Promise wanes for mRNA onshore production

Morgan Liotta

4/05/2021 4:11:50 PM

With local manufacturing of mRNA vaccines looking increasingly slim in the short term, where does that leave Australia?

Empty vaccine vials.
To expand capacity for mRNA manufacturing, funding is only one part of the equation.

Since blood clot concerns related to the AstraZeneca vaccine surfaced, there has been a pull towards mRNA vaccines, with Pfizer now the preferred candidate for people under the age of 50.
But with supply dependent on offshore manufacturing, some experts have said that it leaves Australia in a vulnerable position, relying too heavily on overseas supply.
Australian mRNA experts, advocating for local production, recently saw a glimmer of hope with the Federal Government investigating and commissioning an audit of organisations with the capability to expand to the new technology.
New South Wales Premier Gladys Berejiklian met with leading experts in the field to discuss the state’s potential to produce the vaccines by creating a new medical manufacturing and research industry.
While the Victorian Government last month invested $50 million for mRNA vaccine production in Melbourne, with experts predicting that something could be up and running within 12 months.
But that is no longer looking likely.
Experts have suggested that a lack of knowledge regarding the potential of each vaccine candidate undergoing clinical trials last year, as well as the costs involved, have contributed to a missed opportunity for onshore production.
And even with considerable funding, Australia would still not be in a position to produce mRNA vaccines.
That is according to Professor Trent Munro, a biotech and biopharmaceutical expert who was involved in the development of the University of Queensland’s COVID vaccine candidate.
‘The money is only one part. You need the operational partner to do that. And that’s what I haven’t seen yet,’ Professor Munro said.
‘Australia needs to find ways of attracting more industry here. We need the financial incentive, but we also need the business incentive to bring the companies here to do the work.’
newsGP recently reported that the Australian RNA Production Consortium (ARPC) estimates it could take between $50–100 million to have the appropriate infrastructure in place to be able to produce the vaccines at scale.
The cost to produce the candidates that are currently available is unknown and relies on Government negotiation with Pfizer or Moderna.
‘In the future, we would be looking to develop our own vaccines that, when we’re not in a pandemic, could go through normal clinical trials that we could run here,’ mRNA researcher and ARPC member Associate Professor Archa Fox told newsGP.
‘But, currently, it would be great to be able to make the exact ones that those companies make.’
Associate Professor Fox, a strong advocate for investment in local production, recently wrote about what Australia would need to get started.
Once a biotech firm has approval to make clinical-grade therapeutics, production can then be set up.
‘As a rough estimate, we calculate it could cost as little as $100 million to make sufficient vaccine domestically. But it will mean a significant lag time, perhaps 12 months, to set up the infrastructure and train staff,’ Associate Professor Fox wrote.
But the manufacturing capacity and technology is still needed.
‘The lack of capacity to make mRNA is both a threat and an opportunity for the Australian biotechnology sector,’ Associate Professor Fox wrote.
‘Given the speed at which this technology has been applied to COVID-19, it would be useful to have this production capacity in Australia, so we can quickly respond to future pandemics.’
Associate Professor Fox Dr Fox says the other benefit of mRNA technology is that it can be adapted for new and emerging variants of COVID-19, as well as for other diseases.
‘With investment by the Federal Government and willingness from the private sector, Australia could be part of this innovation wave,’ she wrote.
‘This technology would be useful for COVID-19 mRNA vaccines, future pandemics, and future medicines more broadly.’
Another issue Australia faces, according to experts, is the ‘commercialisation’ of intellectual property.
Implementing intellectual property incentive tax rates would ‘decrease the flow’ of Australian medical intellectual property overseas, and ‘underpin the growth of advanced manufacturing jobs, infrastructure investment and sovereign self-reliance in critical medicines, vaccines and other health equipment and supplies’.
And while recent state and federal investments show promise, Australia is falling behind in manufacturing.
Applications to the Federal Government’s $1.5 billion Modern Manufacturing Strategy for funds to upgrade Pfizer’s manufacturing facility in Adelaide have been unsuccessful.
Other mRNA vaccine candidates have also pulled out of Australian production.
GlaxoSmithKline announced last year its Melbourne-based plant would close by the end of 2022, and in 2014 CSL chose to invest in Switzerland over Australia for its new plant.
Professor Munro warned Australia is ‘moving in the wrong direction’.
‘Why are companies pulling out of manufacturing in Australia, rather than coming in?’ he said.
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