In what is seen as a critical and exciting milestone in Australia’s Covid-19 response, the Therapeutic Goods Administration (TGA) has granted approval for CSL-Seqirus to manufacture the AstraZeneca Covid-19 vaccine in Australia.
The vaccine is being manufactured at two sites in Melbourne:
- CSL-Behring Australia in Broadmeadows who are manufacturing the active raw vaccine material.
- CLS-Seqirus in Parkville who are manufacturing the final vaccine doses, and filling and packaging vaccine vials.
Quality control testing is being carried out at both facilities.
In a statement released over the weekend, TGA explain that specific approval of Australian manufacturing was required to ensure that the locally-manufactured vaccine had exactly the same composition and performance as the overseas-manufactured vaccine – to ensure Australian manufacture is to the same quality and free of contaminants.
While this approval follows on from the 16 February 2021 approval by the TGA of the overseas-manufactured AstraZeneca vaccine, the final step of the Australian-manufactured vaccine is TGA batch release, which is required for each and every batch of any vaccine supplied in Australia.
This is said to involve a review of documents supplied by the commercial sponsor describing how the vaccine batch was made, tested, shopped 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 this week.
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, will complement imported vaccine supplies.
