How is vaccine efficacy determined?

[coffeebean]

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?

[retiredguy123]

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.

[biker1]

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.

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?

[thelegges]

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.

[TNLAKEPANDA]

Just give it to all the politicians and let’s see what happens. I will not be first in line.

[New Englander]

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?

[Two Bills]

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.

[graciegirl]

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.

[retiredguy123]

What are PPE's?
Personal protective equipment

[Byte1]

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.

[thelegges]

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

[Dana1963]

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

[New Englander]

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. :confused:

[thelegges]

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. :confused:

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.

[blueash]

Lots of good replies in this thread. Incorrect information was posted regarding the protocol availability.
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 (https://www.modernatx.com/sites/default/files/mRNA-1273-P301-Protocol.pdf) The Pfizer is HERE (https://pfe-pfizercom-d8-prod.s3.amazonaws.com/2020-11/C4591001_Clinical_Protocol_Nov2020.pdf)

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 (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31604-4/fulltext) 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.

[biker1]

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.


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.

[Worldseries27]

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?
you may receive hundreds of opinions.
I'm going to watch clue or murder on the orient express again to see if anything changes.

[ts12755]

Immune to lawsuits... Big Pharma wins again... Just like Big Tech is immune to lawsuits (Sec 230)...

[msilagy]

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.

[Raywatkins]

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.

[banjobob]

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?

[Dr Winston O Boogie jr]

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.

[Girlcopper]

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. :confused:
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

[dewilson58]

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. :confused:


How did you decide in the past??? You probably didn't. :ho:

[Carlsondm]

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.

[Buckeye Bleau]

PPE is Personal Protection Equipment

[Rlheinz19@yahoo.com]

What are PPE's?

Personal Protective Equipment

[Buckeye Bleau]

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.

[MandoMan]

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.

[oneclickplus]

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.

[collie1228]

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.

Of course people died after receiving the vaccine. There were 30,000 people in at least one of the trials, with 15,000 getting the vaccine and 15,000 getting a placebo. In a population of 30,000 people, of all ages, ethnicity, health condition, etc., some people will die. Some will die after drinking milk for breakfast. Did the milk kill them? No. They could have died not necessarily from a vaccine, but just from normal living. Your comment makes it seem like "they" are hiding something. Balderdash. An American corporation could never survive such dishonesty. People who cast dispersion of unfounded suspicion only play into people's fears.

[biker1]

That is not what happened with the vaccine trial. They did not start with infected people. They did not introduce the virus to healthy people. There is no "resolving the ailment" because the vaccine is not a therapeutic.

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.

[merrymini]

Not me!

[cassjax2]

I just started a Covid vaccine trial this week. We were not given instructions regarding masks, etc. I believe we are expected to use common sense and go about our daily lives. Your line of thought sounds like you think we should be kept away from the public, which I don’t understand. If I had the vaccine (not the placebo) it seems to me that it would be safer to be around me rather than someone who who hasn’t had a vaccination.

[KRM0614]

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?
They don’t know ! Just making money off of vaccine without substantial testing ! It’s a joke

[New Englander]

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

I'm not a regular person. :icon_wink:

[Byte1]

There have been no reported deaths related to the vaccine trials. Where did that come from?
And who said it was going to be six months before "we" get our vaccinations?
What's with all the "misinformation" being spread as fact?

[New Englander]

How did you decide in the past??? You probably didn't. :ho:

That's true but Covid has changed everything.

[Altavia]

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.

It is also likely Pfizer is stability testing in parallel various conditions that may ease the requirements. Launch what they know is stable first.

Moderna has been testing RNA vaccines longer so likely have more long term experience/data.

[dewilson58]

That's true but Covid has changed everything.
Not much has changed..........historically there have been multi-producers. As in the past, this will be a push supply chain rather than a pull supply chain. The needlers will get what they get rather than ordering. The needle'ees don't have enough information (or brain power) to judge which med is better.

[Two Bills]

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.

Where do people get this stuff from?:ohdear:

[jhbellew]

We are participating in the Oxford covid trial.

[Trishakaye]

If Zeke Emanuel gets his way, those of us 70 and older will be last in line.

[graciegirl]

We are participating in the Oxford covid trial.

I cannot, CANNOT, thank you enough. I think I remember reading this from you before and I think I also recall that you may be retired medical. I am guessing an M.D.

I am so grateful for your gift of high intelligence and the decision to train it further and the courage to go to work every day dealing with many very challenging and impossible situations. Thank you for taking this risk.

No. I see this is your first post. I still thank you so very much.

