Coronavirus 2019-2020 thread (no unsubstantiated rumours!)

[dratsabknihcllik]

I still remember when Iran's initial days against this disease articles of 'mass-grave' were circulating. Moreover, none of the freedom loving people questioned the decision of adding more sanctions against Iran and judging by the comments in social media it was clear that many (if not most from certain countries) were actually pleased to read those articles.

A few weeks later we (unfortunately) see footage of mass graves in NY, the richest city in the world.

 

[AndrewS]

Basically, I feel that with a virus like COVID-19, having a control group is not being fair to the control group. Someone could be infected during the 1 year study and suffer serious long term consequences, give it to his/her family or even die, which might have been prevented by putting them in the vaccine group. But then again, you're not really doing them any more harm than not selecting them for the study so I guess it's not that bad.

It's not about being "fair" to the control group.
The whole point of a clinical trial is that it is using the volunteers as test subjects, to calculate the risks versus the benefits.
A clinical trial is NOT being run for the benefit of the participants, so they can get a vaccine early.

I see it very simply as about getting enough data to make an informed decision as to whether to vaccinate:

Group 1: millions of healthcare workers
Group 2: tens of millions of other high-risk people like the elderly or those with cancer or other serious diseases
Group 3: billions of healthy low-risk people

Each of these groups has a different threshold for how safe a vaccine needs to be.

But the benefits of a proven vaccine is really high for all of these groups.

So it makes sense to accept a higher risk level for Phase 1/2/3 trials and to get usable results quickly, because it is likely that only a small percentage of the volunteers will get really sick or die. And the rest would presumably be immune.

And as you say yourself, you're not really doing a control group (taking a placebo) any more harm anyway.

 

[AndrewS]

why not to make the placebo group smaller than one fourth
Yesterday at 6:54 AM

(I know there's no link to numbers there, as I've twice asked the poster, and got ignored twice LOL)

How much smaller could you make a control group?

If you go from 125 to only 50 in a control group, then a single anomaly is really going to screw up the results of that group.

 

[AndrewS]

But, if we cannot find something safer to challenge with, I stand by my course that the current COVID-19 is safe enough in young healthy individuals to do a 2 month challenge trial in bio-containment. The risks have to be weighed against the rewards. And while you might think it's crazy, some renowned experts do not, so let's not say that no ethics committee would or should approve; it's just that no ethics committee chaired by you would approve.

I agree that the benefits of a proven vaccine are so high for millions and billions of people - that it makes sense to pursue higher-risk challenge testing.

Only a small number people (less than 10000) would be deliberately infected with COVID-19 in any case.

 

[Jura The idiot]

How much smaller could you make a control group?

If you go from 125 to only 50 in a control group, then a single anomaly is really going to screw up the results of that group.

actually I was thinking 10%, to see the power of suggestion (I can imagine subjects could have fever by just thinking they got COVID-19, if it was good idea to enter the test, if they're going to make it, and so on)

 

[Jura The idiot]

speaking of vaccines,

"As of 8 April 2020, the global COVID-19 vaccine R&D landscape includes 115 vaccine candidates (Fig. 1), of which 78 are confirmed as active and 37 are unconfirmed (development status cannot be determined from publicly available or proprietary information sources)."

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Fig. 1 | Pipeline of COVID-19 vaccine candidates by technology platform. Exploratory projects (split into confirmed and unconfirmed) are in the early planning stage with no in-vivo testing, and preclinical projects are at the stage of in-vivo testing and/or manufacturing clinical trials material.

 

[AndrewS]

actually I was thinking 10%, to see the power of suggestion (I can imagine subjects could have fever by just thinking they got COVID-19, if it was good idea to enter the test, if they're going to make it, and so on)

The Placebo (psychological) effect on human physiology is a real thing.

There are numerous prior studies which demonstrate the Placebo effect, so you need to account for this.

