The Therapeutic Goods Administration has approved the manufacture of the AstraZeneca COVID-19 Vaccine (ChAdOx1-S) in Australia.
The Australian manufacture of COVID-19 Vaccine AstraZeneca, established by a Melbourne-based biotechnology company CSL, has involved extensive work by both industry and the TGA in the last six months.
Manufacture of biological medicines, such as vaccines, is a highly-specialised process, and specific approval was required to ensure that the locally-manufactured vaccine had the same composition and performance as the overseas-manufactured vaccine.
The vaccine is being manufactured at two sites in Melbourne. CSL-Behring Australia in Broadmeadows is manufacturing the active raw vaccine material, while the final vaccine doses, where vials are filled and packaged at CSL subsidiary Seqirus in Parkville. Quality control testing of the raw material and product is also taking place in these facilities.
The final step for the Australian-manufactured vaccine is TGA batch release, which is required for every batch of any vaccine supplied in Australia. It 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.
The first batches of the vaccine are expected to be released in the next few days.
The federal 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.
As part of Phase 1B of Australia’s COVID-19 vaccine program, more than 1,000 general practices will join the COVID-19 vaccination program from tomorrow.
Clinics have initially been supplied with imported AstraZeneca vaccine, and will progressively increase in number to more than 4,000 by the end of April, along with over 100 Aboriginal Health Services and 130 Commonwealth operated GP-led Respiratory Clinics.