Re-Analysis Of Pfizer Phase 3 Trials Prompt Researchers To Call For Global Moratorium

It is now apparent, blazingly so, that those who were accused of being “conspiracy theorists”, peddling mis- and disinformation, and spreading false and mal-information have been thoroughly vindicated with the release of a new scientific paper titled, “COVID-19 mRNA Vaccines: Lessons Learned from the Regional Trials and Global Vaccine Campaign” as reported by The Expose. The seven researchers, consisting of M. Nathaniel Mead, Stephanie Seneff, Russ Wolfinger, Jessica Rose, Kris Denhaerynck, Steve Kirsch and Peter A. McCullough, reanalyzed the Pfizer trial data due to their understanding of the vaccine has expanded and reports of problems with the phase 3 trials emerged.

The research group found “statistically significant increases in serious adverse events (SAE’s) in the vaccine group” during the reexamination of the Pfizer trial data. After the Emergency Use Authorization (EUA), numerous SAE’s were identified, including “death, cancer, cardiac events, and various autoimmune, haematological, reproductive, and neurological disorders.”

As the paper noted, Pfizer’s covid “vaccines” never underwent adequate safety and toxicological testing according to previously established scientific standards.  It goes on to detail the absolute risk reduction, the underreporting of harms during trials, the shifting narratives and illusions of protection, quality control and manufacturing process-related impurities, the biological mechanisms underlying adverse events (“AEs”) and why, based on how our immune systems work, the vaccine is ineffective. 

The researchers are calling for a global moratorium on the mRNA products.

Given the extensive, well-documented SAEs and unacceptably high harm-to-reward ratio, we urge governments to endorse a global moratorium on the modified mRNA products until all relevant questions pertaining to causality, residual DNA, and aberrant protein production are answered.

Mead M, Seneff S, Wolfinger R, et al. (January 24, 2024) COVID-19 mRNA Vaccines: Lessons Learned from the Registrational Trials and Global Vaccination Campaign. Cureus 16(1): e52876. doi:10.7759/cureus.52876

Here are some exerpts from The Expose article by Rhoda Wilson, which also provided content from the study that proves what many researchers – professional and amateur – were saying all along.

The paper noted that the gene therapy products (“GTPs”) vaccine platform has been studied for over 30 years as an experimental cancer treatment, with the terms “gene therapy” and “mRNA vaccination” often used interchangeably.

“Although we employ the terms ‘vaccine’ and ‘vaccination’ throughout this paper, the covid-19 mRNA products are also accurately termed gene therapy products (GTPs) because, in essence, this was a case of GTP technology being applied to vaccination,” they wrote.

As such, throughout their analysis, the terms “vaccines” and “vaccinations” are used interchangeably with injections, inoculations, biologicals, or simply, products.

When the Food and Drug Administration (FDA) awarded the “bait and switch” approval to Pfizer’s Comirnaty, The Sons of Liberty Radio Morning host Tim Brown and this writer revealed some caveats confirming this “bait and switch” as well as the product being a “gene therapy product”. Independent researchers were claiming, and it is now confirmed, these injections could alter human DNA through a reverse transcriptase process that can occur with insertion of foreign mRNA.

Let’s look at some of the takeaways from this new re-analysis of Pfizer’s documents.

Despite the rhetoric, no large randomised double-blind placebo-controlled trials have ever demonstrated reductions in SARS-CoV-2 transmission, hospitalisation or death.

The study designs for the pivotal trials that led to the EUA were never intended to determine whether the mRNA inoculations could help prevent severe disease or premature death.

It was only after the EUA that the serious biological consequences of rushing the trials became evident, with numerous cardiovascular, neurological, reproductive, haematological, malignant, and autoimmune SAEs identified and published in the peer-reviewed medical literature.

Moreover, the covid mRNA vaccines produced via Process 1 and evaluated in the trials were not the same products eventually distributed worldwide; all of the covid-19 mRNA products released to the public were produced via Process 2 and have been shown to have varying degrees of DNA contamination.

Remember when the announcement was giving for these mRNA COVID-19 shots? It was reported the product vials had to be frozen at extremely low temperatures (approx. -70 degrees F.); vials were only viable for 2-4 hours after thawing, and had to be distributed by the military because the freezers needed were expensive. Did you ever see any “special freezers” at your local Wal-mart, CVS, Walgreen’s, or other venue providing these injections?

