The FDA knew many vaccinated people would become COVID cases.

shnarkle

Well-known member
They knew that many so-called breakthrough cases would develop.

The FDA knew lots of people in the clinical trials became COVID cases after being vaccinated before granting emergency authorization of the Covid vaccine.

This knowledge should have prevented the FDA from granting emergency use authorization for the vaccine.

The document, posted on the FDA website, is titled, “Vaccines and Related Biological Products; Advisory Committee Meeting; FDA Briefing Document Pfizer-BioNTech COVID-19 Vaccine.”


It is dated December 10, 2020. The date tells us that all the information in the document is taken from the Pfizer clinical trial, based on which the FDA authorized the vaccine for public use.

A key quote is buried on page 42: “Among 3410 total cases of suspected but unconfirmed COVID-19 in the overall study population, 1594 occurred in the vaccine group vs. 1816 in the placebo group.”

The comparative numbers reveal that the vaccine was not effective at preventing COVID-19. It was certainly not 50% more effective than a placebo shot which is the standard for FDA Emergency Use Authorization.

One needs to understand the theory of the vaccine clinical trial.

The researchers assumed the SARS-CoV-2 virus was spreading everywhere in the world, and during the clinical trial, it would descend on some volunteers.

The billion-dollar question was: how many people receiving the vaccine would become infected, vs. how many people in the placebo group?

If it turned out that FAR FEWER people getting the vaccine became infected with SARS-CoV-2, the vaccine would be hailed as a success. It protected people against the virus.

But as you can see from the numbers above, that wasn’t the case at all.

So now we come to the vital weasel-phrase in the FDA document: “suspected but unconfirmed COVID-19 [cases].”

“Well, you see, we can’t say these were ACTUAL COVID-19 cases. Maybe they were, maybe they weren’t. They’re in limbo. We want to keep them in limbo. Otherwise, our clinical trial is dead in the water, and we’ll never get approval for the vaccine.”

What does “suspected cases” mean? It can only mean these people all displayed symptoms consistent with the definition of COVID-19, but they’re unconfirmed cases because…their PCR tests were negative, not positive.

However, if their tests were negative, why would they be called “suspected cases” instead of “NOT CASES”?

By FDA/CDC rules, a case of COVID-19 means: a person has tested positive, period.

That’s the way cases are counted.

These thousand-plus volunteers in the Pfizer clinical trial were either COVID-19 cases or they weren’t. Which is it?

The official response to that question is obvious: the FDA decided to throw the data from all those “suspected cases” in the garbage and ignore them. Poof. Gone.

Because if the FDA had paid serious attention to the “suspected cases,” they never would have authorized the vaccine for public use. They would have stopped the clinical trial and undertaken a very deep and extensive investigation.

Which they didn’t. The FDA document also states: “Suspected COVID-19 cases that occurred within 7 days after any vaccination were 409 in the vaccine group vs. 287 in the placebo group.”

Right after vaccination, 409 people who received the shots became “suspected COVID cases.” This alone should have been enough to stop the clinical trial altogether. But it wasn’t.

In fact, the FDA document tries to excuse those 409 cases with a slippery comment: “It is possible that the imbalance in suspected COVID-19 cases occurring in the 7 days post vaccination represents vaccine reactogenicity with symptoms that overlap with those of COVID-19.”

Translation: You see, a number of clinical symptoms of COVID-19 and adverse effects from the vaccine are the same. Therefore, we have no idea whether the vaccinated people developed COVID or were just reacting to the vaccine. So we’re going to ignore this whole mess and pretend it’s of no importance.

It’s called cooking the data. It’s a way of writing off and ignoring COVID symptoms in the vaccine group. Saying “we don’t know” is nothing more than a con and a hustle.
 

Authentic Nouveau

Well-known member
Last year I posted a clip on a Dr Greenberg and

Manufacturing Depression: The Secret History of a Modern Disease

He mentioned Psychotropic meds were 35% effective, they got approved.​

Big difference even between "getting approval" and approval with known side effects.​

 

Authentic Nouveau

Well-known member
They knew that many so-called breakthrough cases would develop.

The FDA knew lots of people in the clinical trials became COVID cases after being vaccinated before granting emergency authorization of the Covid vaccine.

This knowledge should have prevented the FDA from granting emergency use authorization for the vaccine.

