The data is clear: the more vaccines you give your child, the more likely it is that they will develop chronic diseases including autism

I surveyed the parents of 10,000 kids on a variety of common chronic health conditions.

For every single condition in my survey, vaccination raised the odds that the child would develop the condition; the more vaccines, the higher the risk.

My survey confirms the results of other research that has been done showing similar risk elevations for chronic neurological diseases (ND).

This is devastating for our kids. Vaccines are literally poisoning them. This is why the health authorities will never conduct such a study such as the ones I point out below.

In fact, in 2009, 10 members of Congress including Rand Paul, tried to pass a bill forcing NIH to do a study, but the bill never made it out of the first committee because they don’t want you to ever find out that they’ve been poisoning our kids for decades.

Anyone can replicate the study I did. It took me just 24 hours to run. I invite any mainstream “fact checker” in the world to validate the results; I have the contact info for all the parents.

If the CDC wants to resolve the question quickly, all they have to do is give Professor Brian Hooker access to the VSD and Medicaid databases. Why not do that? Don’t they want people to know the truth?

Finally, the most important thing is that none of the vaccines have been needed in America for the last 25 years. Pediatric clinics which eschew vaccines have uniformly better clinical outcomes than their peers who vaccinate in the same population of kids.

This is a long but very important article.

This graph was done by Matt Briggs, an independent statistician. It’s crystal clear: kids with more vaccines are more likely to suffer from chronic conditions.

Here is the summary of the survey. The right column is the odd-ratio for kids getting the condition with 10-15 vaccines compared with kids with no vaccines or Vitamin K shots. So if you got 10-15 vaccines, you are 4.5X more likely to develop autism than an unvaccinated child.

And we know from other studies (pediatric clinics with thousands of unvaccinated kids), that when you eliminate vaccination and the use of Tylenol, the autism rates drop to near zero. So this result isn’t a surprise.

Here’s the table:

You can download the survey, the record-level data and the analysis.

These results shouldn’t be a surprise at all. They are similar to other studies comparing vaccinated with FULLY unvaccinated kids (see the next section).

The bottom line: Kids with more vaccines are much more likely, not less likely, to have a large number of chronic neurological conditions.

For example, from the table above:

  • ADHD: 7x

  • Autoimmune disorders: 21x

  • Autism: 5x

  • Asthma: 9.3x

  • Epilepsy: 4x

  • Sinusitis: 33x

The largest signal was for sinusitis (33X more likely than fully unvaccinated); this basically is so rare in the fully unvaccinated that it causes the number to be high.

It is as devastating as giving your child a vaccine at birth as has been clearly pointed out in the Control Group study

In short, listening to your doctor was a huge mistake that your child will likely never recover from.

Check this out:

Here are other studies you should look at, all showing that the vaccines are significantly elevating the chance your child will get a chronic disease.

These are all published in the peer-reviewed scientific literature. None of these studies have been retracted (even though Gorski would lie and claim they are retracted). I show the odds ratio for autism for comparison with my survey.

  1. Hooker: 5.03

  2. Mawson: 4.2

  3. Control group: Infinite. “For those with zero exposures to post-birth vaccines, pre-birth vaccines, or the K shot, the total rate of autism in the entire CGS is 0% (0 of 1,024)”

  4. Lyons-Weiler: The study was too small to assess autism risk, but showed better health outcomes among the unvaccinated than the vaccinated in other conditions. See this article which notes that the unvaccinated had better compliance to their wellness checks than the vaccinated which eliminates a common argument that anti-anti-vaxxers use. It says, “the unvaccinated families made their well-child visits with greater frequency than the vaccinated families.”

The Thomas study shows similar results. The study was unethically retracted by the journal over the objection of the authors, i.e., the journal didn’t follow the COPE guidelines. They said that “the conclusions were not supported by strong scientific data” which is NOT a valid reason to retract a study once it is published. The journal retracted the paper after an anonymous person claimed (without any evidence) that the results could be due to fewer office visits by the unvaxxed. The author provided evidence that this was not the case, but the journal ignored the evidence. Why? Because the paper got 250,000 views, it had to be retracted because it was counter-narrative and too popular. Later, a new paper showed proof that the reason the journal gave for retracting the paper was clearly false. The journal decided not to admit they were wrong and did not reverse the retraction of the Thomas paper. This is corruption of the highest magnitude. Please complain here using DOI:10.3390/ijerph17228674. The authors of that study would love to debate anyone on the ethics of this retraction. Any takers?

  1. Paul Thomas: Showed generally consistent results overall. The study showed a RIOV of “developing autism” of 4.0 which dropped lower for more vaccines because kids are more likely to develop autism when they are younger and have had fewer vaccines.

Note: it’s possible that vaccines may be causing transgenderism, homosexuality, and many other conditions. I didn’t even think of that when I drafted the survey

Another Internet survey of 13,000 people showed a similar result, the unvaccinated were much better off in all areas measured in the survey (red bars always dramatically smaller):

Comparison unvaccinated-vaccinated

There were controls to detect bias (birth defects, genetic disorders) which were not elevated proving that the survey was not biased. The OR for these conditions were both close to 1 exactly as we predicted.

The survey is analyzed using odds-ratios so the mix of vaxxed vs. unvaxxed is completely irrelevant.

So it doesn’t matter that 12% of the kids in my survey were unvaccinated. It simply means that I only had to survey 10,000 kids to get a decent comparison group; if others did their survey, they’d have to survey nearly 1M kids to find the same number of unvaccinated kids as I did. So I am able to do studies that are impractical for most other people to do.

The only way to attack my survey is to show that the parents all colluded and lied about their kids.

To defend against this attack, I have the contact info for each respondent and invite any fact checker to verify all the entries are accurate provided if you check, you have to publish the results.

The survey took 2 hours to write and was fully executed in 24 hours. The results were not shown to the public until after the survey was completed, making it impossible to game the results. All the data was collected on Airtable so that there would be a record of any data manipulation.

It is astonishing to me that none of the people who argue that vaccines don’t cause neurological diseases (ND) will do such a survey and show that the data I collected is inaccurate. Why won’t they do that?

Why won’t the CDC simply open up access to the VSD and CMS databases so we validate the results ourselves? Why hasn’t the CDC ever used VSD to do the same study? They’ve had 25 years to do that and never did. Why?

We aren’t aware of any study, comparing the fully unvaccinated vs. partially or fully vaccinated kids that doesn’t have similar numbers.

When you read the peer-review literature carefully, you’ll find that they always consider the “unvaccinated” group to have kids without the particular vaccine under study.

So when they compare the MMR vaccine, they compare it to the kids who didn’t get the MMR vaccine. So it’s like comparing the autism rates of kids who got 28 vaccines with the rates of kids who got 27 vaccines. This is how they hide the signal. They design studies which are designed to fail.

Just because they don’t find a signal, it doesn’t mean that it isn’t there. It just means their study design didn’t find the signal.

They will NEVER compare the chronic disease rates in kids who got all recommended vaccines (well over 50 shots, many with multiple vaccines) vs. completely unvaccinated kids. It simply has never happened.

The excuse that unvaccinated kids are too hard to find is ridiculous. The Amish have thousands of such kids and there are hundreds of such kids that can be located in a heartbeat. All they have to do is call me and I’ll be happy to help.

There is another study with around 50,000 kids that was done. It’s not published yet, but the results confirm the studies that were done above: the more you vaccinate kids the greater the difference in chronic diseases vs. the unvaccinated.

The medical journals will likely reject the study because it goes against the narrative. The study was done by a well known researcher.

Yes. More on that in an upcoming article. If you remove the vaccines and Tylenol, the rates of autism drop to near zero.

In 2007, Generation Rescue (GR), an organization that is trying to alert Americans that vaccines cause autism, hired a third party polling firm (SurveyUSA) and paid them $200,000 to do a survey. The advantage to using a third party to do the survey is that GR cannot manipulate the results.

Like my survey, the GR survey found significant elevations for all diseases and conditions.

In the summary report, GR noted the following lack of interest by the CDC in doing any studies comparing vaccinated to unvaccinated kids:

No studies have ever been done to compare ND rates of children who received vaccines with those who received no vaccines, which is what our survey accomplished. Moreover, no studies have ever explored a link between vaccines and ADHD, despite the fact that 1 in 13 U.S. children have this diagnosis (versus 1 in 150 for autism).

The glaring absence of a study to compare vaccinated and unvaccinated children for ND rates caused Congresswoman Carolyn Maloney (D-NY) to introduce this bill to compel the National Institutes of Health to do such a study.

Those statements are as true today as they were 16 years ago.

No public health authority has ever done such a survey. Ever.

I predict that such a survey will never be done because they don’t want the truth to be known.

The bill, H.R.3069 — 111th Congress (2009-2010), was introduced on June 26, 2009 with 9 co-sponsors including Ron Paul. It never made it out of committee.

Here’s the summary:

Requires the Secretary of Health and Human Services (HHS), acting through the Director of the National Institutes of Health (NIH), to conduct a comprehensive study to: (1) compare total health outcomes, including the risk of autism, between vaccinated and unvaccinated U.S. populations; and (2) determine whether vaccines or vaccine components play a role in the development of autism spectrum or other neurological conditions.

The bill would have forced the NIH to do just ONE study.

Why would anyone be opposed to finding the truth?

The answer is simple: because our government simply does not want anyone to know the truth.

People would go nuts if they found out that the CDC has been harming our kids for decades with these vaccines and not telling anyone. It would destroy all faith in the mainstream press, the medical community, Congress, and US government agencies. So they killed the bill and there is no press about it. All silenced by the mainstream media.

Some people will gaslight you into believing that surveys are not “science.” That is false.

In fact, Professor Anders Hviid, an author of the highly cited Denmark study which claims that vaccines don’t cause autism, was so proud of his nationwide questionnaire study on COVID that was published in Nature that he pinned it to his Twitter profile; he’s the senior author on that study!

Professor Hviid then blocked everyone from viewing his tweets within 24 hours after I emailed him to ask him for his data.

If these surveys are all wrong, where are their surveys done by a reputable independent polling firm with no conflicts of interest showing the “correct” numbers?

The silence and lack of interest tells you everything.

Here’s what Judy Gerberding, the CDC Director said in 2005:

I think those kinds of studies could be done and should be done.

Let’s speed this up. Let’s look for the early studies that could give us at least some hypotheses to test and evaluate and get information flowing through the research pipeline as quickly as we can. So we are committed to doing that/

We think we will be able to provide more accurate information in the next year or so than we’ve been able to do up to this point. And I know that is our responsibility.

Guess what happened? They did nothing.

Why didn’t they just run exactly the same poll that Generation Rescue did in 2007? Just employ a different third party respected research firm to replicate their study and see if they get similar results. That would have been easy and a great start. Total cost: $200,000.

Instead they did nothing…. nothing!

It reminds me of Sgt Schultz:

When An AM or PA see something they know is wrong, or against the rules. :  r/AmazonFC

The CDC doesn’t want to know what is going on. If they were honest, why not run exactly the same poll that GR did and show the results are different? Why not give Professor Brian Hooker and Dr. James Lyons-Weiler full access to VSD and Medicaid to do their research? I’ll pay for their time. It would cost the CDC nothing, nothing!

If the CDC was honest and had nothing to hide, they would give researchers such as Professor Brian Hooker, James Lyons-Weiler, and other scientists who have published papers on autism in the peer-reviewed scientific literature, free, full, unfettered access to the VSD and Medicaid databases to do research.

