Coronavirus 2019-2020 thread (no unsubstantiated rumours!)

Rettam Stacf

Junior Member
Registered Member
Today at 6:54 AM
Hend. why don't you post a source to this, people were talking it for a whole day

The information about CanSino Biologics' Phase 2 clinical trial can be found in the article (below) which I quoted in my earlier post here in this thread.

By the way, test subjects will live in their own home during Phase 2 trial, instead of in a central facility under constant monitoring for Phase 1.

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the issue was placebo Today at 6:54 AM
The Chinese recombinant vaccine, developed by CanSino Bio and the Military Academy of Medical Sciences, will enter Phase 2 clinical trials with 500 volunteers.
250 will receive an average dose of 1ml,
125 with a low dose of 0.5ml, and
125 with a placebo.

which is inside your link, too
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:
"The report said 250 volunteers would be given a medium dose, another 125 a low dose and another 125 would get a placebo."
 

Equation

Lieutenant General
Best article about the COVID-19 yet.

"
China’s political and economic leaders can be ruthless and self-directed, but they did approach COVID with an efficiency that Trump, and the American state, is utterly incapable of matching. Blaming the Chinese won’t make COVID go away and won’t make the American economy any stronger.

Instead of looking to the East for scapegoats and distractions, Americans need to look at home for big answers to immense problems."

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Rettam Stacf

Junior Member
Registered Member
A couple of less serious news relating to Covid-19

Walmart CEO talked about the 5 phases of panic buying based on store sales data.

Week 1 - Hand sanitizers, soap and disinfectant
Week 2 - Toilet paper
Week 3 & 4 - Spiral ham (due to Easter) and baking yeast and flour
Week 5 (projection) - Hair clippers and hair dye

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While in Czech Republic, police told nudists that they still have to cover up their nose and mouth

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Quickie

Colonel
like i said before, this phase of the trial is to test the safety of the vaccine, not the effectiveness

Sorry for interjecting. I think you still miss the point manqiangrexue was trying to convey.

Imo, the volunteers who got the placebo may tend to engage with riskier behavior and end up more likely getting infected compared to those in the population who know they have not got the vaccine and therefore are more careful.

How useful the result from the placebo trial, is questionable. What is for sure is that the volunteers getting the placebo may be unnecessary risking their life in the way they interact with people, thinking that they have already been vaccinated. In this sense, I tend to agree with manqiangrexue that the placebo testing may not really be that good of an idea.
 

localizer

Colonel
Registered Member
I disagree. There will be volunteers who want to be deliberately infected.

Remember, the death rate is almost ZERO for under 40s.

And if 50% of the population is going to be infected anyway, why not get the vaccine, and then have an even better chance of surviving.

Doctors and nurses (who have had the vaccine) would want to be deliberately infected as well.

Better to receive a small COVID-19 dose now, which will confer immunity.
The alternative is to be exposed to large amounts of virus in a hospital, which could potentially overwhelm the immune system.

The indications from other viruses are that the amount of exposure can matter a lot.
But we'll have to TEST this with deliberate infections

Article on intentional infection study below.
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@vesicles @Bltizo u guys think they will ever do a trial where they intentionally infect with covid?
 

Rettam Stacf

Junior Member
Registered Member
Found this 2014 paper from National Institute of Health (US) titled " Placebo use in vaccine trials: Recommendations of a WHO expert panel ". I am not even remotely knowledgeable in this field. But I do want to quote a few points from the article.

..... Randomised, placebo-controlled trials are widely considered the gold standard for evaluating the safety and efficacy of a new vaccine.

..... Placebo use in vaccine trials is clearly acceptable when (a) no efficacious and safe vaccine exists and (b) the vaccine under consideration is intended to benefit the population in which the vaccine is to be tested.

..... Placebo use in vaccine trials is clearly unacceptable when (a) a highly efficacious and safe vaccine exists and is currently accessible in the public health system of the country in which the trial is planned and (b) the risks to participants of delaying or foregoing the available vaccine cannot be adequately minimized or mitigated (e.g. by providing counselling and education on behavioural disease prevention strategies, or ensuring adequate treatment for the condition under study to prevent serious harm).

