Australian-made AstraZeneca COVID-19 vaccine approved by Therapeutic Goods Administration

The first Australian-made doses of the AstraZeneca vaccine have been given the green light in what experts say is a “major step”.

A COVID-19 AstraZeneca vaccine vial in the vaccine clinic at Sydney Road Family Medical Practice. Picture: Lisa Maree Williams

The first batch of Australian-made doses of the AstraZeneca vaccine have been given the green light in what experts say is a “major step in Australia’s response to the COVID-19 pandemic”.

The Therapeutic Goods Administration (TGA) announced on Tuesday evening that 832,000 doses produced in Melbourne had been approved and is “now available for Australians”.

The nation’s medical regulator released the supplies following Sunday’s announcement it had signed off on domestic manufacture of the vaccine, describing it as a “critical and very exciting milestone in Australia’s response to the COVID-19 pandemic”.

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Since Sunday, the Australian-made doses have been going through batch testing in Canberra to ensure “that the locally-manufactured vaccine has the exactly the same composition and performance as the overseas-manufactured vaccine, the same quality, and is free of contaminants”, the TGA said in a statement.

Each batch of vaccine supplied undergoes a TGA “batch release”, which involves “a review of documents describing how it was made, tested, shipped and stored as well as testing by the TGA’s in-house lab to ensure it’s been made according to required standards”.

Australia’s first four batches have since been cleared with the TGA calling it “a major step in Australia’s response to the COVID-19 pandemic”.

“We will now be able to provide secure access to large numbers of doses of a domestically-produced vaccine,” it said.

TGA approval is required for each and every batch of any vaccine supplied in Australia.

Medical practices across Australia have started COVID-19 vaccinations for eligible Australians under the Phase 1b rollout. Picture: Lisa Maree Williams

The Australian government says it will produce 50 million doses of the vaccine locally “in the coming months” manufactured on its behalf by CSL.

The vaccine will be manufactured at two sites in suburban Melbourne. CSL-Behring Australia in Broadmeadows is making the active raw vaccine material, while the final doses are being manufactured and vials filled and packaged at CSL company Seqirus in Parkville.

Health Department secretary Brendan Murphy said the AstraZeneca vaccine was Australia’s “workhorse”.

He said domestic production of the jab will allow authorities to expand the rollout, adding the vaccine was “safe and effective”.

All subsequent batches of the Melbourne-manufactured vaccine completed in the coming weeks and months will go through the same individual batch testing and release process by the TGA.

The Australian-produced AstraZeneca vaccine will be progressively available through more than 4,000 distribution points, including general practices, GP-led respiratory clinics, and Aboriginal Health Services.

AstraZeneca Australia is the largest national manufacturer of pharmaceuticals.

At least 281,500 people have already been vaccinated across Australia.

SIX MILLION ELIGIBLE FOR VACCINATION

It comes the day after more than six million Australians will become eligible for the COVID-19 vaccine on Monday as more than 1000 GP clinics start vaccinating people.

The phase 1b rollout came into effect on Monday, with the first of the general population included in the cohort set to be vaccinated.

It covers the over 70s, healthcare workers, Aboriginal and Torres Strait Islander adults over 55 and adults with a specified medical condition.

Critical and high-risk workers including Defence, police, fire, emergency services and meat processing are also included under phase 1b.

1000 GP clinics joined the COVID-19 vaccination program as part of the rollout.

John Brown looks at a COVID-19 vaccine information pack ahead of receiving the COVID-19 AstraZeneca vaccine in Sydney. Picture: Lisa Maree Williams

Deputy chief medical officer Michael Kidd conceded flooding across Australia, particularly in NSW, would cause “some delays” in the rollout that state, but elsewhere it would happen “as anticipated”.

“We have had practices where we haven’t been able to yet deliver the first doses of the vaccine because roads are closed and of course we have some practices which themselves have had to close,” he said.

“Obviously safety first is paramount at this time, so once it is safe and the roads are reopened, those deliveries will take place and people in those areas will be able to start getting their first doses of the AstraZeneca vaccine.”

Health Minister Greg Hunt has said the government “clearly and unequivocally” continued to support the AstraZeneca rollout.

“The TGA does not have any evidence of a biologically plausible relationship that could suggest a cause and effect relationship during vaccination and blood clots,” he told parliament.

It comes as a US health agency raised concerns that AstraZeneca may have included out-of-date information during trials of its COVID-19 vaccine, the day after the company said its drug was highly effective in preventing the disease.

AstraZeneca had said Monday that stage three US trials had shown its vaccine was 79 per cent effective at preventing the disease. It said the jab was 79 per cent effective at preventing symptomatic COVID-19 in the overall population, 100 per cent effective at preventing severe disease and hospitalisation and 80 per cent effective at preventing the disease in the elderly.

— with Newswire