The document, posted on the FDA website, is titled, “Vaccines and Related Biological Products; Advisory Committee Meeting; FDA Briefing Document Pfizer-BioNTech COVID-19 Vaccine.”


It is dated December 10, 2020. The date tells us that all the information in the document is taken from the Pfizer clinical trial, based on which the FDA authorized the vaccine for public use.

A key quote is buried on page 42: “Among 3410 total cases of suspected but unconfirmed COVID-19 in the overall study population, 1594 occurred in the vaccine group vs. 1816 in the placebo group.”

The comparative numbers reveal that the vaccine was not effective at preventing COVID-19. It was certainly not 50% more effective than a placebo shot which is the standard for FDA Emergency Use Authorization.

One needs to understand the theory of the vaccine clinical trial.

The researchers assumed the SARS-CoV-2 virus was spreading everywhere in the world, and during the clinical trial, it would descend on some volunteers.

The billion-dollar question was: how many people receiving the vaccine would become infected, vs. how many people in the placebo group?

If it turned out that FAR FEWER people getting the vaccine became infected with SARS-CoV-2, the vaccine would be hailed as a success. It protected people against the virus.

But as you can see from the numbers above, that wasn’t the case at all.

So now we come to the vital weasel-phrase in the FDA document: “suspected but unconfirmed COVID-19 [cases].”

“Well, you see, we can’t say these were ACTUAL COVID-19 cases. Maybe they were, maybe they weren’t. They’re in limbo. We want to keep them in limbo. Otherwise, our clinical trial is dead in the water, and we’ll never get approval for the vaccine.”

What does “suspected cases” mean? It can only mean these people all displayed symptoms consistent with the definition of COVID-19, but they’re unconfirmed cases because…their PCR tests were negative, not positive.

However, if their tests were negative, why would they be called “suspected cases” instead of “NOT CASES”?

By FDA/CDC rules, a case of COVID-19 means: a person has tested positive, period.

That’s the way cases are counted.

These thousand-plus volunteers in the Pfizer clinical trial were either COVID-19 cases or they weren’t. Which is it?

The official response to that question is obvious: the FDA decided to throw the data from all those “suspected cases” in the garbage and ignore them. Poof. Gone.

Because if the FDA had paid serious attention to the “suspected cases,” they never would have authorized the vaccine for public use. They would have stopped the clinical trial and undertaken a very deep and extensive investigation.

Which they didn’t. The FDA document also states: “Suspected COVID-19 cases that occurred within 7 days after any vaccination were 409 in the vaccine group vs. 287 in the placebo group.”

Right after vaccination, 409 people who received the shots became “suspected COVID cases.” This alone should have been enough to stop the clinical trial altogether. But it wasn’t.

In fact, the FDA document tries to excuse those 409 cases with a slippery comment: “It is possible that the imbalance in suspected COVID-19 cases occurring in the 7 days post vaccination represents vaccine reactogenicity with symptoms that overlap with those of COVID-19.”

Translation: You see, a number of clinical symptoms of COVID-19 and adverse effects from the vaccine are the same. Therefore, we have no idea whether the vaccinated people developed COVID or were just reacting to the vaccine. So we’re going to ignore this whole mess and pretend it’s of no importance.

It’s called cooking the data. It’s a way of writing off and ignoring COVID symptoms in the vaccine group. Saying “we don’t know” is nothing more than a con and a hustle.
None of the medical outsiders want to tackle this.
 

shnarkle

Well-known member
None of the medical outsiders want to tackle this.
This is why I like memes so much. Not only are they incapable of tackling it, they can't even come up with any sensible memes.

People have a choice to buy into this incoherent narrative, or simply ignore it. Those who reject it, but choose not to ignore it are left with only the prospect of ridiculing them.

edit image violation
 
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vibise

Well-known member
This is why I like memes so much. Not only are they incapable of tackling it, they can't even come up with any sensible memes.

People have a choice to buy into this incoherent narrative, or simply ignore it. Those who reject it, but choose not to ignore it are left with only the prospect of ridiculing them.
Oh my. So scientists should stop doing science and publishing their results and spend their time creating memes.

Because the unvaccinated people getting sick and dying want to see memes, not facts.
 

Authentic Nouveau

Well-known member
: “Among 3410 total cases of suspected but unconfirmed COVID-19 in the overall study population, 1594 occurred in the vaccine group vs. 1816 in the placebo group.”