It's even possible that a marginally effective vaccine could become a more *useful* vaccine due to the Placebo effect.

But you don't know for certain until you test.

 

[Jura The idiot]

The Placebo (psychological) effect on human physiology is a real thing.

There are numerous prior studies which demonstrate the Placebo effect, so you need to account for this.

It's even possible that a marginally effective vaccine could become a more *useful* vaccine due to the Placebo effect.

But you don't know for certain until you test.

OK you're saying kind of opposite what I meant 24 minutes ago
LOL it's funny someone wouldn't get the virus because s/he was a part of testing and believed in that vaccine, while s/he in fact got placebo

but yeah anything's possible

 

[superdog]

Basically, I feel that with a virus like COVID-19, having a control group is not being fair to the control group. Someone could be infected during the 1 year study and suffer serious long term consequences, give it to his/her family or even die, which might have been prevented by putting them in the vaccine group. But then again, you're not really doing them any more harm than not selecting them for the study so I guess it's not that bad. For complete scientific data, a control group is better than not having one, but I think unless there are grievous problems, the data obtained from just the vaccine group is good enough since normally, you're not expecting to learn anything from the control group anyway. As you said, science is just clues, so some imperfection in data is acceptable, in my opinion, to prevent giving a placebo to hundreds of people (when you have something that very well might work) and sending them out to a COVID-19 infested environment.

If you ask me, I would think that being assigned to the vaccine group actually bears a higher health risk, considering it is not yet a human validated vaccine and I'm not in hotspot places like New York.

With that said, if circumstances allow, I don't really mind becoming a test subject.

You think everything should be done by the books and I think this is a special case that would be unfair to the placebo group to do it that way. I don't think we're going to make any headway so this is my last post on that.

Sorry, I meant that you said that no ethics committee would or should approve human challenge trials with COVID-19. Now if there is something proven to be immunological the same as COVID-19 but with greatly attenuated virulence, that would be ideal; actually, that would be a vaccine LOL. But, if we cannot find something safer to challenge with, I stand by my course that the current COVID-19 is safe enough in young healthy individuals to do a 2 month challenge trial in bio-containment. The risks have to be weighed against the rewards. And while you might think it's crazy, some renowned experts do not, so let's not say that no ethics committee would or should approve; it's just that no ethics committee chaired by you would approve.

From the article by localizer (do check out the link as well):

"Stanley Plotkin of the University of Pennsylvania, inventor of the current rubella vaccine and a leader in the vaccine field, says a carefully designed “human challenge” trial could offer clear proof of a vaccine’s worth at blinding speed. “We’re talking 2, 3 months,” says Plotkin, who has co-authored a commentary, now being submitted for publication, that describes how this might be ethically done. “People who are faced with a terrifying problem like this one will opt for measures that are unusual. And we have to constantly rethink our biases.” A similar proposal for coronavirus challenge studies was published

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. "

I'm not always a by-the-book person but you can say I'm on the cautious side, primarily due to the very high stakes involved with the COVID-19 vaccine compared to vaccines of other less impactful illnesses. Scientific matters aside, I fully understand why some may feel it's necessary to take radical off-the-book measures and I've read the Plotkin article. Ultimately it should be a scientific decision made by regulatory bodies with consultation. I think authorities in the US and Europe may be more risk taking compared to their counterparts in China due to their high infection rate and elevated social-economic crisis, so it's possible they may bear the risk to approve a less validated vaccine.

 

[AndrewS]

I think authorities in the US and Europe may be more risk taking compared to their counterparts in China due to their high infection rate and elevated social-economic crisis, so it's possible they may bear the risk to approve a less validated vaccine.

On the other hand, China is a poorer country, so there isn't the social safety net nor individual savings to sustain continual lockdowns.

Plus the legitimacy of the Chinese government is directly tied to its management of the Chinese economy.
In the US and Europe, the leaders just go into retirement after losing an election, but the system remains.

So China may be more risk-taking