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Selasa, 23 Maret 2021

First batches of locally made AstraZeneca vaccine approved for use in Australia - 9News

Australia's Therapeutic Goods Administration (TGA) has approved the release of more than 832,000 doses of locally-made AstraZeneca COVID-19 vaccine to be administered.

This evening the TGA confirmed it had approved the release of four batches totalling 832,200 doses.

The clearance follows last Sunday's TGA approval for the vaccine to be manufactured in Australia by CSL-Seqirus at its Broadmeadows facility.

CSL's Chief Scientific Officer, Dr Andrew Nash with a replica 1ml vial of the cells that will enter a Biorector to replicate and make 30 million doses of the University of Oxford/AstraZeneca Vaccine candidate. (Photograph by Chris Hopkins)

The Australian-produced AstraZeneca vaccine has been widely touted as the solution to inoculating Australians against serious disease as a result of COVID-19.

"TGA testing of the vaccine batches in our Canberra laboratories plus review of extensive manufacturing documentation, has ensured 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 confirmed in a statement.

"The TGA's clearance of the vaccine for local manufacture is a major step in Australia's response to the COVID-19 pandemic.

A health worker prepares a dose of the AstraZeneca vaccine to be administered at a vaccination center set up in Fiumicino, near Rome's international airport, Thursday, February 11, 2021. AstraZeneca is of the three vaccines authorized by the European Medicines Agency for use in the 27-nation bloc, the other two are Pfizer-BioNtech and Moderna. (AP)

"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 Australian-produced AstraZeneca vaccine will be progressively rolled out to more than 4,000 distribution points including general practices, respiratory clinics and Aboriginal Health Services.

Further approval will be required for each and every batch supplied and made in Australia.

Prime Minister Scott Morrison visits the CSL vaccine manufacturing facility on February 12, 2021 in Melbourne, Australia. Pharmaceutical company CSL is manufacturing Australia's Oxford-AstraZeneca COVID-19 vaccines. (Photo by David Caird-Pool/Getty Images) (Getty)

"TGA approval is required for each and every batch of any vaccine supplied in Australia," the TGA said in a statement.

"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."

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https://news.google.com/__i/rss/rd/articles/CBMimAFodHRwczovL3d3dy45bmV3cy5jb20uYXUvbmF0aW9uYWwvY292aWQtdmFjY2luZS1maXJzdC1iYXRjaGVzLW9mLWxvY2FsLWFzdHJhemVuZWNhLXZhY2NpbmUtYXBwcm92ZWQtZm9yLWF1c3RyYWxpYW5zLzkyOTY2M2Y4LTgzYTAtNGI5MC05ZjMzLTAxZWI3Y2EzMjFkMtIBRWh0dHBzOi8vYW1wLjluZXdzLmNvbS5hdS9hcnRpY2xlLzkyOTY2M2Y4LTgzYTAtNGI5MC05ZjMzLTAxZWI3Y2EzMjFkMg?oc=5

2021-03-23 09:10:47Z
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