The pre-clinical trial is now complete, with early laboratory trials demonstrating the vaccine effectively neutralises COVID-19 and is safe to use in humans. It has also determined the correct human dosage.
More than 100 Queensland volunteers between the age of 18-55 have already been recruited for the Phase 1 human clinical trials which started in Brisbane on 13 July 2020.
With COVID-19 appearing to have a higher degree of disease severity in older individuals, The University of Queensland (UQ) is now seeking 96 Queenslanders over the age of 56, to volunteer for the Phase 1 human trials to help gauge the vaccine’s safety among an older demographic, as well as the immune response elicited.
By conducting the expanded safety study, UQ will be able to gather key data to support the large-scale efficacy trials that vaccine partners CSL are planning to run in the near future.
The Phase 1 clinical trial will confirm the safe dosage range and identify if there are any side effects. There is a lot of pressure on making a safe and effective vaccine available globally: without a vaccine our health, way of life and economy will continue to be impacted. The UQ team is working with CEPI and regulatory authorities like Australia’s Therapeutics Goods Administration to fast-track the process without compromising safety.
The Phase 1 clinical trials will conclude around September 2020. If they are successful, the clinical studies will be expanded. CSL will manufacture the vaccine for Phase 2 and 3 clinical trials and will also manufacture the final vaccine for Australian and global demand if the trials are a success. CSL anticipates that they can produce up to one hundred million doses towards the end of 2021.