But they won’t.

They never will.

Because hiding the data is critical.

And that tells you everything you need to know, doesn’t it?

Here’s my handy list of other things you should know:

  1. Here is a complete list of necessary vaccines:

  2. Have you ever wondered why vaccines work so well? Check out the graphs here. You’ll find this most interesting.

  3. None of the vaccines used in America today were ever tested against a true placebo (saline shot). This was noted in Turtles all the way down and has never been disproven.

  4. There are no post-marketing studies of vaccine safety for any vaccine in America that prove the vaccines are safe. Only the states have the data and they aren’t sharing the data or doing the studies. See my article on data transparency for details and also my article “Is it safe?” for details on why that is.

  5. Did you know CDC doesn’t have the vaccination record-level data for any vaccine from any state? So the CDC can’t know if the vaccines are safe. They could ask the states to provide these records, but they are too shy to ask the states for the data. I got this directly from the head of Media Relations at the CDC. I was floored.

  6. The states aren’t doing the safety analysis either. When I contacted California State Epidemiologist Erica Pan, she ghosted me immediately after I asked her, “Do you believe in data transparency?”

  7. None of the states make record-level public health data public. If they do that, we’d improve clinical outcomes. There’s no study showing keeping this data secret improves clinical outcomes. I believe that they keep this data hidden to cover the harms caused by vaccines. I’d love to be proven wrong. Simply open up the records.

  8. A lot of people believe that vaccines have eliminated many diseases and are a net benefit to society. I’ve yet to see the proof of any of that today. While it “sounds” plausible, the risk benefits of each vaccine are dynamic and depend on the current morbidity and mortality of the disease relative to that of the vaccine. Where is the data on that? I haven’t seen it. Have you? There should be an on-going annual evaluation of risk vs. benefit for each vaccine. This has never been done. Why not let us into the VSD to make these assessments instead of blindly assuming vaccines have no risks?

Colleen Gaffney wrote:

One other thing that I found alarming, my daughter came home from school last year and said that in health class they were all talking about things that they were allergic to. Out of 24 students, my unvaccinated daughter was the only one that wasn’t allergic to anything. So ironic.

Please consider becoming a paid subscriber. I do this full time and your support allows me to do this work on your behalf and expose the corruption.

I can guarantee you that the US government is definitely not funding any of my work. Can you guess why?

The evidence is clear. The primary reason we have an epidemic in autism and other chronic diseases and neurological conditions is due to the vaccination program in America.

Read that again. The vaccines are causing the epidemic in neurological disorders in America.

If we eliminate the use of all vaccines entirely, our kids will be dramatically healthier. I couldn’t find a single counter example of this anywhere in America. All the clinics that have tried this approach have superior outcomes. Every. Single. One.

All the pediatric clinics I’m aware of which eschew vaccination have superior health outcomes. No exceptions.

That is the reason that no health authority anywhere in the world will debate us (Hooker, Mawson, Lyons-Weiler, Wakefield, …) on this. It’s just never going to happen.

That is also the reason that our access to VSD and Medicaid is DENIED. It is forbidden to use these databases for any research that might show the vaccines are a problem. They will never allow any of our scientists to see the data. If the vaccines are safe, they would be tripping over themselves to let us in so we can prove to ourselves we were wrong.

Don’t take my word for it on vaccinations.

My advice is simple: NEVER trust your doctor on this topic. Always do your own research before consenting to any injection for yourself or your children. You can never undo a vaccine. There is no way to “unvaccinate” yourself.

Before you consider taking a vaccine, always DEMAND see to the large scale public health data record-level data which can be analyzed to show safety and efficacy. Isn’t it funny how they all refuse to produce that data? NOBODY will publicly release the public healthy record-level data. NOBODY. It can be easily done without any privacy issues. That’s just an excuse.

Have you ever seen any large scale studies based on public record-level data proving it is safe? I haven’t. There’s a reason for that: there are no such studies. Zero. I defy anyone to prove me wrong on that. They won’t expose the data. If the vaccines are truly safe, why are they hiding the data?

This is why surveys such as the one I did are so important because they won’t give us access to THEIR records so we have to do our own data collection.

These surveys assess what is really happening. In just 24 hours, I was able to gather sufficient evidence to convince myself that vaccines are an unmitigated disaster.

I have NEVER heard of anyone doing something similar to what I did and getting a different result. Have you? They have never shown us THEIR studies. Why is that?

And that, my friends, is the reason why, when your doctor asks whether you want a vaccine injection for yourself or your child, you should always just say NO.

Nobody wants to make the public health records public. And now you know why.

Please consider sharing this article and help save a life or two.

Simply re-tweet my Twitter post. Thanks!

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Popular Hiking App Releases 27,000 Trail Maps to Download for Free, Increasing Hiker Safety

popular-hiking-app-releases-27,000-trail-maps-to-download-for-free,-increasing-hiker-safety

One of the most popular hiking apps has made 27,000 trail maps available for download for free in a bid to increase hiker safety.

Most hikers, if they’re honest, will at some point have experienced this situation: they thought they needed to follow one trail, but instead they followed another. Seeking to reorient themselves, they timidly pulled out their smartphone and see, as they suspected, there was no reception of any kind.

Last year, search and rescue missions were up 32% across the US. This is mainly down to the hikers being inadequately prepared. Access to offline maps would help ensure that all hikers can be best prepared for their hike.

To that end, the Irish hiking app HiiKER has released all trail maps in its database for download free of charge. They can either choose to download them directly to their smartphone or as a GPX file to their smartwatch—saving the battery of their device while away from electricity access.

“Hiker Safety is our absolute priority. Offering hikers Free Offline maps on HiiKER, means that everyone can feel confident that they’re on track, regardless of mobile service,” said Paul Finlay, CEO and Founder of HiiKER.

The app team claims that other incumbent Hiking apps such as Alltrails, Strava, and OutdoorActive charge for access to offline maps. As this service is critical to hiker safety, HiiKER is offering it to hikers for free.

Now used by over 600,000 hikers worldwide, the app which began life on the Emerald Isle three years ago is now one of the most-used hiking apps on the market, with over 27,000 hiking routes available to users.

OTHER COOL APPS: All Dogs Have Completely Unique Nose Prints–like Fingerprints–And There’s an App to ID Each Pet

HiiKER also works alongside trail management organizations to ensure the data they include in their app is always up to date.

One such organization, the Continental Divide Trail Coalition, welcomed the news of the free offline maps.

SHARE This Great App And Its Resources With Your Hiking Friends… 

X-rays and Webb Telescope Provide Dazzling Views of Space Invisible to the Unaided Eye

x-rays-and-webb-telescope-provide-dazzling-views-of-space-invisible-to-the-unaided-eye
credits from left to right and top to bottom – Chandra: NASA/CXC/SAO, XMM: ESA/XMM-Newton; IR: JWST: NASA/ESA/CSA/STScI, Spitzer: NASA/JPL/CalTech; Optical: Hubble: NASA/ESA/STScI, ESO; Image Processing: L. Frattare, J. Major, and K. Arcand

Looking for a cool way to get your kids involved in astronomy? Just show them this picture.

These images are composite pieces of technological artwork that would be invisible to the naked eye. Five space-based observatories teamed up with one down here on Earth to color in famous regions of space with X-rays and infrared light—neither of which can be seen by us.

The image in the top left is of NGC 346, a star cluster in the Large Magellanic Cloud, 200,000 light years from Earth. The purple and blue haze on the left are X-rays, a form of high-energy light, left over from a supernova explosion. On the right, infrared data from the James Webb and the now-retired Spitzer space telescopes shows plumes of gas and dust that all those twinkling stars are either currently using, or have used to create their shining, burning forms.

The X-rays are being detected by the space-based Chandra X-ray Observatory, developed by Harvard, and humanity’s flagship X-ray observatory.

To the right side, NGC 1672 is a spiral galaxy, but one that astronomers categorize as a “barred” spiral, meaning that the arms close-in to the center appear more like straight bars rather than curved tentacles. Here, Chandra’s purple-colored X-rays reveal black holes amid the James Webb and Hubble telescopes infrared and optical light picture of this galaxy.

MORE SPACE IMAGES: Webb Telescope Reveals Yet More Details Never-Before-Seen in Cassiopeia – An Exploding Star

Messier 74 is also known as the “Phantom Galaxy” because it’s relatively dim and difficult to spot with telescopes in a region that is otherwise pretty close to Earth. It’s anything but dim in this image, captured face-on thanks to our planet’s position.

Webb outlines gas and dust in the infrared lights which we see as green, yellow, red, and magenta, while Chandra’s data spotlights high-energy activity from stars at X-ray wavelengths colored in Purple. Hubble’s optical data showcases additional stars and dust along the dust lanes.

MORE ASTRONOMY NEWS: Unprecedented Gamma-Ray Burst is ‘The BOAT’ – Brightest of All Time in Human History

Messier 16, also known as the Eagle Nebula, is a famous region of the sky often referred to as the “Pillars of Creation.” The Webb image shows the dark columns of gas and dust shrouding the few remaining fledgling stars just being formed. The Chandra sources, which look like dots, are young stars that give off copious amounts of X-rays.

Here, the X-rays are in red and blue, and highlight the huge activity given off by some stars in the area.

SHARE This Stunning Work With Your Friends On Social Media… 

VSRF Update Tomorrow: Mattias Desmet

VSRF Weekly Update
Thursday, June 1
7pm Eastern | 4pm Pacific

Register here to watch on Zoom
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I am pleased to welcome to tomorrow’s show Professor Mattias Desmet, the renowned expert on mass formation theory. We will discuss the societal implications of institutional influence, indoctrination, and the harmful aspects surrounding COVID-19 mandates, lockdowns, and vaccination efforts.

In his book, “The Psychology of Totalitarianism” Mattias Desmet presents a compelling analysis of the societal response to the pandemic. Desmet, a former professor of clinical psychology at Ghent University in Belgium, is widely recognized as a leading authority on the theory of mass formation. His work has been featured in prominent media outlets and viewed by millions worldwide.

For  several years, Desmet has been exploring the pervasive nature of institutional influence and its impact on public perception. He highlights the challenges faced by alternative voices, often stigmatized and overshadowed by an apparent “Ministry of Truth” reinforced by a multitude of “fact-checkers.” These dynamics curtail freedom of speech and impose censorship, creating an environment of limited self-expression.

As always on the VSRF Weekly Update, we encourage critical thinking and open dialogue about the COVID-19, the vaccines, mandates, and lockdowns. Through our conversation with Mattias Desmet, we aim to shed light on the psychological aspects of mass formation and challenge prevailing narratives. Join us as we explore the implications of institutional influence, the consequences of limited freedom of speech, and the potential long-term effects on mental health.

Bring a friend and bring your questions.

Thank You

I want to continue to thank everyone who has reached out to donate over these past few weeks. Your commitment to our cause is deeply inspiring and is enabling us to produce our show this week and in the coming few weeks. I appreciate everyone contributing as much as possible to ensure that VSRF continues to carry out our mission, which includes critical support and care for the vaccine injured. 

With your help, we will win! 

You can donate by credit card, check, and bank wire.

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Report 73: Pfizer Knew by November 2020 That Its mRNA COVID Vaccine Was Neither Safe Nor Effective. Here Is What Pfizer’s Employees and Contractors Knew and When They Knew It.

