Australia is one of many nations seeking to make the type of COVID-19 vaccine pioneered by Pfizer and Moderna during the pandemic – but can we make doses onshore anytime soon without help from big pharma?
- The federal government is assessing proposals to set up mRNA vaccine manufacturing in Australia
- Several companies that have entered bids are putting forward COVID-19 vaccines still in the trial phase
- Experts say the best chance at making vaccines here soon is striking a deal with Moderna
ABC News has confirmed several players, including CSL, BioCina, Luina Bio and IDT, are proposing to set up large-scale local manufacturing of mRNA vaccines.
The Commonwealth is now assessing their bids and almost 10 others as part of a push to get these types of vaccines made here.
Experts say local manufacturing could ensure steady a supply of these sorts of vaccines, and help with developing booster shots for variants of COVID-19 that may become specific to our region.
But getting this happening anytime soon could hinge on a single global player.
“There’s a lot of goodwill and international cooperation [currently] that people haven’t seen before in the biotechnology and the biopharmaceutical sector,” RNA expert Archa Fox, from the University of Western Australia (UWA), said.
“But at the end of the day, there is obviously also profit involved as well.”
Who are the main players in mRNA COVID vaccines?
Messenger-RNA (mRNA) is literally a molecule.
Research into its use in vaccines and in other areas of biomedical research such as cancer had been going for years before the pandemic hit.
Yet it was the American multinational pharmaceutical company Pfizer, in partnership with German biotech company BioNTech, that got the first ever mRNA vaccine to market.
That was its COVID-19 jab and it was approved late last year, and only for emergency use.
While Pfizer grabs a lot of the headlines, it was actually BioNTech that developed the groundbreaking vaccine. Pfizer, one of the biggest pharmaceutical corporations in the world, carried out mass clinical trials and led global manufacturing.
RNA expert and Monash University professor Colin Pouton said there was currently no capacity to manufacture clinical-grade mRNA vaccines in Australia, although there were some facilities that could do parts of the process.
He said producing this sort of vaccine was a multi-step process that involved making DNA, then turning that into mRNA, and then putting that into lipid nanoparticles that essentially held the molecule.
“It’s really because we don’t have the facility to make a large enough batch under specific conditions that we can’t do it here,” he explained.
His research team is about to spend half a million dollars sending DNA to Belgium to have it processed for its mRNA COVID-19 vaccine research. It will get back just 2,000 vials.
“It’s going to be quite a costly process,” he said.
Compare that to the global machine making Pfizer on a mass scale.
The conglomerate has some manufacturing hubs in Australia, but none are set up to mRNA vaccines here.
Its COVID vaccine manufacturing involves the use of 280 materials from 86 suppliers in 19 countries. There are two supply lines – one each in the US and Europe – that exclusively manufacture the final product.
“This is to ensure quality, speed and scale,” Pfizer told ABC News in a statement.
“Vaccine manufacturing is a biological production. It is extraordinarily complex under any circumstances, and even more so during a pandemic.
While the exact details of Australia’s commercial agreement with Pfizer remain opaque, it is understood the federal government buys the vials straight off the company for use here.
“We utilise road and air modes of transportation from Europe and the US to Australia to get product to the federal government’s designated locations,” a Pfizer spokesperson said.
Australia has so far ordered 40 million doses of Pfizer. On the weekend, the government announced it has also ordered 85 million booster shots of Pfizer, which would start arriving next year.
Then there is Moderna’s vaccine.
Moderna is comparable to BioNTech – it was mostly a biotechnology developer when the pandemic hit. It came up with its mRNA COVID-19 vaccine and then needed to figure out how to make it on a global scale.
“They’re not like Pfizer, which has got a whole range of existing infrastructure across the world for doing commercial product manufacturing,” UQ biotech and pharmaceutical expert Trent Munro said.
“Moderna has had to rely on partnerships with other companies, so-called contract manufacturing companies, to help boost their manufacturing capacity.”
That is the sort of commercial arrangement that CSL already has with Oxford’s AztraZenca to make 50 million doses of its COVID-19 vaccine here in Australia for us. It’s a viral vector vaccine, which is made in a different way to mRNA shots.
To use an analogy, contract manufacturing is like a fashion label in Australia that goes to an existing offshore factory and shows it how to make its latest clothing line.
