Another three month wait for CSL-produced COVID-19 vaccine

Australians will have to wait at least another three months to be injected with the first locally produced COVID-19 vaccine, as manufacturer CSL says it will not ‘fast-track’ production.

CSL’s manufacturing facilities in Melbourne’s Broadmeadows.

Australians will have to wait at least another three months to be injected with the first locally produced COVID-19 vaccine, as manufacturer CSL says it will not “fast-track” production and “compromise safety”.

CSL, Australian’s biggest health company, is producing 50 million doses of AstraZeneca and Oxford University’s vaccine at its advanced production facility at Broadmeadows, in Melbourne’s northern suburbs.

The AstraZeneca vaccine, known as AZD1222, will form the bulk of the Morrison government’s $3.3bn COVID-19 immunisation program, which has secured four types of vaccines and been brought forward several weeks to the start of March.

CSL began producing the ­Astra­Zeneca vaccine under licence in November and said in a statement on Thursday afternoon it had been working “around the clock” to complete the first bulk batches, which face four weeks of “extensive quality control tests”.

After testing is completed, the bulk vaccine product will be filled into individual vials at the factory of influenza vaccine business, ­Seqirus, at Parkville in Melbourne’s inner suburbs.

It comes as the government faces growing pressure to begin vaccinating Australians against COVID-19 as soon as a vaccine receives regulatory approval from the Therapeutic Goods Administration. Health Minister Greg Hunt has stood firm on the March rollout date, with government sources citing batch testing, delivery schedules and production ­capacity has a roadblock to bringing it forward any further.

CSL said while it has accelerated its vaccine production program, it had not fast-tracked it because it was critical to ensure the necessary safety and quality assurance processes were followed to maintain public confidence in the COVID-19 immunisation program.

“CSL anticipates that the first locally produced doses of the vaccine will be ready in the second quarter of 2021, subject to regulatory approval,” the company said in a statement.

“While some timings have been accelerated by running select processes in parallel, no part of the process will be fast-tracked where it might compromise the safety of the vaccine. To do this could be detrimental to public confidence in vaccinations, and CSL’s ability to deliver on its commitment.

“All of this work has resulted in the completion of the first batches of bulk drug substance — the active ingredient used to make drug product — at our Broadmeadows biotech manufacturing facility, which are now subject to extensive quality control tests to confirm that the technical processes delivered to us by AstraZeneca are performing as expected.

“The quality review process will take approximately four weeks before proceeding to the fill and finish step, and finished product will be then subject to regulatory approvals.”

While doses of the first locally produced COVID-19 vaccine will not be available until at least April, AstraZeneca will import about 3.8 million doses from Europe next month to ensure it meets the March deadline for the beginning of the government’s immunisation program. The TGA has yet to approve the vaccine, which has received emergency use approval in the US and the UK.

CSL received $300m from the federal government to retool to produce the Oxford-AstraZeneca formulation and the locally developed University of Queensland vaccine that failed last month.

As the bulk product has been produced at Broadmeadows, the company said new equipment had been installed in the Seqirus fill and finish production lines at Parkville. These production lines are “undergoing qualification and testing to ensure the delivery of a safe and effective vaccine”, CSL said. Part of the testing to be completed includes sterility testing, which takes 17 days on average.

In addition to the 53.8 million doses of the Oxford-AstraZeneca offering, Canberra has contracted to buy 51 million doses of the American Novavax vaccine and 10 million doses of the Pfizer-BioN­Tech vaccine given emergency-use authorisation by US and British regulators.

It is expected Pfizer’s mRNA immuniser will be the first given to Australians — another challenge when it needs to be refrigerated at minus-70C for transporting.