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An American Affidavit

Saturday, March 11, 2023

How Pfizer's Trials Were Fraudulent

 

How Pfizer's Trials Were Fraudulent

Analysis by Dr. Joseph Mercola Fact Checked

  • March 09, 2023


Story at-a-glance

  • Die Welt, a mainstream media outlet in Germany, revealed that numerous subjects who suffered adverse events, including deaths, during Pfizer’s COVID-19 shot trials were removed from the trial data
  • A person known as “Pfizer subject C4591001 1162 11621327” died three days after receiving the second dose of Pfizer’s COVID shot, reportedly due to stroke and arteriosclerosis; it was deemed unrelated to the shots
  • The CDC has since warned that people ages 65 and older who received Pfizer’s updated (bivalent) COVID-19 booster shot may be at increased risk of stroke
  • Die Welt also revealed contradictions in Pfizer documents, adverse events from the shot downplayed and mass unblinding of study subjects, which wasn’t revealed in a later approval study
  • In November 2020, Pfizer claimed their COVID-19 shot was 95% effective against COVID-19, but this was highly misleading and based on flawed methodology, including excluding people who got COVID-19 within 14 days after their first shot
  • Pfizer has profited immensely despite the concerns, earning a record $100 billion in 2022, including $37.8 billion for its COVID-19 shots and $18.9 billion for its antiviral drug Paxlovid

Details continue to emerge about coverups and fraud that took place during Pfizer's COVID-19 shot trials. Die Welt, a mainstream media outlet in Germany, revealed that numerous subjects who suffered adverse events, including deaths, were removed from the trial data.1,2

Meanwhile, trial data were manipulated "to create the illusion" the shot is 90% effective, for instance by excluding participants who got injected and developed COVID-19 within the next 14 days.3 Taken together, it leaves little doubt that COVID-19 shots cannot be trusted.

Deaths Occurred Within Days of Shots

The Die Welt report described several deaths that occurred shortly after the injections, but were excluded from the trial data. Among them was a person known as "Pfizer subject C4591001 1162 11621327." The person, a 60-year-old man, died three days after receiving the second dose of Pfizer's COVID shot, reportedly due to stroke4 and arteriosclerosis.

Independent journalist Igor Chudov detailed the case on Substack, noting that the man was discovered via a welfare check, and may have died within two days of the shot. Chudov reported:5

"According to the medical examiner, the probable cause of death was progression of atherosclerotic disease. Relevant tests were unknown. Autopsy results were not available at the time of this report.

In the opinion of the investigator, there was no reasonable possibility that the arteriosclerosis was related to the study intervention, concomitant medications, or clinical trial procedures, but rather it was related to suspected underlying disease. Pfizer concurred with the investigator's causality assessment."

However, it appears the medical examiner may have been unaware the man had received an experimental COVID-19 shot shortly before his death, and didn't give the examination a closer look. Pfizer also neglected to request the medical examiner's report to assess a potential link. Chudov continued:6

"They just took the police report's word that he died of 'arteriosclerosis,' stated that Covid Vax cannot cause 'arteriosclerosis,' and ruled it 'unrelated.' The patient was buried and forgotten. If I may guess, the examiner's diagnosis was not even accurate. The medications that the deceased took, indicate no ongoing, severe sclerotic disease."

Pfizer Falsely Ruled Deaths Were Unrelated to Shots

Another subject in Pfizer's trial also died 20 days after the shots. The death was ruled as due to a cardiac arrest. But pharmaceutical specialist Susanne Wagner told Die Welt:7

"According to the current state of science, these two cases would be assigned to the vaccination, especially since the U.S. health authority CDC is currently investigating strokes in vaccinated people and it is known. [Pfizer's investigators] falsely ruled these deaths unrelated."

Indeed, an announcement made by the U.S. Centers for Disease Control and Prevention and the Food and Drug Administration warned that people ages 65 and older who received Pfizer's updated (bivalent) COVID-19 booster shot may be at increased risk of stroke.8

The CDC's Vaccine Safety Datalink (VSD), which uses near real-time surveillance to track vaccine safety, flagged the potential safety issue, revealing that those 65 and over were more likely to have an ischemic stroke 21 days after receiving Pfizer's bivalent COVID-19 shot compared to 22 to 44 days later.9

The FDA and CDC released the statement on a Friday night before a three-day weekend, "which is proof they wanted to bury it," Dr. Meryl Nass, a board-certified internal medicine physician with special expertise in vaccine safety and vaccine mandates, said.10 Even Florida Surgeon General Dr. Joseph Ladapo tweeted about the odd timing:11,12

"What better time than a Friday afternoon for @CDCgov and @US_FDA to let Americans know that the mRNA shots they've been pushing may be causing strokes? Don't worry, we'll make sure the word gets out — just like we've been doing for months."

Die Welt also revealed contradictions in Pfizer documents and mass unblinding of study subjects, which wasn't revealed in a later approval study:13

"In one fell swoop, the test management said goodbye to 53 subjects on August 31, 2020. The test candidates were 'unblinded,' which means they were informed about their vaccination status, a process that the Pfizer study protocol expressly only provides for 'in emergencies.'

But there is nothing about it in the approval study. In protocol documents that are available to WELT, and which are actually not intended for the public, those responsible get caught up in contradictions."

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Severe Adverse Reaction to Shots Brushed Off

Another example revealed by Die Welt involves trial participant Augusto Roux, a lawyer in Argentina. After receiving his second dose of Pfizer's COVID-19 shot, he experienced shortness of breath and chest pain, and passed out. Within days, he visited a hospital for his symptoms, where he tested negative for COVID-19 but a CT scan showed fluid, or pericardial effusion, in Roux's heart.