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AndrewS

Brigadier
Registered Member
@vesicles @Bltizo u guys think they will ever do a trial where they intentionally infect with covid?

Let's say the vaccine results come in 1month faster if you decide to deliberately infect 1000-10000 volunteers (who have been vaccinated) with COVID-19, and keep them in a fully equipped hospital.

In the past month, there have been over 50,000 deaths from COVID-19, and this will probably accelerate in the coming months.

So I'd like you to try arguing against this scenario.
 
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superdog

Junior Member
I don't know what that means; that sounds like diplomatic language for "everything has a purpose." Specifically, what do you expect to be looking for in individuals injected with saline in terms of phase 2 safety and what would your conclusion be?
Do you have experience in experimental design and human testing? If not, it's understandable you don't get it.

When you measure physiological changes in people who got the vaccine (e.g. any change to body temperature, to bodily functions, any kind of discomfort, fluctuations in various blood indications etc.), these changes are not always extreme and may only appear in a small number of your test subjects. You cannot immediately jump to the conclusion that "these changes must only be caused by the vaccine, impossible to occur otherwise". How do you know they were triggered by the vaccine, and not merely by the psychological effects of participating in the research? Or by some sampling bias/confounding conditions you overlooked during sampling and during the experimental process? Heck, even antibody tests are not always reliable, sometimes people may get false positives by infection from other coronaviruses (including the types that cause common cold), by non-infectious conditions like cancer, or by some other causes we still don't know, and it doesn't mean you're immune to COVID-19. This had been an issue in previous SARS research and could also pose a challenge in COVID-19 studies.

This is why it is standard practice to have a placebo control whenever feasible in medical research, it is always helpful to have a control group that eliminates as much confounding factors as possible. Certainly not "nothing" to be gained.

0.2% is nearly 0, and that is under the circumstances of free-living conditions where people don't go to the hospital at the faintest symptom. If you selected a group of healthy people aged 18-23 and had them in a heavily monitored bio-containment hospital, I'd bet you'd get nothing extreme happening to any of them. The threshold of statistical significance is generally regarded as just over 30 for an experiment like this; you're talking about hundreds because that is what is needed for a normal phase 3 in which they are all released to live their lives and are periodically checked-in on to see if anybody randomly contracted the virus.

Here's another one:
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I'm not saying we are there yet and need to jump in with whatever is on hand as I haven't been following with how far each company/entity has gotten with their vaccine but I don't agree with the statement that no ethics committee would or should ever approve human challenge trials. Remember, while being incredibly focused on protecting the health 30 young individuals down to the hair, people are dying by the tens of thousands out there. And there are very poor young guys who don't really stand a chance in upward mobility who wouldn't mind risking blowing a lung if they get paid a house in the city for it. I know this sounds like exploiting the poor but if I was 22, broke, and without education, you bet I'd take a house to be in this trial.
When you're talking about potentially killing someone or cripple them for life in a human experiment you want to run, even at 0.1% probability it's not "nearly zero" but a serious safety risk to be addressed, and in most cases it is a direct "No! WTF are you thinking?" from the ethics board. Of course you may argue that some risks deserved to be taken in order to save much more lives at the end, desperate times requires desperate measures right? I'm not opposed to idea of "sacrificing for the greater good" per se. Yet the flaw in this argument is that by skipping large scale clinical trials and only test it on a few dozen "young and healthy, artificially infected" subjects, you run a high risk of omitting serious side effects. In addition, you cannot confirm the efficacy of the vaccine on those who are not so young, not so healthy, or those who appeared young and healthy but contacted a higher dose/different strain of the virus than your highly limited artificial infection sample. I believe it's a bad idea to skip standard phase 3, so intentionally infecting small samples at an earlier phase becomes an unnecessary risk.

We have to remember that a vaccine not properly tested for side effects can kill a lot of people directly, and a vaccine that's only partially effective but thought to be completely effective can kill a lot of people indirectly (by putting millions of people back to high risk environments thinking they have immunity when many do not). There is a reason the USA, China and other countries are not planning to skip large scale trials, it is not because they couldn't find brave subjects willing to face sub-percentile risk of dying.
 
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