"Close enough for gubment work"
 

shnarkle

Well-known member
: “Among 3410 total cases of suspected but unconfirmed COVID-19 in the overall study population, 1594 occurred in the vaccine group vs. 1816 in the placebo group.”

"Close enough for gubment work"
They then point out the relative effectiveness which would be "95%". Of course the absolute efficacy is closer to 1 or 2%, but then everyone already knew that, right? Oh, the vast majority of sheeple watching the mainstream news outlets, and got jabbed, and died didn't know that? Caveat emptor losers.
 

Authentic Nouveau

Well-known member
Oh my. So scientists should stop doing science and publishing their results and spend their time creating memes.

Because the unvaccinated people getting sick and dying want to see memes, not facts.
The vaxxed are getting infected.
FACTS!!!!!


This is why rational Americans have reason to distrust so-called scientists.

Used car salesmen have stricter disclosure requirements and cleaner ethics.
 

Authentic Nouveau

Well-known member
They then point out the relative effectiveness which would be "95%". Of course the absolute efficacy is closer to 1 or 2%, but then everyone already knew that, right? Oh, the vast majority of sheeple watching the mainstream news outlets, and got jabbed, and died didn't know that? Caveat emptor losers.
So you can still have a dandy chance of getting infected.

I wouldn't buy a used car if they told me it would start and run maybe 35% of the time. Then the excuse that with used cars, they often don't run.
 

vibise

Well-known member
Covid helped people build a valid distrust of scientists.
Actually, the RW has long argued long and hard that "elite" experts should not be trusted, and that certainly includes scientists, especially as scientists have argued that smoking causes cancer, that climate change is real and caused by human activity, that vaccines work and do not cause autism, that evolution happened and is the foundation of modern biological science....
 

Yakuda

Well-known member
They knew that many so-called breakthrough cases would develop.

The FDA knew lots of people in the clinical trials became COVID cases after being vaccinated before granting emergency authorization of the Covid vaccine.

This knowledge should have prevented the FDA from granting emergency use authorization for the vaccine.

The document, posted on the FDA website, is titled, “Vaccines and Related Biological Products; Advisory Committee Meeting; FDA Briefing Document Pfizer-BioNTech COVID-19 Vaccine.”


It is dated December 10, 2020. The date tells us that all the information in the document is taken from the Pfizer clinical trial, based on which the FDA authorized the vaccine for public use.

A key quote is buried on page 42: “Among 3410 total cases of suspected but unconfirmed COVID-19 in the overall study population, 1594 occurred in the vaccine group vs. 1816 in the placebo group.”

The comparative numbers reveal that the vaccine was not effective at preventing COVID-19. It was certainly not 50% more effective than a placebo shot which is the standard for FDA Emergency Use Authorization.

One needs to understand the theory of the vaccine clinical trial.

The researchers assumed the SARS-CoV-2 virus was spreading everywhere in the world, and during the clinical trial, it would descend on some volunteers.

The billion-dollar question was: how many people receiving the vaccine would become infected, vs. how many people in the placebo group?

If it turned out that FAR FEWER people getting the vaccine became infected with SARS-CoV-2, the vaccine would be hailed as a success. It protected people against the virus.

But as you can see from the numbers above, that wasn’t the case at all.

So now we come to the vital weasel-phrase in the FDA document: “suspected but unconfirmed COVID-19 [cases].”

“Well, you see, we can’t say these were ACTUAL COVID-19 cases. Maybe they were, maybe they weren’t. They’re in limbo. We want to keep them in limbo. Otherwise, our clinical trial is dead in the water, and we’ll never get approval for the vaccine.”

What does “suspected cases” mean? It can only mean these people all displayed symptoms consistent with the definition of COVID-19, but they’re unconfirmed cases because…their PCR tests were negative, not positive.

However, if their tests were negative, why would they be called “suspected cases” instead of “NOT CASES”?

By FDA/CDC rules, a case of COVID-19 means: a person has tested positive, period.

That’s the way cases are counted.

These thousand-plus volunteers in the Pfizer clinical trial were either COVID-19 cases or they weren’t. Which is it?

The official response to that question is obvious: the FDA decided to throw the data from all those “suspected cases” in the garbage and ignore them. Poof. Gone.

Because if the FDA had paid serious attention to the “suspected cases,” they never would have authorized the vaccine for public use. They would have stopped the clinical trial and undertaken a very deep and extensive investigation.