Introduction

Through the review of two documents – Pharmacovigilance Plan for Biologic License Application #125742 Of Covid-19 mRNA vaccine (nucleoside  modified) (BNT162b2, PF-07302048) and 5.3.6 Cumulative Analysis of Post-Authorization Adverse Event Reports of PF-07302048 (BNT162b2) Received Through 28-Feb-2021 – referred to below as “PV” and “5.3.6,” Dr. LaLonde, the lead author of this report, came to understand Pfizer knows its product does not work and that it poses a danger to the public. In this report, he has demonstrated these admissions in Pfizer’s own words. When these documents are overlaid with the Emergency Use Authorization (EUA) from 2020 and the EUA from late 2021, it is apparent the Company ignored safety signals and used weak statistics to justify product use. When these documents are viewed together, there is sufficient evidence to say Pfizer understood that there were problems with its mRNA COVID product before the original EUA was submitted in November 2020.

 

Abbreviations

PV = Pharmacovigilance Plan for Biologic License Application #125742 Of Covid-19 mRNA vaccine (nucleoside  modified) (BNT162b2, PF-07302048). Date of Report: 28 July 2021, Version 1.1

EUA 2020 = Emergency Use Authorization (EUA) for an Unapproved Product Review Memorandum. Date of Document: 20 November 2020, Author: Marion F. Gruber, Ph.D., Director, CBER/OVRR

5.3.6 = Reissue of 5.3.6 Cumulative Analysis of Post-Authorization Adverse Event Reports of PF-07302048 (BNT162b2) Received Through 28-Feb-2021. Approval Date: 30 April 2021.

EUA 5-11 = Emergency Use Authorization (EUA) for an Unapproved Product Review Memorandum. Date of Document: 06 October 2021, Author: Peter Marks, M.D., Ph. D., Director, CBER, and Acting Director, CBER/OVRR.

SOC = System Organ Class

AE = Adverse Event

 

Executive Summary in chronological order:

  • In November 2020 (EUA 2020), Pfizer dismissed safety signals in its clinical trial C4591001 (ages 16+). Moreover, although Pfizer considered any adverse event (AE) within six weeks of product use to be reasonably associated with the product (EUA 2020, p. 10), it dismissed the observed safety signals in EUA 2020, 5.3.6, PV, and EUA 5-11.
  • In November 2020 (EUA 2020), Pfizer had a weak demonstration of efficacy based on very few occurrences (eight cases versus 162 cases). C4591001 was essentially invalid because investigators failed to confirm or deny 3,410 suspected COVID cases (1,594 vaccinated and 1,816 placebo). If COVID occurred in the thousands and investigators used only 170 cases for efficacy, their statistics did not reflect reality. Investigators then destroyed their clinical trial by unblinding and vaccinating all placebo cohort participants (PV, p. 13, pp. 18-19). In effect, this act terminated the trial. Pfizer acknowledged unblinding and vaccinating the placebo cohort would adversely affect the data (EUA 2020, p. 53). The company cut off data collection the day after placebo participants were vaccinated (EUA 5-11, p. 12).
  • Through December 2020 to February 2021 (5.3.6) field reports, Pfizer observed AEs including deaths and permanent harms. Per Pfizer’s own standard of AEs within six weeks of product use being considered product-related (EUA 2020, p. 10), Pfizer de facto recognized its product caused AEs, because many of the AEs in 5.3.6 occurred within hours or days of product use.
  • In its report dated July 28, 2021 (PV), Pfizer still planned to use C4591001 (a portion of which was due April 2023) to reach final conclusions on its mRNA COVID product’s efficacy and safety. The cut off of data collection on March 12, 2021, should be understood as Pfizer’s acknowledgement of the termination of its clinical trial. Pfizer attempted to substitute titer-based lab tests for efficacy, but later admitted lab titers do not represent disease protection (i.e., efficacy) (EUA 5-11, p. 13).
  • In Pfizer’s July 2021 report (PV), Pfizer acknowledged pericarditis and myocarditis as risks of product use. Pfizer did not call it a dose-response, but it reported pericarditis and myocarditis risks as higher after dose #2 (PV, p. 50). Pfizer reported a similar dose-dependent pattern elsewhere (EUA 2020, p. 6, p. 42, p. 56; EUA 5-11, p. 46). All other AEs noted in the EUA 2020, from study C4591001, and AEs reported from the field in 5.3.6 were ignored. Additional studies listed by Pfizer in PV seem to not exist online.
  • In October 2021 (EUA 5-11), efficacy was weakly demonstrated. Investigators did not draw upon C4591001 for support. Rather, they substituted titers for efficacy.
  • In Pfizer’s October 2021 EUA 5-11 submission, Pfizer described a dose-response relationship between its product and AEs in both dosage and dose number. Investigators speculated that subclinical damages would manifest in the long-term. The implication is that continued doses with subclinical damages would eventually manifest as clinical damages. Pfizer admitted a young male subject’s AE, previously dismissed, was actually related to product use months after initial signal detection. This event represented a pattern of behavior: no matter what AE occurred, investigators concluded it was unrelated to Pfizer’s product.
  • EUA 5-11 introduced unsupported points to push product use in children. Pfizer introduced claims on transmission prevention and attacked the unvaccinated. Investigators did not provide clinical trial evidence for support. The product did not have well-demonstrated benefits, so any risks (and there are many) immediately rendered a poor risk-benefit ratio.

 

Emergency Use Authorization (EUA) for an Unapproved Product Review Memorandum. Date of Document: 20 November 2020, Author: Marion F. Gruber, Ph.D., Director, CBER/OVRR.

EUA 2020 Regarding Efficacy 

Pfizer’s original efficacy claim was based upon ratios between very small numbers over a short period of time (six weeks), representing extremely weak evidence. The vaccinated group had eight COVID-19 cases, and the placebo group had 162 cases (EUA 2020, p. 20). Investigators used this simple ratio to determine high efficacy, as 162 is around 20 times greater than eight. Compare these occurrences against the 17,411 in the vaccine cohort and the 17,511 in the placebo cohort used for the statistical evaluation (EUA 2020, p. 23). Eight and 162 were infinitesimal. If an individual took the vaccine, it dropped their risk of a positive PCR test from 0.92% to 0.045% in a six-week period. To put it another way, one should consider the result as doses needed to treat the population. Investigators vaccinated about 17,500 individuals (35,000 doses) to prevent approximately 150 COVID cases. For the other 17,350, the benefit was effectively zero during the six weeks. For them, vaccination was only risk.

This analysis described the purest meaning of the investigators’ results. They arrived at a statistic derived under a narrow set of parameters, the most important of which was the very short-term nature of six weeks. In this context, the fraction of a percentage drop in COVID risk was inconsequential to the population. Pfizer failed to discuss the alternative conclusions based on few occurrences in a short time span. Pfizer would have understood that 35,000 doses to save about 150 cases was not practical for a public health intervention. This approximation of doses-needed-to-treat is just as valid as the efficacy claim in the context of a six-week period. It is the same result at which Pfizer arrived, drawn from the same evidence; however, it is rephrased in more practical language. A reasonable person would not take an experimental drug if the benefit was a 0.88% drop in COVID risk.

To create strength in statistical evaluation, the trial needed to run for two years to allow occurrences to build up in the placebo and experimental cohorts. Only then could valid conclusions be made. The result would either hold up and become stronger with time as vaccinated participants resisted disease over the long term, or investigators would find that COVID cases also accumulated in the vaccinated cohort just as they did in the placebo cohort. The practical reality was that this short-term cultivation of data was enough to perform a statistical math exercise only. Investigators did not demonstrate 95% efficacy over a year or longer period of time. If efficacy waned in the short-, middle-, or long-terms, it would not be captured by this preliminary analysis. For a short, preliminary, investigative trial with further follow-up planned, Pfizer’s conclusion was technically acceptable, despite issues, as long as the clinical trial continued, unaltered, to the planned 24-month completion date.

On page 41 (EUA 2020), the investigators reported there was a significant issue in their clinical trial, which would have affected even their preliminary efficacy assessment. There were suspected COVID cases numbering in the thousands that were never tested. The authors discussed this finding in the context of safety, discussing both reactogenicity and adverse events, but they failed to provide commentary on efficacy.

https://www.fda.gov/media/144416/download, p. 41.

They unwittingly admitted in this section that they did NOT test large numbers of participants with suspected cases of COVID. Since testing was a critical procedure to determine efficacy, it brings serious questions to the legitimacy of the clinical trial. Based on this information, the EUA clinical trial C4591001 results were not valid. This conclusion should stand until personnel operating these trials provide important context and relevant information proving otherwise.

 

The EUA 2020: Implications of Failure to Test Suspected COVID-19 Cases

Investigators reported 1,595 suspected COVID cases in the vaccine group and another 1,816 suspected COVID cases in the placebo group (EUA 2020, p. 41). Remember, investigators determined efficacy on 170 total COVID cases between the cohorts. If they thought they had thousands of other COVID cases and never confirmed them through testing, they not only violated Pfizer’s protocol but also failed to include cases necessary to reach the correct determination of efficacy. If what the investigators reported was true, the C4591001 study would have been invalid by November 2020. The section to follow will highlight the implications of this testing problem regarding efficacy.

If the investigators were correct about missing COVID cases and these 3,410 cases failed to make their analysis due to their failure to test, the real comparison could have been 1,602 vaccinated against 1,978 placebos. The risk to placebo participants could have been 11.3% compared to 9.2% in the vaccinated cohort for a 2.1% drop in risk of COVID. Practically speaking, it would not be a great difference in scale between the occurrences between the cohorts. Most importantly, their efficacy would be closer to 19% with these numbers. Consider how this incidence rate would affect the clinical trial. If investigators witnessed thousands of cases of COVID in both cohorts in this short period, they were on track to run out of trial participants in about a year if it continued. Efficacy in that scenario would approach zero, and investigators would have been able to see that inevitability coming if thousands were getting COVID in both cohorts.

The true efficacy could be 95%, 19%, 0%, or some other figure. Hypothetically, there could have been more COVID cases in the vaccinated group, which would have represented negative efficacy.  We cannot know because the investigators did not follow up on suspected cases with testing. It begs the question of how they decided who and when to test. The failure to test thousands of potential cases combined with the arrival at eight vs 162 gives the appearance that investigators cultivated the results. If there is a valid explanation, the public deserves to hear it from the investigators.

 

EUA 2020 Regarding Safety

 The standard for considering AEs to be potentially related to the product are as follows: “From a safety perspective, a 2-month median follow-up following completion of the full vaccination regimen will allow identification of potential adverse events that were not apparent in the immediate post-vaccination period. Adverse events considered plausibly linked to the vaccination generally start within 6 weeks of vaccine receipt” (EUA 2020, p. 10). For reference, the EUA findings from C4591001 represented six weeks of follow-up on average per patient.

In the vaccine group, investigators reported occurrences of myocardial infarction (MI) as 0.02% (four to five patients, p. 40), cerebrovascular accident (CV) as 0.02% (four to five patients, p. 40), appendicitis as 12 patients (0.04%) (p. 40), and Bell’s palsy as four patients (~0.02%) (p. 37). The standard of using few occurrences to make conclusions, as used for efficacy, applied here, too. During the short, six-week study, the risk of MI or CV quadrupled or quintupled in the vaccine group as compared to the one placebo death from MI and the one placebo death from hemorrhagic stroke (EUA 2020, p. 40). Risk of appendicitis increased 50% with vaccination (12 versus eight). Bell’s palsy did not occur in any placebo participants. These observations were safety signals.

