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2.5m Australian made COVID-19 vaccine doses yet to be approved by TGA, AstraZeneca

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More than half of the three million COVID-19 vaccine doses that Australia has manufactured remain in cold storage and cannot be rolled out yet because they are undergoing further batch testing in Europe by the drug company AstraZeneca.

News.com.au has confirmed that despite CSL producing more than 3 million doses of the COVID-19 vaccine here in Australia that the majority of these doses have not been approved for distribution.

Instead, only the first 832,200 doses that left CSL-Seqirus’ Parkville factory with great media fanfare on the back of trucks on March 23 are being used to vaccinate Australians.

Another 2.5 million doses remain in cold storage while undergoing final approval and testing. Of these doses, a couple of hundred thousand doses were finally approved for use last Thursday but the majority remain “on ice”.

That suggests that CSL has manufactured 3.2 million COVID-19 doses and rising. However, of these 3 million plus doses only around a third – one million doses – have been approved for use and can actually be used to vaccinate Australians. That means less than half of the vaccines produced have actually been rolled out.

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The Morrison Government remains under fire for failing to meet its own targets for the vaccine rollout including the number of vaccines being produced on a weekly basis and the number of Australians actually vaccinated.

In a statement, CSL told news.com.au that this batch testing was vital to ensure the safety and efficacy of the vaccine and that it hoped to hit the target of one million doses in the future.

“Our highest commitment is always to patient safety, and the stringent checks and balances placed on each batch are a critical part of delivering vaccines to the Australian public. These checks, undertaken by CSL, AstraZeneca and the TGA, ensure the quality of the vaccines and that they meet all required standards. We will not release any product until all parties are completely confident that each batch of vaccine meets the highest quality standards,’’ a CSL spokesperson said.

“We are working around the clock to provide vaccines to the Australian public and are proud to have been able to release locally made doses of a new vaccine in just four months since beginning manufacture. In the first week of the local rollout, 832,000 doses were released ahead of schedule to the Australian Government.

“Further batches of finished doses are now being released on a rolling basis every week. When approved by the TGA, they are delivered to the national network of vaccination centres and GP clinics. CSL hopes to reach a rolling output of 1 million doses a week as soon as possible.”

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The vaccines do not need to be physically sent back to Europe but the scientific work is being shared electronically and reviewed overseas.

They also need to be approved by the Therapeutic Goods Administration.

On March 25, Prime Minister Scott Morrison told ABC radio that CSL was producing “more than 900,000 of them coming out a week”.

CSL confirmed to news.com.au that this figure is not correct and they have never produced more than 900,000 in a single week. They remain hopeful of doing so in the future.

“They are now rolling off the line, filled and finished out of Parkhill down there in Melbourne, you know, over more than 900,000 of them coming out a week,’’ the Prime Minister said.

“And so the decision to have a domestic manufacturing capability here has been the big change, a game changer. We would not have a vaccination programme were it not for the wisdom of that decision that my Government took.”

CSL said they were unable to go into a rolling commentary on the numbers of doses that have been released to the Australian Government from AstraZeneca, and would leave it to the Government to update the community on what is available.

“When approved by the TGA, they are delivered to the national network of vaccination centres and GP clinics. CSL hopes to reach a rolling output of 1 million doses a week as soon as possible,” a spokesperson said.

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Health Department secretary Professor Brendan Murphy has hailed Australia’s decision to locally produce the vaccine as among the “single best thing” Australia has done given the threats in Europe to block vaccine exports.

CSL remains contracted to make 50 million doses of the AstraZeneca vaccine with taxpayers paying a premium for the vaccines.

Labor’s government services spokesman Bill Shorten said the problem was not simply one of supply but also at the distribution end with GPs.

“They are not paying overtime. If you want to do mass vaccinations you need to do it on weekends and after hours. It’s not a case of greedy doctors, it’s a case of paying people for their work,” he told news.com.au.

“If you want 24-7 vaccinations, then just pay for it.”

Mr Shorten said he had an open mind as to whether they should scrap the phased rollout based on age and just go for mass vaccination as quickly as possible.

“In California they scrapped it. They should consider it. There’s a reason why the Americans did 4 million in a weekend and we haven’t,” he said.

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