Australia is playing catch-up when it comes to pharmaceutical manufacturing, which could limit our ability to make and distribute any future COVID-19 vaccines, experts say.
The government announced a deal with the developers of a potential vaccine to the disease that has taken more than 400 lives in Australia and decimated the economy. But experts have warned more resources are needed for production and manufacturing of drugs and vaccines, as our sovereign capability is too low.
Prime Minister Scott Morrison announced a "letter of intent" with pharmaceutical company AstraZeneca on Wednesday to allow a COVID-19 vaccine to be manufactured onshore if the candidate under development by Oxford University is successful.
While details are still to be decided, it would be manufactured under a licensing agreement by Australian company CSL, which has a facility in Broadmeadows in Melbourne.
But outside of CSL, there are concerns about what other facilities exist locally to be able to manufacture vaccines and drugs needed.
A report commissioned by the Department of Defence in 2017 found "manufacturing capabilities exist for diagnostics and vaccines, however overall capacity is low".
It found "capacity to upscale production is a major weakness" of Australia's onshore medical countermeasure capability, which includes vaccines, therapeutics and and diagnostic technologies in the event of a pandemic or other major event.
The government's COVID-19 Vaccine and Treatment Strategy, also released on Wednesday, said information was being gathered about existing manufacturing capability and an audit would look at what elements of local industry could be adapted to produce vaccines or treatments.
Dr Rob Grenfell, health director of the Health and Biosecurity Unit at CSIRO, said Australia was fortunate to have CSL onshore in Australia, which can produce two types of vaccines, including the Oxford vaccine.
"We are going to find that we have got limited capability to produce onshore, a successful vaccine candidate," Dr Grenfell said.
"It would be very exciting if it was the Oxford, because that is something CSL has indicated it could modify production techniques to do so, also if the UQ one was successful that they could do that."
That is more important than the vaccine. In Australia there is this myopia about vaccine, vaccine, vaccine.Dr Craig Rayner
CSL has already signed a partnership deal with the University of Queensland, which also has a promising vaccine candidate.
If another kind of vaccine was successful though, like the Moderna vaccine candidate that is in phase three trials in the US, a facility would need to be built if it was to be manufactured onshore.
"The vast majority of pharmaceutical grade substances are imported into Australia," Dr Grenfell said.
"We would need to be investing sizeable effort and finances into developing the facilities to build here, part of that government push is to do a stocktake of what is here that may benefit in investment to bring it up to the level that is needed."
Options to invest in could even include manufacturers that make animal and agricultural vaccines, Dr Grenfell said.
"They would have to actually also go through changes to their production capabilities to change to a different product, but also to go through to lift themselves to standards required into the human sector."
"There is a need to invest in this," Dr Grenfell said, pointing out that both CSIRO and CSL were started by the federal government after the Spanish Flu 100 years ago.
"That was then when a realisation came that we needed to have a much more solid focused investment on our sovereign capability," he said.
Associate Professor Craig Rayner, who wrote the report for Defence in 2017, said Australia's capability had improved since then, but the country would be "lucky" if one of the successful vaccine candidates was able to be produced onshore.
While Australia has an important role to play in the global race to develop and manufacture a vaccine for COVID-19, Dr Rayner said therapeutics were actually the most important sovereign capability the government needed to focus on.
"That is more important than the vaccine. In Australia there is this myopia about vaccine, vaccine, vaccine."
Dr Rayner sits on the World Health Organisation's Therapeutics Working Group and is president of integrated development at Certara, a global company that works on drug development. He says more time needs to be spent on repurposing existing treatments to use against COVID-19, as the success rate of medicines over vaccines is higher.
"There is a tremendous need for increasing onshore sovereign capability in general across the product development sphere," he said.
"Right now we have Remdesivir, which we cannot get access to, which actually treats the disease," he said.
Australia needs to expand its thinking on what it could be doing now to ensure treatments for COVID-19 could be manufactured locally, he said, as well as what capabilities could be repurposed for that instead of focusing only on vaccine development.
"Ninety per cent of drugs which are on the pharmacy shelves, they originate through their whole supply chain into China, into India, so we have very little supply chain surety in moments like this or other defence situations or political situations, which actually support the provision of essential medicines in Australia," he said.
Dr Rayner said the Australian government needed to get more advice from people who work in production of drugs when developing its strategies around vaccines and treatments.
A spokesman for Health Minister Greg Hunt said Australia had made more than $300 million in investments in vaccines, therapeutics and COVID-19 medicines. Of the $333 million, $256 million was on vaccines.
The strategy includes research, purchasing agreements, international agreements and onshore manufacturing, the spokesman said.
"We are confident that these investments and actions will secure early and sufficient access to a safe and effective vaccine," he said.
"The government is assured that CSL has the capacity to produce sufficient vaccine for the entire Australian population, either for Australian-based vaccines or under licence for leading international vaccines."