Scientists create Australia's first mRNA vaccine candidate

Victorian scientists and manufacturers have created Australia’s first mRNA COVID-19 vaccine candidate — and first ever mRNA drug product — in just five months, enabling clinical trials to begin early in 2022.

The project has been led by mRNA Victoria — created by the Victorian Government in order to drive the establishment of a sovereign mRNA manufacturing industry — in partnership with the Monash Institute of Pharmaceutical Sciences (MIPS), The Peter Doherty Institute for Infection and Immunity and IDT Australia, in what has been described as a landmark collaboration between Victoria’s medical research and manufacturing sectors.

Professor Colin Pouton, who led the MIPS team that developed the vaccine, said it has the ability to rapidly adjust its composition in response to emerging virus mutations. This is particularly important as new strains continue to emerge, including the variant recently discovered in South Africa.

“The new variant Omicron has an unprecedented number of mutations in its receptor binding domain,” Prof Pouton said. “How concerned we should be about this variant remains to be seen, but our RBD mRNA vaccine program is perfectly suited to producing a specific vaccine to protect against this new variant.

“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.”

The Victorian Government invested $5 million to enable manufacture of the COVID-19 vaccine candidate, with dedicated equipment shipped to manufacturer IDT Australia from Canada. The machine processed nanoparticles into final liquid drug form, sterilised the product and filled vials with mRNA vaccine.

This enabled 450 doses of the vaccine candidate to be produced by IDT, in preparation for 150 people to take part in Phase 1 clinical trials to be run next year by the Doherty Institute. The Australian Government also provided over $1.5 million through its Medical Research Future Fund (MRFF) in 2020 to Monash and the Doherty Institute to begin the clinical trial process.

Scientists around the country have expressed their excitement about the development, with the founder of the RNA Network of Australasia, Professor Thomas Preiss, describing it as “a real watershed moment for our country”.

“We might well see from this a new mRNA COVID-19 vaccine come to market,” Prof Preiss said. “This alone would be an important development as we are faced with an ongoing demand for vaccines to fight the pandemic.

“Equally importantly, RNA has plenty of potential as a therapeutic beyond vaccines. The breakthrough in Melbourne then shows us that, as a country, we have the wherewithal to build an RNA R&D ecosystem that can efficiently develop these new drugs. The hope now is that we will furthermore put them into local production and service a growing global market.”

Associate Professor Archa Fox, who serves as President of the RNA Network, added that the announcement is “a significant step forwards towards creating our first home-grown Australian mRNA vaccine”.

“mRNA vaccines have been proven to be both quick to design and highly effective at preventing severe COVID-19 disease,” Assoc Prof Fox said. “Because of the high cost of buying in vaccine from overseas, and the potential to be at the back of the queue for future pandemics, we urgently need to build expertise, capacity and capability in Australia to make mRNA vaccines and RNA therapeutics more broadly.”

The Victorian Minister for Innovation, Medical Research and the Digital Economy, Jaala Pulford, concluded that it is “an incredible achievement to have made an mRNA vaccine candidate that is ready for clinical trials”, describing the breakthrough as “an Australian first that confirms Victoria as a leader in mRNA therapeutics and manufacturing.”

Image credit: ©stock.adobe.com/au/Matthieu

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