If you didn’t, there is a reason why – a bait and switch with the approved product versus the product produced for mass injection.

Moreover, the covid mRNA vaccines produced via Process 1 and evaluated in the trials were not the same products eventually distributed worldwide; all of the covid-19 mRNA products released to the public were produced via Process 2 and have been shown to have varying degrees of DNA contamination.

The process-related impurities were absent from the covid-19 mRNA products used in the registrational trials. Virtually all doses used in those trials originated from “clinical batches” produced using what is known as Process 1.  As a post-authorisation emergency supply measure for global distribution, however, a method much more suitable for mass production known as Process 2 was devised utilising bacterial plasmid DNA.

The failure of regulatory authorities to heretofore disclose process-related impurities (e.g., SV40) has further increased concerns regarding safety and quality control oversight of mRNA vaccine manufacturing processes.

In actuality, Pfizer had three products in trial. First, the Comirnaty, which was approved, and known as BNT162-01. The other two, which involved differing dosages, were BNT162b1 and BNT162b2. The product being injected into everyone’s arm, including children, is the product BNT162b2, per the Emergency Use Authorization (EUA). While Comirnaty was approved by the FDA, BNT162b2 retained EUA, as well as did Moderna’s mRNA product. This is a clear violation of law. And, according to this new re-analysis, Pfizer nor the FDA can claim product BNT162-01 (Comirnaty) is the same as BNT162b2 (EUA product) because “process-related impurities were absent from the COVID-19 mRNA products used in the registrational trials” using Process 1 while Process 2 utilizing bacterial plasmid DNA occurred with the product released to the public. There were process-related impurities in BNT162b2 that were not disclosed to the public. This is a blatant “bait and switch”.

Political and financial incentives may have played a key role in undermining the scientific evaluation process leading up to the EUA.

Before the pandemic, the US National Institutes of Health invested $116 million (35%) in mRNA vaccine technology, the Biomedical Advanced Research and Development Authority (“BARDA”) had invested $148 million (44%), while the Department of Defence (“DOD”) contributed $72 million (21%) to mRNA vaccine development.

BARDA and the DOD also collaborated closely in the co-development of Moderna’s mRNA vaccine, dedicating over $18 billion, which included guaranteed vaccine purchases. This entailed pre-purchasing hundreds of millions of mRNA vaccine doses, alongside direct financial support for the clinical trials and the expansion of Moderna’s manufacturing capabilities.

Once the pandemic began, $29.2 billion – 92% of which came from US public funds – was dedicated to the purchase of covid-19 mRNA products; another $2.2 billion (7%) was channelled into supporting clinical trials, and $108 million (less than 1%) was allocated for manufacturing and basic research.

Using US taxpayer money to purchase so many doses in advance would suggest that, before the EUA process, US federal agencies were strongly biased toward successful outcomes for the registrational trials.

After spending so many taxpayer dollars on this “technology” and BARDA and DOD “collaborating” in the development of Moderna’s mRNA injection, the scene was set for a “too expensive to fail” injection. All the political players wanted to indulge in some “idol worship” from constituents who believed “they would be saved” from the invisible boogeyman.

We know these injections were developed at “warp speed” or the “speed of science” as one Pfizer employee noted. However, the “speed of science” is usually an average of 10 years in phase three trials, with many Departments of Health identifying 10-15 years as the norm for evaluating safety. Yet, Pfizer did it all in seven months. This is not the “speed of science” but the process of “ignoring science.”

Then, there is the abolishing of safety standards.

With the covid vaccines, safety was never assessed in a manner commensurate with previously established scientific standards, as numerous safety testing and toxicology protocols typically followed by the FDA were sidestepped.

Historical accounts bear witness to instances where vaccines were prematurely introduced to the market under immense pressure, only to reveal disabling or even fatal AEs later on. Examples include the 1955 contamination of polio vaccines, instances of Guillain-Barré syndrome observed in flu vaccine recipients in 1976, and the connection between narcolepsy and a specific flu vaccine in 2009.

Against this backdrop, it is not surprising that so many medical and public health experts voiced concerns about covid mRNA vaccines bypassing the normal safety testing process.

Concerns about inadequate safety testing extend beyond the usual regulatory approval standards and practices.

As there were no specific regulations at the time of the rapid approval process, regulatory agencies quickly “adapted” the products, generalised the definition of “vaccine” to accommodate them, and then authorised them for EUA for the first time ever against a viral disease.

