Vaccines

UK Government Approves Challenge Trials For Research on Covid-19

The initiative could pave the way for other uses of challenge trials in the UK and beyond. It might even stimulate reconsideration of other policies banning payment for voluntary risk-taking that could save many lives.

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The UK government recently approved the use of "challenge trials" in research on the effects of Covid-19. Reason science writer Ronald Bailey summarizes the plan and its implications:

Regulators in the United Kingdom have just authorized the first COVID-19 human challenge trial, in which volunteers will be deliberately exposed to the coronavirus. The researchers hope to determine how much of the virus is necessary to cause an infection, how the immune system reacts to the virus, and how infected people transmit the virus to others.

Ninety healthy volunteers, aged 18 to 30, will be involved in the trial, which will begin in March. (The chances of someone in that age group dying of COVID-19 are estimated at around 1 in 14,000.) The volunteers will be closely watched in a controlled environment and will have access to immediate treatments for the disease. They will also be compensated with payments of around £4,500 ($6,300) over the course of a year.

The U.K. government adds that the experiment could lead to subsequent trials in which "vaccine candidates, which have proven to be safe in clinical trials, could be given to small numbers of volunteers who are then exposed to the Covid-19 virus, helping to identify the most effective vaccines and accelerate their development."

As Bailey points out, "If human challenge trials had been allowed earlier, they could have significantly sped up the development and deployment of COVID-19 vaccines, saving tens of thousands of lives and sparing millions the misery of illness." Vaccine testing could have been completed much faster than with conventional trials.

Hopefully, challenge trials will now be used to test additional vaccines that could potentially be cheaper, more effective, or easier to deploy than currently available ones. And the same should be done to accelerate testing of vaccines for other dangerous diseases. At the very least, the UK initiative cannot easily be dismissed as the work of crazy mad scientists or supposedly dangerous radical libertarians.

I am among those who have been beating the drum for challenge trials since early in the pandemic. In this May 2020 post, I made the moral case for challenge trials (including the use of financial incentives to attract volunteers), and addressed a variety of possible objections, such as claims that paying volunteers might "exploit" the poor. In October, I summarized evidence indicating that the idea of challenge trials commands broad public support in countries around the world. Unlike some other ideas backed by libertarians, this one is backed by mainstream public opinion. The outliers on this issue are the bioetheticists and members of the medical and political establishment who oppose challenge trials.

Prominent advocates of challenge trials include economist Alex Tabarrok, and philosophers Richard Yetter Chappell and Peter Singer. There aren't many issues where Chappell and Singer (who are far to the left of me) agree with Tabarrok and myself. But challenge trials fit the bill.

As I have pointed out previously, the challenge trial issue has a similar structure to several other areas where we can save many lives by giving people the right to take risks, in exchange for pay, in order to help others get vital medical treatment or supplies. These include legalizing organ markets and legalizing the sale of blood plasma in the many countries that still ban it (fortunately the US is not among them).

It is a terrible tragedy that the US and other governments literally kill many thousands of people every year by banning transactions that could save their lives. On top of that, we also inflict needless misery on many thousands of people who are forced to undergo kidney dialysis for years on end, or suffer from diseases that might have been prevented by speeding up vaccination research. Hopefully, the UK's authorization of challenge trials for Covid research will help lead to a reconsideration of these awful policies. It's a matter of life and death in the most literal possible sense.

 

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  1. Good luck with that. Fortunately I believe in the UK there is less liability than in the US.

  2. Organ donation should be presumed. People should have to check off a box on their driver’s license to refuse donation.

    The Kelo doctrine applies to chattel. That means corpses and body parts.

    With presumed donation, the transplant rate goes up by 10 times, compared to adjoining jurisidictions.

    1. Uh no. Pay me if you want my organs.

      1. I support paying you or your estate. All that boohoing by relatives would stop immediately.

    2. The Kelo doctrine is an abomination that should be burned with fire. It has no place in any just society. That fact that it could theoretically lead to one positive social outcome is not sufficient to justify its many abuses.

      1. Judge Kosinski late of the Ninth Circuit persuaded me otherwise. If you build a public highway on taken property, who uses it? It is for the benefit of a trucking firm, making a private profit. Not much difference from Kelo.

        I support the change of paying the owner the new, higher value, rather than the old lower value. The old low value is yet another denial of reality by the lawyer profession.

  3. A lot of medical research would go much more quickly with higher availability and more human/primate testing. As it is, current practices have led a bit more to scifi levels of advancement in rodent medicine.

  4. Imagine the market for isogenic organs grown from the person’s adult stem cells. Imagine CRISPR treatments of chronic illness. Imagine dial a baby. Instead of an outrageously priced $50 pill, you will be paying $50000 for a treatment.

    It will be in China, not in our nation. The obstructionist lawyer profession must be stopped from throttling progress.

    1. Affirms the antecedent, spoken like a true progressive.

      1. The biggest mass murderer last century was probably the FDA. Well, second to the generally business-unfriendly environments of dictatorships worldwide, keeping billions more from the productivity levels of western nations.

