How is vaccine efficacy determined?

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  #1  
Old 11-21-2020, 05:44 AM
coffeebean coffeebean is offline
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Default How is vaccine efficacy determined?

I have one question as to how the Covid vaccine efficacy is determined. From what I understand, people who participate in the vaccine trials are either vaccinated with the actual vaccine or are vaccinated with a placebo. Then, all of people who participate in the trial go out into the community to "live their lives normally".

Now the question.......are those people in the trial wearing masks and social distancing or are these people in the trials not wearing masks and social distancing? Even if the trial people do NOT follow guidelines, people around them in the community may be following guidelines and wearing masks and social distancing.

I hope you are following my train of thoughts here. Bottom line......just how is the efficacy of a vaccine determined if masking and social distancing are being practiced by those involved in the trial and by the community they are exposed to?
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Last edited by coffeebean; 11-21-2020 at 03:20 PM.
  #2  
Old 11-21-2020, 07:27 AM
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The only way to know that is to read the parameters of the vaccine trial. After a drug is approved for use, the results and methodology of the trial are published in great detail and available for anyone to read.
  #3  
Old 11-21-2020, 07:42 AM
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It doesn't matter as long as the sample size is large enough and randomized. The people who do these tests apply sound statistical procedures during the experimental design and interpretation of the results. The assumption is that the exposure is the same, in an average sense, for the two groups. The efficacy is the ratio between the positive cases of the two groups as tested some period of time after the second dose. Since they are dealing with relatively small numbers, about 170 positive cases out of about 40,000 total participants for the Pfizer/BioNTech study, the application of sound statistical procedures is important.

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Originally Posted by coffeebean View Post
I have one question as to how the Covid vaccine efficacy is determined. From what I understand, people who participate in the vaccine trials are either vaccinated with the actual vaccine or are vaccinated with a placebo. Then, all of people who participate in the trial go out into the community to "live their lives normally".

Now the question.......are those people in the trial wearing masks and social distancing or are these people in the trials not wearing masks and social distancing? Even if the trial people do follow guidelines, people around them in the community may be following guidelines and wearing masks and social distancing.

I hope you are following my train of thoughts here. Bottom line......just how is the efficacy of a vaccine determined if masking and social distancing are being practiced by those involved in the trial and by the community they are exposed to?

Last edited by biker1; 11-21-2020 at 08:07 AM.
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Old 11-21-2020, 07:42 AM
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905 staff at Mayo Clinic have tested positive while wearing masks, and PPE.

Once vaccines are in place those are the numbers I would pay attention to. Staff that is exposed everyday, while wearing PPEs.
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Old 11-21-2020, 07:55 AM
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Just give it to all the politicians and let’s see what happens. I will not be first in line.
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Old 11-21-2020, 11:11 AM
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Quote:
Originally Posted by thelegges View Post
905 staff at Mayo Clinic have tested positive while wearing masks, and PPE.

Once vaccines are in place those are the numbers I would pay attention to. Staff that is exposed everyday, while wearing PPEs.
What are PPE's?
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Old 11-21-2020, 11:28 AM
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Originally Posted by thelegges View Post
905 staff at Mayo Clinic have tested positive while wearing masks, and PPE.

Once vaccines are in place those are the numbers I would pay attention to. Staff that is exposed everyday, while wearing PPEs.
But that does not mean all who tested positive caught the virus whilst wearing masks and PPE.
Plenty of sources of infection outside of hospital premises.
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Old 11-21-2020, 12:18 PM
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Originally Posted by TNLAKEPANDA View Post
Just give it to all the politicians and let’s see what happens. I will not be first in line.
I will take your place.

I have followed closely who researched it and how it was tested.

