On Vaccine Development and Testing

[Segnosaur]

You don't want your subjects in a high-risk environment, you want your subjects in a highly-controlled environment in order to remove as many complicating variables as you can from your test model.

Here is a useful article on vaccine development and testing.

In normal circumstances you might want test subjects in a low risk environment.

But there is a lot of pressure to develop a vaccine quickly. Deliberately exposing subjects to the virus to test for effectiveness is generally frowned upon. So a controlled experiment with high risk individuals is probably second best.

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[EHocking]

In normal circumstances you might want test subjects in a low risk environment.

But there is a lot of pressure to develop a vaccine quickly. Deliberately exposing subjects to the virus to test for effectiveness is generally frowned upon. So a controlled experiment with high risk individuals is probably second best.

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Did you read the secion on challenge testing in post 62? It is used to accelerate testing.

As has probably been posted before.

The ethical way to test is to infect healthy, young individuals that have a higher chance of surviving the virus without a vaccine.
Here's an interesting article on challenge testing (which is what we're really talking about).
Speed coronavirus vaccine testing by deliberately infecting volunteers? Not so fast, some scientists warn

 

[Roboramma]

https://www.theguardian.com/science...ne-trials-that-infect-people?CMP=share_btn_tw

Controversial trials in which volunteers are intentionally infected with Covid-19 could accelerate vaccine development, according to the World Health Organization, which has released new guidance on how the approach could be ethically justified despite the potential dangers for participants.

So-called challenge trials are a mainstream approach in vaccine development and have been used in malaria, typhoid and flu, but there are treatments available for these diseases if a volunteer becomes severely ill. For Covid-19, a safe dose of the virus has not been established and there are no failsafe treatments if things go wrong.

Scientists, however, increasingly agree that such trials should be considered, and the WHO is the latest body to indicate conditional support for the idea.

 

[rjh01]

https://www.theguardian.com/science...ne-trials-that-infect-people?CMP=share_btn_tw

The article says they will only test it on young people. What happens if it works against young people but not older people? One example of this is flu vaccines which are not as effective on older people as young people.

 

[Roboramma]

The article says they will only test it on young people. What happens if it works against young people but not older people? One example of this is flu vaccines which are not as effective on older people as young people.

Don't make the best the enemy of the good?

Nothing is ever certain. While a challenge trial may not solve all problems, and some larger scale trial may be necessary to test it's efficacy in other age groups, we can still be much more confident in it's efficacy in all age groups after having successfully completed a challenge trail on a younger demographic (similar to how animal testing isn't conclusive on safety or efficacy in humans, but we still use it to inform us on those things before doing human testing).

Here's a quote that made sense to me:

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

Challenge trials, however, don’t solve all problems. In particular, to limit the risk we would want to restrict the patients in a challenge trial to be young and healthy. But that raises a problem of external validity. We also want the vaccine to be safe and effective in less healthy and elderly people which requires secondary challenge trials or field testing in that population.

 

[rjh01]

Yes, I agree with Roboramma that a challenge trial using young people will not solve all problems. I suggest two trials. The first one being the current one and when it has passed that one, then do one on older people. I can just imagine the ad for such a trial
"What to do something for the country and the world? Will involve serious risk to your life. Must be over 65 years. No other qualifications required."

 

[Roboramma]

Yes, I agree with Roboramma that a challenge trial using young people will not solve all problems. I suggest two trials. The first one being the current one and when it has passed that one, then do one on older people. I can just imagine the ad for such a trial
"What to do something for the country and the world? Will involve serious risk to your life. Must be over 65 years. No other qualifications required."

The testing that's possible without having first done a challenge trial on younger volunteers is still possible after having done a challenge trial. So why do the challenge trial?

Let's say we've got 10 vaccine candidates. Challenge trials on each one go through and we find that only 2 were effective. Those other 8 don't need to be tested now. Are they completely safe and effective on older people? We can be much more confident about that after having successfully completed that first trial!