Moderna’s mRNA vaccine is not approved for use in Australia yet.
However, it has been widely used in the US and elsewhere, and the federal government has ordered 25 million doses, pending approval from the Therapeutic Goods Administration.
What Australia is now hoping to do locally
Interest is clearly growing in mRNA.
“There’s such a buzz around RNA as a technology platform, because it’s gone past the proof of concept,” Professor Munro said.
And there is clearly a political opportunity in making more COVID-19 vaccines in Australia, with Prime Minister Scott Morrison apologising for a slow vaccination rollout.
Earlier this year, the federal government announced an “approach to market” (ATM) where it asked for proposals to set up end-to-end mRNA vaccine manufacturing in Australia. That means a set-up that can do the whole supply chain domestically, without imports.
Crucially, it wants proposals that can deliver so-called population-scale quantities — enough doses for our entire country — within three years.
The ATM notes this is not just about delivering mRNA vaccines for COVID, but about tapping into the broader potential of this emerging space of biotechnology to help with areas like influenza or cardiovascular research.
The Commonwealth is also not obliged to fund anything out of this process.
More than a dozen applications are now being assessed, including those from CSL, BioCina, Luina Bio and IDT.
Investment firm BioCina is putting forward the use of its facility in Adelaide, which it somewhat ironically acquired off Pfizer just before COVID-19 erupted.
BioCina’s US-based chief executive Ian Wisenberg said one of the hurdles in the ATM process was finding a partner with a suitable mRNA COVID vaccine-19 that their Adelaide facility could make.
“We all know of the Pfizer and Moderna vaccines,” Mr Wisenberg said.
“But whether they are willing to do a regional deal is the question.”
The reason why a deal is crucial is because an existing factory in Australia can’t just start making Pfizer or Moderna’s vaccines. It needs the knowledge and, importantly, it needs their patents and intellectual property.
“[Big pharmaceutical companies] have been putting hundreds of millions of dollars into the know-how and their capability to deliver these products,” Professor Munro said.
“They’re going to want to protect that from a commercial point of view.
Interestingly, Pfizer and BioNTech just signed an early-stage agreement like this with a South African manufacturer to make their vaccine there.
BioVac’s going to obtain drug substances from the Pfizer/BioNTech supply chain in Europe and then manufacture the doses for the entire African Union by 2022.
But Pfizer is ruling out a similar arrangement for Australia anytime soon.
“We are utilising our centralised global manufacturing hubs in Europe and the US to increase capacity and scale for production to supply to Australia,” the spokesperson said.
“This will continue to be the company’s strategy for the time being.
This leaves Moderna.
The federal government has already said it is “engaging” with the US company on local Australian manufacturing, regardless of the current ATM process that is underway.
In May, federal Health Minister Greg Hunt told media the government was in “active discussions with Moderna as a possible candidate under [the] approach to market”.
“And our hope is that we will have at least one, if not more than one, manufacturing operation in Australia. I won’t make a guarantee on that, but I am confident that over the future period, we will have mRNA production in Australia,” he said on May 13.
The same month, the conglomerate even registered a subsidiary company here called Moderna Australia.
It is unclear if any of those who have submitted confidential proposals to the federal government’s call-out have managed to secure the company’s IP or a partnership, or if Moderna is leading its own proposal.
Monash University’s Colin Pouton believes Moderna is Australia’s “only short-term solution” of getting mRNA COVID-19 vaccines made here quickly.
“That could be done by a few companies. It could certainly be done by CSL. It could also be done by IDT,” he said.
CSL in Melbourne is the only pharmaceutical manufacturer in Australia that is already making a COVID-19 vaccine here: AstraZeneca.
Neither CSL nor IDT would comment on the nature of their proposals.
UWA’s Archa Fox said if a Moderna manufacturing deal was secured for Australia, large-scale production could be happening within 12 to 18 months.
“Being optimistic, I would be saying 12 months from the date at which the government gives a green light and funds roll out,” Dr Fox said.
“But I think there’s others in my team that would say that two to three years is more realistic.”
Moderna did not respond to queries. The federal government also declined to comment about how far along its talks with the American pharmaceutical and biotechnology company were now.
