The Pfizer coronavirus vaccine has been provisionally approved for use in Australia with the first jabs set for late next month.
The Therapeutic Goods Administration has ticked off on the vaccine after it met strict standards around safety, quality and efficacy.
Two doses at least 21 days apart will be required with a priority group expected to receive the vaccine as soon as it arrives in Australia.
The Morrison government is confident that is on track for later February but has conceded there is a possibility a delay in shipping or production could push it to early March.
The TGA said in a statement it approved the vaccine “following a thorough and independent review of Pfizer’s submission”.
“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.
“Australians can be confident that the TGA's review process of this vaccine was rigorous and of the highest standard.
“The decision to provisionally approve the vaccine was also informed by expert advice from the Advisory Committee on Vaccines [ACV], an independent committee with expertise in scientific, medical and clinical fields including consumer representation.”
How many Covid vaccine doses will be distributed?
Health Minister Greg Hunt said Australia would “likely” start with about 80,000 doses a week.
“Let's be more conservative on that,” Mr Hunt told reporters.
“Further guidance for March and beyond will be provided across the globe by Pfizer in mid-February.
“They are making global decisions on those allocations but continuous supply was their goal objective and their anticipation and guidance as of last night.”
Prime Minister Scott Morrison said “we paid a premium for it” but cautioned “it’s a very challenging global situation”.
“If there are any other things that occur between now and then, we will stand here and explain what is happening and that is the appropriate way to engage in this vaccination program,” he said.
“We will be up-front with Australians about the vaccine, about its timing, about the rollout.
“We will communicate clearly about what the vaccine is and what families will want to know about the vaccine and to make their own choices in an informed way about that.”
Mr Morrison hopes to have four million doses distributed by the end of March.
He also praised Australia’s response to the pandemic adding: “over this summer, we could have gone into a third wave”.
“We could have been facing, right now, as Australia kicks in again after Australia Day with people going back to work - we could have been going in and in the midst of a very serious third wave,” Mr Morrison said.
“Australians, to date, have beaten that third wave.
“But the fight goes on.”
Advice to be provided for the elderly
Chief Medical Officer Brendan Murphy was asked whether there were concerns about distributing the vaccine to the elderly after several people died in Norway.
A number of elderly Norwegians died and suffered side effects after taking the Pfizer vaccine.
Dr Murphy said “we have been concerned about this”.
“For the very elderly and frail, that will need a very careful clinical decision,” he said.
“That is something that would need to be - where the risks versus - the benefits of vaccination need to be carefully considered.”
He added The Australian Technical Advisory Group will provide advice to people who are frail or “close to the end of life”.
The Pfizer vaccine is currently being used in the US and the UK.
The US Centers for Disease Control and Prevention said on Sunday 21,848,655 doses of Covid vaccine had been distributed.
The tally includes people receiving the Pfizer vaccine along with the Moderna vaccine.
Professor Anthony Harnden, deputy chair of the Joint Committee on Vaccination and Immunisation (JCVI) has warned people might need to receive a Covid jab annually due to many variants of the virus now in circulation.
“We are living in a world where coronavirus is so prevalent and rapidly mutating there are going to be new variants that pop up in all sorts of different countries,” he told Sky’s Sophy Ridge on Sunday program.
with AAP and Reuters
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