Remember that time CNBC’s Rick Santelli caused a media firestorm by (half-seriously) suggesting that people should infect themselves with SARS-CoV-2 to try and blunt the economic fallout?
Well, months later, scientists around the world are seriously debating the ethics of so-called “human challenge” trials – where participants are intentionally “challenged” (i.e. deliberately infected with a pathogen) to test the efficacy of a vaccine or treatment. On Monday, the WHO will hear from an advisory group of scientists who will discuss the pros/cons of running these trials with young, healthy volunteers who are at the lowest risk for the most severe consequences. The Netherlands is already ramping up plans for a trial that will involve the deliberate infection of hundreds of volunteers, and the British are finalizing plans for a “challenge” study of their own.
Skeptics like DoubleLine’s Jeff Gundlach have doubted the extremely high efficacy numbers (~95%) released by Pfizer and Moderna, with the bond trading legend claiming he ‘doesn’t buy it’. Aside from the headline numbers, which Gundlach feels are unrealistically high, he pointed to other shortcomings like the small number of actually infected patients documented in each ‘Phase 3’ trial.
Isn’t the fact that the WHO is seriously considering the ‘feasibility’ of these studies a tacit admission that the data we’ve seen so far is somehow lacking?
To be sure, there are plenty of scientists who have serious reservations about exposing volunteers to SARS-CoV-2. As we have reported, while consenting adults should be allowed to take whatever risks they want, there’s a known unknown regarding this relatively new illness – namely, the fact that many patients experience a brief bout of the ‘worst flu of my life’, while others – nicknamed ‘long haulers’ – can remain ill for months, experiencing ‘waves’ of debilitating symptoms with no end in sight.
Interestingly, proponents of ‘challenge’ studies argue that recruiting young, healthy volunteers will help minimize risks, while the benefits to society are high.
‘Human challenge’ trials have been shot down in the past – including during the Zika virus outbreak in 2016, when an ethics committee denied a proposal to use HCTs to test a Zika virus vaccine due to concerns about the risks it could pose to volunteers and their sexual partners.
According to the Guardian, Monday’s WHO advisory group meeting to focus on reviewing existing plans for “human challenge trials” and discuss associated technical concerns will not involve any groups representing research participants, or members of the public.
However, observers representatives from the Wellcome Trust, the Bill & Melinda Gates Foundation, the National Institutes of Health and the FDA are expected to attend.
Advocates of challenge trials insist there is plenty of merit in conducting them, despite the latest data released by Moderna, Pfizer and AstraZeneca, arguing that the data produced will be much more helpful in determining relative efficacy of various experimental COVID vaccines. The executive director of an organization that was shut out of Monday’s WHO meeting, perhaps because he suggested that participants should be ‘part of the discussion’.
Joshua Morrison, executive director of 1Day Sooner, said: “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 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.
The UK has invested about £30MM to back a human challenge trial, although ethical approval is still pending. In the US, support for these types of trials is waning – according to the Guardian – following the Pfizer/Moderna PR blitz.
But as polls continue to show that roughly half of Americans remain skeptical of the vaccines and their efficacy, would moving ahead with ‘human challenge’ trials help change their minds?