[Bucco]

Originally Posted by Trishakaye

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

COVID-19 vaccines face logistical challenges, expert says | Hub

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.

Originally Posted by 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?

[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.

Originally Posted by blueash

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 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.

[coffeebean]

Originally Posted by 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.

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]

Originally Posted by Choro&Swing

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]

Originally Posted by 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.

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

[coffeebean]

Originally Posted by 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.

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.

Originally Posted by 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.

[biker1]

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

Originally Posted by coffeebean

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

[coffeebean]

Originally Posted by biker1

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.

Originally Posted by coffeebean

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.

Originally Posted by coffeebean

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]

Originally Posted by 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.

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.