Coronavirus Updates

[Sovereignty]

 

[Innula Zenovka]

 

[Sovereignty]

Expert says human challenge trials are "unethical" -- and treat people "like laboratory animals"

Haseltine said such trials are typically only necessary when a virus is not “raging,” and the coronavirus is currently in widespread circulation.

He added that participants would likely be mainly healthy, young people, so the trials would not yield information about those most at risk for serious illness.

William A. Haseltine

I suspect the link will break as CNN updates their web site so here's the whole thing.

Human challenge trials are “unnecessary, uninformative and unethical,” a former professor at Harvard Medical School said Friday.

Also known as controlled infection trials, human challenge involves the intentional exposure of participants to a virus to allow more rapid assessment of a vaccine’s efficacy.

“Basically, it's treating (people) like laboratory animals,” William Haseltine told CNN.

The United States National Institute of Allergy and Infectious Diseases is working to create a strain of coronavirus that could be used in human challenge trials of a Covid-19 vaccine, although there are no plans to do so, NIAID Director Dr. Anthony Fauci said earlier Friday.

Haseltine said such trials are typically only necessary when a virus is not “raging,” and the coronavirus is currently in widespread circulation.

He added that participants would likely be mainly healthy, young people, so the trials would not yield information about those most at risk for serious illness.

“Are we really ready to infect people with live virus that can kill them?” Haseltine said.

 

[Chalice Yao]

Human challenge trials are “unnecessary, uninformative and unethical,” a former professor at Harvard Medical School said Friday.

Also known as controlled infection trials, human challenge involves the intentional exposure of participants to a virus to allow more rapid assessment of a vaccine’s efficacy.

“Basically, it's treating (people) like laboratory animals,” William Haseltine told CNN.

<snip>

“Are we really ready to infect people with live virus that can kill them?” Haseltine said.

Counterquestion:
If it could lead to saving thousands and thousands of lives in the future, *and* the participants are doing so voluntarily and with full knowledge of what they're getting into, then why. The. Fuck. Not?
Also I think he shouldn't underestimate older people willing to take part in such things for the sake of those that still have a whole life ahead of them; The biggest one along those lines I remember from recentish years was Fukoshima:

A group of more than 200 Japanese pensioners are volunteering to tackle the nuclear crisis at the Fukushima power station.
The Skilled Veterans Corps, as they call themselves, is made up of retired engineers and other professionals, all over the age of 60.
They say they should be facing the dangers of radiation, not the young.

Although that also might be in part a very cultural thing.


In the end I always love it when 'Ethics' are the reason that more people might suffer in the end. Be it the outlawing of abortion, or denying by law a terminally ill person to end their bedridden world of constant pain to just end it all. Or, like in this case, not wanting to allow trials where people voluntarily get infected so there might be a higher chance to save many more.

Ethics become a double-edged sword that hurts you (or rather, others) if the worse outcome is chosen for others "Because Ethics" instead of rational pros and cons.


.

 

[Innula Zenovka]

'Sheer fear': mental health impacts of Covid-19 come to fore

Cases of PTSD, anxiety, depression and insomnia lead to calls for routine follow-up of survivors

www.theguardian.com

 

[Innula Zenovka]

Counterquestion:
If it could lead to saving thousands and thousands of lives in the future, *and* the participants are doing so voluntarily and with full knowledge of what they're getting into, then why. The. Fuck. Not?
Also I think he shouldn't underestimate older people willing to take part in such things for the sake of those that still have a whole life ahead of them; The biggest one along those lines I remember from recentish years was Fukoshima:


Although that also might be in part a very cultural thing.


In the end I always love it when 'Ethics' are the reason that more people might suffer in the end. Be it the outlawing of abortion, or denying by law a terminally ill person to end their bedridden world of constant pain to just end it all. Or, like in this case, not wanting to allow trials where people voluntarily get infected so there might be a higher chance to save many more.

Ethics become a double-edged sword that hurts you (or rather, others) if the worse outcome is chosen for others "Because Ethics" instead of rational pros and cons.


.

What's the advantage to Human Challenge trials over the way the trials are being conducted at the moment?

At present it's

• Test on lab animals
• Test on small groups of volunteers to establish that it produces the expected response by the body's immune system and to establish safety.
• Test on large groups of volunteers to establish how effective it actually is in general use, and also to identify rarer side effects

Oxford COVID-19 vaccine to begin phase II/III human trials | University of Oxford

University of Oxford researchers have begun recruiting for the next phase in human trials of a COVID-19 vaccine in human volunteers.

www.ox.ac.uk

I see from the article that there are no immediate plans actually to conduct any Human Challenge tests of any form of the virus they might develop, but it's unclear to me why they might need to at all.

