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Oct 21, 2020 - 4:36:30 AM
Players Union Member

rinemb

USA

12654 posts since 5/24/2005

With all the vaccines about to go to final trials, many volunteers will be needed. As well as consideration of ethics. It seems many volunteers are stepping up...on paper anyway. They will be injected with the live virus after being vaccinated to see if they get covid-19 or not. They could get ill, very ill, or die.
Before, we could sneak it into prisoners, or military folks, etc .
Then there is what happened in early polio vaccinations.
Brad

Oct 21, 2020 - 4:38:02 AM
Players Union Member

rinemb

USA

12654 posts since 5/24/2005

Who will/would volunteer?
Brad

Oct 21, 2020 - 4:45:22 AM

Texasbanjo (Moderator)

USA

25101 posts since 8/3/2003

I am pretty sure that anyone who volunteers to be such a tester is told what the chances are of success and/or failure and probably has to sign some legal document agreeing not to sue if things go south. Unfortunately, for the masses to get the vaccine, there have to be folks willing to take chances so scientists can be sure the vaccine is safe for the majority.

Oct 21, 2020 - 5:20:30 AM
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Players Union Member

OM45GE

USA

101733 posts since 11/7/2007

I spent over 20 years in the Biopharmaceutical industry, largely supporting clinical trials including for vaccines. Participants for drug trials are usually patients suffering from the disease.

Obviously it’s different with vaccines because you have to see if the product prevents a disease. However, that doesn’t necessarily mean challenging anyone with a live pathogen. You can test for the body is developing antibodies and whether those antibodies are effective against the pathogen in the lab.

If a pathogen is already widespread, like COVID or diseases like malaria, you can do epidemiological studies to see if natural infection rates are reduced in folks who have been vaccinated.

Oct 21, 2020 - 5:54:22 AM
Players Union Member

rinemb

USA

12654 posts since 5/24/2005

from Bill "If a pathogen is already widespread, like COVID or diseases like malaria, you can do epidemiological studies to see if natural infection rates are reduced in folks who have been vaccinated."

It was a BBC radio story. They mentioned that because of the "hurry-up" to demonstrate effectiveness, they (various developers) may need volunteers for live virus injection. Trying to pick a virus from samples that seemed to statistically not be so severe?
I assume ethically, you would need adult volunteers.

Bill, thank you for your response. I would like to hear more. Brad

Oct 21, 2020 - 5:55:23 AM
Players Union Member

rinemb

USA

12654 posts since 5/24/2005

How about going to prisoners, and offer early outs-for volunteering. Then again, is that ethical?
Brad

Oct 21, 2020 - 6:54:13 AM

Owen

Canada

6802 posts since 6/5/2011

Warning... possible thread drift alert:  ...To my mind, it's probably more ethical than operating prisons in a manner that pretty much ensures a high recividism rate.     

Edited by - Owen on 10/21/2020 06:55:16

Oct 21, 2020 - 1:52:44 PM

Bill Rogers (Moderator)

USA

24064 posts since 6/25/2005

quote:
Originally posted by rinemb

How about going to prisoners, and offer early outs-for volunteering. Then again, is that ethical?
Brad

Two ethics issues here; 1) Prisoners--sure, as log as the prisoner is fully informed of all possibilities and gives informed consent. 

2) The public--I think it would have to be non-violent crime prisoners only.  Early release otherwise raises serious questions about public endangerment.  

Release would have to be a form of parole, with commission of further crime(s) resulting in reimposition of the original sentence on top of any new sentences..

Oct 21, 2020 - 2:01:23 PM
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10907 posts since 1/15/2005

quote:
Originally posted by OM45GE

I spent over 20 years in the Biopharmaceutical industry, largely supporting clinical trials including for vaccines. Participants for drug trials are usually patients suffering from the disease.

Obviously it’s different with vaccines because you have to see if the product prevents a disease. However, that doesn’t necessarily mean challenging anyone with a live pathogen. You can test for the body is developing antibodies and whether those antibodies are effective against the pathogen in the lab.

If a pathogen is already widespread, like COVID or diseases like malaria, you can do epidemiological studies to see if natural infection rates are reduced in folks who have been vaccinated.


Bill you just ruined a perfectly good discussion that will eventually turn into a 2nd amendment discussion, whether everyone should receive free healthcare, or all people deserve a free house.  Thanks!

