How is vaccine efficacy determined?

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Old 11-22-2020, 04:52 AM
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Regarding the Pfizer/BioNTech vaccine, the cold storage requirements for shipping and end use are apparently not as extreme as longer term storage. Reference was made to this on a recent press conference at the White House. It appears that Pfizer/BioNTech have shipping containers that use dry ice and the vaccine can be maintained for a week or more with dry ice. Also, once thawed, the vaccine is apparently usable for up to 5 days. Needless to say, the essentially "just in time delivery" nature of this vaccine complicates the logistics but it doesn't sound as if new refrigeration equipment will be needed at every end use location.

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Originally Posted by blueash View Post
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.

Last edited by biker1; 11-22-2020 at 05:36 AM.
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Old 11-22-2020, 06:05 AM
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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 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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Old 11-22-2020, 06:47 AM
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Old 11-22-2020, 06:53 AM
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I read once a vial is opened it must be used in 6 hours or disposed of. I think there are several doses in a vial. The info is available online - double check tho.
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Old 11-22-2020, 07:20 AM
Raywatkins Raywatkins is offline
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Not sure about the 2 vaccines mentioned in the thread, but a friend of mine here in the UK is participating in the Oxford/Astra Zeneca trial.
He had blood taken before the first injection along with nasal and throat swabs.
He has had to provide swabs each week.
Before second jab he had to give blood again.
He will give a further blood sample before he completes the trial. (He may have done that now as I haven’t seen him for a few weeks due to the national lockdown here in UK.)
There is ongoing study to see how long protection lasts.
This trial either uses the real vaccine or the one for measles as the placebo.
They apparently look for antibodies in the blood.
Hope that helps.
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Old 11-22-2020, 07:38 AM
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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?
Also I am curious it is reported that you are immune if you had contracted Covid and if true how many millions of tested positive are now immune?
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Old 11-22-2020, 08:35 AM
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Originally Posted by Byte1 View Post
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.
My son was telling me that he read a report that said that people that have had numerous colds may be more immune to Covid19 than people that seldom get colds. They have developed more of an immunity from fighting off colds.

The cold is another Corona virus so it's not unfeasible that this is true.

There's a lot that we don't know about this particular virus. It seems to affect people in the same categories very differently. Scientists are learning more and more every day.

As for the vaccine, I'll be first inline if no one else wants to be. I don't believe in a lot of these government conspiracy theories.
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Old 11-22-2020, 08:36 AM
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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.
Guess we all just needto wait until the vaccines are approved and more info comes out. Riight now, when a vaccine is approved it will only be available to nursing homes, hospitals etc. Regular people cant have it until around 6 mos after its approved
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Old 11-22-2020, 08:51 AM
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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.

How did you decide in the past??? You probably didn't.
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Old 11-22-2020, 08:51 AM
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About nurses getting COVID ....My daughter is an RN and was infected, but not by her COVID job. She has joint custody with a guy who likes to go to political rallies without a mask. I don’t believe he and his friends social distance either. My daughter and grand daughters were very sick for several weeks.
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Old 11-22-2020, 09:08 AM
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Default Personal Protection Equipment. PPE

PPE is Personal Protection Equipment
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Old 11-22-2020, 09:11 AM
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Originally Posted by New Englander View Post
What are PPE's?
Personal Protective Equipment
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Old 11-22-2020, 09:15 AM
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What you are describing with the 50% receiving a placebo is a blind study that is used for a different purpose.
In this case they only want to know if it is effective or not and to what percentage it is efficacious.
So they would use known infected individuals and introduce the vaccine or healthy people then give them the pathogen and the vaccine. Right now they say over 90% effective so it resolved the ailment in over 9 of 10 participants.

There were some participants that died after receiving the vaccine, I am not sure where they would fall in the numbers, but then they don’t want to tell you about them.
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Old 11-22-2020, 09:35 AM
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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?
People just go about their lives in the way they would if they hadn’t got the vaccine—or a placebo. If they wore masks before, they continue the way they were; they don’t go out of their way to be reckless. After all, they may have received a placebo! This only works because there are a LOT of people doing this and because there is a serious attempt to have similar people on both sides.

In essence, this is how it works. The drug company waits until 100 people who received placebos have caught the virus. When that happens, they count how many people who received the vaccine have caught the virus. If it was 5, then the vaccine is 95% effective. Again, this only works because of statistics.

It helps that we are in an epidemic situation where a lot of people are getting sick. If it’s a vaccine for something much rarer, it takes a lot longer to figure out if the vaccine works.
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Old 11-22-2020, 09:54 AM
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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?
While the answer to this can be ascertained by reading the parameters of the trial, what can not be obtained is the long-term effects of any vaccination. They can deem it safe but will it be? The simply can't know the answer at this time.

Remember thalidomide? It was deemed safe enough to be dispensed over the counter to pregnant women. Result? 2000 dead children and 10,000 deformed children.

My point? This was only for pregnant women. With all the hype (yes, HYPE) over COVID, tens or hundreds of millions are going to line up for this vaccination.

My family and I won't be in line.
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