Confident enough to merit a challenge trial with older adults? I don't expect so, but I'm no expert. We can still do the same field trials (vaccinate thousands of people in the at first group and see how many of them get sick compared to a control group) that we would have done otherwise. Only now we're using only those vaccine candidates that successfully made it though the challenge trial. Does a challenge trial prevent that? Doesn't a challenge trail make that more safe, more likely to be effective than just taking vaccines that have been tested on mice?

Please actually make your case for making the best the enemy of the good, because I'm not seeing it.

 

[rjh01]

The testing that's possible without having first done a challenge trial on younger volunteers is still possible after having done a challenge trial. So why do the challenge trial?

Let's say we've got 10 vaccine candidates. Challenge trials on each one go through and we find that only 2 were effective. Those other 8 don't need to be tested now. Are they completely safe and effective on older people? We can be much more confident about that after having successfully completed that first trial!

Confident enough to merit a challenge trial with older adults? I don't expect so, but I'm no expert. We can still do the same field trials (vaccinate thousands of people in the at first group and see how many of them get sick compared to a control group) that we would have done otherwise. Only now we're using only those vaccine candidates that successfully made it though the challenge trial. Does a challenge trial prevent that? Doesn't a challenge trail make that more safe, more likely to be effective than just taking vaccines that have been tested on mice?

Please actually make your case for making the best the enemy of the good, because I'm not seeing it.

I do not see much disagreement here with what I have posted. I doubt that field trials will work unless there are a large number of cases in the community. And it may take years to show an effect which we do not have. In which case we are left with challenge trials. We can either do these or give the vaccine to everyone and hope that it does not have too many dangerous side-effects.

It is an example of the Trolley_problem^WP. You can kill a few people who participate in the challenge testing or you can kill more by delaying the release of the vaccine to do more testing or releasing the vaccine only to show it does not effectively work and possibly delaying the release of one that does work.

Edit. Just to be clear. The first challenge trial is essential. Just to prove it works in some cases.

 

[Ulf Nereng]

Would they be offering this to prisoners? "We'll take ten yearts off your sentence if you participate in this dangerous trial?" Or would that be unethical or ilegal?

 

[Roboramma]

Would they be offering this to prisoners? "We'll take ten yearts off your sentence if you participate in this dangerous trial?" Or would that be unethical or ilegal?

Probably wouldn't make it past ethics review boards.

 

[Roboramma]

I do not see much disagreement here with what I have posted. I doubt that field trials will work unless there are a large number of cases in the community. And it may take years to show an effect which we do not have. In which case we are left with challenge trials. We can either do these or give the vaccine to everyone and hope that it does not have too many dangerous side-effects.

It is an example of the Trolley_problem^WP. You can kill a few people who participate in the challenge testing or you can kill more by delaying the release of the vaccine to do more testing or releasing the vaccine only to show it does not effectively work and possibly delaying the release of one that does work.

Edit. Just to be clear. The first challenge trial is essential. Just to prove it works in some cases.

Sorry, my last reply was based on a reading of your previous post as sarcastic. It seems we agree more than I thought.

I'm not entirely sure about either the wisdom or necessity of a second challenge trial on an older age group, but I wouldn't be opposed to it if experts felt it was justified. I do think these things should be rationally considered, and in particular should be considered under the current conditions.

 

[Roboramma]

Challenge Trials to be done in Britain:
https://marginalrevolution.com/marginalrevolution/2020/09/challenge-trials-in-britain.html

Their source is this article in the Financial Times, but it's behind a paywall so I can't see it.

However, this is a quote from that article:

London is to host the world’s first Covid-19 human challenge trials — in which healthy volunteers are deliberately infected with coronavirus to assess the effectiveness of experimental vaccines. The UK government-funded studies are expected to begin in January at a secure quarantine facility in east London, according to several people involved in the project, which will be announced next week.

…The project’s academic leader is Imperial College London, and it will be run by hVivo, a spinout from Queen Mary University of London that was bought earlier this year by Open Orphan, a Dublin-based pharmaceutical research organisation.

…The petition organiser of 1Day Sooner in the UK is 18-year-old Alastair Fraser-Urquhart who is devoting his time to the campaign before going to University College London to study cancer biology next year.