The opposition has accused the federal government of “kicking the can down the road” on plans to develop a domestic mRNA vaccine manufacturing capability, following revelations it doesn’t expect this to be operational until at least 2023.
The federal government has confirmed that it is unlikely an Australian company will be able to license an existing mRNA COVID-19 vaccine and produce it locally, with plans instead shifting to an entirely locally developed vaccine, meaning that it won’t be until at least 2023 that this is operational.
The industry department approached the market earlier this year for a private company or consortium to provide a full blueprint for an end-to-end manufacturing capability for mRNA vaccines, including for COVID-19.
It came after the federal government provided an undisclosed amount of funding in the May budget for this program. Applications for this approach closed in July, with the government receiving 12 responses from state governments, large biotech firms and startups.
While also considering funding a private company to build a new capability, the Coalition has also been in long-running discussions with Moderna, which has developed a COVID-19 mRNA vaccine, to establish Australian operations.
Former industry minister Karen Andrews said in October that Australia would have mRNA “production lines” within the next year while current minister Christian Porter later said this would more likely be in 12 to 18 months. The government now believes Australia won’t have any local mRNA capability until at least 2023.
In a statement to InnovationAus, Mr Porter dashed hopes that the current holders of mRNA vaccine intellectual property (IP) – Pfizer and Moderna – would agree to license these products to be manufactured in Australia.
A similar operation is currently running in Australia with CSL domestically manufacturing the AstraZeneca vaccine, and there had been hopes that a local firm would manufacture the Pfizer or Moderna vaccines domestically. But Mr Porter now says the chance of this is “remote”.
“Expert estimates of when scalable manufacture of mRNA medical products could be achieved in Australia vary but while there is a range of variance, it seems to centre on full capability in 2023,” Mr Porter said in the statement.
“This type of timeframe is the consequence of both the complexity of establishing new mRNA facilities … it is also a necessary consequence of the fact that at present only two companies in the world own IP to an approved mRNA product and the likelihood of either of the existing approved IP owners licensing that IP to others to produce product, which is the basis of any shorter timeframes, is remote.
“That means that our thorough considerations involve continuing discussions with Moderna on establishing its own facility, as well as looking to companies or collaborations locally that are both developing their own, or have access to development IP and will be capable of completing all the steps in mRNA production.”
Applicants that match this criteria include a bid by Monash University, likely backed by the Victorian government, which recently launched early trials of its own mRNA COVID-19 vaccine.
These delays are also due to Australia’s lack of companies able to produce these vaccines, with struggles in commercialising research into productive deep tech firms, RMIT lecturer in entrepreneurship, Julian Waters-Lynch, wrote this week.
Shadow industry minister Ed Husic said the government has “kicked the can down the road on domestic mRNA manufacture”.
“In October last year, then-industry minister Karen Andrews said we’d be making mRNA vaccines locally within 12 months. Nine months later in June, Christian Porter said a reasonable timeframe would be 12 to 18 months,” Mr Husic told InnovationAus
“Now, almost a year on, they’ve moved the goalposts again, saying 2023. Millions of Australians are stuck in lockdown because of the Morrison government’s failures during this pandemic. With a Minister for Industry whose head isn’t in the game, can we trust this will actually happen?”
Local mRNA manufacturing will be part of Australia’s long-term ability to combat pathogens, not just COVID-19, Mr Porter said.
“Whilst the current focus of mRNA is around the current COVID pandemic, the enduring benefit for Australia in establishing onshore mRNA manufacturing will be more aligned to future variants of COVID-19 or other pathogens,” he said.
“But just as importantly, it is also about the use of mRNA to tackle other serious health issues, which is where Australians can really benefit as the technology is applied to disease, such as cardiovascular conditions and a whole range of other serious medical conditions.”
The federal government has already paid consulting giant McKinsey more than $4 million to assist with its plans for mRNA vaccines, including $2 million last year to work on a business case which won’t be released publicly, and a further $2 million to assist with the approach to market.
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