Hi Peter! That line of argument should be an important part of this discussion as well.
For an individual person, it’s unquestionably better to give them an untested vaccine and no disease (as in administering an untested vaccine in the context of a conventional trial), rather than an untested vaccine and a disease (as in a human challenge trial). The tradeoffs between conventional trials, HCTs, and untested emergency voluntary mass vaccination campaigns, are less clear at a population level, which is why I think it needs more study and debate.
I focused this post around HCTs because they seem more conventional than emergency untested vaccination campaigns. It seemed to me that anyone hesitant about changing the status quo would be more likely to support HCTs than a mass untested vaccination campaign.
Now, I’m not so sure. The ethical qualm with HCTs is rooted in a medical ethic that prioritizes the wellbeing of the individual.
Imagine we face a another pandemic. We knowthe disease is deadly and that we have no treatment for it. We have reason to think the vaccine is relatively safe and at least somewhat helpful. Under those conditions, it seems like the best way to prioritize the wellbeing of individual patients is to allow them to take an untested vaccine.
So the key unquestioned assumption is not the ethics of HCTs. That at least has been examined, if insufficiently. It’s not even the ethics of administering an under- or untested medical treatment, which we already do all the time.
Instead, it’s the ethics of requiring that phase III trials have the minimum power/study size to gather adequate safety and efficacy data.
Why can’t we instead say that in emergency circumstances, it’s unethical to limit the study size? Instead, when a disease becomes a deadly pandemic to the extent that we’re considering lockdowns, the entire population should have the opportunity to voluntarily participate in a vaccine trial. We already allow Phase I and Phase II to be combined. Why not also allow Phase III to be expanded?
I’m going to start exploring that angle; I wonder if that will be a more tractable approach to rethinking our pandemic response.
Hi Peter! That line of argument should be an important part of this discussion as well.
For an individual person, it’s unquestionably better to give them an untested vaccine and no disease (as in administering an untested vaccine in the context of a conventional trial), rather than an untested vaccine and a disease (as in a human challenge trial). The tradeoffs between conventional trials, HCTs, and untested emergency voluntary mass vaccination campaigns, are less clear at a population level, which is why I think it needs more study and debate.
I focused this post around HCTs because they seem more conventional than emergency untested vaccination campaigns. It seemed to me that anyone hesitant about changing the status quo would be more likely to support HCTs than a mass untested vaccination campaign.
Now, I’m not so sure. The ethical qualm with HCTs is rooted in a medical ethic that prioritizes the wellbeing of the individual.
Imagine we face a another pandemic. We know the disease is deadly and that we have no treatment for it. We have reason to think the vaccine is relatively safe and at least somewhat helpful. Under those conditions, it seems like the best way to prioritize the wellbeing of individual patients is to allow them to take an untested vaccine.
So the key unquestioned assumption is not the ethics of HCTs. That at least has been examined, if insufficiently. It’s not even the ethics of administering an under- or untested medical treatment, which we already do all the time.
Instead, it’s the ethics of requiring that phase III trials have the minimum power/study size to gather adequate safety and efficacy data.
Why can’t we instead say that in emergency circumstances, it’s unethical to limit the study size? Instead, when a disease becomes a deadly pandemic to the extent that we’re considering lockdowns, the entire population should have the opportunity to voluntarily participate in a vaccine trial. We already allow Phase I and Phase II to be combined. Why not also allow Phase III to be expanded?
I’m going to start exploring that angle; I wonder if that will be a more tractable approach to rethinking our pandemic response.