‘A critical and very exciting milestone’: Approval of domestically manufactured COVID-19 vaccine boosts Australia’s vaccination campaign
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.”
The AstraZeneca vaccine is being manufactured at two sites in suburban Melbourne. CSL-Behring Australia in Broadmeadows is manufacturing the active raw vaccine material, while the final vaccine doses are being manufactured and vials filled and packaged at Seqirus in Parkville (a CSL company).
Seqirus fill and finish will run 24 hours a day, seven days a week, with the release of around one million doses a week.
Quality control testing of the raw material and product is also being carried out in these facilities.
Each batch must be approved by the TGA, CSL and AstraZeneca.
The first batches are expected to be released in the coming days as the Phase 1b rollout gets under way (this Phase sees more than 1,000 general practices join the vaccination program for adults aged 70+, those with a specified medical condition or severe disability, and critical and high risk workers among other priority groups).
No reports of blood clots
The TGA has not received any reports of blood clots following AZ vaccination in Australia. The TGA attended the European Medicines Agency (EMA) safety committee meeting on March 18, which found the number of blood clotting cases reported after vaccination was lower than expected in the general population. "We advise that people in Australia should continue to get the AstraZeneca vaccine when eligible," concluded the TGA on Friday.
“Manufacture of biological medicines such as vaccines is a highly-specialised process and the establishment of Australian manufacture of COVID-19 Vaccine AstraZeneca by CSL - Seqirus has involved extensive work by both industry and the TGA over the last six months,” said the TGA as it announced the CSL – Seqirus manufacturing approval yesterday.
“This approval is a critical and very exciting milestone in Australia's response to the COVID-19 pandemic.
“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.”
Alongside the 53.8 doses from AstraZeneca, the Australian Government has also entered into three other COVID-19 vaccine supply agreements: with Pfizer/BioNTech (10 million doses manufactured overseas); Novavax (51 million doses, with the vaccine yet to be authorized) and doses through COVAX.
Australia’s home-grown vaccine candidate – a partnership between the University of Queensland and CSL which had been lined up to supply 51 million doses – was dropped in December after Phase 1 participants returned false positive test results for HIV.