[Bucco]

There have been no reported deaths related to the vaccine trials. Where did that come from?
And who said it was going to be six months before "we" get our vaccinations?
What's with all the "misinformation" being spread as fact?

Misinformation spread as facts is frustrating and dangerous, isn't it ?

[Bucco]

If Zeke Emanuel gets his way, those of us 70 and older will be last in line.

Not sure what you mean...

"Ezekiel Emanuel, chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania, believes the vaccine needs to be given to people who have the highest risk of transmitting the virus."

Makes sense to stop a pandemic. Never saw age mentioned.

Emanuel outlines approach he'd take for distributing initial doses of COVID-19 vaccine | FierceHealthcare (https://www.fiercehealthcare.com/payer/zeke-emanuel-outlines-best-approach-for-distributing-initial-doses-covid-19-vaccine)

COVID-19 vaccines face logistical challenges, expert says | Hub (https://hub.jhu.edu/2020/11/12/ezekiel-emanuel-logistics-of-covid-vaccine/)

The second link to John Hopkins is a great discussion of the variables involved and the motives for the vaccine. Good reading.

[tedquick]

My wife and I were in the Moderna vaccine trial. My wife, who has both heart and lung issues got the placebo (frowny face) while I got the actual vaccine. Since I developed achy muscles and a fever for a few hours I got tested for anti-bodies and fortunately had them. I then gave plasma and they also confirmed that I had the anti-bodies. Both Pfizer and Moderna “work” with the mRNA and each requires two shots, at least the Moderna shots are 28 days apart. I am a huge believer in both manufacturers.

[Healthiest]

I completely agree with you and don't trust that it's 95% effective. We don't know if maybe the people who got the vaccine even came into contact with someone who had the virus. It could be that maybe the people who got the placebo were out and about more, didn't wear masks, etc.

I do want to get the vaccine, but still wonder about how effective it really is. The only way to truly test it is to get volunteers who agree to be exposed to the virus after being vaccinated.

I'm surprised there isn't more in the news about this and how this 95% claim might not even be acurate.

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?

[Healthiest]

Thank you for posting the protocol. I've skimmed it, but can't find answers to questions I have. I'm wondering if there were requirements that the participants were out in the community--for example, working or something else. How do we know if someone who got the vaccine just sat in their house the whole time and never was out and about to possibly be exposed.

Lots of good replies in this thread. Incorrect information was posted regarding the protocol availability.


The methodology, usually called a protocol, is available now. The moderna vaccine is HERE (https://www.modernatx.com/sites/default/files/mRNA-1273-P301-Protocol.pdf) The Pfizer is HERE (https://pfe-pfizercom-d8-prod.s3.amazonaws.com/2020-11/C4591001_Clinical_Protocol_Nov2020.pdf)

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 (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31604-4/fulltext) 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.

[coffeebean]

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.

From what you have said, the vaccine can also be used as a therapeutic to an individual who is diagnosed with Covid?

Very interesting about the participants in the trial who died. Is it possible those who died were infected with Covid already and were too ill for the vaccine to be effective in curing them? Just a thought.

[coffeebean]

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.

Thank you. This is the answer to my question in my OP.

[coffeebean]

That is not what happened with the vaccine trial. They did not start with infected people. They did not introduce the virus to healthy people. There is no "resolving the ailment" because the vaccine is not a therapeutic.
Oh, that is the exact opposite information from another poster.

[coffeebean]

I just started a Covid vaccine trial this week. We were not given instructions regarding masks, etc. I believe we are expected to use common sense and go about our daily lives. Your line of thought sounds like you think we should be kept away from the public, which I don’t understand. If I had the vaccine (not the placebo) it seems to me that it would be safer to be around me rather than someone who who hasn’t had a vaccination.

You didn't quote anyone so I assume you are responding to the OP.........

No, I do not think anyone in a trial should be kept from the public. In fact, just the opposite. I know the folks in the trials must go about their business and live their lives like they normally would. My thoughts are if someone in the trial goes out into the public wearing a mask and social distancing, that could skew the results of the trial if the actual vaccine was given. Anyone who is being careful by abiding by the CDC guidelines with make the vaccine efficacy look better than it would be if that same person went about his/her life with no mask and no social distancing. The second scenario is more risky therefore that person is more apt to contract the virus than someone who is more careful.

[biker1]

That is why you have a large, random sample and sound statistical procedures are used for the experimental design.

I completely agree with you and don't trust that it's 95% effective. We don't know if maybe the people who got the vaccine even came into contact with someone who had the virus. It could be that maybe the people who got the placebo were out and about more, didn't wear masks, etc.

