A potentially more effective influenza vaccine is set to become a significant medical breakthrough by Australian researchers, but only thanks to US funding.
Flinders University researchers have developed a drug they believe could make seasonal flu vaccines more effective, and this will now be tested in a 12-months clinical trial across the US. The study is backed by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the US National Institutes of Health (NIH).
But while this is great news for an Australian development, it has triggered a spat over the lack of homegrown support for the research, including from the National Health and Medical Research Council (NHMRC). With the sparks flying, chief executive officer Professor Anne Kelso saw a need to defend her organisation against allegations that its funding has an undue bias towards ‘the big end of town', the larger Australian research institutes.
In a public statement, she rejected the criticism from Professor Nikolai Petrovsky, the main driver of the vaccine development, which Business Insider reported in early July.
“NHMRC does not direct funding to any institution. Funding decisions are an outcome of a competitive process that relies on the collective judgement of independent peer reviewers,” she said, while congratulating Petrovsky for actually having received NHMRC money exceeding $1 million.
With the sparks flying (in an orderly kind of way), it is noteworthy that Petrovsky’s grudge with the NHMRC isn't new.
In 2007, he already accused the medical funding body of showing a "dangerous bias", then reported by the ABC.
In response, former NHMRC chief executive Professor Warwick Anderson accepted the criticism pointing out that an international review was to look into the NHMRC's grant process. It led to a major overhaul of the system, which has just been implemented, but how it will correct the often lamented tendency of the NHMRC to fund risk averse research remains still to be seen.
Nevertheless, the wounds obviously run deep. Petrovsky told Business Insider that his research career had been put on the line when the NHMRC rejected a grant proposal, but that his project was then saved by the US National Institute of Health (NIH).
The US funding body went on to become a major supporter of his research, and of the company Vaxine Pt Ltd he founded in 2002 to commercialise a novel adjuvant for human vaccines called Advax (according to Petrovsky, the US funder has supported his research with over US$50 million to date).
Adjuvants are compounds that can significantly enhance the effectiveness of a vaccine by turbocharging the immune response of indivuals. They are thought to be especially useful in groups of persons that tend to respond less well to vaccines, such as the elderly, or to accelerate the response to a vaccine, such as in a pandemic.
Their safety profile is generally good safety profile, although in some case they have shown adverse affects, and how they work is not fully understood.
Also, according to a recent review paper of adjuvanted influenza vaccines, they do not address a basic problem of influenza vaccines, which is that the influenza virus evolves to variants the vaccine then cannot protect against anymore.However, there are several different types of adjuvants now part of licensed influenza vaccines, and there is a need for new and improved developments, including to boost vaccine responses in a pandemic situation.
Petrovsky and Vaxine achieved a major breakthrough with its Advax platform in 2009, when it developed, in partnership with US firm Protein Sciences, the first vaccine against swine flu.
The US influenza trials may now deliver Petrovsky's research another major boost. The new drug is als based on Advax and, according to the researchers, was completely designed by artificial intelligence, which could be a world first for a human drug.
"It represents the start of a new era where artificial intelligence (AI)is going to play an increasingly dominant role in drug discovery and design", Petrovsky said in a statement.
He told the ARDR that the new approach concerns the CpG55.2 component of the drug called Advax-CpG55.2.
The details of the process are yet to be released, but Petrovsky told Business Insider that it is based on a program called 'Search Algorithm for Ligands', or SAM, which was developed at Flinders University. Petrovsky's team 'trained' the algorithm using sets of components with known capacity to stimulate the human immune system, and then used to select promising drug candidates from a large library of synthetic compounds.
According to Petrovsky, the process of drug development is much faster than conventional approaches.
The upcoming trial for Advax-CpG55.2 is a Phase I study with up to 240 healthy persons (the ARDR has uncovered that several media outlets wrongly reported an unrelated Phase II trial due to a wrong link in Flinders' press release) to evaluate whether it is safe and effective in boosting the current Flu vaccines Fluzone and Flublok.
Petrovsky remains frustrated, though, by the lack of support he received in Australia, and the NHMRC is not the only target of his criticism.
As recently reported by the ABC, he vented his anger at South Australian health bureaucrats for preventing a trial from taking place in Adelaide, and threatened to move his research, including Vaxine, out of Australia entirely, which caused a local political stir.
Amid the ensuing broil, South Australia's health agency responsible for terminating two of the trials explained that these simply did not meet 'mandatory requirements'.
"Our priority is to always deliver safe and appropriate research trials to our community," said Adjunct Professor Sue O'Neill, the chief executive officer of the Southern Adelaide Local Health Network.
It's called Red Tape, and its merits areperhaps a matter of perspective. However, Petrovsky's overall point is that the US provided a much more welcoming ground for his research. Based on the outcome its a point difficult to dispute.