Investigators reported six deaths during the trial (two vaccine versus four placebo). One vaccine subject was over 55 and experienced cardiac arrest 62 days after dose #2. The other subject was over 55 and died of unlisted causes three days after dose #1, but investigators noted he was obese with atherosclerotic disease. The placebo deaths were one MI, one hemorrhagic stroke, and two unknown causes. Of these six, one was under 55-years-old, and the specific age is not disclosed. Investigators assured the public that “all deaths represent events that occur in the general population of the age groups where they occurred, at a similar rate” (EUA 2020, p. 40).

The investigators took time in the EUA to declare the AEs as chance events consistent with the general population at large. This acknowledgement is extended to deaths (p. 43), appendicitis (p. 43), and Bell’s palsy (p. 52), yet no commentary accompanies MI and CV. These assertions are not valid per their own standard from page 10 — i.e., “From a safety perspective, a 2-month median follow-up following completion of the full vaccination regimen will allow identification of potential adverse events that were not apparent in the immediate post-vaccination period. Adverse events considered plausibly linked to the vaccination generally start within 6 weeks of vaccine receipt” — where they noted any occurrences within their six-week trial period would be plausibly linked to product use. It was also not valid because the investigators were charged with running a clinical trial where findings from the vaccine group were compared specifically to the placebo group. It was the entire purpose of the clinical trial. Rather than doing this analysis in an open and honest way, the investigators, who realized there could be significant safety issues, blamed chance. Nonetheless, investigators used very small numbers to determine that efficacy was high. They then ignored the same small numbers to determine safety, which included dismissal of adverse events that occurred within a short time after doses. The methods that were good enough for efficacy were suddenly not good enough for safety.  

 

The Fate of the Placebo Cohort

In light of the problems highlighted above with statistics based on small numbers, the investigators had one course of action to pursue truth in their clinical trial. They needed to run the 24-month clinical trial to completion. The missed COVID cases were an issue, but they could potentially make up for it with due diligence by tracking down these cases and by following both cohorts to the two-year completion date. In the event the product worked very well with an excellent safety profile, the evidence over a longer span would tell that truth despite imperfections in the process. It was in the best interests of Pfizer and the world’s patients to witness this truth. If it turned out the product did not work or that it was not safe or both, the integrity of the clinical trial C4591001 was critically important to stop product use.

On page 53 of the EUA 2020, the investigators discussed the consideration to unblind and to vaccinate the placebo cohort. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) provided discussion.

“The committee discussed potential implications of loss of blinded, placebo-controlled follow-up in ongoing trials including how this may impact availability of safety data to support a Biologics License Application (BLA). Some pointed out the importance of long-term safety data for the Pfizer-BioNTech COVID-19 vaccine as it is made using technology not used in previously licensed vaccines. In response to the question whether the ongoing Phase 3 study would still be sufficiently powered if eligible placebo recipients were vaccinated, Pfizer asserted that, even with an anticipated loss of placebo-controlled follow-up of 20%, the study would maintain adequate statistical power and would be positioned to accrue additional data on vaccine efficacy, including efficacy against severe disease, as well as safety, although unblinding of the study would reduce interpretability of results” (Bold Added, EUA 2020, p. 53).

Pfizer already had statistical issues documented above and acknowledged within the EUA 2020 that they were open to reducing their study’s power further by unblinding and vaccinating the placebo cohort participants. There was no rubric for how they would choose which participants would be among the unblinded 20%, but they had a solution in mind. Nonetheless, with this 20% standard established by Pfizer in this November 2020 EUA, Pfizer vaccinated their entire placebo cohort. Pfizer documented it outside the view and knowledge of the world’s patients (Table 5, PV, pp. 18-19). Pfizer reported the vaccination of 19,696 placebo participants, representing the entirety of their placebo cohort. Pfizer completed this process rapidly, finishing on 12 March 2021.

Investigators moved to unblind and vaccinate placebo participants immediately after the EUA 2020 was approved. Per Pfizer’s own 20% standard established in the EUA 2020 (p.53), the power of this study was effectively destroyed on March 12, 2021 (PV, ps.18-19). Thus, Pfizer essentially ended its clinical trial, C4591001, in March 2021. Whatever continued on was something else approximating an observational study. If the product was highly efficacious and safe, it was not in Pfizer’s interest to manipulate the placebo cohort. A complete clinical trial with clean data, free of manipulation, was in the best interest of patients and society, because it was much more likely to conclude the truth. Pfizer committed this act before it had valid efficacy and safety data. As a result, the trial cannot produce an accurate efficacy analysis.

 

EUA 2020 – Conclusion Summary Statement

 By the completion of the EUA 2020, the investigators knew they had significant shortcomings in their efficacy assessment. They had safety signals that they refused to acknowledge as product related. Yet, Pfizer pushed an efficacy statement it could not support and declared a high level of safety that was refuted by its own reported observations. If the limited data were sufficient for efficacy, the same limited data were sufficient to acknowledge significant safety signals. Furthermore, Pfizer’s failure to capture COVID cases in its study cohorts rendered any efficacy outputs invalid. The investigators were subject matter experts in these areas. The construction of statistics in the EUA, combined with selective observations, indicated they very likely knew or at least suspected the product had limited or zero efficacy and significant safety concerns by November 2020. Their termination of the clinical trial before valid data became available did not serve the interest of society; it seemingly served to hide data from the public.

 

5.3.6 Cumulative Analysis of Post-Authorization Adverse Event Reports of PF-07302048 (BNT162b2) Received Through 28-Feb-2021.

FDA Approval Date: 30 April 2021

Obtained by Court Order

 

5.3.6 Regarding Safety

 The 5.3.6 document (38 pages) was a safety-monitoring report authored by Worldwide Safety at Pfizer (WSP). The findings represented adverse events submitted voluntarily to Pfizer’s safety database from various sources, including medical providers and clinical studies, between 01 December 2020 and 28 February 2021. The AEs consisted of 42,086 cases reporting 158,895 total adverse events. The AEs were broken into System Organ Classes (SOCs) with each SOC further divided into individual conditions observed in the field. The report described AEs with percentages representing proportions of reports received. Any percentages should not be taken as incidence rates of occurrence, as this observational data was not a clinical trial. Nonetheless, it should have been evident to Pfizer that its product harmed patients, which included permanent harms and 1,223 deaths.

Within the first three months after rollout of product, providers in the field reported damages across all organ systems to Pfizer. Reference the table below. This table includes special concern areas being tracked by Pfizer through 2020 and 2021. The first special concern, anaphylaxis, is considered an “Identified Risk” (IR), Vaccine-Associated Enhanced Disease (VAED) is considered a “Potential Risk” (PR). The third category of “Missing Information” (MI) concerns “Pregnancy and Lactation,” “Use in Pediatric Individuals,” and “Vaccine Effectiveness.” These IR, PR, and MI categories were predetermined categories of interest from the EUA 2020 that garnered more information in 5.3.6. All other SOCs charted below fell outside those original categories.

 

SOCPageNumber,

%

Serious

(N, [%])

Non-Serious

(N, [%])

Report Author’s Notations
Anaphylaxis (IR)102,958

7.0%

2,341

5.6%

617

1.5%

VAED (PR)1175 potential cases
Pregnancy and Lactation (MI)12-13413

0.98%

84

0.2%

329

0.78%

Spontaneous abortions and neonatal deaths reported; alterations to breastfeeding
Pediatric (MI)1334

0.08%

24

0.05%

10

0.02%

One Facial Paralysis
Vaccine Effectiveness (MI)13-151,665*

4.0%

1625

3.9%

21

0.05%

“Serious” is considered a case of COVID; no immunity conferred
Cardiovascular161,403*

3.3%

946

2.2%

495

1.2%

130 myocardial infarctions, 91 cardiac failures
COVID-19173,067*

7.4%

2,585

6.1%

774

1.8%

Unremarkable; deals with positive cases
Dermatological1720

0.05%

16

0.04%

4

0.01%

Unremarkable; Reactions
Haematological18932*

2.2%

681

1.6%

399

0.95%

Numerous examples of spontaneous bleeding from mucous membranes
Hepatic18-1970*

0.2%

53

0.13%

41

0.1%

Metabolic alterations within the liver
Facial Paralysis19-20449*

1.07%

399

0.95%

54

0.12%

Authors refer to studies C4591001, C4591011, C4591012, C4591021
Immune-Mediated and Autoimmune201,050*

2.5%

780

1.9%

297

0.70%

32 Pericarditis, 25 Myocarditis
Musculoskeletal20-213,600*

8.5%

1,614

3.8%

2,026

4.8%

3,525 Arthralgia
Neurological21501*

1.2%

515

1.2%

27

0.06%

204 Seizure, 83 Epilepsy
Other 21-228,152*

19.4%

3,674

8.7%

4,568

10.8%

7,666 Pyrexia

Herpetic conditions

Pregnancy Related22Refers to pages 12-13
Renal2269*

0.17%

70

0.17%

0

0%

All serious: 40 acute kidney injury, 30 renal failure
Respiratory22-23130*

0.3%

126

0.3%

11

0.03%

44 respiratory failures
Thromboembolic Events23151*

0.3%

165

0.4%

3

0.007%

60 Pulmonary Embolism, 39 Thrombosis, 35 Deep Vein Thrombosis (DVT)
Stroke23-24275*

0.6%

300

0.7%

0

0%

All serious; Ischaemic and Haemorrhagic conditions reported
Vasculitis2432*

0.08%

25

0.06%

9

0.02%

Specific condition leading to one fatality not noted
Medication Error262056*

4.9%

124

0.29%

1932

4.6%

Seven fatalities not categorized as “Serious.” Authors lack information leading to fatalities, considered noncontributory

(N, [%]): Annotation refers to number of cases (N) and the proportion of AE reports [%]

*: denotes counting discrepancies within the 5.3.6 report

Report Author’s Annotations: Any commentary in this column represents sample highlights from each SOC. All readers are encouraged to read the 5.3.6 document to understand the scale, depth, and width of Pfizer’s aggregated safety reports from the field.

 

Accounting was not well-done in this Pfizer report and was best illustrated by Table 1 (5.3.6, p.7). The authors reported the adverse events by age brackets that were not standardized in age range, which led to potential issues in understanding age-related effects. The age groupings were <17, 18-30, 31-50, 51-64, and >75. This non-standardized approach obscured any age-related effects among AEs. Most AEs occurred in the 31-50 range, but this age range was also the widest age range. When this document first became available for review, it was difficult to make sense of how data was gathered and grouped. More information on this topic emerged later in the PV document. Table 1 did relay important findings. There were 1,223 deaths in the field that providers thought were product related. There were also 520 reports of AEs with sequelae, 11,361 reports of “not recovered at the time of report,” and another 9,400 events without known resolution criteria.

There was one concept Pfizer confirmed in their reporting system regarding latency. When aggregated, it was apparent that reported AEs developed immediately after product use. The median latency for each category is less than a week. See the table below. By Pfizer’s own standard from the EUA 2020 (“From a safety perspective, a 2-month median follow-up following completion of the full vaccination regimen will allow identification of potential adverse events that were not apparent in the immediate post-vaccination period. Adverse events considered plausibly linked to the vaccination generally start within 6 weeks of vaccine receipt”), this realization alone should have been enough to suggest AEs were product related. Yet very consistently and predictably throughout the 5.3.6 report, Pfizer stated, “Conclusion: This cumulative case review does not raise new safety issues. Surveillance will continue.” It begs the question when Pfizer would admit there were significant safety issues with its product and when they would notify the public.

