The Canadian COVID Care Alliance (CCCA) — a group of over 500 independent Canadian doctors, scientists and healthcare practitioners committed to providing evidence-based information to the public about COVID — sent an amazing slide deck to The Vault Project revealing the dangers of Pfizer’s COVID vaccine and flaws with its clinical trials.
The data was shocking and raises questions as to how U.S. regulatory agencies could ever approve Pfizer’s COVID vaccine for use in humans.
According to the document, it normally takes 5 to 10 years to develop a vaccine. In rare circumstances, it can be done in as little as 5 years. However, Pfizer did not follow established protocols. The pharmaceutical giant skipped animal testing, mislabeled specimens, falsified data, failed to follow participants who reported adverse events, combined Phase II/III clinical trials, only presented two months of data before requesting Emergency Use Authorization, combined results of multiple trials to make the vaccine look more effective, unblinded their clinical trials and will not complete Phase III trials until 2023.
The original clinical trial that started it all
Pfizer’s original trial report was published on Dec. 31, 2020, in the New England Journal of Medicine (NEJM) (the editor-in-chief sits of the NEJM sits on the FDA’s vaccine advisory panel that determines whether a COVID vaccine is recommended by the way). Pfizer claimed, based on only two months of data, that its vaccine was safe and effective showing a 95% efficacy seven days after the second dose.
But that 95% was actually something termed “relative risk reduction.” Absolute risk reduction was only 0.84%.
Absolute risk reduction is the number of percentage points your own risk goes down if you do something protective. Relative risk reduction tells you by how much the treatment reduced the risk of bad outcomes relative to the control group who did not have the treatment.
Simply put, absolute risk reduction is the only way to identify the true context of something reported in a clinical trial, and is the most useful way of presenting research results to help guide decision-making. However, Pfizer ignored absolute risk reduction when boasting about the efficacy of its vaccine.
Pfizer’s report on the efficacy of its mRNA vaccine through 6 months showed an efficacy of 91.3% — which means it reduced positive cases compared to the placebo group. However, it also showed an increase in illness and deaths. So any perceived (temporary) benefit the vaccine may have provided, comes at a cost of increased harm.
For example, the group during the clinical trial that received Pfizer’s COVID vaccine had a 300% risk change with related adverse events compared to the placebo group, 75% risk change with severe adverse events and a 10% risk change serious adverse events involving the ER or hospitalization.
During Pfizer’s clinical trial, data shows a total of 20 deaths in the group that received the vaccine compared to 14 deaths in the placebo group. After unblinding the participants, 3 in the Pfizer group died and 2 in the placebo group died. At least nine deaths in the Pfizer group were related to cardiovascular events.
According to CCCA, when designing a trial for the efficacy and safety of a potential treatment, the focus should have be on the target population who could benefit most from the treatment. In the case of COVID vaccines, this would be those aged 72 and older. Instead, Pfizer chose participants in the younger age groups who would be less likely to need a vaccine and less likely to suffer an adverse event during the trial. In addition, a younger person is more likely to respond well to a vaccine compared to an elderly person.
Only 4% of Pfizer’s trial subjects were over the age of 75.
Pfizer says its vaccine is safe, but the company only tested its vaccine in mostly healthy, young people. Statistics show that 95% of people who’ve died from COVID had at least one co-morbidity. In the Pfizer trial, only 21% had a co-morbidity.
People with allergies, psychiatric conditions, immunocompromised people, pregnant women, people with bleeding disorders, people with natural immunity, etc. were excluded from clinical trials, yet a fourth dose of Pfizer’s COVID vaccine is being pushed on the immunocompromised and vaccines are mandated for those who’ve already had COVID.
Pfizer failed to test all participants for COVID
Pfizer’s clinical trial did not test all participants for COVID. Instead, investigators were instructed to test only those with symptoms. This means asymptomatic infection was missed and results are unreliable due to the high level of subjectivity investigators had and their ability to manipulate results.
In fact, there was no evidence at all that Pfizer’s COVID vaccine reduces the spread or transmission of COVID. It wasn’t even a “study endpoint” during the clinical trial.