Oct 21, 2020 - 2:11:20 PM
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KCJones

USA

966 posts since 8/30/2012

quote:
Originally posted by rinemb

Before, we could sneak it into prisoners, or military folks, etc .
 


Before? As if the government suddenly became ethical after 1975 and is now trustworthy and doesn't have any secret testing programs. "We realize our mistake, and we're better now! You can trust us, we're the government!" Ha!wink

quote:
Originally posted by Bill Rogers
quote:
Originally posted by rinemb

How about going to prisoners, and offer early outs-for volunteering. Then again, is that ethical?
Brad

2) The public--I think it would have to be non-violent crime prisoners only.  Early release otherwise raises serious questions about public endangerment.  

Release would have to be a form of parole, with commission of further crime(s) resulting in reimposition of the original sentence on top of any new sentences..

It's been said that consent is not possible where a large power differential exists. A large power differential certainly exists in this situation. Thread drift warning: Why do we even have non-violent "criminals" in prison at all?

A similar ethical question: Should the government have an incentivized sterilization program? Get sterilized and we'll pay you $1000. Would that be ethical? What you think about this question could inform you about whether vaccine testing on prisoners is ethical.

Edited by - KCJones on 10/21/2020 14:12:53

Oct 21, 2020 - 2:27:24 PM
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10340 posts since 2/22/2007

--"It's been said that consent is not possible where a large power differential exists---"

That is a nonsense statement made by people who no longer wish to take responsibility for their past choices. The concept was invented by lawyers with a large financial stake in convincing a jury that a now-regretful "yes" was really a "no" all along. Just because a choice was a difficult one does not mean that it was not in fact a choice.

Oct 21, 2020 - 2:57:32 PM
likes this

2247 posts since 2/10/2013

TV says a person involved in testing died. That will probably shorten the volunteer list.

Oct 21, 2020 - 3:13:52 PM

6581 posts since 7/24/2013

The people volunteering are Patriots and Heroes, significantly more so than folks standing up to the tyranny of masks.

Oct 21, 2020 - 3:18:06 PM

Owen

Canada

6802 posts since 6/5/2011

quote:
Originally posted by banjo bill-e

<snip> Just because a choice was a difficult one does not mean that it was not in fact a choice.


As I posted in the "toxic" thread:   "A decade+ on remote reserves demonstrated/confirmed to me, beyond any doubt, that "choice" and "realistic choice" can be, and usually are, two VERY different things." 

Oct 21, 2020 - 3:37:32 PM
likes this

3703 posts since 12/6/2009

quote:
Originally posted by rinemb

With all the vaccines about to go to final trials, many volunteers will be needed. As well as consideration of ethics. It seems many volunteers are stepping up...on paper anyway. They will be injected with the live virus after being vaccinated to see if they get covid-19 or not. They could get ill, very ill, or die.
Before, we could sneak it into prisoners, or military folks, etc .
Then there is what happened in early polio vaccinations.
Brad


that statement is simply not true. testing does not include putting anything dangerous into your system. the vaccine is made with dead cells/viruses etc. and they certainly do not inject you with any disease bugs of any kind. the results they look for is how well your body reacts to these dead cells as to how your system develops its own anti bodies from taking the vaccine...the dead cells fool the immune system into thinking they are real bugs..which it is designed to do. the real testing is what doe the body react to as side effects......not the disease but what the vaccine me cause as to other factors. some ignorant people claim they get the disease from the vaccine when that is impossible....they more then likely have an adverse reaction to the vaccines chemical make up not any disease associated.......don't confuse todays methods of testing with those from a long time ago when anything was allowed....and no one was injected ever with live polio cells.

Oct 21, 2020 - 3:59:51 PM
Players Union Member

OM45GE

USA

101733 posts since 11/7/2007

quote:
Originally posted by rinemb

from Bill "If a pathogen is already widespread, like COVID or diseases like malaria, you can do epidemiological studies to see if natural infection rates are reduced in folks who have been vaccinated."

It was a BBC radio story. They mentioned that because of the "hurry-up" to demonstrate effectiveness, they (various developers) may need volunteers for live virus injection. Trying to pick a virus from samples that seemed to statistically not be so severe?
I assume ethically, you would need adult volunteers.

