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| A specific hypothetical Covid vaccine question (Page 3/5) |
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maryjane
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DEC 03, 03:07 PM
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Boondawg
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DEC 03, 03:17 PM
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| quote | Originally posted by Patrick:
I guess I'm a little puzzled... |
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Me too, but about something else!
PM sent.
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Jake_Dragon
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DEC 03, 03:18 PM
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Unless they are at risk I don't see any reason they cant wait.
Who knows what will shake out before its their turn again.
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blackrams
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DEC 03, 03:34 PM
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| quote | Originally posted by PK:
Hello MJ,
I have some very outdated experience in this area of study.
Yes I think it would be a thoughtful "thank you" to the study population that got placebo. Owed, maybe not unless written in to the protocol...but probably the right thing to do. I know that this is in the protocol for one of the studies (probably Oxford one).
It may be a little more complicated, as subjects are normally monitored after a study is unblinded for further data and health monitoring. Once you have jabbed all of the placebos with vaccine you have lost your control group for any further study.
Cheers
PK
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According to Dr. Fauci,
The way to continue the study (with all participants being vaccinated) would be to give the study participants another round or two of shots. Those who received the placebo would receive the vaccine and those who got the vaccine would get the placebo. The participants would still not be told who got what in the beginning. That way, the study could continue with the two groups (different dates of vaccination) and provide even better data.
Rams
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PK
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DEC 03, 03:46 PM
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It might make the study continue but would not help for any further long term post trial safety data.
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blackrams
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DEC 03, 03:55 PM
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| quote | Originally posted by PK:
It might make the study continue but would not help for any further long term post trial safety data. |
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Please enlighten me as to what safety data you're referring to.
The vast majority of the population has not received any vaccinations which is precisely where the placebo participants are. Any long term post trial data of non-vaccinated people would be available in the general population I would think.
Having two different groups with separate vaccination dates would provide significantly more safety data reference the actual vaccine.
Maybe I'm simply not understanding your point. Please enlighten me.
Rams
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maryjane
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DEC 03, 04:33 PM
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| quote | Originally posted by blackrams:
Please enlighten me as to what safety data you're referring to.
The vast majority of the population has not received any vaccinations which is precisely where the placebo participants are. Any long term post trial data of non-vaccinated people would be available in the general population I would think.
Having two different groups with separate vaccination dates would provide significantly more safety data reference the actual vaccine.
Maybe I'm simply not understanding your point. Please enlighten me.
Rams
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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.[This message has been edited by maryjane (edited 12-03-2020).]
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blackrams
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DEC 03, 05:04 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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While that may be a valid reason, I (personally) believe better and more data reference the vaccine and it's effectiveness and safety would be gained using Dr. Fauci's proposal. I don't pretend to be qualified to make or defend that opinion. Shrug. 
Rams
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maryjane
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DEC 03, 05:27 PM
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| quote | | using Dr. Fauci's proposal |
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Which is?
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blackrams
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DEC 03, 08:12 PM
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| quote | Originally posted by maryjane:
Which is? |
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Although paraphrased, this is what I heard him say when asked about how to address placebo participants on whatever news I had tuned in this morning.
| quote | According to Dr. Fauci,
The way to continue the study (with all participants being vaccinated) would be to give the study participants another round or two of shots. Those who received the placebo would receive the vaccine and those who got the vaccine would get the placebo. The participants would still not be told who got what in the beginning. That way, the study could continue with the two groups (different dates of vaccination) and provide even better data. |
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I'll try to find it. Found it.
| quote | Dr. Fauci sketched out one possible way to balance the obligation owed to people who took the placebo against the need for more data from the trials. Vaccine makers could give everyone who got the placebo the vaccine — while also giving everyone who got the vaccine the placebo. None of the trial participants would know which order they got the doses. The trial could therefore continue to be blinded.
In that scenario, researchers would be able to compare the two groups to see if the vaccine’s protection faded over time. The newly vaccinated placebo group would still enjoy a strong immune response, while the people originally vaccinated starting in July 2020 might have a weaker one. If both groups remained at low risk of infection, that would show that the vaccine was long-lasting.
“In my mind, that’s one really good option of fulfilling the ethical constraints at the same time as you get new knowledge,” Dr. Fauci said.
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https://washingtonsources.o...the-real-ones/94761/
Rams[This message has been edited by blackrams (edited 12-03-2020).]
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