CSL Limited (ASX:CSL) has signed a Heads of Agreement (HoA) with the Australian Government for the supply of 51 million doses of the University of Queensland’s (UQ) COVID-19 vaccine candidate (V451), and a separate HoA with AstraZeneca to manufacture the Oxford University candidate (AZD1222), should clinical trials of both prove successful.
CSL CEO & Managing Director, Paul Perreault, said the total number of vaccines ordered by the Government is based on a two dose per person regime. Upon completion of successful clinical trials, CSL expects the first tranche of doses to be available by mid-2021.
The social and economic impact of the COVID-19 pandemic has brought a high level of urgency to the task of developing a vaccine against the SARS-CoV-2 virus, and to manufacture a successful vaccine at high quality and in sufficient quantities,” Mr Perreault said.
“CSL has been working at pace to respond to the pandemic and has invested significant resources in the rapid development and large-scale manufacture of UQ-CSL V451, along with a number of other therapeutic programs.
“Together with partners including the University of Queensland and Coalition for Epidemic Preparedness (CEPI), our development and manufacturing teams have been working extremely hard to advance this program to ensure the availability of a safe and effective vaccine should clinical studies prove successful,” he said.
The HoA is between CSL’s influenza vaccines company, Seqirus, who will hold regulatory responsibility as the marketing authorisation holder, and the Australian Government. Production of the vaccine to support late stage clinical trials has commenced at CSL’s biotech manufacturing facilities in Broadmeadows, Melbourne.
Mr Perreault said results from the pre-clinical and early clinical studies for UQ-CSL V451 are promising; however, it is impossible to predict the level of success the candidate will have in late stage clinical trials.
“CSL’s focus is to produce a safe and effective vaccine. 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’ proprietary adjuvant MF59®, which has an extensive safety track record in humans,” he said.