A Victorian-made mRNA vaccine gets to the next stage

While other types of vaccine, like AstraZeneca, are currently being made in Australia, there is as yet no large-scale way to make mRNA vaccines (such as the Pfizer or Moderna vaccines), meaning these vaccines have to be shipped in from overseas.

But a team of Victorian researchers have just announced they’ve developed the first local mRNA vaccine for COVID-19, which is heading into Phase I clinical trials.

A Melbourne plant run by IDT Australia has produced 450 doses of the vaccine, which will be given to 150 people to test its safety, and whether it provokes an immune response. Results from the trial are expected in 2022.

The vaccine was co-developed by the Monash Institute of Pharmaceutical Sciences (MIPS), the Doherty Institute and IDT Australia, and was funded by the Victorian government.

“This is a major milestone in Australia’s ability to manufacture homegrown COVID-19 mRNA vaccines,” says Professor Terry Nolan, head of the vaccine and immunisation research group at the Doherty Institute.

“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.”

Australia can’t yet make any mRNA vaccines onshore at scale, because there isn’t a facility that has all the equipment and expertise needed to make mRNA vaccines from end-to-end – although a number of places are capable of doing parts of the process.

For instance, BioCina, which officially opened its plant in Adelaide last week, has microbial fermentation equipment with the right certification (Good Manufacturing Process, or GMP), which is needed to make the mRNA. But it’s still working on the subsequent stages of the process – lipid nanoparticle coating, which stabilises the mRNA so it can go into human bodies – and it doesn’t have a fill/finish facility, which safely bottles the vaccines for distribution.

The IDT plant, in Boronia in Melbourne, doesn’t yet have microbial equipment and skills to make mRNA at scale (although it did make the mRNA for the 450 trial vaccines). It can, however, do the latter stages of the vaccine making – lipid nanoparticle coating, and bottling of the vaccine – using equipment it purchased from Canada.

Both companies, along with several others, have put in a bid with the federal government to fund the expansion of their facilities, so they can cover the other parts of the vaccine manufacture process.

“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,” says Associate Professor Archa Fox, a researcher at the University of Western Australia and president of the RNA network of Australasia.

“This announcement by MIPS/Doherty/IDT is a significant step forwards towards creating our first homegrown Australian mRNA vaccine.”

“We might well see from this a new mRNA COVID-19 vaccine come to market. This alone would be an important development as we are faced with an ongoing demand for vaccines to fight the pandemic,” says Professor Thomas Preiss, leader of the RNA Biology Group in the College of Health & Medicine at the Australian National University.

“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.”