Which they didn’t. The FDA document also states: “Suspected COVID-19 cases that occurred within 7 days after any vaccination were 409 in the vaccine group vs. 287 in the placebo group.”

Right after vaccination, 409 people who received the shots became “suspected COVID cases.” This alone should have been enough to stop the clinical trial altogether. But it wasn’t.

In fact, the FDA document tries to excuse those 409 cases with a slippery comment: “It is possible that the imbalance in suspected COVID-19 cases occurring in the 7 days post vaccination represents vaccine reactogenicity with symptoms that overlap with those of COVID-19.”

Translation: You see, a number of clinical symptoms of COVID-19 and adverse effects from the vaccine are the same. Therefore, we have no idea whether the vaccinated people developed COVID or were just reacting to the vaccine. So we’re going to ignore this whole mess and pretend it’s of no importance.

It’s called cooking the data. It’s a way of writing off and ignoring COVID symptoms in the vaccine group. Saying “we don’t know” is nothing more than a con and a hustle.
Does anyone actually believe the govt cares about human life? This stuff they are putting in people's body doesn't even fit the CDC definition of a vaccine. What's scary is how many people have rolled over for it and how hard it's being pushed. The govt has lied for almost 2 years about this and the idiots still can't figure out why people don't trust them.
 

Authentic Nouveau

Well-known member
Does anyone actually believe the govt cares about human life? This stuff they are putting in people's body doesn't even fit the CDC definition of a vaccine. What's scary is how many people have rolled over for it and how hard it's being pushed. The govt has lied for almost 2 years about this and the idiots still can't figure out why people don't trust them.
Enjoy this tyrant. Ardern the prime Mistress (adulterous) of new Zealand

take all non government information with a grain of salt
dismiss anything else
we will continue to your single source of truth
 

rossum

Well-known member
Does anyone actually believe the govt cares about human life?
So, President Trump, the head of the US government, who set up operation Warp Speed to develop vaccines quickly does not care about human life? Then why do allegedly pro-life Republicans support him?
 

vibise

Well-known member
FDA Aims to Give Full Approval to Pfizer Vaccine on Monday

https://www.newsmax.com/newsfront/pfizer/2021/08/20/id/1033220/

They will most likely push harder to mandate the vaccine once it's FDA approved.
The military would certainly mandate any FDA approved covid vaccine, as it has mandated other vaccines.

I also wonder if full approval would affect how insurers deal with the unvaccinated in terms of premiums or payments for covid-related care.

Many people claim that they would not get a vaccine that only had FDA Emergency Authorization, so this would remove that objection. Some of these people might go ahead and get vaccinated, but I suspect that others are only using the EA situation as an excuse.

I hope that any FDA announcement of full approval is accompanied by a detailed explanation of the procedures followed and the data used to make this decision.
 

vibise

Well-known member
That was funny. It said it "could" give the vaccine campaign a boost.

No. It will give the vaccine campaign a mandate, in their eyes.

Prepare for your liberties to be put to death.
You are not at liberty to do anything you want to do that puts others in harm's way.

If you don't want to get vaccinated, then you will be greatly inconvenienced, which is as it should be.
 

LifeIn

Well-known member
A key quote is buried on page 42: “Among 3410 total cases of suspected but unconfirmed COVID-19 in the overall study population, 1594 occurred in the vaccine group vs. 1816 in the placebo group.”
This is a new twist on ways to twist information into misinformation. The key term here is "suspected but unconfirmed". The peddlers of misinformation want you to think these were nearly the same as the confirmed covid cases, except that the PCR test came back negative. A more reasonable interpretation is that tens of thousands of people were enrolled in the trial. They subjects were told what the vaccine was for, and that they should report any suspected symptoms to medical personnel as soon as possible so that if it is covid, they can be treated if necessary, or at least isolated to keep from spreading it. So all these tens of thousands of participants were on a hair trigger looking for any sign of a cough, sore throat, fever, chills, fatigue, etc. The participants who got any of these symptoms may have thought they had covid, but had not yet been evaluated by a medical test. At that time they were classified as suspected cases. But suspected by whom? Doctors? No. Average people. So 3410 average people suspected they had covid, but when tested it turned out that most of them didn't. That leaves the confirmed cases as the only ones that are used to evaluate vaccine effectiveness - as they should. See?
 
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