Bill, thank you for your response. I would like to hear more. Brad


I hadn’t heard that story Brad. I’ll search the BBC and see if I can find it. 

To my knowledge, none of the companies I worked for - all well known, global firms - did any studies that involved deliberately exposing subjects to pathogens. They were working on treatments for serious illnesses like Lysosomal Storage Disorders, cancer, diabetes, MS, renal disease, cardiovascular diseases, etc.  Everyone in the trials was already suffering from the disease and there was never a shortage of volunteers. 

Only my most recent employer, from which I retired three years ago, worked on vaccines. If you got a flu shot this year there’s about a 40% chance it was one of theirs. Vaccines like those for the flu don’t go through clinical development trials because the basic vaccines themselves have a proven safety record and the process of including the specific flu viruses is also well studied. 

We were developing vaccines for diseases like malaria, Zika, Denge Fever etc., which did need large scale trials. However the phase three efficacy trials (to see if they worked) could be epidemiological because people were exposed to the pathogens naturally.

Incidentally, the reason the efficacy of flu shots varies is that companies have to decide which strains of the virus to include in the vaccines before the flu season is underway. They look at what strains are prevalent in the far east and past experience to make as good a decision as possible, but they don’t always get it right. 

I’m happy to answer any specific questions if I can. I’m not a scientist, but I was involved in building the groups that ran the drug and related functions and am very familiar with the process from end to end. 

Edited by - OM45GE on 10/21/2020 16:01:25

Oct 21, 2020 - 4:06:51 PM

6581 posts since 7/24/2013

quote:
Originally posted by OM45GE
quote:
Originally posted by rinemb

from Bill "If a pathogen is already widespread, like COVID or diseases like malaria, you can do epidemiological studies to see if natural infection rates are reduced in folks who have been vaccinated."

It was a BBC radio story. They mentioned that because of the "hurry-up" to demonstrate effectiveness, they (various developers) may need volunteers for live virus injection. Trying to pick a virus from samples that seemed to statistically not be so severe?
I assume ethically, you would need adult volunteers.

Bill, thank you for your response. I would like to hear more. Brad


I hadn’t heard that story Brad. I’ll search the BBC and see if I can find it. 

To my knowledge, none of the companies I worked for - all well known, global firms - did any studies that involved deliberately exposing subjects to pathogens. They were working on treatments for serious illnesses like Lysosomal Storage Disorders, cancer, diabetes, MS, renal disease, cardiovascular diseases, etc.  Everyone in the trials was already suffering from the disease and there was never a shortage of volunteers. 

Only my most recent employer, from which I retired three years ago, worked on vaccines. If you got a flu shot this year there’s about a 40% chance it was one of theirs. Vaccines like those for the flu don’t go through clinical development trials because the basic vaccines themselves have a proven safety record and the process of including the specific flu viruses is also well studied. 

We were developing vaccines for diseases like malaria, Zika, Denge Fever etc., which did need large scale trials. However the phase three efficacy trials (to see if they worked) could be epidemiological because people were exposed to the pathogens naturally.

Incidentally, the reason the efficacy of flu shots varies is that companies have to decide which strains of the virus to include in the vaccines before the flu season is underway. They look at what strains are prevalent in the far east and past experience to make as good a decision as possible, but they don’t always get it right. 

I’m happy to answer any specific questions if I can. I’m not a scientist, but I was involved in building the groups that ran the drug and related functions and am very familiar with the process from end to end. 


I have a super dumb question. What's the limit to the strains they can vaccinate for in one vaccine? Why can't they cram all the strains in there?

or is it possible and I'm the first genius to think of it :) 

Oct 21, 2020 - 4:52:24 PM

6670 posts since 5/26/2003

There are nine vaccine candidates in phase III testing now. Each one is being tested on thousands of volunteers. The data from phase III allows the regulators to approve (or not), the wide scale release to the general public.

Oct 21, 2020 - 4:58:08 PM

6670 posts since 5/26/2003

The seasonal influenza strains mutate rapidly and constantly. The annual injection is a variable soup of several strains which have been estimated to be the most likely candidates for the next seasonal outbreaks.