 

SOCAE Development RangeAE Development Median
Cardiovascular<24 hours – 21 days<24 hours
Covid-19<24 hours – 374 days5 days
Dermatological<24 hours – 17 days3 days
Haematological<24 hours – 33 days1 day
Hepatic<24 hours – 20 days3 days
Facial Paralysis<24 hours – 46 days2 days
Immune-Mediated and Autoimmune<24 hours – 30 days<24 hours
Musculoskeletal<24 hours – 32 days1 day
Neurological<24 hours – 48 days1 day
Other<24 hours – 61 days1 day
Renal<24 hours – 15 days4 days
Respiratory<24 hours – 18 days1 day
Thromboembolic<24 hours – 28 days4 days
Stroke<24 hours – 41 days2 days
Vasculitic<24 hours – 19 days3 days

 

5.3.6 – Conclusion Summary Statement

The 5.3.6 document was reviewed elsewhere in the War Room/DailyClout Pfizer Documents Analysis Project, because it was dense and required further exploration as a result. In the context of what Pfizer knew about safety and efficacy in March 2021 and remembering 5.3.6 was not available to the public without a court order, Pfizer confirmed its product caused significant, severe AEs across all organ systems. What could have been chance AEs in the EUA 2020 C4591001 study were substantiated by field reporting. There were many more AEs than MI, CV, appendicitis, and Bell’s palsy. Death was confirmed as an adverse event based on field reports. Per Pfizer’s EUA 2020, any findings within six weeks would reasonably have been linked to the product. These AEs were often reported within days of product administration. By March 2021, Pfizer knew its product had safety issues, and it knew from the EUA that its efficacy was questionable at best, and invalid or null at worst. 

Pharmacovigilance Plan for Biologic License Application (PV)

Report Date: 28 July 2021

Obtained by Court Order

 

The PV document updated and tracked Pfizer’s plans to detect and to address safety signals. The 99-page document summarized studies and findings up to the date it was published. It added myocarditis and pericarditis as concerning adverse events (AEs) related to the product. Other System Organ Classes’ (SOCs) AEs were on the same scale as pericarditis and myocarditis, yet they were ignored as important risks. After the EUA 2020, Pfizer should have been curious about C4591001 AEs, specifically MI, CV, and facial paralysis (Bell’s Palsy). In 5.3.6 reporting, it identified 130 MI, 275 strokes, and 449 paralyses among many other AEs compared to just 32 cases of pericarditis and 25 cases of myocarditis. There were 165 serious thrombolytic events reported as a separate category in 5.3.6 as well. No AEs were addressed from 5.3.6 other than the predetermined list from the EUA 2020 (IR, PR, MI), and the newly added cardiac AEs (listed under “Immune-Mediated/Autoimmune” on p. 20 in 5.3.6). PV does not provide updated data on MI, CV, paralyses, or thrombolytic events. For reference, appendicitis does not even appear in 5.3.6. What was once witnessed and discussed in the EUA 2020 C4591001 clinical trial and witnessed in field reporting received no further mention in PV. No warnings reached the public on potential harms. Claims of efficacy remained high, and no additional safety signals were addressed from other SOCs.

PV identified ongoing studies that may develop knowledge on efficacy and safety. When a search for those studies was completed on clinicaltrials.gov, many studies did not appear (last checked May 22, 2023). C4591001 was listed as completed on February 10, 2023. No results are available. C4591015, a clinical trial focused on pregnant women, was completed on July 15, 2022. It listed “Primary Endpoints” as 4-30-2023. No results are available. BNT-162-01 showed the results were submitted for review on April 11, 2023. No results are available. C4591007 was listed as pending completion on October 3, 2023. The following clinical trials were listed in PV and were not found on clinicaltrials.gov: C4591008, C4591009, C4591011, C4591012, C4591022, W1235284, and W1255886. PV listed pending report dates for many of these studies. No interim results appear online, as many studies likewise do not appear. Notes on these studies appear in Appendix 1 of this report.

The most important pages of the PV report dealt with vaccinations to the placebo cohort in the EUA study, C4591001. In the EUA 2020, Pfizer outlined the statistical evaluation problems if it vaccinated more than 20% of the placebo cohort (EUA 2020, p. 53). Table 5, “Exposure to BNT162b2 by Age Group and Dose (C4591001) – Open Label Follow-up Period – Subjects Who Originally Received Placebo and Then Received BNT162b2 After Unblinding,” showed Pfizer vaccinated 19,696 placebo participants, representing the entirety of their placebo cohort, by March 12, 2021 (PV, p. 18-19). Pfizer continued to cite the C4591001 study throughout PV as an ongoing clinical trial although Pfizer knew the study was no longer valid per its own standards as laid out in the EUA 2020 (p. 53).

 

Pharmacovigilance Regarding Safety

Pfizer’s acknowledgement of myocarditis and pericarditis set a precedent for what AEs Pfizer took seriously as safety signals. Yet, Pfizer ignored other AEs. Reference the chart below to compare other SOCs from 5.3.6 against myocarditis and pericarditis as reported in PV. Hundreds of serious AE reports occurred across all SOCs including fatalities and unresolved conditions. There were just 32 cases of pericarditis and 25 cases of myocarditis in 5.3.6. All other SOCs exceeded myocarditis and pericarditis in 5.3.6 and are not mentioned in PV. Other AEs were on scale with myocarditis and pericarditis yet were not added as publicly acknowledged AEs for informed consent. Pfizer seemingly broke from its own standard by ignoring other significant product harms that it observed at the degree as accepted harms.

Pfizer does acknowledge a serious risk pattern from its product through additional product doses. “Evaluation by the US CDC has found reports [of myocarditis and pericarditis] to be most frequent in adolescent and young adult male patients following the second dose of vaccine” (Bold added. PV, p. 50). The appendix of the EUA 5-11 noted the emergence of AEs after additional doses as acknowledgement of a dose-response effect (EUA 5-11, p. 46). The EUA 2020 acknowledged higher rates of AEs after dose two and also noted more AEs in younger participants (EUA 2020, p. 6, p. 42, and p. 56). Pfizer understood there was a relationship between AEs and continued product exposures, and it was observed across the documents. This example with myocarditis and pericarditis was the only place Pfizer admitted the connection between additional doses and the risks of significant AEs. Within the context of the serious AEs across all organ systems, it is reasonable to assume additional doses increase the risks of other types of AEs. This assumption would require a mechanism to explain how the product damaged all organ systems as opposed to narrower, specific types of damage.

 

System Organ ClassDocumentSeriousFatalUnresolved
Myocarditis (added)PV45914106
Pericarditis (added)PV370363
Cardiovascular5.3.6946136140
Haematological5.3.668134267
Hepatic5.3.653514
Facial Paralysis5.3.63990183
Immune-mediated or Autoimmune ***5.3.678012215
Musculoskeletal5.3.61,6140959
Neurological5.3.65151689
Other5.3.63,674961,429
Renal5.3.6702315
Respiratory5.3.61264118
Thromboembolic5.3.61651849
Stroke5.3.63006185
Vasculitic5.3.625121
(IIR) AnaphylaxisPV23419229
(IPR) VAEDPV1383865
(MI) PregnancyPV7538
(MI) LactationPV5
(MI) PediatricPV24016

This table demonstrates that AEs from all SOCs are on the same risk scale as the added AEs of myocarditis and pericarditis. Other SOCs from 5.3.6, in fact, exceed them.

(added) AEs now included as safety signals. The occurrences are not from 5.3.6.

*** This category from 5.3.6 contained results for myocarditis and pericarditis.

(IIR) Important Identified Risk – considered an important safety signal.

(IPR) Important Potential Risk – considered a potential safety signal.

(MI) Missing Information Category

 

Pfizer delivers on a possible mechanism through its discussion on lab-derived efficacy measures, where the company acknowledged it knew about systemic spread of the product. Pfizer knew from rat studies (pp. 9-10) that the product ingredients did travel away from the injection site and aggregated elsewhere (liver, spleen, adrenal glands, ovaries). Pfizer reassured the public that fertility was not affected, and the company touted immunity in offspring, too (PV, p. 11). Nonetheless, this important piece served as a mechanism for breadth of AEs witnessed in its documents. Pfizer may not have had a singular type of AE in large excess, but it witnessed and documented a variety of AEs across SOCs. Pfizer’s documentation of systemic spread should have allowed them to connect its product to harms. Harms occurred in any organ system exposed to Pfizer’s product, and harms occurred with additional exposures to the product.

For reference before the EUA 5-11, Pfizer did review animal studies and introduced lab values in animal models to determine efficacy. Investigators claimed 100% efficacy in immune response in Rhesus Macaques based on chemical immune reaction (PV, p. 9). Although provocative, this reaction would not necessarily indicate human immunity to COVID. Although not evident in this time frame, Pfizer’s celebration of 100% efficacy based on lab titers in animals served as the preamble to using lab-based titers as a substitute for clinical trial data. The upcoming EUA 5-11 expanded this concept of replacing clinical trial data Pfizer presumably knew were not valid.

A discrepancy noted in 5.3.6 received some clarifying information in PV. The age brackets for AE reporting were unusual in 5.3.6 with non-standardized intervals. There was a large age bracket of ages 31 to 50, while other brackets covered about 10 years or less. When authors shared statistics from their safety database, notable coincidences emerged. Myocarditis in ages over 16 occurred most often in young men with a mean age of 37.2 years old and a median age of 32.0 years old (PV, p. 48). For pericarditis in ages over 16, there was no gender difference, and the mean age was 51.5 years old, while the median age was 51.0 years old. The way ages were assembled in 5.3.6, split and diluted myocarditis AEs. In the upcoming EUA 5-11, it was shown again that myocarditis occurred most often in males under age 40 with no incidence rate provided by the investigators (EUA 5-11, pp. 14-15). Investigators did provide incidence rates for these AEs for patients between the ages of 12 and 17. It was striking how Pfizer reported these demographics across documents and how it grouped these cardiac conditions under a different category in 5.3.6. It hinted at something specific with myocarditis in men ages 18 to 39, but there was never an explanation about it. Elaboration by Pfizer investigators would be helpful for understanding how they chose to report these findings and if there were important findings in this age group. With investigators speculating about subclinical, long-term damages in EUA 5-11 (p. 15), and through documentation of various severe AEs leading to death, Pfizer should share what it knows about this avoided age group.

 

Pharmacovigilance Plans

Section III (PV, pp. 71-92) dealt with the actual Pharmacovigilance plan. This section outlined the courses for current and future studies. Pfizer reviewed the categories of focus. There were Important Risks (Anaphylaxis, Myocarditis, and Pericarditis), Important Potential Risks (VAED/VAERD), and Missing Information (Pregnancy/Lactation, Vaccine Effectiveness, Use in Pediatrics <12). Pfizer outlined its sources for signal detection on PV pages 71-72, which included references to literature and to Web-based reporting systems. Pfizer documented that it knew what was happening with its product in scientific literature, in the field, and within its own reports. Pfizer planned to perform future studies for each category above. Studies of other SOCs were not planned. Perhaps safety signal detection would take place coincidentally, but Pfizer had already ignored safety signals to date.

