Bombshell fda document re Pfizer trials not reported

[ecstatichamster]

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. Suspected COVID-19 cases that occurred within 7 days after any vaccination were 409 in the vaccine group vs. 287 in the placebo group. It is possible that the imbalance in suspected COVID-19 cases occurring in the 7 days postvaccination represents vaccine reactogenicity with symptoms that overlap with those of COVID-19. Overall though, these data do not raise a concern that protocol-specified reporting of suspected, but unconfirmed COVID-19 cases could have masked clinically significant adverse events that would not have otherwise been detected.

https://www.fda.gov/media/144245/download

Jon Rappaports excellent column

The FDA Cover-Up That Led to the Approval of the Pfizer Jab - LewRockwell

As I’ve been documenting for the past year, the COVID experts have been contradicting themselves six ways from Sunday. As charlatans, they’re abject failures. They can’t keep their own story straight. Thanks to an alert reader, I’ve come across a new blockbuster. BY THEIR OWN STANDARDS, the FDA...

www.lewrockwell.com

Authorization was a crime—according to their own data.

Here we go.

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.” [1]

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 [who received a saltwater shot].”

Those shocking numbers have never seen the light of day in news media.

The comparative numbers reveal that the vaccine was not effective at preventing COVID-19. It was certainly not 50% more effective than no vaccine at all—the standard for FDA Emergency Use Authorization.

 

[haidut]

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. Suspected COVID-19 cases that occurred within 7 days after any vaccination were 409 in the vaccine group vs. 287 in the placebo group. It is possible that the imbalance in suspected COVID-19 cases occurring in the 7 days postvaccination represents vaccine reactogenicity with symptoms that overlap with those of COVID-19. Overall though, these data do not raise a concern that protocol-specified reporting of suspected, but unconfirmed COVID-19 cases could have masked clinically significant adverse events that would not have otherwise been detected.

https://www.fda.gov/media/144245/download

Jon Rappaports excellent column

The FDA Cover-Up That Led to the Approval of the Pfizer Jab - LewRockwell

As I’ve been documenting for the past year, the COVID experts have been contradicting themselves six ways from Sunday. As charlatans, they’re abject failures. They can’t keep their own story straight. Thanks to an alert reader, I’ve come across a new blockbuster. BY THEIR OWN STANDARDS, the FDA...

www.lewrockwell.com

Authorization was a crime—according to their own data.

Here we go.

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.” [1]

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 [who received a saltwater shot].”

Those shocking numbers have never seen the light of day in news media.

The comparative numbers reveal that the vaccine was not effective at preventing COVID-19. It was certainly not 50% more effective than no vaccine at all—the standard for FDA Emergency Use Authorization.

At this point, any "approval" from FDA is basically as good and reliable as the assurances from the local drug dealer that his product is pure and uncut. FDA has a long history of approving drugs even when given direct evidence that the trials were fraudulent. Not simply inadequate trials, but fully fraudulent. See first couple of paragraphs of the thread below.

Flagship Blood Thinner Worse Than Aspirin For Preventing Strokes, Trial Halted

Many of you may have seen the ads on TV for the blood thinner Xarelto. Sadly, those ads have lately started to show increasingly younger people with apparent blood clotting issues, some of them clearly in their 20s. Xarelto is the latest attempt of the pharma industry to replace the old and...

raypeatforum.com

 

[PxD]

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. Suspected COVID-19 cases that occurred within 7 days after any vaccination were 409 in the vaccine group vs. 287 in the placebo group. It is possible that the imbalance in suspected COVID-19 cases occurring in the 7 days postvaccination represents vaccine reactogenicity with symptoms that overlap with those of COVID-19. Overall though, these data do not raise a concern that protocol-specified reporting of suspected, but unconfirmed COVID-19 cases could have masked clinically significant adverse events that would not have otherwise been detected.

https://www.fda.gov/media/144245/download

Jon Rappaports excellent column

The FDA Cover-Up That Led to the Approval of the Pfizer Jab - LewRockwell

As I’ve been documenting for the past year, the COVID experts have been contradicting themselves six ways from Sunday. As charlatans, they’re abject failures. They can’t keep their own story straight. Thanks to an alert reader, I’ve come across a new blockbuster. BY THEIR OWN STANDARDS, the FDA...

www.lewrockwell.com

Authorization was a crime—according to their own data.

