CSL agrees to manufacture COVID-19 vaccines for Australia
Biotech company CSL has signed two separate heads of agreement (HoA) for COVID-19 vaccines should clinical trials prove successful: one with the Australian Government for the supply of 51 million doses of University of Queensland (UQ) vaccine candidate V451 and another with AstraZeneca to manufacture University of Oxford candidate AZD1222.
The UQ HoA is between CSL’s influenza vaccines company, Seqirus, which will hold regulatory responsibility as the marketing authorisation holder, and the Australian Government. Preclinical and early clinical study results suggest that UQ-CSL V451 is promising and effective in animal models; however, it is impossible to predict the level of success the candidate will have in late-stage trials.
UQ is now undertaking a Phase 1 clinical study on UQ-CSL V451 to assess safety and immunogenicity in healthy volunteers, many of which are aged 56 and over. CSL will take full responsibility for the subsequent Phase 2b/3 clinical trial, which is expected to commence in late 2020. Production of the vaccine to support late-stage clinical trials has already commenced at CSL’s biotech manufacturing facilities in Broadmeadows, Melbourne.
“CSL’s focus is to produce a safe and effective vaccine,” said CSL CEO and Managing Director Paul Perreault. “It is important that on completion of clinical trials the public has confidence in UQ-CSL V451, which makes use of the well-established recombinant protein technology platform, and Seqirus’s proprietary adjuvant MF59, which has an extensive safety track record in humans.”
Should the trials prove successful, CSL expects the first tranche of vaccine doses to be available by mid-2021, with the total number of vaccines ordered by the Australian Government based on a two-dose-per-person regime.
The Oxford vaccine has meanwhile already entered Phase 3 trials and has been found to generate strong immune responses, though these trials have been temporarily put on hold after one of their 50,000 participants suffered what AstraZeneca described in a statement as a “potentially unexplained illness”. Like UQ-CSL V451, AZD1222 requires a two-dose-per-person regime.
Having completed a comprehensive assessment of its capabilities, CSL has agreed with AstraZeneca to manufacture approximately 30 million doses of AZD1222, with first doses planned for release to Australia early next year. CSL will manufacture the vaccine from its Australian facilities and schedule production around the UQ-CSL V451 manufacture, as well as manufacture of the company’s vital core therapies.
The Australian Government will also provide funding to support CSL’s readiness to manufacture AZD1222, thus expanding Australia’s onshore COVID-19 vaccine manufacturing capabilities. This funding will be used to establish at-risk components required to produce the commercial manufacture of a recombinant vector-based COVID-19 vaccine, including the acquisition of specialised equipment, recruitment, training and redeployment of personnel and retooling and reconfiguration of existing manufacturing facilities to current Good Manufacturing Practice standards.
AstraZeneca has established a separate commercial arrangement with the Australian Government to supply the AZD1222 vaccine to Australia once it successfully completes clinical trials. Successful manufacture and supply of AZD1222 under contract to AstraZeneca is subject to Australian regulatory approval.
“We are pleased that we can produce the AZD11222 without compromising the production of our core products — influenza vaccines and plasma and recombinant protein therapies — and provide a second option for a COVID-19 vaccine candidate to Australia,” Perreault said.
“Acknowledging that CSL is the only company in Australia with manufacturing facilities capable of producing this vaccine, we thank the Australian Government for their support, ensuring Australia has access to onshore COVID-19 vaccine production and supply. Our facilities will require modifications in order to fulfil the compliance requirements for working with vector-based vaccines, as well as the addition of skilled personnel and further capital investment.
“While there are still a number of milestones to be met, we are hopeful that by next year we’ll be in the fortunate position of having a vaccine candidate to support Australia and the world’s emergence from this crisis.”
In total, the two vaccine candidates are expected to provide more than 84.8 million doses for the Australian population, with early access to 3.8 million doses of the Oxford vaccine in January and February 2021. Prime Minister Scott Morrison did, however, acknowledge that both vaccines would need to be proven safe and effective, and meet all necessary regulatory requirements, prior to being made available freely to the Australian public.
“By securing the production and supply agreements, Australians will be among the first in the world to receive a safe and effective vaccine, should it pass late-stage testing,” he said.
“There are no guarantees that these vaccines will prove successful; however, the agreement puts Australia at the top of the queue, if our medical experts give the vaccines the green light.”
The Prime Minister also remains committed to ensuring early access to the vaccines for countries in the Pacific as well as regional partners in Southeast Asia. Both agreements allow for additional orders to be negotiated and for doses to be donated or on-sold (with no mark-up) to other countries or international organisations.
Minister for Industry, Science and Technology Karen Andrews said these agreements demonstrate what can be achieved when researchers and industry work together.
“Now our nation’s manufacturing prowess will ensure Australia is in the strongest position to roll out a vaccine as quickly as possible, if and when it proves safe and effective,” she said.
“The work we are doing now will also build our knowledge and strengthen our local manufacturing capability, which will grow our pharmaceutical and medtech sectors for the future.”
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