Oct 21, 2020 - 5:10:51 PM

6670 posts since 5/26/2003

quote:
Originally posted by Dagnabbit

There are nine vaccine candidates in phase III testing now. Each one is being tested on thousands of volunteers. The data from phase III allows the regulators to approve (or not), the wide scale release to the general public.


Whoops!  Actual vaccine candidates in Phase III is 11.

Oct 21, 2020 - 5:25 PM
Players Union Member

OM45GE

USA

101733 posts since 11/7/2007

quote:
Originally posted by South Jersey Mike
I have a super dumb question. What's the limit to the strains they can vaccinate for in one vaccine? Why can't they cram all the strains in there?

or is it possible and I'm the first genius to think of it :) 


The most I’ve heard of is four, called quadrivalent. I honestly don’t know if they could do more. This year’s vaccine is quadrivalent.  The four strains in the US version are A/Hawaii, A/Hong Kong, B/Washington and B/Phuket. Other countries may do different strains  

One problem is that the viruses can mutate during the flu season, making the vaccines less effective. 

Oct 22, 2020 - 1:58:42 AM

3009 posts since 4/29/2012

quote:
Originally posted by banjo bill-e

--"It's been said that consent is not possible where a large power differential exists---"

That is a nonsense statement made by people who no longer wish to take responsibility for their past choices. The concept was invented by lawyers with a large financial stake in convincing a jury that a now-regretful "yes" was really a "no" all along. Just because a choice was a difficult one does not mean that it was not in fact a choice.


There speaks a man who was never a smoker.

Oct 22, 2020 - 2:44:46 AM

3009 posts since 4/29/2012

quote:
Originally posted by Richard Hauser

TV says a person involved in testing died. That will probably shorten the volunteer list.


The man who died in testing was a Brazilian doctor who worked with Covid patients and died of Covid. Unfortunately he was randomly selected to be in the control group that was not given the vaccine. So this does NOT mean that there are new safety concerns around the vaccine (although it's very easy to read the shoddy reporting of this and come to exactly that conclusion).

Oct 22, 2020 - 3:08:36 AM

177 posts since 9/6/2019

quote:
Originally posted by AndrewD
quote:
Originally posted by Richard Hauser

TV says a person involved in testing died. That will probably shorten the volunteer list.


The man who died in testing was a Brazilian doctor who worked with Covid patients and died of Covid. Unfortunately he was randomly selected to be in the control group that was not given the vaccine. So this does NOT mean that there are new safety concerns around the vaccine (although it's very easy to read the shoddy reporting of this and come to exactly that conclusion).


Andrew, a lot of the time that is the exact intent of the reporting. To lead you to a conclusion that is either blatantly false or at least very sketchy. Many "news" articles lead with a headline designed to push you to a conclusion and then bury the real story about 3/4 of the way down because they know not many read the entire thing.

One in particular comes to mind. A 17 year old girl died from COVID here in America and the headlines and initial portion of the story pointed out that she was given Hydroxychloroqine by her parents. 3/4 of the way into the story they reported that she was very obese and had suffered from serious medical conditions her entire life, including an autoimmune disorder which is most likely the actual reason she died, but they just had to get the dig in at the drug.

Oct 22, 2020 - 8:17:20 AM
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Players Union Member

DC5

USA

14463 posts since 6/30/2015

quote:
Originally posted by OM45GE
 

The most I’ve heard of is four, called quadrivalent. I honestly don’t know if they could do more. This year’s vaccine is quadrivalent.  The four strains in the US version are A/Hawaii, A/Hong Kong, B/Washington and B/Phuket. Other countries may do different strains  

 


That has to be the best disease name ever.  Like the fictional anti-depressant Damnitol

Oct 22, 2020 - 9:07:45 AM
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Players Union Member

OM45GE

USA

101733 posts since 11/7/2007

quote:
Originally posted by DC5
quote:
Originally posted by OM45GE
 

The most I’ve heard of is four, called quadrivalent. I honestly don’t know if they could do more. This year’s vaccine is quadrivalent.  The four strains in the US version are A/Hawaii, A/Hong Kong, B/Washington and B/Phuket. Other countries may do different strains  

 


That has to be the best disease name ever.  Like the fictional anti-depressant Damnitol


LOL

I think it’s a region of Thailand which makes it a great destination - as in “Phuket, I need a vacation, let’s go to Thailand “

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