Commentary: Infecting volunteers with COVID-19 may speed up vaccine development
The idea of intentionally infecting people in the quest for a vaccine is not alien to medical research, says Anjana Ahuja.
LONDON: Josh Morrison, a former corporate lawyer in New York, wants to be deliberately exposed to coronavirus.
He hit on the idea after reading a scientific paper suggesting that infecting volunteers could speed up vaccine development.
Mr Morrison, an advocate of living organ donation and himself a kidney donor, set up an online register for willing human guinea pigs.
“Even developing a vaccine one day sooner could avert tens of thousands of deaths,” he implores on the One Day Sooner website, which has 15,000 signatories already.
The US vaccine developer Moderna has been in touch. The prospect is now being discussed by the World Health Organization and the US National Institutes of Health.
The idea of intentionally infecting people in the quest for a vaccine is not alien to medical research – but it is tightly regulated. It has been used to tackle diseases including malaria, cholera and flu, for which effective treatments exist.
The pandemic is now prompting scientists to recalculate what counts as reasonable risk. There is no life-saving treatment and the long-term effects of COVID-19 are unknown.
As Rutgers University bioethicist Nir Eyal and others wrote in the Journal of Infectious Diseases paper that caught Mr Morrison’s eye: “Challenging volunteers with this live virus risks inducing severe disease and possibly even death” but “could reduce the global burden of coronavirus-related mortality and morbidity”.
Trials that expose people to deliberate infection are called challenge studies, because they challenge the immune system with a pathogen.
They can shorten the most time-consuming stage of testing – phase 3 trials, which establish whether a vaccine works effectively at scale. This stage often involves thousands of people.
After a period of time, the vaccinated test group should show fewer infections than the unvaccinated control group.
That process, though, hinges on volunteers becoming infected as they go about their normal business. But this can take months – perhaps longer in an era of stay-at-home orders, social distancing and self-isolation.
Instead, Prof Eyal suggests, phase 3 trials should purposely give COVID-19 to around 100 young, healthy volunteers. It would only be done for a test vaccine that already looks promising.
If volunteers are already healthcare or other highly exposed frontline workers, that further reduces the relative risk. Prof Eyal told the journal Nature it might be “curiously safer” for such workers to be deliberately infected, as those who sicken might be caught more quickly on a trial than in real life.
Volunteers could be paid but Prof Eyal fears that might damage public trust in a vaccine and fuel accusations of preying on the poor.
Whether cash is involved or not, there is a tinge of Russian roulette to the proposal – some healthy youngsters have succumbed to COVID-19.
Perhaps extraordinary times justify extraordinary measures.
“COVID-19 is an unprecedented global challenge that requires us to work in an unparalleled way,” sums up Charlie Weller, head of vaccines at the Wellcome Trust.
“All options for speeding up vaccine development” should be on the table, she says, though a life-saving antiviral may be required before infecting volunteers.
There is good reason for caution. The ethical principles governing human testing are ultimately rooted in the Nuremberg Code, a postwar set of guidelines designed to protect human rights.
These have evolved substantially, but still generally preclude deliberate infection with untreatable, incurable disease.
Infecting the healthy with COVID-19 upends those finely calibrated judgments. But coronavirus has upended everything.
As we brace ourselves for a new normal to allow society to reopen, we may have to adopt a new ethical normal to conquer the disease that closed it down.