Pfizer’s missing data
Pfizer is missing data for thousands of participants (many of whom were suspected to have COVID in the vaccinated group but weren’t tested), which, if included would have reduced the relative risk reduction to 19% — less than the 50% eligible for (Emergency Use Authorization) EUA.
Pfizer mixed cohorts to boost efficacy numbers
According to CCCA, Pfizer also took results from their adult trial, which began on July 27, 2020, and added them to the results of the 12-15-year-olds trial, despite the adolescent trial starting four months later. The result was boosted efficacy numbers.
Pfizer failed to properly track adverse events
Pfizer should have tested for antibodies and tracked adverse events in terms of symptoms, but they didn’t test for adverse events at the subclinical (pre-symptom) level. According to CCCA, this is problematic because symptoms/diseases are typically endpoints of processes that take months, years or even decades to surface.
Pfizer failed to track biomarkers (like d-dimers for evidence of blood clotting disorders, c-reactive protein for evidence of inflammation, troponin levels for heart damage, etc.) that would have been early warning indicators for disease caused by their vaccine.
When participants were actively followed during the clinical trial, a high number of adverse events were reported. When the vaccine was rolled out, passive surveillance was used and the signal was lost.
Adolescent trial of 12- to 15-year-olds showed all risk, zero benefit
The Pfizer-BioNTech vaccine is now recommended for the 12- to 15-year-old age group and studies for boosters are underway. Yet, Pfizer’s study of adolescents aged 12 to 15 was too small to show risk and showed no benefit — only 1,005 participants were vaccinated and 978 received the placebo.
Pfizer boasted great results but the adolescents they tested were at a statistically 0% risk of death from COVID, so receiving the vaccine wouldn’t have benefited them in the first place. What the vaccine did do was increase the risk of adverse events, which the clinical trial wasn’t designed to detect.
There was at least one very serious adverse event — Maddie de Garay (age 12). “Maddie developed gastroparesis, nausea and vomiting, erratic blood pressure, memory loss, brain fog, headaches, dizziness, fainting, seizures, verbal and motor tics, menstrual cycle issues, lost feeling from the waist down, lost bowel and bladder control and had a nasogastric tube placed because she lost her ability to eat. For the past 10 months, she has been in a wheelchair and fed via tube. “
In Pfizer’s report, her adverse reaction was described as “functional abdominal pain.”
Pfizer also used predictive modeling and stated their vaccine will cause myocarditis but said there would be zero deaths. Yet, this violates the first principle of medicine (do no harm) and science shows a mortality rate of 20% at 6.5 years in those who have myocarditis.
Pfizer continues to advertise their vaccine as safe and effective, but data is lacking and they even admit their clinical trial was too small to detect rare side effects. In addition, Pfizer changed their vaccine formula, so the vaccine that was used in the clinical trial was not the one ultimately approved for EUA (nor is it the same as the licensed Comirnaty vaccine that is not used in the U.S.).
Pfizer’s concerning post-marketing pharmacovigilance report
On Nov. 17, 2021, the FDA released the first batch of what will ultimately be a 329,000-page document the agency hopes to produce over the next 75 years. A group called the Public Health and Medical Professionals for Transparency requested access to the data FDA used to approve Pfizer’s COIVD vaccines.
One post-marketing pharmacovigilance report submitted to the FDA where Pfizer tracked real-world adverse events during the first 2.5 months after EUA showed over 1,200 deaths, 25,000 nervous system adverse events, and under “safety concerns,” listed “vaccine-associated enhanced disease.”
Pfizer’s financial incentives and lawsuits
Pfizer is poised to make more than $36 billion from their COVID vaccine in 2021. Their bottom line is their shareholders — not public health — and they have a long history of lying, misleading the public and engaging in unscrupulous practices.
On July 2, 1994, a unit of Pfizer Inc. agreed to pay $10.75 million to settle Justice Department claims it lied to get federal approval for a mechanical heart valve that fractured, killing hundreds of patients worldwide.
