What would it take for Australia to manufacture mRNA vaccines?

Before Pfizer and Moderna’s COVID-19 mRNA vaccines hit the circuit, the technology had never been used in humans. But four months after they received regulatory approval, they have been safely administered to hundreds of millions of people in multiple countries.
 
With Australia’s vaccine rollout running into significant issues amid concerns of blood clots related to the AstraZeneca vaccine – long considered the backbone of the country’s program and the only candidate that can be manufactured locally – many have called for the Federal Government to develop the capacity to develop mRNA vaccines onshore.
 
In response, the Government has commissioned an audit of local organisations with production capability, such as CSL, to consider ways to establish and sustain large-scale manufacturing.
 
Experts say the decision makes sense, given that Pfizer is now the preferred vaccine for millions of Australians under the age of 50, in place of locally produced adenovirus AstraZeneca vaccine.
 
But Associate Professor Archa Fox says experts have been calling for action for months. She is among members of the Australian RNA Production Consortium (ARPC) who have been lobbying the Government since the middle of 2020.
 
‘There was understandable scepticism in terms of this technology at that point because it’d never been approved before for clinical use,’ she told newsGP.
 
‘But … we could see the potential [and] the RNA methodology has really come up trumps, and that’s what’s so exciting to us, that we can really see a future for this technology.
 
‘It’s possible that this will become the gold standard, we don’t yet know, but we think it’s quite possible.
 
‘So we really feel, for so many reasons, not just for sovereign manufacturing capability, but also for the potential to grow a biotech sector in Australia, that we should invest.’  
 
But what would it actually take for Australia to join the handful of countries that can make these new-generation vaccines?
 
Associate Professor Fox says it could take anywhere between 3–12 months to have the infrastructure up and running, depending on how large an investment is made.
 
‘If we have really significant investment and we have willingness for tech transfer from Pfizer or Moderna, then we could do what happened in Germany, which was a three-month turnaround to ramp it up – that was pretty exceptional,’ she said.
 
‘We were assuming in our lobbying that we wouldn’t’ t be getting that amount of investment, so we were predicting a 12-month turn around.
 
‘It’s all just a matter of money.’   
 
In terms of capital expenditure, the ARPC has estimated it could take between $50–100 million to set up the infrastructure to be able to produce the vaccines at scale.
 
In order to produce the exact vaccines that are currently in circulation, however, the cost of tech transfer remains the big unknown.
 
‘That’s something that the Government has to negotiate with Pfizer or Moderna,’ Associate Professor Fox said.
 
‘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. But, currently, it would be great to be able to make the exact ones that those companies make.’  
 
For Stuart Turville, an Associate Professor in the Immunovirology and Pathogenesis Program at the Kirby Institute, investing in the local manufacture of mRNA vaccines is ‘a no brainer’ given the growing concern around new COVID variants and the ability to rapidly change the vaccine’s sequence to address any new threats.
 
He says while it may not get Australians vaccinated against COVID by the end of 2021, it is about forward planning to address potential issues around supply and demand, particularly given the possible requirement for annual booster shots.
 
‘We’ve got brilliant people, hardworking people, and we just need somebody to step up and say, “Let’s just do this”,’ Associate Professor Turville told newsGP.
 
‘If we have the more fluid ability to produce the vaccines, to change the vaccines and have that element of control, we won’t have to negotiate [because] in 2022, what’s the next negotiation? Is it the booster shot? Is there a gnarly virus out there that needs a booster and who’s going to make that first?’   
 
CSL has publicly said it is considering moving to mRNA capacity, but it would require significant investment.
 
Federal Health Minister Greg Hunt said the Government is looking into Australia’s capacity to adapt, but that it would take ‘a considerable amount of time’.
 
‘And so the fastest way to get vaccines into arms is through our Pfizer contracts,’ he said.
 
But Associate Professor Turville says investing in RNA technology will have benefits that go well beyond Australia itself, as well as the current pandemic.
 
‘It’s about pandemic preparedness in the future,’ he said.
 
‘If we do it now, we get it up and running, we show that it works, we show we can do it, we show we can update formulations, then we can really help out not only Australia, but also our neighbours. Situations like Papua New Guinea are just devastating.’  
 
Associate Professor Fox agrees that by investing now, it will expand local capacity to develop, test and manufacture vaccines for a range of viruses and diseases.
 
‘There’s a lot of potential for cancer therapeutics [as well as] viruses that we care more about in Australia than other parts of the world might care about, so we need a local industry that can be able to develop this technology,’ she said.
 
‘For example, things like HTLV [human T-cell lymphotropic virus], which is a terrible problem for our Indigenous communities. We do have researchers here in Australia who want to develop RNA vaccines against that virus, [but having] to go international to develop this is really putting them at a disadvantage.
 
‘So it’s a very exciting technology and we really don’t want to be left behind. That’s the message we’re trying to put out there to venture capitalists, to investors, to different levels of government.
 
‘It’s not just about COVID.’  
 
Log in below to join the conversation.

AstraZeneca COVID-19 Moderna mRNA vaccines pandemic Pfizer RNA technology vaccine rollout