A physician noted in his chart, "Adverse reaction to the coronavirus vaccine (high probability)." Despite this connection and ongoing health problems, this adverse reaction was downplayed by Pfizer and listed as unrelated to the shots. According to Die Welt:14

"Over the next few months, Roux lost 14 kilos [30.8 pounds], he had liver problems, and his heart sometimes beat irregularly … The diagnosis for the symptoms after the second vaccination is very likely to be 'pericarditis,' inflammation of the heart. All of this fits exactly with a clinical picture that the Paul Ehrlich Institute also has in its list of 'rare side effects' for mRNA vaccines.

… His story, one might think, should appear in Pfizer's pivotal study papers, but it doesn't. The pharmaceutical company's papers say Roux informed the research team that he was hospitalized with pneumonia on both sides, following the initial report, which was classified as an 'adverse event of toxicity level 1.'

That could have nothing to do with the vaccine, the file goes on to say, it is probably a Covid infection. Not a word that Roux had tested negative for Corona in several PCR tests."

Pfizer Created an 'Illusion' of Effectiveness

In November 2020, Pfizer claimed its COVID-19 shot was 95% effective against COVID-19, but this was highly misleading and based on flawed methodology.15 One trick used to get this misleadingly high efficacy figure is to ignore people who got COVID-19 within 14 days after their first shot.

In Pfizer's trial, 37.2% of those who were tested for COVID-19 within 13 days of their first shot were positive — but not counted as such. How can this skew results? As explained on Substack's "Where are the numbers," a newsletter about the abuse of science and statistics:16

"Imagine the most extreme case in which every vaccinated person gets covid within the first two weeks of their first dose. Then, assuming (as is likely) that none get infected a second time within the 19 weeks, according to the study definition no vaccinated people ever got covid over the whole period of the study.

If only one person in the the unvaccinated comparative cohort had got covid, over the same period, the vaccine efficacy (defined as one minus the proportion of vaccinated infected divided by the proportion of unvaccinated infected times 100) will be reported as 100%."

The study found that during any two-week period from December 28, 2020, to May 19, 2021, the COVID-19 infection rate was about 0.8%, compared to 37.2% among those tested within two weeks of their first shot.

"If people were tested every two weeks then we could reasonably conclude the vaccinated were getting infected — within two weeks of their first jab — at a rate that was almost 50 times greater than the general rate for this population," but "if you don't look for covid, by not testing for it, or by ignoring the test results you won't find it."17

They also pointed out that no deaths occurred among the participants who tested positive for COVID-19 and had at least one COVID-19-like symptom, including among the 812 (out of 1,482) who were unvaccinated. But since this clearly makes the shots look unnecessary and ineffective, it was conveniently ignored:18

"[T]here was a grand total of zero deaths: an infection fatality rate (IFR) of 0%. And 812 of those were unvaccinated. Bear in mind that this when covid was supposed to have been rampaging globally and causing widespread death.

And of course that nugget somehow never got mentioned in the abstract, mains results, conclusions, or discussion. It only appeared in the detailed results section (along with the fact that only 2% were hospitalized)."

More Deaths in the Shot Group Than the Placebo Group

Former Blackrock portfolio manager Edward Dowd also warned about problems with Pfizer's trial. A friend from the biotech industry told him that the all-cause mortality endpoint had been missed by Pfizer in the original clinical trial, meaning that in the jab group there were more deaths than in the placebo group. Normally, during the drug approval process, if you fail that endpoint, you do not get approved.

Dowd said. "When that came out in November, the biotech executives who saw that decided they weren't going to get boosters, and the people who weren't vaxxed were not going to get vaxxed."19

Whistleblower Brooke Jackson, a regional director formerly employed by Pfizer subcontractor Ventavia Research Group, which was testing Pfizer's COVID-19 vaccine, also witnessed falsified data, unblinded patients, inadequately trained vaccinators and lack of proper follow-up on adverse events that were reported.

"I was working on Pfizer's trial," she said in the film "Anecdotals."20 "What I saw was like nothing I've ever seen before." She explained:21

"The speed in which they were enrolling in the study — four to five coordinators pushing through 40, 50, 60 patients a day. We were not storing the vaccine at its appropriate temperature, the failures in reporting serious adverse events. We had so many reports of adverse events … we just could not keep up. The study doctor signed a physical exam when he wasn't even in clinic.

Then Ventavia had unblinded every patient that was randomized in the trial. When we brought it to their attention, that's what we were instructed to do — remove the evidence and destroy it. Emails about mislabeled blood specimens per Pfizer's protocol, we should have immediately stopped enrolling, but they never told Pfizer.

I would bring the concerns to my managers and it was, 'We're understaffed.' The FDA — they only see what Pfizer gives them. So I was documenting all of this. And on the 25th of September, I went directly to the FDA, and about six and a half hours later, I lost my job. I was fired."

The FDA and Pfizer attempted to hide the COVID-19 shot clinical trial data for 75 years, but the FDA was ordered by the U.S. District Court for the Northern District of Texas to release redacted versions of trial documents on a much faster schedule. As part of the court order, 80,000 pages of documents related to the FDA's approval of Pfizer's COVID-19 shots were released June 1, 2022.22

Among those documents were case report forms revealing that deaths and severe adverse events took place during Phase 3 trials, but, as reported by Children's Health Defense, Pfizer had "a trend of classifying almost all adverse events — and in particular severe adverse events — as being 'not related' to the vaccine."23

Pfizer has profited immensely nonetheless, earning a record $100 billion in 2022, including $37.8 billion for its COVID-19 shots and $18.9 billion for its antiviral drug Paxlovid.24



+ Sources and References
Posted by Baldwin Templeton at 12:42 PM
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