        Nobody wants to die or be injured from a drug too fast. But those deaths pale compared to the cumulative tens of millions dying as medical science falls further and furthdr behind where it would have been with looser restrictions and more wealthy, free, research-capable nations.

        The idiot politician stands in front of cameras, and ths parasitic lawyer in front of a judge, both preening of doing something about something going wrong. And so science slows, and thousands die from uninvented things.

        Good job, dudes. Thanks for helping make the world a better place!

        1. The FDA is more failed lawyer garbage. It should be replaced by verified user Yelp reviews by doctors and patients.

          It gets 90% of its budget from review fees. That is an irremediable conflict of interest. It allows exclusion criteria of patient samples. Those are to avoid lawsuits. They violate the most impoetant requirement for a parametric statistic test, random selection. These dunces skipped classes in 11th grade statistics.

  5. the US and other governments literally kill many thousands of people every year by banning transactions that could save their lives

    Hmm, you could also say, “potential organ donors literally kill many thousands of people every year by refusing to donate their organs”

  6. I am saddened that the UK had abandoned a system of ethics that have long been part of our civilizstion, and chosen the path of Stalin.

    Stalin was a great proponent of it being OK to harm imdividuals as long as it is for the greater good. But the promised utopia and its greater good never arrived, and the harm remained,

    1. I think you’re missing a critical step here. The test subjects in the UK are volunteers – people choosing to step forward to help protect their communities. Yes, they are taking risks to do so – but so do police, firefighters, soldiers, good samaritans on the street and even parents.

      By contrast, Stalin was rather more coercive.

      We have always valued to good of the many above the good of the one. The difference in our system of ethics is that the one may not be compelled to make that sacrifice.

    2. I am saddened that the UK had abandoned a system of ethics that have long been part of our civilizstion, and chosen the path of Stalin.

      I don’t really know what you are referring to with Stalin, but the “ethics” we are talking about here are really principles that try and keep researchers’ moral hands clean while murdering the public. I don’t call that ethics. I call that powerful industry self-protection.

      The UK is to be praised.

    3. Stalin was a great proponent of it being OK to harm imdividuals [sic] as long as it is for the greater good. But the promised utopia and its greater good never arrived, and the harm remained

      You mean like “progressive” income taxes (and proposed “wealth” taxes) in the US? Or, for that matter, almost any taxation.

  7. My concern with challenge trials is the validity of the results.

    They are testing for safety in ninety healthy 18-30 year-olds. What does that tell us about safety in older, less healthy, individuals?

    I suppose if you find the vaccine unsafe in this trial you can just stop there, but I don’t see what you get beyond that.

    1. No, they are not testing for safety. The challenge study isn’t about vaccines at all. It’s about how the disease progresses.

      1. It’s about:

        Quantifying how much exposure is required to produce disease in an unvaccinated individual.

        Quantifying level of contagiousness before symptoms develop.

        Quantifying level of contagiousness while symptoms are present.

        Quantifying contagiousness after disease/symptoms subside.

        1. Thanks, Matthew.

          I read carelessly.

      2. You may test a representative sample. You may survey the effects in the total population. Testing a sample of paid volunteers seems more ethical.

        1. I wasn’t questioning the ethics, but the value of the results.

          As Matthew points out, I misunderstood the objective.

  8. I hate being cynical about all this, this is excellent progress but we should have done this months ago. Now we already have a lot of vaccines in development and production. Nothing that happens in this trial will convince the FDA or the NHS to approve things things faster. To approve them faster they need to … stop wasting time and approve them faster.

    Had we done a challenge trial in March of last year we could have approved within 3 months (the period for observing long term effects) so that is June. Had we shut this down in June everything would have worked out a lot better for everyone.

    1. Another Monday morning quarterback with no training in the relevant medicine.

    2. “Had we done a challenge trial in March of last year”

      That timeline is entirely wrong. Let’s use Pfizer’s vaccine, because it was fastest.

      Pfizer announced plans to start vaccine development with BioNTech on March 17th. They then went into initial human testing with 4 different vaccine candidates on April 29th and May 1st, with preliminary results for the initial testing (phase 1, a well tolerated vaccine) coming out July 1st.

      So, you couldn’t possibly do “challenge testing” that would mean anything before July 1st.

      By July 27th, you had large scale testing in 30,000 volunteers. This is phase 2/3. Importantly, it’s in the “real world” setting, unlike a challenge setting. In a month (and remember, the dosing takes about a month) you had decent initial results, but you really want at least 2 months to check for infection rates, especially given COVID’s long incubation time. So you’re looking at September. Then regulatory review took a month.

      Even with “challenge testing” you weren’t really going to get around that. You might shave off a month. But you wouldn’t know if it was real-world applicable.

      Why do all that testing? Because of all the vaccines that DIDN’T work or worked poorly. Astra Zenica had roughly 70% effectiveness. Merck killed their vaccine. Several other programs just didn’t work well.

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