Messenger RNA vaccines – the type used by Pfizer and Moderna – have been at the forefront of the world’s COVID-19 response despite the new technology having never received approval for widespread medical use prior to the pandemic.
Currently, Australia’s only active coronavirus vaccine manufacturing site is located in Melbourne. Owned by biotech company CSL, the plant has been producing more than one million doses per week of the AstraZeneca vaccine – which utilises more common viral vector inoculation technology.
But with health advice recommending against the use of the AstraZeneca vaccine for under 60s, the Federal Government has been forced to reconsider its rollout strategy and set aside an undisclosed pool of money in the 2021-22 budget to support onshore mRNA vaccine manufacturing.
The Commonwealth put out an approach to market for local mRNA vaccine manufacturing on May 21, giving Australian firms eight weeks to lodge applications for grant monies.
Between five and 15 groups are expected to file applications, officials from the Department of Industry and Science told a Senate Estimates hearing last month.
The winning applicant would be the first manufacturer of mRNA vaccines in the southern hemisphere.
Biologics contract development and manufacturing firm BioCina, a subsidiary of global private investment firm Bridgewest Group, went public in May with a bid to manufacture mRNA vaccines at a 4600m2 plant in Thebarton in conjunction with the University of Adelaide and the South Australian Health Medical Research Institute.
The firm acquired the Thebarton site from Pfizer in August 2020, and it is touted by BioCina as “the most advanced facility of its kind in Australia” and the only one to have received approval from the US Federal Drug Administration.
In May, BioCina CEO Ian Wisenberg said production at the Thebarton facility could begin “within 12 months” if they received funding from the Federal Government.
Wisenberg now says the firm is “deep in the throes” of putting together a response to the Commonwealth’s approach to market.
“We’re well-heeled to be able to enter into mRNA manufacturing,” Wisenberg told InDaily.
“This is a national requirement and something that we feel very strongly on that needs to be a concerted effort and a collaborative effort.”
The application deadline for the Commonwealth’s approach to market is next Friday, July 16.
For Wisenberg’s firm to begin manufacturing, it needs to secure a technology transfer agreement with one of the pharmaceutical companies that created the vaccine.
“The big piece that the government has kind of put on the shoulders of companies like BioCina, or the consortiums if you will, has been the access to or acquisition of IP (intellectual property) around the full technology,” Wisenberg said.
He said it is more likely BioCina will be able to strike a deal with US biotech company Moderna due to that firm’s stated interest in working with the Australian Government to investigate local manufacturing opportunities.
Moderna reached an agreement with the Federal Government on May 12 to supply 15 million doses of its mRNA vaccine to Australia by the end of 2021 and a further 10 million in 2022.
The Moderna vaccine is yet to receive approval from the Australian Therapeutic Goods Administration, but it was granted provisional determination from the TGA on June 24, which allows the biotech company to apply for provisional registration for its vaccine in Australia.
“I believe we found some options either with Moderna or another company,” Wisenberg said.
“I am extremely excited about what we’re putting together as a proposal to the government, and hopefully bringing in other consortiums whether it be New South Wales or even Victoria CSL.”
The Victorian Government has committed $50 million to support CSL develop an onshore mRNA manufacturing capability.
The Federal Government has also allocated $2.2 million in funding to the University of Queensland to promote the development of mRNA vaccine at their Australian Institute for Bioengineering and Nanotechnology.
Wisenberg said BioCina would be looking to partner with other companies to fill in the parts of the manufacturing and distribution process his company does not specialise in yet.
“As we look at our expertise and where we have comfort – it’s in getting to a drug product,” he said.
“We can manufacture the raw material which is a plasmid, we can do the process development and manufacturing of mRNA, we can therefore get to the drug substance which is the bulk.
“[But] to get to a drug product, you need to specialise. We need the lipid nanoparticles and the encapsulation technology which we don’t have currently.
“That’s something that could come with a potential partner that we’ve identified that has that technology, and we’ve identified the equipment partner as well.”
Department of Industry and Science General Manager for Commercialisation David Luchetti told Senate Estimates last month it could take up to four years to start an mRNA manufacturing site from scratch.
“For a greenfields site, it could take three years, four years, because you’re starting afresh,” he said.
“The facility needs to get all the regulatory approvals that it needs to obtain through the process … so it’s difficult to identify just how quickly it could happen.
“But we think it could be as short as a year if it’s a brownfields site. It could be three years, maybe a little bit longer for a greenfields site.”
Industry and Science Minister Christian Porter has said he believes a site could be up and running within 18 months.
Wisenberg said an onshore mRNA vaccine manufacturing site will allow Australia to react “more fluidly” to future pandemics, variants and diseases with the same RNA platform.
“You could realistically be stockpiling some of the technology such that when these [pandemics] hit, you can react very quickly,” Wisenberg said.
“You can only react very quickly if [the expertise and manufacturing] is in-country, you don’t want to be reliant on other countries for dealing with what might be a localised event.
“It’s not about COVID as in COVID-19, but COVID-22.”
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