Pages 73-84 outlined Pfizer’s intent to complete further studies to evaluate efficacy and safety. Studies were outlined by category with due dates specified. Many interim report dates had passed, without reporting, by May 22, 2023. Clinical trial C4591001 was the first study listed on the list of ongoing studies (PV, p. 92). Pfizer intended to make use of this study despite tampering with the placebo cohort months prior to this Pharmacovigilance plan.

Consider what it meant when the C4591001 clinical trial was not completed to term. The claims of efficacy and safety have never been supported. There were only sparse, preliminary results of efficacy based on statistical misrepresentation. Adverse events indicated the product perhaps was not safe in the EUA 2020 and definitely not safe in 5.3.6 by March 2021. The clinical trial was meant to run to 24 months to allow for a proper and robust evaluation of two large cohorts. Pfizer destroyed this trial before relevant results were ever realized. Whatever remained of the trial was completed on February 10, 2023, but even those results are still not available.

The problems with C4591001 made it even more imperative to complete the other studies listed within the PV document. With that in mind, our team set out to verify the status of these studies nearly two years after they were planned and promised by Pfizer. It turns out many of these studies do not exist. Pfizer seems to have had no intention of pursuing the relevant clinical trial data needed to determine a valid efficacy statement. Its dismissal of safety signals both in its own C4591001 trial and in field reporting suggested the company had no strong interest in product safety signals. The absence of promised studies to determine efficacy and to monitor safety completed its failure of honest evaluations.

 

PV – Conclusion Summary Statement

By July 2021, Pfizer observed its product traveled throughout the body and caused AEs across all organ systems in immediate timeframes after administration with additional doses increasing the likelihood of harm. It also became apparent Pfizer had no intention to report those observations to the public in those terms. Clinical trials planned and listed within PV were also abandoned. If C4591001 was going well, it would have been reported ad nauseum. Since C4591001 was altered well ahead of this report, Pfizer hoped the introduction of titers would give an alternative measure to claim efficacy regardless of disease protection. Investigators in the EUA 5-11 (p. 17) documented this lab-based evaluation was not valid for proving protection from COVID.

Consider the political environment and mandates at the time of this published report in 2021. Pfizer knew it had these problems, and yet the company allowed public statements on efficacy and safety to continue unopposed. The decision not to halt product use represented a top-to-bottom failure at Pfizer. The people compiling these reports were subject matter experts. They knew what the findings meant even as they reported a lack of safety concerns and as they reported high efficacy. They understood every problem posed so far. Even with what Pfizer learned by the time it published PV, the company continued onward to the children. 

Where does this lead in the next EUA for five- to 11-year-old children in October 2021? Read this section understanding that the interim results for the young 12- to 15-year-old cohort are due within weeks. There appears to be a rush to complete the EUA 5-11 before relevant trial information becomes available.

Emergency Use Authorization (EUA) for an Unapproved Product Review Memorandum

Submission and Receipt Date: October 6, 2021

Review Completion Date: October 29, 2021

 

After nearly a year of product use and with investigators knowing the issues with safety and efficacy, one would hope for the EUA for five- to 11-year-olds, the EUA meant to authorize use for the youngest Americans, to lay out a very logical case for product use. This document should have been Pfizer’s best effort, but it was not. The document itself appeared hastily constructed suggesting several authors assembled it quickly with disjointed opinions. It contained typos, incoherent commentary, and contradictory narratives. These narratives included claims that vaccinating children would stop spread, although investigators provided no evidence to support the claim and subsequently listed the claim itself as a gap in their knowledge. Investigators also attempted to suggest titers could represent efficacy and later suggested it was not a valid measure. Another narrative included the conclusion of a favorable risk-benefit ratio and yet showed an unfavorable risk-benefit ratio while admitting the COVID risk to children was always minimal.

The primary conclusions made by investigators in the EUA 5-11 were, again, based on weak evidence. Authors concluded efficacy using small numbers and lab values. They did not draw substantial support from C4591001. Authors concluded safety in the face of mounting evidence that the product was not safe. They consistently concluded beneficial risk-benefit ratios while demonstrating with computer modeling that they had an unfavorable risk-benefit ratio. Tucked into the appendix is an admission that investigators understood a dose-response problem with the product (EUA 5-11, p. 46). They learned in C4591007 that AEs were related to both dosage and dose number. Investigators speculated about what these findings could mean for long-term safety (EUA 5-11, p. 15).

 

EUA 5-11 Regarding Efficacy

In the clinical trial C4591001, investigators used weak evidence for efficacy. In EUA 5-11 (using study C4591007), they relied on a similar format. After two months of follow-up, they noted three COVID cases (out of 1,518 participants) in the vaccine group compared to sixteen cases (out of 750 participants) in their placebo group (p. 26). The incidence rate was 0.02% in the vaccine group and 2.13% in the control group. These percentages are statistically significant but, again, take place over a very short time span. Efficacy is not well-supported by this evidence.

Curiously, in the eleven months since the original EUA 2020, investigators did not report great increases in follow-up in C4591001. They reported around 60% of test and placebo cohorts at four or more months of follow-up, leaving around 40% of the cohorts at much less follow-up (EUA 5-11, p. 12). Pfizer cut off data collection on March 12, 2021, leaving a six-month gap before the EUA 5-11. The data cutoff is consistent with Pfizer’s understanding that the clinical trial effectively ended after vaccination of the entire placebo cohort. Efficacy claims in the October 2021 EUA for five- to 11-year-olds lack support from the original trial as a result. With the added context from PV (pp. 18-19) which was not made available to the public until after the court order, the public can now see that Pfizer abandoned its efficacy monitoring in C4591001. Pfizer, per their own standard (EUA 2020, p. 53), knew its efficacy analysis was no longer valid without a placebo cohort and terminated its data collection on March 12, 2021. If Pfizer had continued the clinical trial with blinded placebos as planned, it would have had up to six more months of data for EUA 5-11. Instead, Pfizer’s investigators turned to vaccinating children knowing they destroyed what could have been the most important data to parents. The public was denied whatever truth C4591001 could have provided. The public once again was forced to accept another document lacking evidence.

The investigators understood the problems with short-term follow-up of only two months. They introduced immunobridging as a metric for efficacy. In brief, investigators used bloodwork to look for production of antibodies as a response to product use. They assumed an antibody titer implied protection. On page 17 (EUA 5-11), investigators made it clear that “the immune marker(s) used for immunobridging do not need to be scientifically established to predict protection,” yet they used immunobridging to determine efficacy. Investigators claim 100% efficacy (EUA 5-11, p. 13) based on these titers despite a subsequent admission on page 17 that they do not know what titer concentration would confer protection. Investigators used a test for efficacy that they knew was not valid.

 

EUA 5-11 Regarding Safety

Pfizer identified a dose-response relationship and connected it to the potential for long-term damages. The EUA Appendix (p. 46) discussed the dosage reduction in children. Investigators found, during C4591007, two factors that led to more adverse reactions: 1) the dose number, and 2) the dosage. Investigators found a dose-response relationship between the product and AEs in their own trial. Furthermore, the number of doses being related to adverse events was significant because it suggested cumulative risks with continued dosages. Investigators did not report severe adverse events in the appendix like myocarditis. The solicited AEs for which they were checking became more severe. Nonetheless, these dose-dependent concepts dovetailed with potential long-term concerns that investigators had about the product (EUA 5-11, p.15). The investigators suggested that subclinical damages would aggregate over time through repeated doses and AEs would eventually manifest clinically in children. With negligible risk to children from COVID, AEs from product use posed more risk than the disease itself.

There was an explanation for the addition of pericarditis and myocarditis in this EUA that was not present in PV (EUA 5-11, p. 13). There were two cases of pericarditis in the C4591001 study by the June 2021 cutoff date. One case was a 55-year-old male 28 days (“within 6 weeks,” a standard from EUA 2020) after dose #2 (risk factor “dose number” in EUA 2020, p. 6; PV, p. 50; EUA 5-11, p. 46). Investigators deemed this adverse event unrelated to product in both PV and EUA 5-11 despite the factors identified by investigators that would suggest a relationship. The second case took place in an unblinded placebo, a male 16 years of age (risk factor “young male” in PV, p.50) that developed myopericarditis two days after dose #2. After two months of symptoms, his cardiologist still recommended “limited activity” (EUA 5-11, p.13). PV, in July 2021, denied product involvement even when faced with a known AE related to product use: “Two (2) serious adverse events [PT Pericarditis] were reported, both deemed not related to study treatment by the Investigator” (PV, p.47). An admission that the AE was related to Pfizer’s product finally emerged within the October 2021 EUA 5-11. The product resulted in an unresolved condition at the last follow-up. In this case, “The investigator concluded that the there [sic] was a reasonable possibility that the myopericarditis was related to vaccine administration due to the plausible temporal relationship. FDA agrees with this assessment” (EUA 5-11, p. 13).

Investigators attempted to explain away a known AE risk in PV, got caught, and were forced to amend the report for the EUA 5-11. There was a discrepancy here. The structure of these documents suggested this 16-year-old patient’s side effect was important to product risk labeling. Yet, when he was identified in the PV document as unrelated, myocarditis and pericarditis were already identified as important risk factors. It begets the question whether critical evaluation was taking place. Further information from the investigators is needed as this issue is not explained clearly in the provided documents.

Investigators should have been suspicious of product involvement with AEs per their own standard from EUA 2020, yet they continued the denial of product involvement with AEs through 5.3.6 and PV despite relevant factors learned along the way. Only in EUA 5-11 did they finally admit the product could have been related to the 16-year-old’s AE. They never admitted the potential for product involvement in the 55-year-old male’s AE despite relevant factors involved that they identified.

Pericarditis and myocarditis were added as label warnings based on this one case above from C4591001 and based upon VAERS reports (EUA 5-11, pp. 13-14). (PV notes “Important Identified Risk ‘Myocarditis and Pericarditis’” on page 8 sourced from Pfizer Safety Database). Investigators finally acknowledged the risk of myocarditis and pericarditis from product use by the October 2021 in EUA 5-11. What finally forced this acknowledgement? Was it because the side effects took place in young males and would be more difficult to explain away than other side effects? A thorough explanation from investigators is required to eliminate this suspicion, especially after the age bracket issues identified in 5.3.6 with young patients ages 18-39.

Myocarditis and pericarditis adverse events were on scale with other AEs reported by the field in 5.3.6, yet Pfizer ignored or dismissed those additional AEs. “Review of passive surveillance AE reports and the Sponsor’s periodic safety reports did not indicate any new safety concerns.” They continue digging, “ No unusual frequency, clusters, or other trends for AEs were identified that would suggest a new safety concern, including among the reports described as involving children 5-11 years of age” (EUA 5-11, p. 14).