On May 14, 2004, Pfizer pled guilty and agreed to pay $430 million to resolve criminal and civil charges it paid doctors to prescribe its epilepsy drug, Neurontin, to patients with ailments the drug was not federally approved to treat.
On July 3, 2004, Pfizer reached a $60 million settlement of a class-action lawsuit over its Rezulin diabetes drug, which was withdrawn from the market after about 100 people who took it had to have liver transplants or died from acute liver failure.
On Oct. 8, 2008, experts concluded Pfizer “manipulated the publication of scientific studies to bolster the use of its epilepsy drug Neurontin for other disorders, while suppressing research that did not support those uses,” according to experts who reviewed thousands of company documents in a lawsuit against the company.
On Sept. 2, 2009, Pfizer paid $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability arising from the fraudulent marketing of certain pharmaceutical products.
On April 1, 2010, a Pfizer spokesperson revealed they had paid $20 million to 4,500 doctors and other medical professionals within a six-month period. Pfizer also paid $15.3 million to 250 academic medical centers and other research groups for clinical trials in the same period.
On Aug. 12, 2011, Pfizer paid out settlements to Nigerian families whose children were killed during a meningitis drug trial. Many others were paralyzed, maimed or injured.
On Aug. 7, 2012, the Securities and Exchange Commission charged Pfizer with violating the Foreign Corrupt Practices Act when its subsidiaries bribed doctors and other health care professionals employed by foreign governments in order to win business.
On Aug. 7, 2012, Pfizer paid $60 million to settle allegations it bribed doctors and health care professionals employed by foreign governments in order to win business and increase sales.
On Dec. 9, 2013, the U.S. Supreme Court left intact a $142 million jury verdict against Pfizer over the marketing of the epilepsy drug Neurontin.
On Dec. 7, 2016, Britain’s competition watchdog fined a record 84.2 million pounds ($107 million) for its role in ramping up the cost of an epilepsy drug by as much as 2,600%.
On July 15, 2021, Pfizer and two of its subsidiaries agreed to pay $345 million under a proposed settlement to resolve lawsuits over EpiPen price hikes.
On Oct. 15, 2021, a federal court denied requests by Pfizer and other companies to throw out lawsuits by former Zantac patients asking for medical monitoring and compensation for their financial losses. Lawsuits alleging personal injury from the drug can continue as well.
“Manufacturers including GlaxoSmithKline, Sanofi, Boehringer Ingelheim and Pfizer engaged in a decades-long scheme to conceal the inherent dangers and risks associated with Zantac use despite abundant medical and scientific literature that linked ranitidine to NDMA, and we look forward to holding them accountable,” lawyers for the plaintiffs said in a statement.
Pfizer’s conflict of interests
According to CCCA research, 84% of authors who signed on to Pfizer-BioNTech’s 6-month clinical trial study had conflicts of interest, leaving only 16% who didn’t. At least two authors saw their sock value increase by $9 billion due to the results of the study.
CDC redefined “vaccine” for pharmaceutical and political interests
The Centers for Disease Control and Prevention (CDC) used to define “vaccine” as a “product that stimulates a person’s immune system to produce immunity to a specific disease, protecting the person from that disease.” This was the definition the CDC used for years.
On July 27, Dr. Rochelle Walensky, director of the CDC, admitted COVID vaccines do not provide immunity and do not prevent people from catching or transmitting COVID. This presented a problem, so on Sept. 2, the CDC changed its definition for “vaccine” to “a preparation that is used to stimulate the body’s immune response against diseases.”
Pfizer indemnified, vaccines should be withdrawn immediately
Pfizer has been shielded from liability for harm caused by its COVID vaccine(s), and agencies overseeing trials are failing to follow established high-quality safety and efficacy protocols, despite knowing based on available data Pfizer’s COVID vaccine could cause harm.
“Any government official who possesses this evidence and continues to allow its citizens to be inoculated with a toxic agent is, at the very least, negligent,” CCCA wrote.
You can read the full 51-page report below.