CSL and CEPI agreement on COVID-19 vaccine for Australia

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CSL has announced it will partner with the Coalition for Epidemic Preparedness Innovations (CEPI) to accelerate the development and manufacture of the COVID-19 vaccine under development at The University of Queensland (UQ).

The new agreement builds on the support CSL and CEPI have already provided to the development of the 'molecular clamp' enabled recombinant vaccine.

The organisations announced the expanded agreement under which CSL and CEPI will fund the pending phase 1 safety study, expected in July, followed by late-stage clinical trials and industrial-scale manufacturing at the CSL Behring facility in Melbourne.

"While there are a number of critical milestones to be met before the vaccine can be considered successful, CSL anticipates that the production technology can be scaled to produce up to one hundred million doses towards the end of 2021," said the company in a statement.

"CSL would also subcontract other global manufacturers to increase the number of doses that can be produced and broaden the geographical distribution of vaccine production. Should clinical trials be successful, a vaccine could be available for distribution in 2021."

The 'molecular clamp' vaccine platform is a technology patented by UniQuest - UQ’s technology transfer company. The technology is thought to have a potency advantage over other recombinant vaccines. 

Early pre-clinical results of the UQ COVID-19 vaccine candidate showed it produced high levels of antibodies that can neutralise the virus. It will be combined with Seqirus’ (CSL) adjuvant technology - MF59 - to improve immune response, reduce the amount of antigen needed for each vaccine, and enable more doses to be rapidly manufactured.

Under the agreement, manufactured doses will be allocated between CSL and CEPI based on "their relative contribution to overall project costs."

CEPI's allocation will be distributed through the COVID-19 Vaccine Global Access Facility. CSL’s allocation will be used for Australia and countries in the region.

CSL’s chief scientific officer Professor Andrew Cuthbertson said, “CSL will contribute to UQ’s promising vaccine with our proprietary adjuvant, MF59, made by Seqirus, along with expertise in process science and scale-up from our Australian facilities, managing advanced clinical trials and the large-scale manufacture of the recombinant vaccine. Should trials be successful, this vaccine holds the potential to provide protection against this urgent public health emergency for Australians and those around the world vulnerable to this devastating virus.”

CEPI chair Jane Halton AO PSM added, “This is an important step forward in our battle against this virus. We know that the only way to beat this pandemic is through collaboration, across countries and also across sectors. We also know that we cannot afford to wait until we know whether a vaccine works before ensuring we can produce it at scale.

"This partnership will benefit enormously from CSL’s experience and capabilities in vaccine development and large-scale manufacturing, which is why this is such an important development. If this vaccine is successful, the partnership model we have established will enable CEPI to provide a significant number of doses to the COVID-19 Vaccine Global Access Facility for those who need them most, while allowing CSL to fulfil its own long-standing biosecurity commitments.”