So if not Moderna or Pfizer, then what?
Without Moderna, Dr Fox believes the push for mRNA onshore manufacturing becomes a much longer-term strategy.
Part of that approach would be about investing in the biotechnology’s wider potential long-term future, which the federal government has acknowledged is part of the strategy.
“This is a really big opportunity for Australia to become a global player in this new biotech, that is based around RNA,” she said.
IDT’s proposal is understood to involve this sort of “Australian-made” strategy.
Last month, the company told the ASX it was in discussions with the Monash Institute of Pharmaceutical Sciences (MIPS) and the Victorian government to locally manufacture an mRNA vaccine at its Melbourne facility.
The MIPS initiative is being headed up by Colin Pouton. His team’s mRNA COVID-19 vaccine – the one being partially made in Belgium – is about to go into human trials with help from a $5 million grant from the Victorian government.
“It’s a little different to the existing approved mRNA vaccines,” he said.
Professor Pouton did not put a time frame on how long full-scale production of his vaccine could take.
It’s important to note that getting a vaccine through human trials and then approved for widespread use is a long and uncertain process, with this one expedited considerably last year in response to the pandemic.
BioCina’s proposal also involves an mRNA COVID-19 vaccine that is still in the trial phase. They won’t disclose which one.
BioCina’s Ian Wisenberg said they could get production up and running within 14 to 16 months, and they needed less than $200 million in funding to make this happen.
“In that number is a licence fee required by our partner for the IP, and that’s not cheap,” he said.
“And rightly so — they spent a lot of money developing that [vaccine].”
Another bidder, pharmaceutical contractor Luina Bio in Brisbane, is also partnering with a mRNA COVID-19 vaccine that is still in development overseas.
“We expect to be able to go from the start of the project to having a registered vaccine approved by the TGA out the door by two years,” Luina Bio’s chief executive Les Tillack said.
“But we’d say that’s a fairly aggressive time frame.”
It is unclear what the other proposals contain. Some may involve building whole new facilities – so-called greenfields sites.
Senate Estimates heard last month that getting a greenfields operation up and running could take up to four years.
Expert warns we can’t get caught up in mRNA hype
As well as AstraZeneca, Pfizer and Moderna, our government has also ordered 51 million doses of Novovax, pending approval, which is another type of vaccine.
Professor Munro has a healthy dose of scepticism when it comes to Australia achieving end-to-end mRNA vaccine production soon.
He has grounds to be cautious.
He was part of the team that got a local COVID-19 vaccine into human trials last year, only for researchers to discover it induced false-positive HIV results. The team is still working on that vaccine, which does not use mRNA.
“There are many of us in the scientific community who believe that it’s absolutely critical to have a whole range of vaccine solutions and potential solutions for COVID-19,” Professor Munro said.
“We know that different people are going to respond differently. Older individuals, immuno-compromised individuals — all these folks may need different types of vaccine solutions into the future.
“So that has to be part of the continuing investment and not just solely focused on mRNA.
“Although, I think we are convinced that the potential for mRNA-based vaccines and therapeutics is absolutely huge. So that needs to be focused on.”
He was positive about the potential of Australian-developed and made mRNA vaccines.
“Even if then we’re licensing that to the rest of world, I think that’s a great outcome. I think timelines are definitely longer,” he said.
The federal government has not put a dollar figure on how much it is willing to invest in this space. And it has technically made no commitment to doing anything.
Minister for Industry, Science and Technology Christian Porter said receiving the proposals was a “key step” in setting up “a sustainable, sovereign vaccine manufacturing capability to Australia”.
“[This] will protect Australia against future pandemics and support Australian industry to benefit from the long-term potential of mRNA technology,” he said.
He added that proposals would be considered against their access to intellectual property for mRNA products, the ability to produce enough vaccines for our population, and the long-term viability of any facility.
The Victorian government has also put forward $50 million towards an mRNA manufacturing initiative, and it is understood it has supported both CSL and IDT’s proposals.
Globally, other countries, such as South Korea and South Africa, are looking at setting up mRNA in their markets too.
“We’ve got to get started,” Dr Fox said.
“That’s what we’ve been saying for a while. We just need government to give it the green light. Somebody needs to get started doing it here as soon as possible.”