Here we go.

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.” [1]

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 [who received a saltwater shot].”

Those shocking numbers have never seen the light of day in news media.

The comparative numbers reveal that the vaccine was not effective at preventing COVID-19. It was certainly not 50% more effective than no vaccine at all—the standard for FDA Emergency Use Authorization.

How did they go from these numbers to the 95% efficacy numbers? Can anyone explain the chain of data manipulation in a few bullet points here?

 

[Rick K]

How did they go from these numbers to the 95% efficacy numbers? Can anyone explain the chain of data manipulation in a few bullet points here?

- Lies
- Lies
- Lies
?

 

[Lollipop2]

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. Suspected COVID-19 cases that occurred within 7 days after any vaccination were 409 in the vaccine group vs. 287 in the placebo group. It is possible that the imbalance in suspected COVID-19 cases occurring in the 7 days postvaccination represents vaccine reactogenicity with symptoms that overlap with those of COVID-19. Overall though, these data do not raise a concern that protocol-specified reporting of suspected, but unconfirmed COVID-19 cases could have masked clinically significant adverse events that would not have otherwise been detected.

https://www.fda.gov/media/144245/download

Jon Rappaports excellent column

The FDA Cover-Up That Led to the Approval of the Pfizer Jab - LewRockwell

As I’ve been documenting for the past year, the COVID experts have been contradicting themselves six ways from Sunday. As charlatans, they’re abject failures. They can’t keep their own story straight. Thanks to an alert reader, I’ve come across a new blockbuster. BY THEIR OWN STANDARDS, the FDA...

www.lewrockwell.com

Authorization was a crime—according to their own data.

Here we go.

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.” [1]

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 [who received a saltwater shot].”

Those shocking numbers have never seen the light of day in news media.

The comparative numbers reveal that the vaccine was not effective at preventing COVID-19. It was certainly not 50% more effective than no vaccine at all—the standard for FDA Emergency Use Authorization.

This is great @ecstatichamster! Thank you for sharing.

 

[ecstatichamster]

How did they go from these numbers to the 95% efficacy numbers? Can anyone explain the chain of data manipulation in a few bullet points here?

they simply ignored the cases post-vaccine as "vaccine reactogenicity with symptoms that overlap with those of COVID-19" -- and so with ZERO cases "confirmed" they were able to gin up the 95% relative risk reduction.

Note that absolute risk reduction, the only thing that matters, is about 1.5% at best.

Same tricks used to promote statins and get docs to prescribe billions of dollars of these poisons each year. Reduces "risk of death from heart attack by XXX%" is always relative risk and never all-cause mortality and never absolute risk.

It's easy to statistically manipulate these numbers with the willing help from the FDA.

 

[ecstatichamster]

At this point, any "approval" from FDA is basically as good and reliable as the assurances from the local drug dealer that his product is pure and uncut. FDA has a long history of approving drugs even when given direct evidence that the trials were fraudulent. Not simply inadequate trials, but fully fraudulent. See first couple of paragraphs of the thread below.

Flagship Blood Thinner Worse Than Aspirin For Preventing Strokes, Trial Halted

Many of you may have seen the ads on TV for the blood thinner Xarelto. Sadly, those ads have lately started to show increasingly younger people with apparent blood clotting issues, some of them clearly in their 20s. Xarelto is the latest attempt of the pharma industry to replace the old and...

raypeatforum.com

I trust the drug dealer more because he is the seller and he wants repeat business. The FDA is simply the puppet for Big Pharma and they have no consequences to their lies.