The EUA investigators posed a serious set of facts revolving around pericarditis and myocarditis. The Food and Drug Administration (FDA) analysis from Optum healthcare claims database estimated incident rates in ages 16 to 17 of 200 cases per million (0.02%) and in 12- to 15-year-old of 180 cases per million (0.018%) (EUA 5-11, p.15). These rates of adverse events occurred at a similar rate as the AEs of MI, CV, appendicitis, and Bell’s palsy in EUA 2020 (pp. 37, 40).  Investigators suspected that the damage was more significant than the rates above: “Information is not yet available about potential long-term sequelae and outcomes in affected individuals, or whether the vaccine might be associated initially with subclinical myocarditis (and if so, what are the long-term sequelae).” (Bold Added, EUA 5-11, p. 15). This statement was the first time among documents reviewed that the authors turned to long-term questions of adverse events. Investigators went further: “A mechanism of action by which the vaccine could cause myocarditis and pericarditis has not been established.” This unknown mechanism should have been a serious concern overall in light of the variety of AEs observed and in light of animal studies showing the spread of product throughout the body. Pfizer may not have known the exact cellular mechanism linking its product to AEs. However, the company should have been able to piece together that systemic spread of product caused damage across all organ systems in a dose-response relationship in at least the short term and potentially also in the long term. It suspected subclinical damages would affect patients on a significant delay. What is yet to be learned about males ages 18-39? The compilation of this set of safety concerns should have been a full-stop event for Pfizer. The constellation of evidence indicated Pfizer knew it did not have a favorable risk-benefit ratio as investigators identified significant product issues that would cause more damage than the disease itself.

 

EUA 5-11 – Risk-Benefit Analysis

Investigators are honest regarding the minimal risks of COVID to the 5-11 age group. Authors note on page 7 (EUA 5-11) the reality that 15% to 50% of patients are asymptomatic even when they have COVID. They recover within one to two weeks and have milder symptoms than adults. By the time EUA 5-11 was published, there were 44 million identified cases of COVID in the United States with 722,000 deaths (EUA 5-11, p.7). About 8.7% (3.8 million) of cases were in the 5 to 11 age group. A rational assumption was that many more asymptomatic cases were never diagnosed and did not factor in the rates of AEs from COVID. Among the millions of known COVID cases, there were 4,300 hospitalizations and 146 deaths total included in the EUA 5-11 data. The risk of hospitalization and/or death was negligible for the 5-to-11 age group.

These statistics did not support vaccination in this cohort outright because the risk was nearly zero. The benefits would have been imperceptible as so few young children were affected by significant disease. Even a vaccine with rare risks posed as much risk or more risk than the disease itself. Here was what the authors wrote on page 37 (EUA 5-11): “While no cases of severe COVID-19 were accrued during study follow-up to date, it is highly likely that vaccine effectiveness against severe COVID-19 among children 5-11 years of age will be even higher than vaccine effectiveness against non-severe COVID-19, as is the case in adults.” (Bold Added.) This conclusion was incoherent. The data set for C4591007 cannot support this claim since there were no severe disease occurrences (EUA 5-11, p. 26). It was a hopeful speculation. Investigators doubled down on page 38 (EUA 5-11), noting that “widespread deployment” will “have substantial effect on COVID-19 associated morbidity and mortality in this age group [5-11 years].” Their lab values did not support this claim per their own words (p. 17, EUA 5-11). Their own statistics on epidemiology refuted this statement, too. “Widespread” cannot be applied to events that rarely occur. They shared no data from C4591007 in this EUA related to transmission. Their conclusion was wrong because it was unsubstantiated in every respect.

Investigators clearly understood that COVID-19 was tolerated well in the young, and they would have understood that reality was a barrier to product deployment. Their solution was to discuss disease transmission as a new concept in EUA 5-11 (p. 8). Transmission was not discussed in the original EUA in 2020, 5.3.6, or the PV document, yet it emerged in this document. By page 9 (EUA 5-11), they argued dangers posed to adults by transmission from children. Ironically, adults were already approved and could have this allegedly highly efficacious product. Transmission from children should be of no concern to vaccinated adults if Pfizer showed the product works. Investigators went a step further to blame transmission of virus on individuals who are not vaccinated. Again, if the product works, there is limited risk to the vaccinated from the unvaccinated. Pfizer did not provide evidence from C4591007 that the product halted transmission or that unvaccinated individuals caused more transmission. Nonetheless, investigators created an argument that tried to have it both ways. The product supposedly worked well enough to have high levels of protection for adults yet did not work well enough to offer protection around children.

On page 38 (EUA 5-11), investigators documented important “Data Gaps.” Investigators listed “Vaccine effectiveness against asymptomatic infection” and “Vaccine effectiveness against transmission of SARS-CoV-2” as gaps in their knowledge. The investigators, after a section where they argued the need for widespread vaccination in children and declared their product could greatly reduce symptoms and greatly reduce transmission, listed their own conclusions as gaps in their knowledge (EUA 5-11, p. 38). This section highlighted Pfizer’s use of hopeful speculation over data to push for product approval. There can be room to speculate about potential benefits in scholarly work, but the investigators had no data to support their speculations. They had a very limited efficacy statistic from C4591007 and lab titers that they knew did not equate to disease protection. The investigators attempted to jump from two weak data points into a full-throated claim that the product would substantially reduce morbidity, mortality, and transmission. Even under the assumption the product did those things, the investigators never showed that it achieved any of those goals.

The above gaps in benefits were then overlaid with the risks posed to children. On page 38 (EUA 5-11), “…the risk of vaccine associated myocarditis/pericarditis among children 5-11 years of age is unknown at this time.” The investigators’ statement was technically true, but they could have estimated a risk of 0.02% based on myocarditis risks in ages 12-17 (EUA 5-11, p. 15). Based on this statement and the gaps in benefits, the investigators could not have made objective claims that there was a favorable risk-benefit ratio. They admitted openly that they did not know the benefits or the risks. Investigators wanted the public to believe a disease with limited risk to children (4,300 total hospitalizations and 146 total deaths reported in EUA 5-11) justified the widespread use of a product with unsubstantiated efficacy and with safety concerns that they would have known rivaled or exceeded the damage of the disease itself.

After investigators argued a case that should have denied the product approval, investigators turned to computer modeling and showed it definitely should not have been approved. Per the investigators (EUA 5-11, p. 46), for one million vaccinated children during a six-month period, the product would prevent an estimated 45,000 (4.5%) cases, reduce 200 hospitalizations (0.02%), reduce 60 to 80 ICU stays (0.0006%), and prevent zero or one death (0-0.0001%). After vaccinating one million children, a vast majority would have received no benefit. The model factored in risk of myocarditis. Investigators expected about 100 cases of myocarditis (0.01%), about 100 hospitalizations (0.01%), about 30 ICU admissions (0.003%), and zero deaths. The investigators demonstrated in their model extremely limited benefit, in the vicinity of zero percent, and they demonstrated risks on the scale of benefits. Their model did not predict a favorable risk-benefit ratio. It showed it would require tremendous numbers of vaccinations to deter a few COVID hospitalizations. If investigators factored in the numerous other AE risks from 5.3.6, this risk-benefit assessment would have rapidly degraded into the inevitable conclusion that the product risks outweighed any negligible benefits.

 

EUA 5-11 – Conclusion Summary Statement

By the completion of the EUA 5-11, investigators still had efficacy shortcomings. Nearly a year into product use, the public should have heard about the successes of the C4591001 study in motion, yet that was not the case. Unbeknownst to the public, C4591001 was effectively destroyed by Pfizer, negating the ability to derive long-term data. The statistics from C4591007 were likewise weak. Investigators began discussions on boosters, another sign they had weak or absent efficacy. Investigators showed higher doses and cumulative doses contributed to adverse events yet refused to acknowledge risks accumulated in EUA 2020, 5.3.6, and PV. They concluded a favorable risk-benefit ratio yet demonstrated it was unfavorable. Investigators introduced transmission as a reason to vaccinate and blamed unvaccinated individuals for transmission. They had no evidence from C4591007 to support either conclusion.

 

Questions That Need Answers

  • What are the results from C4591001 and other ongoing trials?
  • What process determined which adverse events were considered legitimate and which adverse events were not? The standard was not clear in Pfizer’s documents. There were inconsistencies in the standards that require explanation by the investigators. The investigators are confident the product is safe. Do ongoing clinical trials support safety? Are field reports in conflict with the clinical trials? If so, reconciliation by investigators is needed.
  • The criticisms in this report could be dispelled by strong efficacy and safety measures in the clinical trials. What caused Pfizer to destroy its own clinical trial, C4591001?
  • Why did transmission enter in the EUA 5-11 when it was not discussed previously? Was it meant to make the case to vaccinate a population that did not have a practical benefit?
  • What did Pfizer know about the profile of adverse events in males ages 18 to 39?

 

Commentary on the Advisory Committees and the EUAs

 In pharmacovigilance, an important step before approval of a new drug is the advisory committee review process. According to the Centers for Disease Control and Prevention (CDC), “Safety is a Priority During Vaccine Development and Approval. Before vaccines are licensed by the FDA, they are tested extensively in the laboratory and with human subjects to ensure their safety” (https://www.cdc.gov/vaccinesafety/ensuringsafety/history/index.html). The Advisory Committee on Immunization Practices (ACIP) is the CDC’s advisory committee recommending vaccines. VRBPAC is the FDA’s vaccine/biologic products advisory board  and is part of the Center for Biologics Evaluation and Research (CBER). VRBPAC “…reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases…” (https://www.fda.gov/advisory-committees/blood-vaccines-and-other-biologics/vaccines-and-related-biological-products-advisory-committee) These committees effectively had two chances to address product issues before the FDA EUA-approved and the CDC publicly recommended Pfizer’s mRNA COVID vaccine. It does not appear that the committees did their due diligence. A report on the failures of pharmacovigilance within this these committees is planned as upcoming work in the larger WarRoom/DailyClout Pfizer Documents Analysis project.

 

Conclusion

Efficacy of the BNT162b2 mRNA COVID “vaccine” was not demonstrated by Pfizer during 2020 and 2021. If investigators were pleased with results after six weeks, they could have continued every six weeks with interim reports which could have rolled into 5.3.6, PV, and EUA 5-11.

Pfizer’s declination to continue its own clinical trial by vaccinating placebo participants is a significant problem. There is not an intact clinical trial to show high drug efficacy over time. Maybe there is a good explanation? If so, Pfizer needs to share it, especially with C4591001 ruined and many other studies terminated. Is it possible Pfizer recognized its trial was going to produce unfavorable results and ended it before those results became more obvious? Pfizer would be unable to defend itself using C4591001, especially because it negated the clinical trial by vaccinating the entire placebo cohort in March 2021. The lack of interim trial results, the destruction of C4591001, the shift to antibody titers to try to prove effectiveness, and the addition of hopeful speculation in clinical trial documents indicate problems with BNT162b2’s efficacy.

Safety was not demonstrated by Pfizer. The Company understood its product spread throughout the body, witnessed AEs across all organ systems, witnessed immediate latency, and witnessed dose-response relationships which also caused investigators to speculate about long-term AEs. None of that indicated safety. Taken together, Pfizer, based on its own written standards and its own reports, should have understood its product had significant risks and limited, if any, benefits.

Appendix 1: Study Due Dates from PV Document

Study NumberPopulationPV Due DatesResults Posted?

Clinical Trials Notables

C4591001 (C)EUA studyFinal: 8-31-2023No results available

Completed: 2-10-2023

C4591001 (A)Ages 12-15First Report one-month of two dose: 4-30-2021

Six-Month: 10-31-2021 (report due immediately after EUA 5-11).

