From the moment a pandemic is declared, every day, week and month that passes without a vaccine is significant.
Globally, Coronavirus 2019 (COVID-19) has been seen to infect more than one hundred thousand people in a single day, with a fatality rate of up to five percent.
Despite this urgency, the vaccine development process is still too drawn out, taking on average ten to fifteen years to progress from initial lab work to a regulatory green-light.
Whilst it may not be sensible to skip clinical trial phases – as seen recently in Russia – Professor Nikolai Petrovsky from Flinders University and Vaxine says there are many ways to safely speed up the vaccine development process.
“We certainly shouldn’t throw away the rule book when it comes to pandemic clinical trials and regulatory approval, but we can create a pre-pandemic plan that dramatically accelerates the traditional process,” said Petrovsky.
Ahead of the Innovate Health Conference, Petrovsky makes three key suggestions on how to shorten the vaccine development timeframe, without compromising on safety, tolerability or efficacy – the three pillars of vaccine success.
#1 – Pre-ordained grant system
Having funding available to start vaccine development right at the start of a pandemic can shave months of the traditional process, Petrovsky argued.
“We effectively lost seven months from the start of COVID-19, simply because government research funds were not available – and are only starting to dribble out now, albeit in tiny amounts. If we had access to funding right at the time the pandemic started, we would be much more advanced now,” he said.
Petrovsky believes Australian funding agencies should be mandated to make a quantum of funding available for applicants, immediately after a pandemic is declared, with a maximum review turnaround of two weeks.
These grants could be relatively modest, in the range of 0.5 to 1 million per applicant, allowing ten to twenty groups to start developing vaccines.
“This is a tiny sum in a budgetary sense. Particularly when you compare it to the tens of billions of dollars of economic damage incurred every month a pandemic continues,” he said.
In the absence of data, grants could be primarily judged on a researcher’s track record of producing successful vaccines in the past.
The next step, he suggests, is that every funded vaccine candidate that gains approval to start Phase I human trials receives an automatic grant of $5 million dollars, a further $10 million in Phase II trials, and $50 million for Phase III.
“If we removed the whole cumbersome MRFF/NHMRC peer review process we could initiate the development of vaccines in days of a pandemic starting,” he said – noting that the existing peer reviews required to enter clinical trials are stringent enough.
“So far, only one other Australian vaccine apart from ours has made it into human trials, so such a funding scheme would have only cost the government $10 million so far. This equates to about 10 minutes of economic damage from the pandemic.”
#2 Make a pre-pandemic war plan
Petrovsky draws comparisons with military war response plans and does not believe pre-pandemic strategies have the same level of rigour.
“If someone declares a war, the Defence force will have a war plan already in place that lays out every possible aspect of how to fight back – including the immediate release of large amounts of funding. Upon declaration of a war, that plan is triggered,” he said.
“In the current pandemic, this level of preparation was not seen, with governments taking months to react to what was happening.
“This is most clearly seen in the Australian government’s vaccine response, with their strategy still remaining highly unclear. Almost no funding has been put into attempted vaccine development in Australia, which contrasts strongly to what is happening in other parts of the world -particularly the US,” he said.
Another seemingly unplanned-for barrier is that there are not enough cases of the infection locally for Australian developers to undertake phase III trials and show a vaccine is effective.
“Most Australian government research funding from MRFF/NHMRC demands all the money be spent in Australia, which makes it impossible to use such funds to undertake pandemic trials overseas,” Petrovsky added.
With local vaccine development stunted, Australia is much more vulnerable to uncertainties in access.
#3 Drill down into the pros and cons of each vaccine type before making large commitments
With huge global demand and vaccine scalability constraints, governments often feel pressured to enter into large advance purchase contracts for vaccines, even before they have been shown to work.
Allocating all of a country’s funds to a single vaccine candidate that could turn out not to be successful, runs the risk of leaving no alternative options.
As such, Petrovsky urges governments not to use superficial markers – such as the speed with which particular candidates get into phase I trials – as a surrogate for vaccine safety and efficacy.
“The trouble is, governments who are making these purchasing decisions do not have an in-depth understanding of the scientific strengths and weaknesses of each vaccine type, in the same way a researcher would,” he said.
As one key example, the adenovirus vector and mRNA vaccine methods –currently being sponsored by the USA under operation Warp Speed – are approaches that have never before been approved for human use, making them high risk candidates.
“Some vaccine varieties, like genetically manipulated viruses and nucleic acids, may lend themselves to faster initial development, but trip up on effectiveness, safety or tolerability. Alternatives such as recombinant protein vaccines may take longer to develop, but are more reliable with well proven effectiveness and safety,” Petrovsky concluded.
Professor Nikolai Petrovksy is currently developing a COVID-19 vaccine known as COVAX-19, based on recombinant spike protein vaccine formulated with Advax polysaccharide adjuvant, which is currently just completing phase I trials. He is due to speak at the Innovate Health Conference – held as a virtual event on 31 August to 2 September.