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Melbourne-headquartered biotech CSL (ASX: CSL) has passed a critical hurdle in its plans to produce 50 million COVID-19 vaccines in Australia, after the Therapeutic Goods Association (TGA) today gave approval for the company's subsidiary Seqirus to manufacture the AstraZeneca vaccine.
The announcement allows for Australia's vaccine program to be scaled up as Phase 1B oriented towards the elderly and vulnerable starts tomorrow involving more than 1,000 general practices nationwide, to be ramped up progressively to 4,000 by the end of April.
In that timeframe the vaccine will also be rolled out at more than 100 Aboriginal Health Services and 130 Commonwealth-operated, GP-led respiratory clinics, while authorities are aiming to redirect one million vaccines produced in Europe to Papua New Guinea (PNG) where the virus has become widespread.
The latest decision follows TGA approval on 16 February for overseas-manufactured AstraZeneca vaccines to be administered to patients in Australia.
"Today's approval is a critical and very exciting milestone in Australia's response to the COVID-19 pandemic," the TGA said today.
"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.
"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 active raw vaccine material is being manufactured at CSL-Behring Australia in Broadmeadows, while the final doses are manufactured with the vials filled and packed at Seqirus in Parkville.
Quality testing is also being carried out at both these Victorian sites.
"The final step for the Australian-manufactured vaccine is TGA batch release, which is required for each and every batch of any vaccine supplied in Australia," the TGA said.
"This involves a review of documents supplied by the commercial sponsor describing how the vaccine batch was made, tested, shipped and stored as well as TGA's in-house laboratory testing to ensure the vaccine has been manufactured according to the required standards.
"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 vaccine, which will be manufactured by CSL on AstraZeneca's behalf.
The first doses out of 20 million Pfizer-BioNTech COVID-19 vaccines arrived in Australia in mid-February.
Updated at 8:23 AEDT on 21 March 2021.
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