CSL‘s subsidiary, Seqirus, has signed a final agreement with the Federal Government for the supply of 51 million doses of the University of Queensland-CSL COVID-19 vaccine candidate (V451), should clinical trials be successful.
This follows the Company’s announcement on 7 September 2020 advising that a binding Heads of Agreement had been entered into with the Australian Government.
CSL said the agreement includes ‘an up-front financial commitment’ from the Government to support the clinical and technical development activities in order to progress V451, and, if clinical trials are successful, also secures access to onshore production and supply of the vaccine for Australia.
CLS has a separate agreement in place with the Australian Government and with AstraZeneca to produce approximately 30 million doses of the Oxford University/AstraZeneca vaccine candidate, AZD1222.
The company said that although the two vaccines work through different approaches, they can leverage many facets of the same manufacturing platform technology used to produce recombinant proteins.
“The large-scale Phase 2b/3 clinical study for V451 is almost ready. It will be a randomised, observer-blinded, placebo-controlled study across numerous countries and >100 sites,” reads CSL’s statement.
“The study will evaluate efficacy, immunogenicity and safety in adults aged 18 years and above.
“Subject to progress in the current Phase 1 study, the first subject for the Phase 2b/3 would be enrolled in December 2020, with the goal completing recruitment by March 2021.
“We are committed to demonstrating the vaccine is safe and effective prior to availability in the market. Discussions have already commenced with the Australian Therapeutic Goods Administration (TGA) to ensure this goal is met, while also making the vaccine available to the Australian population in the shortest possible time.”