I am quite satisfied.
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Old 11-21-2020, 12:21 PM
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What are PPE's?
Personal protective equipment
  #10  
Old 11-21-2020, 03:02 PM
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The interesting point of these vaccines is the fact that they have better results than the yearly Flu vaccinations. I never get the Flu shot because I have never had the Flu in my 70 years on earth. However, the vaccines for the C19 virus is so impressive, I might just consider getting it. The facts available on the vaccines is really interesting, ....if true. I have no reason to believe otherwise, but today there is so much misinformation produced by the media, you do get a bit gun shy.
In my opinion, I have plenty of anti-bodies to fight most illnesses even though I have no proof other than the fact that I do not get the flu and I rarely get a cold. If I do get a cold, it might last two days. Don't get me wrong, I have had the pneumonia shot and the shingles shot. I have also had a multitude of shots required to travel to other countries, so I am not adverse to vaccinations, ...just some vaccinations that I feel are unnecessary for me.
I am very impressed with the information available on the CV19 vaccines.
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  #11  
Old 11-21-2020, 03:49 PM
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Quote:
Originally Posted by Two Bills View Post
But that does not mean all who tested positive caught the virus whilst wearing masks and PPE.
Plenty of sources of infection outside of hospital premises.
Most, not all, but a high percentage works 12 to 16 hour shifts, some 7 days a week. Most with families didn’t go home because they didn’t want to take a chance with their spouse or children.

Out of the 9 in my family that are still working, 4 tested positive. Back to work in 14 days.. Only one went home to family, and even with precautions infected the household, not the other way around.

Staff that works the Covid floors are not as Cavalier, as non medical people doing what is best, not to spread to their families, and outside. Many stayed in RVs, or in a home with coworkers. Food was not an issue, facilities were sent food from many resources while working.
Most will tell you the only thing I have strength to do after leaving a shift is go to bed, and get up the next day and do it all over again
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Old 11-21-2020, 04:05 PM
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Quote:
Originally Posted by coffeebean View Post
I have one question as to how the Covid vaccine efficacy is determined. From what I understand, people who participate in the vaccine trials are either vaccinated with the actual vaccine or are vaccinated with a placebo. Then, all of people who participate in the trial go out into the community to "live their lives normally".

Now the question.......are those people in the trial wearing masks and social distancing or are these people in the trials not wearing masks and social distancing? Even if the trial people do NOT follow guidelines, people around them in the community may be following guidelines and wearing masks and social distancing.

I hope you are following my train of thoughts here. Bottom line......just how is the efficacy of a vaccine determined if masking and social distancing are being practiced by those involved in the trial and by the community they are exposed to?
Public review will start Dec 10 with CDC, NIH can reviewed on line during procedings
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Old 11-21-2020, 05:18 PM
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Say in the coming new year if both the Pfizer and Moderna vaccines are approved, how does a person go about deciding which one to get? That is something I've been thinking about.
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Old 11-21-2020, 06:27 PM
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Quote:
Originally Posted by New Englander View Post
Say in the coming new year if both the Pfizer and Moderna vaccines are approved, how does a person go about deciding which one to get? That is something I've been thinking about.
I am banking you will not get to choose, each pharm will have a disruption area. Most likely Hospitals will be shipped first, most have bone freezer that would accommodate the -72c issue, plus, if it’s multi dose (5), so mandatory injection for employees, would work better.

If military is going to be the the primary, for general population, that would most likely be any drug that comes single dose syringe, for rapid injections, and does not require special storage.
So in TV polo grounds with drive up multiple tents would work well, as well as sports stadiums. With two doses, the plan will be in place before anyone get first dose.

Last edited by thelegges; 11-22-2020 at 05:39 AM.
  #15  
Old 11-21-2020, 11:05 PM
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Lots of good replies in this thread. Incorrect information was posted regarding the protocol availability.
Quote:
After a drug is approved for use, the results and methodology of the trial are published in great detail and available for anyone to read.
The methodology, usually called a protocol, is available now. The moderna vaccine is HERE The Pfizer is HERE

When the manufacturers submit their data to the FDA for approval that is a public record.

The Mayo Clinic data of nearly 1000 cases in their employees.. per a Mayo spokesman "Our staff are being infected mostly due to community spread (93% of staff infections)" so this is not due to failure of masks nor other PPE. I do not know how they determined the source but Mayo reported this information.

Lastly, the question posed by the OP as to which vaccine to take... Very soon there will be the two mRNA vaccines but restricted use to certain occupations and high risk. Once vaccine is released to the elderly there very well may be other vaccine products also available including ones with no unusual temperature shipping and storage issues. Efficacy data will be available for all the products before or as they are approved.

One factor is that the Pfizer product has severe temperature requirements. In a study you can be sure the facilities were doing a great job of protecting the vaccine from warming. I am less convinced that community pharmacies and shippers will be able to have the same guarantee of keeping the product extremely cold. I don't see data on how much efficacy is lost if the product is not kept at the recommended temp.
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