US considering coronavirus strain for potential human challenge trials

The nation's top infectious disease expert, Dr. Anthony Fauci, confirmed to CNN on Friday that scientists at the National Institute of Allergy and Infectious Diseases are working to have a strain of coronavirus created that could be used in human challenge trials of a Covid-19 vaccine.

edition.cnn.com

Under what circumstances might they need Human Challenge tests?

 

[danielravennest]

Under what circumstances might they need Human Challenge tests?

Currently we don't need them. Just do the large-scale trials in areas where the virus is currently infecting people, and see if any of the people vaccinated get the disease. Assuming you are doing a double-blind trial, you have an equal population of people in the trial who got a placebo. Comparing how many in each group get sick tells you how good the vaccine is.

You would only need a challenge test for a disease that isn't circulating. Like a new strain of plague (Yersinia Pestis) is found, but only in animals so far. You test a new vaccine against people as a preventive measure. But there is no reason to infect people when COVID-19 is already infecting 250,000 people a day worldwide.

 

[Free]

 

[Sovereignty]

Counterquestion:
If it could lead to saving thousands and thousands of lives in the future, *and* the participants are doing so voluntarily and with full knowledge of what they're getting into, then why. The. Fuck. Not?
Also I think he shouldn't underestimate older people willing to take part in such things for the sake of those that still have a whole life ahead of them; The biggest one along those lines I remember from recentish years was Fukoshima:


Although that also might be in part a very cultural thing.


In the end I always love it when 'Ethics' are the reason that more people might suffer in the end. Be it the outlawing of abortion, or denying by law a terminally ill person to end their bedridden world of constant pain to just end it all. Or, like in this case, not wanting to allow trials where people voluntarily get infected so there might be a higher chance to save many more.

Ethics become a double-edged sword that hurts you (or rather, others) if the worse outcome is chosen for others "Because Ethics" instead of rational pros and cons.


.

I think the most plausible "why the fuck not" part is that they most likely would not be testing people who need the vaccine the most. The immune systems of young healthy people do not respond the same way as older or less healthy people. It puts you in a situation where you are comparing apples and oranges.

(Side note--A previous example of a misleading apple and oranges comparison: the in vitro tests done on HCQ that helped prompt interest in that drug were conducted with a cultured line of cells derived from kidney cells. There were two problems with that. First, the cultured line of cells was derived from kidney cells, not lung cells. Second, cultured cells do not behave like cells either in vivo or just freshly removed from the body. So these cultured kidney cells were not even guaranteed to act like real kidney cells, not that that would be especially helpful in the first place. TWIV discusses these problem.)

Given that the test results would be suspect, it is more dubious to risk giving people an illness to see what happens knowing that the disease has no cure and could be fatal to some.

What's the right call? Hazeltine and others (e.g., the virologists on TWIV) don't think challenge tests are a good idea. I'd say that's especially true when improved testing could offer results comparable to a vaccine but without the risks.

 

[Sovereignty]

That is good news, but the test does not scale up the way Michael Mina envisions. You need machines and people to run the machines. You also need reagents to make the test work. See SalivaDirect Results.

The technology for lateral assay tests like what Mina wants is well known from a variety of applications. Home use of lateral assay tests for determining important health information has precedent: home pregnancy tests. The sensitivity of the tests does not have to be as great as the DirectSaliva test or any of the other tests for which the FDA has issued emergency use authorizations.

Two reasons for accepting less sensitive tests:

• We want to test for transmissibility, not presence of RNA. That requires less sensitivity.
• Results from tests done with current sensitive testing equipment are often days late and no help in preventing transmission. Their sensitivity again is irrelevant.

 

[Sovereignty]

The Plan That Could Give Us Our Lives Back

The U.S. has never had enough coronavirus tests. Now a group of epidemiologists, economists, and dreamers is plotting a new strategy to defeat the virus, even before a vaccine is found.

 

[Innula Zenovka]

Currently we don't need them. Just do the large-scale trials in areas where the virus is currently infecting people, and see if any of the people vaccinated get the disease. Assuming you are doing a double-blind trial, you have an equal population of people in the trial who got a placebo. Comparing how many in each group get sick tells you how good the vaccine is.

You would only need a challenge test for a disease that isn't circulating. Like a new strain of plague (Yersinia Pestis) is found, but only in animals so far. You test a new vaccine against people as a preventive measure. But there is no reason to infect people when COVID-19 is already infecting 250,000 people a day worldwide.

