Human Challenge Trials for Coronavirus

My dad sent me this article. I’ve studied ethics pretty seriously, so he was curious about my opinion. Since I’ve been on the lookout for topics to write about, I figured I should write a post about it.

Before I start, I should warn you that I’m no expert on medical ethics. I don’t know nearly enough about medicine. The closest thing to a class I’ve taken on medicine was high school biology. So, I’ll take you through my reasoning, but make up your own minds about it.

The article discusses the prospect of doing “human challenge trials” for a Coronavirus vaccine. Basically, what that means is that they would recruit young, healthy volunteers, give them the vaccine, deliberately expose them to the virus, then see what happens. The people working on this already have over 7,600 volunteers lined up. The participants would be young and healthy so that they are low-risk patients if the vaccine doesn’t work.

Ethically speaking, this comes down to a risk vs. reward situation. If the potential risks are greater than the potential rewards, the trial should not happen. So, how do they stack up? The most obvious reward is that, if it works, we would have a vaccine for Coronavirus, and could save thousands of lives. The most obvious risk is that participants in the study might become seriously ill or die. This looks like a stalemate, some people with latch on to the potential lives saved and others the potential lives lost, but it’s not really this simple.

Human challenge trials are not the only way to develop a vaccine. They aren’t even the normal way of developing a vaccine. They are a method of getting the testing done faster. So, the reward isn’t really the vaccine itself. The reward is really the time saved. It makes a big difference how much time that is. If it’s days, then the human challenge trials are clearly unethical. If it’s years, then there’s a chance that it’s worth it. The article didn’t explicitly say how much time would be saved, but the feeling I get from reading it is that it would save months. That’s a much smaller reward for some pretty significant risks, and those are just the most obvious risks.

There are a bunch of other risks. For starters, when dealing with a self-selecting group of volunteers for the test, there’s no way to know if the results will apply across the population. Even if it is successful in the trial, there’s no way to know if it will be effective in older people, children, or people with underlying health conditions. There’s also the risk with a potential vaccine that instead of preventing the disease, it makes the disease more severe. And there’s the risk that the results of the trial will be unclear. If the people who take the vaccine only develop mild symptoms, is that because the vaccine mitigated the worst of the virus or is it because it is often mild in young, healthy people?

If you haven’t guessed already, my feeling is that the risks outweigh the rewards and they should not use human challenge trials to develop a vaccine faster. I have one other point I want to make, though. When doing a study, it is important to let the participants know the risks and to get their informed consent. The article almost dismisses that aspect. Since they are all volunteers, of course there is informed consent. I can grant the consent part, but I’m unsure of the informed part. One of the maddening things about this disease is how little we seem to know about it. I understand that may be the fault of the press and the politicians, but how informed are the volunteers really? I don’t have an answer, but it’s an issue that should be taken seriously.

So, that was my basic thought process. I should reiterate that I am not an expert in medical ethics. But, with the information I have, I don’t think human challenge trials are worth the risk. Hopefully, whoever makes the final decision will be much better informed than I.

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