CEPI, the Coalition for Epidemic Preparedness Innovations, CSL and The University of Queensland (UQ) have entered into a new agreement to accelerate the development, manufacture and distribution of a COVID-19 vaccine candidate which has been pioneered by researchers at UQ. The agreement formalizes the support provided by CSL to UQ and CEPI from the outset of the pandemic earlier this year.

CEPI and CSL will fund the development and manufacture of UQ's "molecular clamp" enabled vaccine for COVID-19. Funding contributions will be used to provide support for the pending phase 1 safety study being led by UQ followed by subsequent late stage clinical trials, and industrial-scale manufacturing to allow the production of potentially millions of doses a year, should the product be approved.

The initial phase of large-scale production of the UQ COVID-19 vaccine is planned to take place at CSL's biotech manufacturing facilities in Melbourne, Australia. 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. 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.

CEPI entered into a framework agreement with UQ in January 2019 to provide up to US$ 10.6 million to develop a rapid response "molecular clamp" vaccine platform, a transformative technology patented by UniQuest, UQ's technology transfer company that enables rapid vaccine design and production against outbreak viral pathogens. In January 2020, CEPI expanded its partnership with UQ to use their rapid response molecular clamp vaccine platform to produce a vaccine candidate for COVID-19. UQ is now aiming to take the vaccine candidate in to a phase 1 clinical trial in July.

Enveloped viruses have proteins on their surface that drive fusion of the virus and host cell membranes, a key process in infection. These proteins are also the major target of a protective immune response. Although they are able to induce an immune response, they are inherently unstable and can change shape when expressed on their own. This means that the immune response induced does not efficently recognize the protein on the virus surface and so does not provide protection from subsequent infection.

UQ has overcome this problem by using their proprietary "molecular clamp" technology that locks the unstable, prefusion version of the surface proteins in a form that allows the immune system to respond more effectively. This is achieved using their proprietary "molecular clamp" technology that locks these proteins in their native virus surface form. This synthetic protein can then be purified and rapidly manufactured into a vaccine.

Most recently, early preclinical results of the UQ COVID-19 vaccine candidate showed that it produced high levels of antibodies that can neutralize the virus.

The UQ COVID-19 vaccine will be combined with Seqirus' well-established adjuvant technology – MF59 to improve immune response, reduce the amount of antigen needed for each vaccine, and enable more doses to be manufactured more rapidly.

Under the agreement, the allocation of doses between CEPI and CSL is linked to their relative contribution to overall project costs. Should the UQ COVID-19 vaccine be successful, 100% of CEPI's vaccine allocation will be distributed through the COVID-19 Vaccine Global Access Facility, an instrument of the Vaccines pillar of the ACT Accelerator within which CEPI works in partnership with Gavi and the World Health Organization. CSL's allocation will be used, at a minimum, to support its long-standing biosecurity commitment to the Australian community as well as other key groups, such as its regional neighbors. CSL has granted CEPI a first right of refusal to any surplus doses, to be distributed through the COVID-19 Vaccine Global Access Facility.

"This significant partnership between CEPI, UQ and CSL is an important milestone in the development of UQ's promising COVID-19 vaccine candidate,” said Richard Hatchett, chief executive officer, CEPI. “The partnership will enable the rapid development of the vaccine candidate through clinical trials, and by investing in large-scale manufacturing capacity now, we can reduce the time needed to deliver millions of doses of the UQ vaccine to those who need them most if it proves to be safe and effective."

Jane Halton, chair of CEPI, said, "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."