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If you ever needed proof that necessity is the mother of invention, you wouldn't have to look much further than the coronavirus crisis.
Key points:
- Dozens of attempts are underway globally to devise an effective coronavirus vaccine
- But there are looming dilemmas when it comes to rollout and costs
- Some drug companies could be tempted to pursue riskier strategies during trials
In the last few weeks there has been a surge of research activity and innovation, as dozens of labs join the race to develop a vaccine.
They include teams in Australia. But experts are cautioning not to expect anything to become available for a while.
"In reality, I would say at least a year," University of Queensland virologist Kirsty Short predicted.
"Even though there's some really promising vaccines in development, including one made by UQ, we have to do all the appropriate safety testing."
Some companies, however, are taking bolder — and potentially riskier — approaches to testing.
For example, a US firm working on a vaccine has made the controversial step of bypassing animal testing, and has begun testing on human subjects.
The need for a vaccine is urgent and obvious: the global death toll from COVID-19 currently stands at more than 100,000.
But the extent to which volunteers in vaccine trials should be asked to put themselves at risk for the "greater good" is not an easy dilemma to solve.
There are also unanswered questions about how much a vaccine will cost, and to what extent drug companies will be tempted to put profits before patients.
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Could drug companies profiteer?
During the 1950s, American journalist Ed Murrow asked poliovirus vaccine developer Jonas Salk who owned the patent on his new creation.
"There is no patent," Salk said. "Could you patent the sun?"
The vaccine shot Salk to stardom and, for him, the satisfaction of having saved thousands of people from lifelong paralysis was enough to forego millions of dollars in personal profit.
Salk's answer to Murrow's question has gone down in history as a rare example of altruism within the pharmaceutical industry.
"The fundamental set-up of the pharmacological system … is built around the notion of profiteering," University of Adelaide medical ethicist David Hunter said.
Modern pharmaceuticals are a high-stakes business — the first company to develop a coronavirus vaccine is likely to be poised for a handsome payday.
But the idea of getting rich from a global health emergency does not sit well with some, who have suggested any patent on a coronavirus vaccine should be waived for the benefit of all.
While Dr Hunter said that was unlikely to happen, he also said it was not in the interests of drug companies to hold patients or governments to ransom by demanding exorbitant fees.
"There's a couple of reasons. If a company does do that, it's unlikely their competitors who are trying to bring other vaccines to the market are going to stop in their tracks," he said.
"There would be a huge level of public outcry about that sort of behaviour, and pharmaceutical companies are sensitive to that kind of outcry because it affects their other product lines.
"I don't think there's any real need to profiteer from it because the company's going to make a lot of money selling the vaccine to a lot of people."
Could they be told to hand over the formula?
The idea behind a competitive system is that dangling the carrot of financial gain is the best incentive to quickly produce quality results.
But governments are also major sponsors of research, and have already committed huge sums of money to develop a coronavirus vaccine.
In South Australia, a team of researchers — including virologists and immunologists from different hospitals and rival research institutes — has banded together to establish what immunologist Simon Barry labelled a "fellowship of the virus".
"What we as a team are trying to understand is exactly what's going on in your immune system all the way through the virus course," Professor Barry said.
"If we can understand why some people have mild symptoms and what that means at the cellular level, maybe we can then look and predict which people might have severe responses."
While Australia has systems such as the Pharmaceutical Benefits Scheme and the National Immunisation Program to subsidise treatments and vaccines, drug companies are still at liberty to charge huge fees.
Your questions on coronavirus answered:
But under rarely used World Trade Organisation rules, governments also have the power to "compulsorily license" patented products if there is a public health emergency.
That means a government could independently start producing a vaccine if a pharmaceutical company demanded more than it was willing to pay.
"They do have to compensate the patent holders but the amount they have to compensate is at least to some degree up to the [government]," Dr Hunter said.
The rollout of a coronavirus vaccine, he added, would almost certainly be subsidised by the Federal Government and made freely available to the Australian public.
Should volunteers be deliberately exposed?
The current coronavirus, SARS-CoV-2, belongs to a family of viruses which have so far resisted efforts to devise a vaccine.
While seasonal coronaviruses are relatively common, they only tend to cause mild symptoms and have not really attracted the attention of researchers.
"There hasn't been a coronavirus vaccine yet because there hasn't been a coronavirus like this one," Dr Short said.
"SARS and MERS — people were working on vaccines for them, but they caused only a limited number of outbreaks."
In medicine, the most common model of testing involves administering a drug or vaccine to volunteers and then waiting to compare their health outcomes with a control group who do not receive the treatment.
However, there is another option which is potentially faster, but also riskier and more ethically murky.
"There are two different pathways you can take for vaccine testing. The standard pathway is you go through Stage One, Stage Two, Stage Three clinical trials," Dr Hunter said.
"The other option some people are talking about is what are known as 'challenge trials' — you give the vaccine to your participants and then intentionally expose them to the illness to see if it works. The obvious ethical issue there is the 'see if it works'."
Some academics are already advocating using human challenge trials in coronavirus vaccine testing, suggesting volunteers be sought among "young adults, without chronic health conditions and not otherwise sick" who live in areas with already high transmission rates.
"Volunteers for human challenge studies would be drawn from previously uninfected individuals at relatively low risk of complications or mortality," the authors of a paper in The Journal of Infectious Diseases wrote recently.
Photo:
A boy receives the Salk polio vaccine which was pioneered during the 1950s. (Getty: Bettmann)
Dr Hunter understands the pros and cons but said that, at the moment, if he was on an ethics committee, he would probably say no to a human challenge trial for a coronavirus vaccine.
"You're asking them if they're willing to take the risk of getting it," he said.
"That really plays into a big debate that goes on in the context of research ethics about whether it is OK to allow people to potentially suffer significant harms to gain benefits for others."
Who should get it first?
An associated dilemma is whether participants in human trials should be offered payment as an incentive for the risks they take.
While this is not uncommon, it is something of an awkward question.
"Ethics committees normally don't like people being paid because they feel that payment means they're more coerced," said University of Tasmania immunologist Greg Woods.
"If anything like this does go ahead, it's going to have to be done with all the ethics approvals and all the safety checks. It's not something you would do because of the emergency of the situation."
In a recent article for the ABC, medical ethicists Julian Savulescu and Dominic Wilkinson wrote that doctors would likely have to ration access to "medical resources, including life-saving ventilators", should the crisis worsen.
A similar situation is likely to occur with a vaccine.
Dr Hunter warned that, if and when one is eventually available, it will inevitably be in short supply to begin with, meaning access will be limited.
"The two obvious groups of people who would have priority … would be healthcare professionals, because they're the people who are likely to have the highest exposure risks, then those who are vulnerable, so you'd probably start with the elderly and people with conditions that put them at higher risk."
After that, Dr Hunter said it was highly unlikely that there would be a need to force people to get vaccinated, because of the huge level of public concern and demand.
"You're talking about a disease where we need about 60 to 70 per cent coverage to achieve herd immunity," he said.
"You are going to get that voluntarily."
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Topics: covid-19, diseases-and-disorders, health, medical-ethics, medical-research, science-and-technology, adelaide-5000, sa, brisbane-4000, qld, hobart-7000, tas, australia