Clinical trials for Australia’s first messenger RNA (mRNA) COVID-19 vaccine candidate will begin in the new year, the Victoria state government has announced.
Victoria Medical Research Minister Jaala Pulford said the vaccine candidate production made Victoria a leader in mRNA therapeutics and manufacturing.
“It is an incredible achievement to have made an mRNA vaccine candidate that is ready for clinical trials,” he said.
The vaccine candidate was created to fight against the Beta COVID-19 variant, which has since died out but also began in southern Africa.
The trials will be run by the Doherty Institute, which has provided the research and modelling for Australia’s national plan to reopen the country after the pandemic.
Doherty Institute Head of Vaccine and Immunisation Research Group Professor Terry Nolan said it was a “major milestone” in Australia’s ability to manufacture home-grown COVID-19 mRNA vaccines.
“We are excited to commence Phase 1 clinical trials of this candidate, along with the protein vaccine candidate developed by the Doherty Institute, in the coming months,” he said.
About 120 people aged between 18 and 70, who have had two COVID-19 vaccinations already, will be invited to participate in the trial.
“They have to have had their second dose at least three months earlier. They will receive either the mRNA vaccine or another vaccine, some individuals in this study will receive a placebo,” Nolan said.
“We’re hoping that we get this done quickly before everyone gets their third dose, once they do we’re going to run out of people who are potentially volunteers.”
The mRNA vaccine candidate was created “in just five months,” with 450 doses produced in the Melbourne suburb of Boronia, enabling 150 people to take part in Phase 1 clinical trials run by the Doherty Institute, the release stated. Results are expected later in 2022.
The project comes as part of a “landmark collaboration” led by mRNA Victoria in partnership with Monash Institute of Pharmaceutical Sciences (MIPS), the Doherty Institute, and IDT Australia.
Monash University Professor of Pharmaceutical Biology Colin Pouton said, “We have worked with determination and in close collaboration with IDT to develop the mRNA COVID-19 vaccine candidate—reaching this milestone demonstrates that the skills and experience to make mRNA products are available in Victoria.”
IDT Australia CEO Dr. David Sparling said he was honoured to be part of the project.
“We believe this product will be the first locally developed mRNA COVID-19 vaccine candidate and the first locally manufactured cGMP mRNA drug product,” he said.
The Victoria state government invested $5 million towards the manufacture of the doses, with dedicated equipment shipped from Canada.
The machine processed nanoparticles into final liquid drug form, sterilised the product and filled vials with mRNA vaccine, the release said.
The Victorian government established mRNA Victoria in a bid to support Victorian proposals for the federal government’s Approach to Market on mRNA manufacturing capability.