 

[Jinju]

How did they go from these numbers to the 95% efficacy numbers? Can anyone explain the chain of data manipulation in a few bullet points here?

Hi PxD, in a nutshell, from what I recollect (I did a cursory read through the Pfizer filing):
1. They only used the 'positive' PCR test results while calculating the relative risk reduction
2. The positive Covid numbers were something like 8 in the control group and 160 in the placebo group. Voila there is your 95% efficacy :)

 

[Jinju]

Note that absolute risk reduction, the only thing that matters, is about 1.5% at best.

Totally - the absolute risk reduction is actually below 1%. But that does not make impressive headlines.
Its only skeptics like us who question the narrative.

 

[Ronald1919]

FDA and all vaccine distributors are a criminal gang. Only normies have any faith them.

 

[Nemo]

Authorization was a crime—according to their own data.

Here we go.

And Fleming is now out saying that their efficacy claims aren't even confirmed by their own core studies. They used some peripheral study because their core study showed no efficacy.


View: https://twitter.com/wittgenstein78/status/1397604355822526465

 

[Nemo]

How did they go from these numbers to the 95% efficacy numbers? Can anyone explain the chain of data manipulation in a few bullet points here?

Somebody very smart did that here not long ago. I wish I could find the post.

First, it had something to do with absolute vs relative efficacy. (Math tricks.)

Second, they used a peripheral study for their efficacy claims despite the fact that their core study didn't confirm those claims. In other words, they ignored their own major trial results.

Third, as Hamster is pointing out, they hid data that didn't support their claims.

 

[boris]

How did they go from these numbers to the 95% efficacy numbers? Can anyone explain the chain of data manipulation in a few bullet points here?

Covid-19 vaccine candidate is unimpressive: NNTV is around 256 | The BMJ

Pfizer’s vaccine “may be more than 90% effective.” (Mahase, BMJ 2020;371:m4347, November 9) Specific data are not given but it is easy enough to approximate the numbers involved, based on the 94 cases in a trial that has enrolled about 40,000 subjects: 8 cases in a vaccine group of 20,000 and 86 cases in a placebo group of 20,000. This yields a Covid-19 attack rate of 0.0004 in the vaccine group and 0.0043 in the placebo group. Relative risk (RR) for vaccination = 0.093, which translates into a “vaccine effectiveness” of 90.7% [100(1-0.093)]. This sounds impressive, but the absolute risk reduction for an individual is only about 0.4% (0.0043-0.0004=0.0039). The Number Needed To Vaccinate (NNTV) = 256 (1/0.0039), which means that to prevent just 1 Covid-19 case 256 individuals must get the vaccine; the other 255 individuals derive no benefit, but are subject to vaccine adverse effects, whatever they may be and whenever we learn about them……We’ve already heard that an early effect of the vaccine is “like a hangover or the flu.” Will vaccinees who are later exposed to coronaviruses have more severe illness as a result of antibody-dependent enhancement of infection (ADEI), a known hazard of coronavirus vaccines? Is there squalene in the Pfizer vaccine? If so, will vaccinees be subject to autoimmune diseases, like Gulf War Syndrome and narcolepsy that have been associated with the adjuvant?

 

[Philomath]

How did they go from these numbers to the 95% efficacy numbers? Can anyone explain the chain of data manipulation in a few bullet points here?

Relative risk reduction (RRR) vs absolute risk reduction (ARR. RRR uses the relative risk (RR)—ie, the ratio of attack rates with and without a vaccine—which is expressed as 1–RR. Ranking by reported efficacy gives relative risk reductions of 95% for the Pfizer–BioNTech, 94% for the Moderna–NIH, 91% for the Gamaleya, 67% for the J&J, and 67% for the AstraZeneca–Oxford vaccines. However, RRR should be seen against the background risk of being infected and becoming ill with COVID-19, which varies between populations and over time. Although the RRR considers only participants who could benefit from the vaccine, the absolute risk reduction (ARR), which is the difference between attack rates with and without a vaccine, considers the whole population. ARRs tend to be ignored because they give a much less impressive effect size than RRRs: 1·3% for the AstraZeneca–Oxford, 1·2% for the Moderna–NIH, 1·2% for the J&J, 0·93% for the Gamaleya, and 0·84% for the Pfizer–BioNTech vaccines.

