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Friday, May 01, 2020

Should We Deliberately Infect Vaccine Volunteers with the Coronavirus?

The novel coronavirus has not only sickened millions and killed hundreds of thousands, it has devastated the world economy and limited the freedom of billions. While some hope to have a vaccine in 18 months or sooner, it could take longer--much longer. One reason the search could take a long time is that late-stage vaccine studies usually include thousands of subjects, some of whom receive the target vaccine and some of whom receive a placebo. Then we wait and compare the susceptibility of both groups to the virus. It can take a long time, however, to get statistically meaningful results, especially if quarantine and social distancing measures prevent most people in both arms of the study from getting infected. 

One way to speed up the search for a vaccine is to deliberately infect young, healthy, adult volunteers (living in areas where the virus is already rampant) with the coronavirus as part of a "human challenge" vaccine trial (see, e.g., Eyal et al. and this letter from 35 members of Congress "potentially" supporting this approach.) We usually don't deliberately infect people with viruses that can cause diseases as serious as COVID-19, but these are not ordinary times. In a forthcoming essay in the Journal of Law and the Biosciences, I argue that human challenge vaccine trials for COVID-19 are not only morally permissible, they are morally obligatory, given reasonable empirical assumptions and a few additional caveats.

The journal has an accelerated publication schedule for its COVID-19 papers, so I will likely turn in the all-but-page-proofs version later in the day on Monday. It's a short piece, so if you have any corrections or feedback, I encourage you to email me soon or comment below! 

Posted by Adam Kolber on May 1, 2020 at 02:46 PM in Adam Kolber | Permalink

Comments

Adam, you may find, great interest here:

https://www.nytimes.com/2020/05/13/technology/coronavirus-vaccine-disinformation.html

Posted by: El roam | May 14, 2020 4:06:11 PM

Thanks, El Roam, I hadn't seen that!

Posted by: Adam Kolber | May 11, 2020 8:58:10 AM

By the way Adam, you may find great interest here in this regard:

https://marginalrevolution.com/marginalrevolution/2020/05/human-challenge-trials.html

Posted by: El roam | May 11, 2020 7:38:38 AM

The key language in the paper at least says, "Moreover, quarantine and social distancing measures mitigate contagion but have tremendous societal costs, reducing the freedom of billions of people. They also cause or exacerbate unemployment, substance abuse, domestic violence, and mental health disorders." So the paper may express matters a bit more precisely and avoid some of the ambiguities you all note below.

Posted by: Adam Kolber | May 5, 2020 5:23:20 PM

"And just a small quibble: the virus hasn't limited anybody's freedoms. Governments, on the other hand, have limited hundreds of millions of people's freedoms. You may think that is called for, but don't lay it off on the virus."

If one wants to quibble, it depends on how one applies liability, of course, a nuanced legal question. The virus in my view very well is a "but for" cause here on a basic level, so to me very well can be say to have "limited" us in various ways. OTOH, perhaps, we can say that when a parent stays home to care for a sick child, the child has no role in "limiting" them, since the parent could have just left the child with someone else.

Also, the government alone is the the one with responsibility here. In fact, it is generally understood the people themselves will factor in significantly here for the immediate future. So, e.g., you can allow business to open, but the people will still self-limit themselves because of concerns about the virus. Which is in that way, limiting them.

Posted by: Joe | May 3, 2020 12:06:08 PM

It'll be interesting to see how quickly 'morally obligatory' tuns into people being volun-told to get infected with the vaccine.

And just a small quibble: the virus hasn't limited anybody's freedoms. Governments, on the other hand, have limited hundreds of millions of people's freedoms. You may think that is called for, but don't lay it off on the virus.

Posted by: thegreatdisappointment | May 2, 2020 6:01:05 PM

With thanks to Joe, I think I've now fixed the link to the letter. Much appreciated! (The most pertinent language in the letter appears at the bottom of the first page and the top of the second.)

Posted by: Adam Kolber | May 2, 2020 3:21:54 PM

Okay. Let me try that again:

https://foster.house.gov/sites/foster.house.gov/files/2020.04.20_Ltr%20to%20HHS%20%20FDA%20on%20Rapid%20Vaccine%20Deployment%20for%20COVID-19%20-%20Signed.pdf

Posted by: Joe | May 2, 2020 2:17:01 PM

The letter from the members of Congress can also be found here (the link provided did not work for me).

Posted by: Joe | May 2, 2020 2:15:45 PM

Thanks, El Roam! The legal and regulatory issues you reference are important. This piece, however, happens to focus on the central bioethical issue of the moral permissibility of human challenge trials. Once we establish that we ought to have such trials, then one might turn to the legal and regulatory complications. It's also meant to be a short piece; hence, there is less background.

In terms of temperature, I do indeed hope (and somewhat expect) that higher temperatures and humidity will slow the spread of the virus. With two hemispheres, though, it's always winter somewhere. So, the paper makes some empirical assumptions about what is likely to happen, but it's certainly subject to ongoing evaluation based on the numbers and conditions of infection. Thanks again!

Posted by: Adam Kolber | May 1, 2020 7:15:44 PM

And here, more practically, concerning the US ( Federal regulations and so forth....):

https://research.uci.edu/compliance/human-research-protections/researchers/ethical-guidelines-fed-regs-and-state-statutes.html#federal

Posted by: El roam | May 1, 2020 5:23:07 PM

Here, titled:

" The reason for the Season: why flu strikes in winter"

http://sitn.hms.harvard.edu/flash/2014/the-reason-for-the-season-why-flu-strikes-in-winter/

And again, disclaimer:

Not yet proven that it is so, also, for the Covid - 19

Posted by: El roam | May 1, 2020 5:01:28 PM

Important one (and great to have you back here again Adam). Very complicated issues here. Just two inputs right now:

Firs, we would be more than happy, to get first, the legal or regulatory picture, and then, in light of it, to understand, where do we stand. What are the legal problems. Because, in a way or other, such trials, must comply with the law, or, needing simply legislation. Good way to start, would be with:

"Declaration of Helsinki"

Here:

https://www.who.int/bulletin/archives/79(4)373.pdf

Second, there is that scientific assumption, that in the summer, things would be better. Flu generally speaking, is weaker in the summer, stronger in the winter (due to many reasons, I shall leave a link later, although not yet proven, specifically,concerning the Covid- 19 ). So, empirically, had to be incorporated here ( or in that related article of yours).

P.S: as reminder, in the north hemisphere summer is due to come, and in the south, winter.


Thanks

Posted by: El roam | May 1, 2020 4:55:55 PM

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