News TGA approves Australian-made AstraZeneca coronavirus vaccine

TGA approves Australian-made AstraZeneca coronavirus vaccine

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More than 800,000 Australian-made doses of the AstraZeneca coronavirus vaccine have been approved for use by the national medical regulator.

On Sunday the Therapeutic Goods Administration signed off on domestic manufacture of the vaccine, but was still doing so-called “batch testing.”

That’s when each batch of the vaccine is reviewed to check it has been made to the required standards.

Four batches totalling 832,000 doses have been cleared for supply, in what the TGA described as 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, with the Australian government having procured 50 million doses for delivery in the coming months,” the TGA said on Wednesday.

TGA approval on first day of phase 1b rollout

Australia’s vaccination rollout depends on the locally produced AstraZeneca vaccine, which is being made at two Melbourne sites by CSL.

TGA approval is required all vaccines supplied in Australia, with subsequent batches to also go through the same testing and release process.

The second phase of the vaccination program started on Tuesday, with millions of Australians set to become eligible for their first dose.

Phase 1B includes Australians aged 70 and over, Aboriginal and Torres Strait Islanders aged 55 and over, younger Australians with underlying health conditions and frontline healthcare workers.

It will be progressively available through more than 4000 distribution points, including general practices, GP-led respiratory clinics, and Aboriginal Health Services.