

If recommended for under 16 years

Health Minister Greg Hunt said that within the guidance the government has been provided, it's likely 80,000 doses will be administered 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.'

The rollout will begin across 30 to 50 hospital sites covering aged care and disability residents and workers, frontline healthcare workers, as well as quarantine and border workers.

It will then expand to 1000 vaccine administration sites as the five-phase rollout widens across the population.

TGA boss John Skerritt said the regulator's job was far from finished.

'The monitoring of vaccine safety post-approval is an important part of the regulatory review of vaccines,' he said.

'We now check the individual batches of vaccines that are destined for Australians while closely monitoring the safety and efficacy of the vaccine as it is rolled out.'

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Chief Medical Officer Brendan Murphy said health authorities have got 'major logistics issues' vaccinating 26million people.

a woman in a blue shirt: 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 © Provided by Daily Mail 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 a woman taking a selfie in a room: 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 © Provided by Daily Mail 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

'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.

Regulatory review for the AstraZeneca and Novavax vaccines is ongoing.

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