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| A specific hypothetical Covid vaccine question (Page 4/5) |
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randye
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DEC 03, 08:23 PM
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| quote | Originally posted by maryjane:
I'll give it a shot.
1. The 'double blind' aspect would no longer be valid if the general population was used and there would be questions whether the placebo, the vaccine or the virus in the wild (and think perhaps, mutation) caused the problems that might would arise.
2. the months already invested in the trials would be lost if the general population's reaction (or lack thereof) was suddenly to be used as bellweather for the efficacy or any side effect.
This trial protocol is not a new one. It was pretty much used for the Salk 'killed' polio vaccines 60+ yrs ago, tho it also included a portion of the volunteers as a no placebo observed group that all got the real thing. Salk was adamantly against a placebo, claiming it would b on his shoulders if a placebo patient contracted the dreaded polio while involved in the trial, and it was a responsibility he and others took very seriously. In Salk's words: "a ‘beautiful’ ... experiment over which the epidemiologist could become quite ecstatic but [which] would make the humanitarian shudder.” Many researchers at the time were concerned about the Salk vaccine because it was the first big inactivated vaccine to be introduced by trial in the US and about 1/2 the medical establishment thought a modified live (attenuated) form was the only proper way to go. Sabin introduced one later which was also a resounding success.
There was no problem back then getting parents to volunteer their children, probably because it was primarily children that were most likely to get polio.
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The FDA has to approve all vaccines in this country for human use.
The FDA's charter is to determine SAFETY and EFFICACY
In order to receive clearance for use from the FDA, the manufacturer MUST BY FEDERAL LAW comply with all regulations under Title 21 CFR (Code of Federal Regulations) which is Federal law enacted by Congress.
Those requirements include submitting a test and clinical study plan to the FDA and having that plan approved. The manufacturer then follows that plan and periodically notifies the FDA if any changes are necessary or if unforeseen problems arise.
Once the clinical study trial is completed the manufacturer submits the results data to the FDA for review and, (hopefully), for clearance to market the pharmaceutical to the public. The data submitted to the FDA must demonstrate that the pharmaceutical is both SAFE and EFFECTIVE.
The act of administering the pharmaceutical to the control, (placebo) group in the clinical trial would INVALIDATE the study and would be cause for the FDA to immediately and lawfully withhold any approval of the product. AS THEY SHOULD
"Operation Warp Speed" obtained concessions from the FDA regarding many things in 21CFR, most importantly in drastically compressing the time usually required to run a pharmaceutical clinical trial.
"Rewarding" clinical trial participants by effectively destroying the already foreshortened trial is foolhardy and dangerous.
Members of the public that wish to receive any of the COV2 vaccines should both be warned that they are knowingly taking a pharmaceutical that has NOT completed a traditional clinical trial AND they should be required to sign a wavier that they have been so advised and hold both the manufacturer and the U.S. government harmless.[This message has been edited by randye (edited 12-03-2020).]
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blackrams
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DEC 03, 08:25 PM
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| quote | Originally posted by randye:
"Rewarding" clinical trial participants by effectively destroying the already foreshortened trial is foolhardy and dangerous. |
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Well, there ya have it. I'm not qualified to even go there. 
But, my prediction is that MadernaTX and Pfizer will both let those who were volunteers/participants of the study know what they got and then we'll see a mass exodus of the placebo receiving participants from the study so they can get the vaccine. That in itself will basically destroy the placebo section of the study.
That's not to suggest that these folks volunteered just to get the vaccine but, I doubt they'll be very happy if denied it either. They can opt out of the study at any point and still received all of the medical surveillance they were promised.
Rams[This message has been edited by blackrams (edited 12-03-2020).]
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Hudini
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DEC 03, 09:41 PM
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2 year contract to not get the vaccine? I understand why but damn.
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maryjane
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DEC 04, 02:40 AM
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| quote | Originally posted by blackrams:
Well, there ya have it. I'm not qualified to even go there.
But, my prediction is that MadernaTX and Pfizer will both let those who were volunteers/participants of the study know what they got and then we'll see a mass exodus of the placebo receiving participants from the study so they can get the vaccine. That in itself will basically destroy the placebo section of the study.
That's not to suggest that these folks volunteered just to get the vaccine but, I doubt they'll be very happy if denied it either. They can opt out of the study at any point and still received all of the medical surveillance they were promised.
Rams
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Yep, there's nothing to prevent any of the volunteers from exiting the study at any time and nothing to prevent them from getting the vaccine once the general public begins receiving it.
Extremely unlikely in the real world today, that FDA or any other govt agency would withdraw approval if or because control/placebo folks started receiving any approved Covid vaccine.[This message has been edited by maryjane (edited 12-04-2020).]
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Boondawg
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DEC 07, 05:36 PM
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 [This message has been edited by Boondawg (edited 12-07-2020).]
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Jake_Dragon
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DEC 07, 06:12 PM
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| quote | Originally posted by Boondawg:
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I see no need to mandate anything.
Just like warning labels, remove them too.
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Rickady88GT
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DEC 07, 06:35 PM
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| quote | Originally posted by maryjane:
Yep, there's nothing to prevent any of the volunteers from exiting the study at any time and nothing to prevent them from getting the vaccine once the general public begins receiving it.
Extremely unlikely in the real world today, that FDA or any other govt agency would withdraw approval if or because control/placebo folks started receiving any approved Covid vaccine.
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If the study is still ongoing, how would they even know if they got a real vaccine or not? Isn't a study, typically years long, something like 7 years? Why would the study end just because the product is on the market?
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Hudini
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DEC 07, 08:10 PM
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| quote | Originally posted by Boondawg:
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And get on the train too. Re-education is mandatory.
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blackrams
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DEC 07, 09:14 PM
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| quote | Originally posted by Rickady88GT:
If the study is still ongoing, how would they even know if they got a real vaccine or not? Isn't a study, typically years long, something like 7 years? Why would the study end just because the product is on the market? |
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This study is supposed to be two years.
Edited: Correction, 25 months.
Rams[This message has been edited by blackrams (edited 12-07-2020).]
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Rickady88GT
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DEC 07, 09:40 PM
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| quote | Originally posted by blackrams:
This study is supposed to be two years.
Edited: Correction, 25 months.
Rams
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Ok, so,...... why would anyone in the study ask for or receive the "experimental" vaccine so soon? The y are the control group of the experiment? If, for example,... the entire group of "lab rats" get the test stuff, who is tested and what are they compared to? How is this a legitimate research project?
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