CSL to mass-produce COVID-19 vaccine before trials

Australia’s biggest health company, CSL, will on Monday start manufacturing a COVID-19 vaccine as Melbourne’s iron curtain lifts.

CSL chief scientific officer Andrew Nash holds up a vial of material used to make the vaccine. Picture: Getty Images

Australia’s biggest health company, CSL, will on Monday start manufacturing a COVID-19 vaccine as Melbourne’s iron curtain lifts, enabling the city’s residents to visit regional areas.

CSL will produce 30 million doses of the vaccine, which pharmaceutical multinational AstraZeneca developed with Oxford University, and is still undergoing phase three clinical trials.

It is hoped the first doses will be available in the first half of next year, with the elderly and vulnerable members of the community first in line for inoculation if the clinical trials are successful.

While Melbourne is experiencing the biggest easing of its four-month lockdown, with the removal of Premier Daniel Andrews’s “ring of steel”, the world is desperately awaiting the arrival of an effective vaccine for a full return to normality, including international travel.

CSL will manufacture the vaccine at its factory in Broadmeadows in Melbourne’s north. The company has revealed the steps involved in its production, including thawing vaccine cells and replicating them in bioreactors. It is expected Australians will need at least two doses of the vaccine to protect themselves from the highly infectious virus.

The Morrison government has invested $1.7bn secure two types of vaccine one from AstraZeneca and another CSL has been developing with the University of Queensland known as UQ-CSL V451. The deal also includes $300m to upgrade the Broadmeadows factory so it can produce two types of vaccine simultaneously.

The company has already produced batches of its UQ vaccine, which is expected to start phase three clinical trials next month. If that trial is successful, CSL will produce 50 million doses of the UQ vaccine as part of the $1.7bn government deal.

CSL chief scientific officer Andrew Nash said while there was still “a long way to go” before the vaccines were released to the Australian public, the AstraZeneca vaccine rolling off production lines was an important milestone reached by the company and its vaccine subsidiary Seqirus.

“This marks the end of many months of around-the-clock preparation by our skilled personnel globally within CSL Behring, Seqirus and research and development,” Dr Nash said.

“Both campaigns are still technically challenging but at this time we are tracking well and expect to produce the AZD1222 (AstraZeneca vaccine) and the UQ-CSL V451 vaccine for Australia by mid-2021.

“There’s still a long way to go and our first priority resolutely remains the safety and efficacy of the vaccines we produce. We are undertaking these manufacturing activities at-risk and in parallel with the clinical trials and approvals processes in recognition of the significant urgency of the COVID-19 pandemic.”

The AstraZeneca vaccine, considered the world’s most advanced, uses live virus cells, which is different from the UQ vaccine, which is based on a “molecular clamp” to trigger a protective immune response.

Dr Nash said the manufacturing process for the AstraZeneca vaccine will start with the thaw of vials containing vaccine cells.

“The cells — frozen under liquid nitrogen to preserve their integrity — need to be thawed in preparation for replication in the bioreactors at the company’s Broadmeadows facility. After growing in the bioreactors, the vaccine is then filtered and purified leaving just the antigen, or vaccine product.

“It is then ready for final formulation and filling into dosage vials.”

The Australian Therapeutic Goods Administration has granted the AstraZeneca vaccine provisional determination, which is the first step towards full approval, which will be considered once clinical trials are completed.