The WHO was yesterday to hold discussions about the feasibility of trials in which healthy young volunteers would be deliberately infected with COVID-19 to hasten vaccine development, amid questions over whether they should go ahead given the promising data from the front-runner vaccine candidates.
Some scientists have reservations about exposing volunteers to a virus for which there is no cure, although there are treatments that can help patients.
However, proponents have said that the risks of COVID-19 to the young and healthy are minimal, and the benefits to society are high.
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The WHO advisory group meeting, which was to focus on reviewing existing plans for “human challenge trials” and discuss associated technical concerns, did not include groups representing research participants or members of the public.
The global body said the meeting was a focused technical consultation with scientific experts, and that such meetings were not usually open to the public, but that future meetings could include civil participation.
More than a dozen scientific experts were expected to convene as part of the advisory group, and observers could include representatives of the Wellcome Trust, the Bill & Melinda Gates Foundation, the US-based National Institutes of Health and the US Food and Drug Administration.
“If the argument is, we’re just giving advice into what the studies should look like — we think research participants should be a part of that. And if the argument is that this [meeting] is completely separate from the ethical side of things, I do think that’s hard to disentangle from the technical concerns,” 1Day Sooner executive director Joshua Morrison said.
1Day Sooner has had the opportunity to contribute commentary to ethical guidelines on human challenge trials, as well as the technical roadmap for such trials published by the WHO this year.
“That’s not really quite the same as being in the meetings where decisions are made,” Morrison said.
In a document detailing the key criteria for the ethical acceptability of COVID-19 human challenge studies issued in May, the WHO recommended human challenge programs should be informed by public engagement, including challenge study participants or those who have expressed interest in participating, in addition to experts and policymakers.
Human challenge trials have the potential to yield results more quickly than conventional vaccine field trials in which researchers must wait for participants to get infected in the real world.
These studies can also be used to compare multiple vaccine candidates, develop treatments and gather data about the immediate aftermath of infection, which would otherwise be difficult.
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