Onshore vax manufacture approved


Approval given for AstraZeneca vaccine to be manufactured in Australia

The Therapeutic Goods Administration has approved manufacture of the AstraZeneca COVID-19 Vaccine (ChAdOx1-S) in Australia.

This follows on from the 16 February 2021 approval by TGA of the overseas-manufactured AstraZeneca vaccine.

The vaccine will be manufactured in Australia by CSL – Seqirus, following “extensive work by both industry and the TGA over the last six months”, the TGA said.

“Today’s approval is a critical and very exciting milestone in Australia’s response to the COVID-19 pandemic,” the agency said in a release.

Specific approval of Australian manufacturing by TGA was required to ensure that the locally-manufactured vaccine had exactly the same composition and performance as overseas-manufactured vaccine, was made to the same quality and is free of contaminants.

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

Quality control testing of the raw material and product is also being carried out in these facilities.

Receipt of the final batch release documentation from AstraZeneca is anticipated imminently and it is anticipated that the first batches will be released in the next few days.

“The Australian Government has purchased 50 million doses of the AstraZeneca vaccine, to be manufactured on their behalf by CSL, and, subject to individual batches passing TGA batch release requirements, these will form the mainstay of Australia’s COVID-19 vaccination program over the coming months, and complement imported vaccine supplies.”

Liz Chatwin, Country President, AstraZeneca Australia and New Zealand said: “Today’s approval by the Therapeutic Goods Administration (TGA), of the AstraZeneca COVID-19 vaccine manufactured by CSL, is an exciting milestone in Australia’s vaccination strategy.

“Our colleagues at CSL have worked tirelessly on the local manufacturing program for the vaccine alongside our team and the TGA, and approval means that the rollout of Australian-made vaccines can commence in the next few days.

This is a very proud moment for everyone at AstraZeneca and CSL across Australia.”

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