I do want to get the vaccine, but still wonder about how effective it really is. The only way to truly test it is to get volunteers who agree to be exposed to the virus after being vaccinated.

I'm surprised there isn't more in the news about this and how this 95% claim might not even be acurate.

[biker1]

And which poster would that be? Buckeye Bleau? What he claimed is incorrect.

Oh, that is the exact opposite information from another poster.

[coffeebean]

And which poster would that be? Buckeye Bleau? What he claimed is incorrect.

See post #50. Yes, it was Buckeye Bleau. Thank your for clarifying.

[biker1]

Did you not bother to read my post? The testing involves a large enough sample size to produce a statistically significant result. I would guess that you are not a scientist and have never had a course in statistics. Please stop second guessing the professionals.

You didn't quote anyone so I assume you are responding to the OP.........

No, I do not think anyone in a trial should be kept from the public. In fact, just the opposite. I know the folks in the trials must go about their business and live their lives like they normally would. My thoughts are if someone in the trial goes out into the public wearing a mask and social distancing, that could skew the results of the trial if the actual vaccine was given. Anyone who is being careful by abiding by the CDC guidelines with make the vaccine efficacy look better than it would be if that same person went about his/her life with no mask and no social distancing. The second scenario is more risky therefore that person is more apt to contract the virus than someone who is more careful.

[biker1]

Well he is wrong.

See post #50. Yes, it was Buckeye Bleau. Thank your for clarifying.

[jklfairwin]

From what I read, all participants were not tested at the end of the trial period. Only those who had symptoms were tested. So there may have been many more who contracted covid but were asymptomatic so not tested and not counted. While they may have been unsymptomatic, the consensus is that asymptotic infected people can still spread it to others. So while the efficacy numbers look great, and may in fact be so, it must be taken with a few grains of salt.

[Altavia]

My wife and I were in the Moderna vaccine trial. My wife, who has both heart and lung issues got the placebo (frowny face) while I got the actual vaccine. Since I developed achy muscles and a fever for a few hours I got tested for anti-bodies and fortunately had them. I then gave plasma and they also confirmed that I had the anti-bodies. Both Pfizer and Moderna “work” with the mRNA and each requires two shots, at least the Moderna shots are 28 days apart. I am a huge believer in both manufacturers.

I'm in the Pfizer trial but suspect ended up in the placebo group. They indicated since you don't know if you got the vaccine or not, and to avoid getting two different vaccines, that group may be given access to the trial vaccine once launched and help continue the studies.

For those questioning the population of the trial participants, I observed a broad cross section of people in the waiting area including hourly workers, university students and medical professionals.

[Altavia]

Did you not bother to read my post? The testing involves a large enough sample size to produce a statistically significant result. I would guess that you are not a scientist and have never had a course in statistics. Please stop second guessing the professionals.


Agree.

There are two kinds of people in the world, those who can learn and those who won't.

Most frightening are those who think being contrarian and obtuse is a substitute for educational and intelligence...

[blueash]

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.

The Astra Zeneca vaccine is not mRNA. The study being done in UK is a different protocol. They are in phase 3 immunizing volunteers with either the Covid test vaccine or a saline vaccine, not measles. They are following the groups by measuring anti-Covid antibodies, T cell immunity, as well as PCR test positive symptomatic illnesses
The protocol is HERE
(https://s3.amazonaws.com/ctr-med-7111/D8110C00001/52bec400-80f6-4c1b-8791-0483923d0867/c8070a4e-6a9d-46f9-8c32-cece903592b9/D8110C00001_CSP-v2.pdf)
There are to be 30,000 subjects in this study, 20K will receive the active vaccine and 10K the placebo.
In earlier phase testing they did not use a saline placebo, instead they used a meningococcal vaccine placebo. Those results are HERE (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31604-4/fulltext) Your relative may have been a participant in this earlier phase testing.

[blueash]

There have been no reported deaths related to the vaccine trials. Where did that come from?
And who said it was going to be six months before "we" get our vaccinations?
What's with all the "misinformation" being spread as fact?

In the interest in getting correct information in this thread, I must point out there was one death in the early AstraZeneca vaccine trial in a person in Brazil (http://www.pmlive.com/pharma_news/azs_covid-19_vaccine_trial_to_continue_after_brazilian_volun teer_death_1354594). They broke the blinding and the death was in the placebo group not in the active Covid vaccine group.
As others have pointed out, when you have nearly 100,000 people in studies there will be deaths because people die. As far as I can find, there have not yet been any reported deaths in the active vaccine arm of the ongoing studies. But there will be. And there will also be deaths in the placebo arm.

