TGA approves CSL-Seqirus local manufacturing of AstraZeneca COVID-19 vaccine

Pharma News: Yesterday, the Therapeutic Goods Administration (TGA) 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.

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. This approval is a critical and very exciting milestone in Australia’s response to the COVID-19 pandemic.

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.”

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.

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. These clinics have initially been supplied with imported AstraZeneca vaccine. Clinics 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. This staged scale up aligns with the supply of the locally-produced AstraZeneca vaccine.