Thanks. I understand why they might want to conduct challenge tests in some circumstances, but there seems no need to create a special version of the virus with which to infect people when the regular version is running wild in many parts of the world.

 

[Sovereignty]

Thanks. I understand why they might want to conduct challenge tests in some circumstances, but there seems no need to create a special version of the virus with which to infect people when the regular version is running wild in many parts of the world.

One reason to create a special virus is to have something that can be used in lower security laboratories as a model of the real virus. TWIV.

Very hard to give a precise TWIV reference w/o spending a lot of time re-listening. ETA: So my previous statement could, in fact, be wrong. The more I think about it, I think it may have come up in a discussion of smallpox vaccination with Vaccinia (name of the bug, name of the medical procedure), but I'm not even sure about that. They discuss too many interesting things.

TWIV 642 and 645 are quite interesting. I'd watch them on YouTube. Much easier to follow the conversation when you can see who is talking.

It's hard to tell by looking, but the title "Bringin’ in 50 keys of spike mRNA" for episode 642 refers to a detailed review of the preliminary results paper for the Moderna vaccine. The TWIV'ers estimate that the current contract with Moderna for its vaccine is to produce 50 kilograms of RNA for $1.5 billion. The discussion of this paper starts at 52:46 and runs for close to 40 minutes. I found this whole discussion quite interesting.

645 has a lot of discussion of biosafety levels (BSL). It has the obvious title "Lions and tigers and zookeepers (oh my)". The discussion of BSL starts at 47:12 with reference to the conspiracy theories about the Wuhan Lab. Part of their debunking is that the conspiracy theories focus on the BSL4 lab at the site which is not yet properly staffed. Problem with those theories is that SARS-CoV-2 requires only BSL3. It is not in the same class as Ebola, Lhassa fever, Marburg virus.

 

[Sovereignty]

Thread:

Horrible headline on Yahoo news story about DirectSaliva:
"NBA, Yale land the COVID testing breakthrough the NFL (and the general U.S. public) has been hoping for"

ETA: MLB, NBA, and NFL use testing for the purpose Michael Mina envisions--preventing transmission. The tests that use machines, though, do not scale up to provide that to large groups of people. MLB, NBA and NFL are small potatoes really. Can't include "general U.S. public" in this headline with any kind of journalistic accuracy. Also, MLB and NBA have been doing this kind of testing all summer already. DirectSaliva is nice but more of the same.

 

[Free]

WHO: Herd immunity requires an effective vaccine

www.daily-chronicle.com

Herd immunity is typically achieved with vaccination and most scientists estimate at least 70% of the population must have antibodies to prevent an outbreak. But some experts have suggested that even if half the population had immunity, there might be a protective effect.

WHO’s emergencies chief Dr. Michael Ryan largely dismissed that theory at a press briefing on Tuesday, saying we should not live “in hope” of achieving herd immunity.

 

[Beebo Brink]

WHO: Herd immunity requires an effective vaccine

www.daily-chronicle.com

If you have to infect 70% of people to stop the spread.... you didn't stop the spread.

 

[Innula Zenovka]

 

[Free]

Coronavirus creeps into US mink farms, “unusually large numbers” dead

Transmission risks to humans are unclear.

arstechnica.com

 

[Free]

COVID spit test is faster, cheaper, avoids shortages—and now greenlit by FDA

It’s not a rapid test to use at home, but it still stands to help speed things up.

arstechnica.com

The US Food and Drug Administration this weekend authorized a saliva-based diagnostic test for COVID-19 that costs less than $5, is faster than current laboratory tests, and may dodge supply shortages plaguing the country—without losing much in accuracy, according to early data.

The test, called SalivaDirect, was developed by researchers at Yale University, who have no plans to commercialize the test and have made the test’s protocol completely open and available.

If the protocol becomes widely adopted, it could help improve the country’s COVID-19 testing, which is currently dismal. Some patients face weeks-long waits to get results. With such long delays, contact tracers have no chance of reaching out to those exposed before they have the chance to pass on the infection. The delays stem from the sheer volume of tests coming in, as well as shortages of critical supplies, such as nose swabs and chemical reagents necessary to run the tests. SalivaDirect tries to address both of those problems.

 

[Innula Zenovka]

If you have to infect 70% of people to stop the spread.... you didn't stop the spread.

Herd immunity is more usually achieved through vaccination, though -- as I understand it, herd immunity is what happens when sufficient people have become immune to a virus, whether because of prior infection or vaccination, that the virus can no longer spread in a community.

Waiting for herd immunity to develop because so many people have been infects is no sort of solution, of course, but the same herd immunity will, one hopes, soon develop when a vaccine is discovered.