[Velvet]

In the interest in getting correct information in this thread, I must point out there was one death in the early AstraZeneca vaccine trial in a person in Brazil (http://www.pmlive.com/pharma_news/azs_covid-19_vaccine_trial_to_continue_after_brazilian_volun teer_death_1354594). They broke the blinding and the death was in the placebo group not in the active Covid vaccine group.
As others have pointed out, when you have nearly 100,000 people in studies there will be deaths because people die. As far as I can find, there have not yet been any reported deaths in the active vaccine arm of the ongoing studies. But there will be. And there will also be deaths in the placebo arm.

I have been wondering about the death in the trial. I could not find out at the time if the individual was in the placebo group or not. Very happy that you posted this now. We re so lucky to have you at TOTV.

[Two Bills]

The Oxford/Astra Zeneca trial results show a 70% immunity rate, which was a little dissapointing.
However, they have subsequently found that giving a small dose vacination first, followed by a larger booster, the immunity rate went up to 90%.
Trials and research contiue.

Covid-19: Oxford University vaccine shows 70% protection - BBC News (https://www.bbc.co.uk/news/health-55040635)

[coffeebean]

Did you not bother to read my post? The testing involves a large enough sample size to produce a statistically significant result. I would guess that you are not a scientist and have never had a course in statistics. Please stop second guessing the professionals.

Yes, I read your post. Your point being there is a large enough sample size so the scientists can evaluate the efficacy. No, I'm not a scientist nor ever took a course in statistics. That is why I questioned how the efficacy is determined.

[coffeebean]

From what I read, all participants were not tested at the end of the trial period. Only those who had symptoms were tested. So there may have been many more who contracted covid but were asymptomatic so not tested and not counted. While they may have been unsymptomatic, the consensus is that asymptotic infected people can still spread it to others. So while the efficacy numbers look great, and may in fact be so, it must be taken with a few grains of salt.

How can a trial be conducted and not all participants be tested at the end of the trial? I find that to be negligent on the part of the people conducting the trial. Hope this information you read about is totally wrong about not testing all participants. Actually, that just makes no sense at all.

[coffeebean]

Agree.

There are two kinds of people in the world, those who can learn and those who won't.

Most frightening are those who think being contrarian and obtuse is a substitute for educational and intelligence...

Sorry but I do not agree. My concerns about how the trial participants conducted themselves with regards to using safe practices vs no safe practices when they went out into the community were very valid. Your remarks are not called for.

[coffeebean]

I have been wondering about the death in the trial. I could not find out at the time if the individual was in the placebo group or not. Very happy that you posted this now. We re so lucky to have you at TOTV.

I posted this article some time ago on this forum.......

28-year-old volunteer in AstraZeneca COVID-19 vaccine trial dies | Healthcare Finance News (https://www.healthcarefinancenews.com/news/28-year-old-volunteer-astrazeneca-covid-19-vaccine-trial-dies)

[Altavia]

Sorry but I do not agree. My concerns about how the trial participants conducted themselves with regards to using safe practices vs no safe practices when they went out into the community were very valid. Your remarks are not called for.

Regrets Coffeebean, that comment was not directed towards you. You are clearly trying to understand and learn.

[Altavia]

How can a trial be conducted and not all participants be tested at the end of the trial? I find that to be negligent on the part of the people conducting the trial. Hope this information you read about is totally wrong about not testing all participants. Actually, that just makes no sense at all.

Participants are requested to report in weekly and for any symptoms or positive test results throughout the study.

Antibodies are rechecked at 6, 12 and 24 months.

Full protocol here:

https://pfe-pfizercom-d8-prod.s3.amazonaws.com/2020-09/C4591001_Clinical_Protocol.pdf


8.11.2.4. Visit 4 – 6-Month Follow-up Visit: (175 to 189 Days After Visit 2)

• Record SAEs as described in Section 8.3.

• Record nonstudy vaccinations as described in Section 6.5.

• For participants who are HIV positive, record HIV viral load and CD4 count results from the most recent test performed since Visit 3 (if any).

• Collect a blood sample (approximately 20 mL) for immunogenicity testing.

• Record details of any of the prohibited medications specified in Section 6.5.1 received by the participant if required for his or her clinical care.

• Ask the participant to contact the site staff or investigator (this could be via the COVID-19 illness e-diary) immediately if he or she experiences any respiratory symptoms as detailed in Section 8.3.

• Schedule an appointment for the participant to return for the next study visit.

• Complete the source documents.

• The investigator or an authorized designee completes the CRFs.

• Record any AEs that occur within the 48 hours after the blood draw as described in Section 8.3.