Due to the GTPs’[gene therapy product] reclassification as vaccines, none of their components have been thoroughly evaluated for safety. The main concern, in a nutshell, is that the covid mRNA products may transform body cells into viral protein factories that have no off-switch – i.e., no built-in mechanism to stop or regulate such proliferation – with the spike protein (“S-protein”) being generated for prolonged periods, causing chronic, systemic inflammation and immune dysfunction.

When the S-protein enters the bloodstream and disseminates systemically, it may become a contributing factor to diverse AEs in susceptible people. [Emphasis Mine]

Isn’t this what many were saying? Absolutely, which is why the government, medical associations, licensure boards, pharmaceutical companies, and NGOs (non-governmental organizations) were weaponized against professionals and the people.

Other important factors were discovered as well.

Stratifying by age, the infection fatality rate (IFR) in 2021 showed an age gradient with approximately a three to four-fold increase for each decade, starting as low as 0.0003% (nearly zero) among children and adolescents, increasing to 0.5% in those aged 60-69. Even in older age groups (>70 years), the IFR varies from 1-5% depending on comorbidities and treatment access. As a basic principle, all-cause mortality (ACM) tends to increase with age. In the case of COVID-19, the presence of comorbid disease greatly modifies the influence of age on mortality. For younger generations (<40 years), SARS-CoV-2 infection severity and fatality rates since 2020 have been comparable to those of influenza. Even in countries that showed excess mortality in 2020, death rates among children were extremely low. In Sweden, where 1.8 million children were allowed to freely attend school in 2020, zero COVID-19 deaths were recorded among them by summer 2021.

…

After carefully analyzing the ACM for the Pfizer and Moderna trials, Benn and colleagues found 61 deaths total (31 in vaccine, 30 in placebo) and a mortality RR of 1.03 (0.63-1.71), comparing the vaccinated to placebo. These findings can be interpreted as “no significant difference” or no gold-standard evidence showing these mRNA vaccines reduce mortality.

…

One of the often-overlooked shortcomings of the registrational trials was the final reports’ exclusive focus on RR while omitting absolute risk reduction. The latter measure gives a better indication of a drug’s clinical utility than the former relative measure since it is scaled by the sample size. RR is the ratio of COVID-19 symptom rates in the vaccine versus placebo groups, which was reported as 95% and 94.5% for the Pfizer and Moderna products, BNT162b2 and mRNA-1273, respectively. Absolute risk refers to the probability of an outcome (in this case, symptoms of clinical infection), based on the number of people experiencing the outcome in relation to the population at large. It is typically calculated as the number of events that occurred in a study population divided by the number of people in that population. Both types of risk estimation are required to avoid reporting bias and to provide a more comprehensive perspective on vaccine efficacy. Omitting the absolute risk statistics leads to overestimation of the clinical benefits of the vaccines. In contrast with the 95% RR figure, the absolute risk reductions for BNT162b2 and mRNA-1273 were 0.7% and 1.1%, respectively. These estimates were derived from publicly available data that ultimately enabled EUA for the vaccines to be granted by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). However, the data reviewed by the VRBPAC did not include absolute risk reduction measures, thus deviating from FDA’s guidelines, which state that both approaches are crucial in order to avoid the misguided use of pharmaceuticals.

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An absolute risk reduction of approximately 1% for the COVID-19 mRNA vaccinations meant that a substantial number of individuals would need to be injected in order to prevent a single mild-to-moderate case of COVID-19.

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For example, assuming an NNV [number needed to vaccinate] of 119 and an IFR of 0.23% (both conservative estimates), approximately 52,000 vaccinations would be needed to prevent one COVID-19-related death. Thus, for the BNT162b2 injection, a generous estimate would be two lives saved from COVID-19 for every 100,000 courses of the biological. … Regarding potential harms, assuming 30% false-positive reports and a moderate under-reporting factor of 21, we calculate a risk of 27 deaths per 100,000 doses of BNT162b2.

This evaluation indicates the harms greatly outweighed the benefit. “For every life saved, there were 14 times more deaths caused by the modified mRNA injections.”

Read the reanalysis for yourself. You will find what you were told by government, Fauci, Birx, the Operation Mockingbird Media (OMM), Trump, Biden, the Center for Disease Control (CDC), etc. was blatantly false. This should firmly establish that not one individual can have any confidence in government, the OMM, government agencies, or the medical industrial complex. Therefore, it is up to every individual to secure for themselves adequate informed consent.