 

[boris]

Relative risk reduction (RRR) vs absolute risk reduction (ARR. RRR uses the relative risk (RR)—ie, the ratio of attack rates with and without a vaccine—which is expressed as 1–RR. Ranking by reported efficacy gives relative risk reductions of 95% for the Pfizer–BioNTech, 94% for the Moderna–NIH, 91% for the Gamaleya, 67% for the J&J, and 67% for the AstraZeneca–Oxford vaccines. However, RRR should be seen against the background risk of being infected and becoming ill with COVID-19, which varies between populations and over time. Although the RRR considers only participants who could benefit from the vaccine, the absolute risk reduction (ARR), which is the difference between attack rates with and without a vaccine, considers the whole population. ARRs tend to be ignored because they give a much less impressive effect size than RRRs: 1·3% for the AstraZeneca–Oxford, 1·2% for the Moderna–NIH, 1·2% for the J&J, 0·93% for the Gamaleya, and 0·84% for the Pfizer–BioNTech vaccines.

Also important to consider that both don't represent any kind of reality. People who were already infected and immune were allowed to participate in the trials, they do not give out the data about how many immune persons were in each group.

There is a popular scheme among supplement companies where the groups are assigned deliberately to create a certain outcome. A supplement company can for example prove that eating anything that they sell, even if it's cardboard, increases intelligence. They let the study participants do a test and then see who did well and who didn't. A person who already did ok, will likely do ok again and not see much change. Naturally someone who does bad on a test will often do better the next time... someone who did bad prepares more for the redo, and after doing the questions they already had right the last time, they have more time to think about the others. So then only after the initial test do they assign the participants to the respective groups. Someone who didn't do well will go in the cardboard group, and the rest to the placebo. The result will show that more people in the cardboard group had an improvement in the test, an that way they "prove" that eating cardboard increases intelligence.

Pharma companies are known to do much shadier things, I would be surprised if they didn't assign more immune people to the vaccine group and thus create a favourable outcome for them.

 

[DrJ]

My experience with the FDA is that they typically don't hire the best and brightest. Mostly drones with credentials that just want a cushy government job that let's them leave at 5pm every day. Now that's not all of them but it's like 80% plus.

Point being there is little accountability there. Superiors don't hold subordinates accountable because: 1) impossible to fire people so you just make enemies to deal with the rest of your career there and 2) if you hold others accountable then others might hold you accountable and it ruins the gravy train. So it doesn't matter if you approve a drug that shouldn't have been approved or don't approve one that should have been. You just go with whatever your reading of the internal politics is and play along.

The FDA isn't intentionally evil, it just effectively appears evil by virtue of its bureaucratic processes and their unintended consequences.

 

[Peatness]

FDA Rep a No-Show at Court Hearing, Citing COVID Concerns; FDA Releases Additional Docs; and FDA Triples Down On 75-Year Production

It is now in the hands of the Court to render a decision... By Aaron Siri A few updates on the battle to get FDA to release the licensure documents for Pf

lorphicweb.com

 

[Beatrix_]

There are new uploads to the Pfizer's docs archive (June 1, 2023)

Pfizer 16+ Documents - Public Health and Medical Professionals for Transparency

Documents with a large file size are provided in a .zip file and will need to be uncompressed after download.

phmpt.org

Public Health and Medical Professionals for Transparency - Public Health and Medical Professionals for Transparency

This nonprofit, made up of public health professionals, medical professionals, scientists, and journalists exists solely to obtain and disseminate the data

phmpt.org