[blueash]

Now we have data from the AstraZeneca [AZ] trials. Be very cautious in comparing their results with the Pfizer and Moderna data. The AZ protocol is entirely different from the other two. They were testing different doses as they went along. Some people got a full dose initial shot followed by another full dose A smaller group got a 1/2 dose followed by a full dose. In this small group they report 90% efficacy.

VERY IMPORTANT Both Pfizer and Moderna defined a Covid illness as the person had SYMPTOMS and a positive Covid test. They were not tested unless they were symptomatic with something more than trivial symptoms. But the AZ protocol required that the volunteers have PCR Covid tests on a regular schedule whether they had symptoms or not. So the AZ failure rate includes asymptomatic and low symptomatic positives. A 70% efficacy of everyone vs a 90% efficacy for sick prevention is a very different criteria and until the breakdown of positives, symptomatic vs not symptomatic, in the AZ study is made available you cannot use efficacy numbers to decide.

In favor of the AZ vaccine are: Only requires refrigeration, no freezing, no super low freezing. Much less expensive to produce, less expensive to ship and store. The technology is old and has a well established safety profile. While I have no concerns about mRNA, it is new and does not have an established long term safety profile.

[Velvet]

I posted this article some time ago on this forum.......

28-year-old volunteer in AstraZeneca COVID-19 vaccine trial dies | Healthcare Finance News (https://www.healthcarefinancenews.com/news/28-year-old-volunteer-astrazeneca-covid-19-vaccine-trial-dies)

Thank you, I must have missed it.

[Byte1]

For crying out loud, people. You all rush to be the first to get your Flu vaccination without even caring whether or not it has side effects, yet you want to know every nuance of how the C19 vaccine is produced, how it is tested, what color it is and whether or not you are the right age or ethnicity to warrant receiving it. If you do not want the shot then don't get it, period. We don't need to hear about how your cousin's sister-in-law's friend was in the test group and they "said".........
It's not even available yet, and you are worried about whether or not someone else should get the shot. I think some of you just want a permanent mandate for mask wearing. I don't blame some of you for covering your face :) but some folks will eat an apple and take an aspirin if someone tells them it will let them remove the mask. If you think that the vaccine is coming out too fast, then don't get. Wait until all your friends have had it for a year and then if you are still around to ask for it, go and pay a hand full of money to get it. When it first comes out, it will be free but who knows for how long. Take a chance and get it, or don't. Who cares? The way I see it, when the test is over 30000 recipients with no one dying a horrible death and no one growing hair on the palms of their hands, what is the harm. What is the chance that you will be the one in a million that may be different and have problems with it?
I still don't know if I will get it, but that is not because I do not believe in it. I just seem to be immune to a lot of illnesses and have to think about the chances of tampering with a good thing. But, that is just me. My spouse will get the vaccination. If they told me that in order to rid myself of the stupid mask requirement, I had to get the shot....I would be the first in line.
We have two vaccines about to be released for consumption. They both are in the 90's% efficiency. That is better than our flu vaccines which average about 40-60% some years. If you are willing to get the flu shot, then I do not see what the problem is with getting the C19 shot.

[coffeebean]

Regrets Coffeebean, that comment was not directed towards you. You are clearly trying to understand and learn.

Apology accepted.

[coffeebean]

Participants are requested to report in weekly and for any symptoms or positive test results throughout the study.

Antibodies are rechecked at 6, 12 and 24 months.

Full protocol here:

https://pfe-pfizercom-d8-prod.s3.amazonaws.com/2020-09/C4591001_Clinical_Protocol.pdf


8.11.2.4. Visit 4 – 6-Month Follow-up Visit: (175 to 189 Days After Visit 2)

• Record SAEs as described in Section 8.3.

• Record nonstudy vaccinations as described in Section 6.5.

• For participants who are HIV positive, record HIV viral load and CD4 count results from the most recent test performed since Visit 3 (if any).

• Collect a blood sample (approximately 20 mL) for immunogenicity testing.

• Record details of any of the prohibited medications specified in Section 6.5.1 received by the participant if required for his or her clinical care.

• Ask the participant to contact the site staff or investigator (this could be via the COVID-19 illness e-diary) immediately if he or she experiences any respiratory symptoms as detailed in Section 8.3.

• Schedule an appointment for the participant to return for the next study visit.

• Complete the source documents.

• The investigator or an authorized designee completes the CRFs.

• Record any AEs that occur within the 48 hours after the blood draw as described in Section 8.3.

Thank you for posting.

[coffeebean]

Thank you, I must have missed it.

You're welcome.

[Lisa Marie]

PPE = Personal Protective Equipment (masks, gloves, gowns, goggles)