Two Year: 4-30-2023

No results available
C4591007 (A)Ages under 12First report with up to one-month post-dose: 9-30-2021

Interims:

Six Month: 3-31-2022

Two Year: 9-30-2023

No results available

Pending Completion: 10-3-2023

 

C4591008**US Healthcare WorkersInterims:

6-30-2021

12-31-2021

6-30-2022

12-31-2022

Final: 12-31-2023

Not found on clinicaltrials.gov
C4591009**US populationInterim: 10-31-2023

Final: 10-31-2025

Not found on clinicaltrials.gov
C4591009**Ages 5-12First Report: 9-30-2021

Six Month: 3-31-2022

Two Year: 9-30-2023

Not found on clinicaltrials.gov
C4591011**US MilitaryInterims:

10-31-2022

6-30-2022

12-31-2022

Final: 12-31-2023

Not found on clinicaltrials.gov
C4591012**VA SystemInterims:

6-30-2021

12-31-2021

6-30-2022

12-31-2022

Final: 12-31-2023

Not found on clinicaltrials.gov
C4591014 (R)Efficacy by Kaiser PermanenteFinal submission: 6-30-2023No results available

Pending completion: 3-25-2024

C4591015 (C)Pregnant WomenPrimary Endpoints: 4-30-2023No results available

Completed 7-15-2022

C4591022 **Pregnancy, Infant OutcomesInterims:

1-31-2022

1-31-2023

1-31-2024

1-31-2025

Final: 12-1-2025

Not found on clinicaltrials.gov
W1235284Comparison to other respiratory diseasesFinal submission: 6-30-2023Not found on clinicaltrials.gov
W1255886Lower Respiratory StudyFinal submission: 6-30-2023Not found on clinicaltrials.gov
BNT-162-01 (A)Cohort 13First submission: 9-30-2021Results not available.

Results submitted 4-11-2023 for review.

Legend:

**: When searched on http://clinicaltrails.gov, these studies are “Not Found” and the site redirects to C4591001

(A): Active            (R): Recruiting          (C): Completed

C4591001 is a composite of 7 different studies listed as (A) or (C)

CSR: Clinical Study Report

Endpoints: The principal outcomes that are measured in a clinical trial.

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The post Report 73: Pfizer Knew by November 2020 That Its mRNA COVID Vaccine Was Neither Safe Nor Effective. Here Is What Pfizer’s Employees and Contractors Knew and When They Knew It. appeared first on DailyClout.

The Favored Franchise and Enforcement Fraud

 By Anna Von Reitz

Information provided to H.E. Cardinal Mamberti and the Vatican Chancery Court regarding our Claim March 6 2005, January 19 2023 in seq: 

Doctor David E. Martin recently appeared before the EU Parliament and presented an exact and exhaustively researched timeline demonstrating the development of the bioengineered and weaponized coronavirus beginning in 1965 with parent patents in Europe, the transfer to the University of North Carolina, and it’s eventual release in Wuhan, China. 
There is no doubt that the coronavirus featured as the cause of the 2019 Pandemic was purposefully constructed in a laboratory environment as a bioweapon that, once injected, would kill the one receiving it, but not be able to transfer to others like a true infectious agent. 
At the same time that the coronavirus was being weaponized in Britain and at the University of North Carolina Chapel Hill,  the pharmaceutical industry appeared before the U.S. Congress threatening that they would suspend production of vaccines because they were being hit with too many lawsuits related to vaccine injuries and deaths. 
Congress responded by releasing the pharmaceutical industry from any possible liability for death and disability claims resulting from vaccines that they produce as consumer products.  
It is not possible for a Municipal Corporation to selectively release one or more of its own commercial corporation franchises from liability related to product performance.  Even if the parent corporation were to formally take on the liability of its franchise, that parent corporation would have to be financially competent to do so and would have to post bond, which was never done.  
In this case, the entire proposal and resulting enactment was a gross conflict of interest and breach of trust, as the same people who were defrauded to fund the British Territorial Municipal Corporation were the self-same victims that the pharmaceutical company franchises sought to evade — thus the victims would be paying for their own injuries either way, and neither the parent corporation nor the pharmaceutical corporations were competent and willing to pay their own liability costs, which they proposed to foist off on the victims.   
As the British Territorial United States Government operates as a Municipal Corporation housed in the District of Columbia, both the Municipal Corporation — and its Congress — have never had state immunity and therefore cannot offer state immunity to its own business franchises, either. 
As a result the pharmaceutical corporations have been operating under the assumption of a phony guarantee holding them harmless from all liability claims and all accountability for their vaccine products. 
According to the pharmaceutical corporations and the legislation produced by the U.S. Congress, the pharmaceutical corporations really could have injected fermented snake oil into the victims and not have been held liable — except that the Congress could not confer any immunity that it does not itself legitimately possess.  
As their own Federal Title 22 makes clear, when a government acts as a corporation it loses any advantage of state immunity and becomes subject to all the laws and limitations that govern corporations, instead.   
The Municipal Corporations and their officers and elected officials acting as self-interested purveyors of products created by their own franchises remain 100% personally and commercially liable.
The Municipal Corporations and their elected officials and officers also try to escape liability by failing to write out their Oath of Office and publish it, resulting in them never actually entering any Public Office.  They are all operating as Imposters as several studies have shown: 
As such, they have no Public Office, no Public Authority, and no Liability associated with the vacant Public Office they appear to occupy — but in the same token, they have no power to enact any legislation impacting the General Public of this country at all; the only threads they hang upon are the purloined and undisclosed registration contracts they obtained while the victims of their avarice were still babies in their cradles.  
As we can all observe, none of these contracts were ever understood as contracts, none were fully disclosed, all are tainted by semantic deceit and other elements of fraud, and all are self-interested on the part of the Undeclared Foreign Agents employed as licensed Uniformed Officers. 
We are researching claims that these same Medical Doctors who were employed in the same capacities during the Covid 19 Pandemic were paid $25,000 per head for every American they identified as dying from the coronavirus — regardless of the actual cause of death. 
If so, this echoes the payoffs and kickbacks that have been paid to Medical Doctors for their signatures on birth registration documents.  The corruption of the “government” corporations has led to the corruption of the people as well.   
These quote-unquote “healthcare professionals” were conscripted without their knowledge or agreement as Licensed Uniformed Officers of the British Territorial Municipal Corporation under Federal Title XXXI, and threatened with loss of their professional licenses  if they did not follow orders and apply officially approved — and deadly — counter-measures. 
We have confirmed payments of approximately one billion dollars each to the 20 largest hospitals in this country to go along with the coronavirus narrative and do the dirty work.  
With this kind of money being spent by the Perpetrators and actually being paid for by the victims themselves, this is one of the most egregious and injurious Breaches of Trust and Service Contract in history.  
Meantime, the pharmaceutical companies producing this witch’s brew felt no threat of liability at all, because their parent corporation winked and promised to forgive all their sins.  Pfizer attorneys have already argued — in court — that they were only doing what the government corporations told them to do, that they were told they would suffer no liability for it no matter what they put in their vaccine. 
Insurance companies have also already argued that the victims were owed no life insurance policy payments because they took the vaccine voluntarily and thereby chose to commit suicide — this, while the Municipal Corporations continued to act under color of law and spent over a billion dollars in advertising, telling people that these vaccines were quote: “safe and effective”, and encouraging them to think that this was a normal vaccination they should take to protect themselves and others.
The Municipal Corporations and their State-of-State franchises parroted this false information all over the airwaves, even though it was widely known in the research and medical communities that vaccines are not effective against coronavirus, and that had been known since the 1990s.
This product also proved completely ineffective in preventing the disease or containing the spread of it via injection.  
Neither of these Municipal Corporations nor their franchises have any natural right to exist and no authority to exempt themselves from liability for their actions. The officers in charge of these organizations have occupied no Public Offices, so that everything they have done has been done in fraud upon the General Public, including claiming state immunity and offering immunity to the pharmaceutical corporations.  
We wish for a clear understanding that it is the job and duty of these Municipal Subcontractors to protect the General Public — not to protect themselves and their franchises at the expense of the people they are supposed to serve.  
We wish for a clear understanding that until and unless these individuals write and sign and publish their Oaths of Office, they have not entered upon any Public Office, nor can they exercise any power associated with that office, elected or appointed. Anyone continuing to exercise the powers of an office without publishing a valid Oath of Office, will be arrested and charged with impersonation and held 100% personally and commercially liable. 
We wish for every employee of both Municipal Corporations and all Federal Agencies to be told officially and in writing that the American State Nationals are returning to the land and soil jurisdiction they are heir to and that we have established our own peacekeeping forces and that those peacekeeping forces, including our Continental Marshals Service and State Assembly Militias, are to be assisted and respected by all Federal and Agency and State of State Employees.  
The current police and law enforcement organizations that are employed by incorporated franchises of the Municipal Corporations are private security personnel that have no authority as government sanctioned military or peacekeeping forces. 
We wish for every incorporated law enforcement organization and every individual officer employed by such organizations whether they are overtly Federal Municipal officers or members of State-of-State franchises employed as Troopers or Rangers, or County franchises employed as Sheriffs,  to be told the truth — that they have no public role or office, no right to draw a public paycheck, and no superior authority. 
We wish these employees of foreign corporations to fully understand that  as Americans, if they are Americans, they share a public duty that has been long-neglected, to enforce the Public Law including the Law of the Land clearly stated by each one of the Federal Constitutions. 
We wish for all these private security personnel to know and understand that they have no right to misaddress any member of the General Public about any statute, code, or regulatory infraction, and when someone objects to their presumptions and offers reasonable proof of their political status as members of our General Public, those persons are to be set free and left alone, so long as they are not injuring anyone or harming property belonging to others. 
Issued by:  Anna Maria Riezinger, Fiduciary
                  The United States of America
                  In care of: Box 520994
                  Big Lake, Alaska 99652
May 31st 2023

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Dr. McCullough: Which Virus Will Cause the Next Pandemic?

Experts Predict Virus Will Be Airborne–Narrows Field Considerably

We are constantly being barraged by fear-mongering messages about a “next pandemic” as if new global catastrophes have been put on a schedule. I have remarked that it would be quite difficult to anticipate an organism arriving from nature and afflicting the entire world’s population of any mammal, let alone man.

Neumann and Kawaoka published a review of past pandemics, a broad list of viral threats, and then indicated that the likely winner would be a zoonosis (virus that jumped from a bat or rodent) to a human. Additionally, for human to human spread it would need to be airborne and highly contagious. We learned with the fizzled Monkeypox scare that homo- bi-sexual transmission from man to man was not enough the scare the world into mass vaccination or hold the public captive very long in the news cycle. President Biden dropped the US Monkeypox Emergency in January 31, 2023 with no press release.

The list of possibilities for future pandemics is listed in the table. Most have no antiviral therapy that is specific, however, the authors fail to mention viricidal nasal sprays/gargles, vitamin D, curcumin, hydroxychloroquine, ivermectin, favipiravir, famotidine, or other agents to mitigate viral specific inflammation such as maraviroc and nonspecific agents including corticosteroids and colchicine.

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The Greatest Crime In Human History Ever Recorded Is Now Available in Paperback Form

The damning information that Pfizer, and as such, what the FDA knew, and wanted to keep hidden for 75 years, has been thoroughly documented and compiled into a paperback book.

These important summaries, which detail astonishing ranges of deaths, disabilities, and other systematic harms to subjects, contain vastly important headlines: twenty forms of menstrual damage to women — how Pfizer covered up a flood of adverse events — PEG in breast milk — within a month of rollout, Pfizer knew the mRNA vaccines did not work.

All funds and proceeds raised go to the research project. So, please, show your support and get your (or a loved one’s) hands on this critical information in one place — by ordering your copy today.

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