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Australia's TGA approves CSL manufacture of AstraZeneca COVID-19 vaccine - BioPharma-Reporter.com

Australia currently has two authorized COVID-19 vaccine – Pfizer and AstraZeneca – but to date has been reliant on supplies from abroad. This has proved problematic with supply shortages: notably with Italy blocking the export of 250,000 doses of the AstraZeneca vaccine to Australia earlier this month.

While the TGA approved the AstraZeneca vaccine for use in Australia on February 16 for vaccines manufactured overseas, it is yesterday approval’s for Australian-manufactured AstraZeneca vaccine by CSL and its subsidiary Seqirus that will now drive the country’s vaccination campaign forward.

Necessity of domestic production

CSL will manufacture 50 million doses of the AstraZeneca vaccine, representing the vast majority of the 53.8 million doses of this vaccine purchased by the Australian Government (and also the majority of COVID-19 vaccines currently available in the country). 

While 3.8 million AstraZeneca doses had been expected to arrive in Australia from overseas by the end of February, only 700,000 arrived as a result of overseas factory issues and European controls. The approval of domestic manufacture, therefore, is crucial for vaccine rollout.

Australia has a world class manufacturing facility right here at home, putting us in a very strong position to supply vaccines when and where they are needed,”​ said Greg Hunt, Minister for Health and Aged Care, announcing the Phase 1B rollout earlier today. “Our contract with CSL for 50 million doses means we do not need to rely on overseas supply to ensure all Australians who want a vaccine, can be vaccinated.

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