President John F. Kennedy once said, a “nation that is afraid to let its people judge the truth and falsehood in an open market is a nation that is afraid of its people.” Apparently, U.S. District Judge Mark T. Pittman, Northern District of Texas, agrees. Pittman quoted Kennedy when he ordered the Food and Drug Administration (FDA) to release hundreds of thousands of pages from documents that FDA used to license Pfizer’s BNT162b2 Covid-19 injections (brand name “Comirnaty”).1
Leading up to Pittman’s landmark decision, the nonprofit Public Health and Medical Professionals for Transparency (PHMPT) had filed a Freedom of Information Act (FOIA) request with FDA to obtain the documentation the agency used to approve Pfizer’s Comirnaty injections for individuals sixteen years of age and older. In doing so, the group was seeking access to data on safety and effectiveness, adverse reaction reports and, significantly, lists of active and inactive ingredients in the shots.2 According to its mission statement, “PHMPT exists for the sole purpose of disseminating to the public the data and information in the biological product files for each of the Covid-19 injections.”3 PHMPT made the FOIA request on August 27, 2021, immediately following FDA’s decision to officially license Comirnaty on August 23, 2021. FOIA requests cannot be submitted for biologics that remain solely under emergency use authorization (EUA) status.4
FDA STONEWALLING
On September 16, after FDA had declined to produce a single document in accordance with the late-August FOIA request, PHMPT’s collective of highly credentialed public health professionals, medical professionals, scientists and journalists submitted a court application, demanding that FDA produce its complete data set by March 2022. According to plaintiffs’ attorney Aaron Siri, his clients “explained that until all of the data is produced, a proper review cannot be conducted because missing even a single data set could throw off any analysis.”5
Remarkably, FDA asked Judge Pittman to give it until the year 2096 to disclose all relevant data. Under the proposed nearly seventy-five-year timeline, the agency would willingly release an initial twelve thousand pages, followed by “a minimum” of five hundred pages a month. While twelve thousand might sound like a lot of pages, the “full trove” of information about the injection’s approval actually amounts to around four hundred thousand pages.6 PHMPT found the proposed delay in their release unacceptable. As Siri stated in court papers, the proposed rate was “so slow that the documents will not be fully produced until almost all of the scientists, attorneys, and most of the Americans that received Pfizer’s product, will have died of old age.”7
FDA justified its proposed timeline citing limited resources, the need to redact personal information and its duty to protect Pfizer’s trade secret interests. As Siri later wrote, “The FDA’s excuses were incredible. The FDA has more than eighteen thousand employees and a budget of over six billion dollars. It would be laughable if any multibillion-dollar company came before a court and claimed poverty to escape making a document production, but that was the FDA’s position.”5 It is worth noting, moreover, that it took FDA itself only one hundred eight days to review all of Pfizer’s documentation before authorizing the EUA injections on December 11, 2020.4
The fact that FDA was unwilling to release its data without a court order speaks volumes. It is plain to see that the agency’s repeated assertions of a “commitment to transparency”—used to build public support for Covid-19 injections— were not sincere. Considering that the biologics initially were rushed to market under EUA and that the experimental messenger RNA (mRNA) technology they embody had never previously been administered to a human population on a mass scale, one might expect the public to be up in arms about FDA’s opacity.
SLOW RELEASE A NO-GO
On January 6, 2022, Judge Pittman ordered the expedited release of all the documents FDA claimed it needed decades to process. In his ruling, Pittman compared FDA’s slow-release request to the actions of totalitarian nations. In addition to President Kennedy, he quoted founding father James Madison as saying that a “popular Government, without popular information, or the means of acquiring it, is but a Prologue to a Farce or a Tragedy.”5
Sharing a similar viewpoint, Siri wrote in an emailed comment that it is “dystopian for the government to give Pfizer billions, mandate Americans to take its product, prohibit Americans from suing for harms, but yet refuse to let Americans see the data underlying its licensure.”6
Thanks to Siri’s efforts and Pittman’s verdict, FDA must release the documents on a phased basis that makes all documents from Pfizer’s clinical trials available to the public by the end of September 2022. Ten thousand pages were released in March, followed by another ten thousand in April; the judge then called for another eighty thousand pages per month for the next three months, followed by seventy thousand pages in August and fifty-five thousand pages in September.8 Siri pronounced the ruling a “great win for transparency,” stating that it “removes one of the strangleholds federal ‘health’ authorities have had on the data needed for independent scientists to offer solutions and address serious issues with the current vaccine program.”1
BOMBSHELL DISCLOSURES IN PFIZER DOCUMENTS
Previously, in the last two months of 2021 and in January 2022, FDA had voluntarily released a small cache of Pfizer documents.8 However, the documents were heavily redacted and so dense in content that they proved difficult to analyze. As part of Pittman’s court order, FDA next released (in March 2022) a thirty-eight-page Pfizer document entitled 5.3.6 Cumulative Analysis of Post-Authorization Adverse Event Reports of PF-07302048 (BNT162B2) Received Through 28-Feb-2021.9
The bombshell document reveals Pfizer’s internal knowledge of an “extremely serious” number of illnesses, injuries and deaths experienced by recipients of its injections.10 Pfizer disclosed that in the first three months of the Covid-19 injection rollout, the company received over forty-two thousand adverse event case reports, amounting to a total of nearly one hundred fifty-nine thousand events—an average of just under four symptoms (events) per case.2 Very few of the serious adverse events brought to Pfizer’s attention are listed as potential harms on FDA’s injection fact sheet for recipients and caregivers.11
The case reports received by Pfizer included over twelve hundred deaths—one in thirty-five clinical trial participants for whom adverse events were reported.8
In 1976, the government pulled the swine flu vaccine after only twenty-five deaths; it seems unconscionable, therefore, that FDA would, after reviewing these alarming data, nonetheless go on to issue an EUA and later formally approve both Pfizer’s Comirnaty injection and Moderna’s Spikevax injection.
As it happens, the Pfizer document had been leaked a few months earlier in December. Following the report’s leak, investigative journalist Sonia Elijah of TrialSiteNews published an analysis of her findings.4 Calling attention to many unknowns, Elijah wrote, “Particularly troubling, the FDA opted to protect Pfizer’s interests by redacting the total number of doses to (b) (4) [a redacted term], hindering the ability to calculate the incidence rates and provide a meaningful analysis of the data.”
She added, “Another deeply concerning fact centers on important limitations cited by Pfizer: ‘the magnitude of underreporting is unknown’” [emphasis in original]. However, as Elijah reminded readers, a credible estimate of “the magnitude of underreporting” had, in fact, been furnished by the government-funded Harvard Pilgrim study conducted from 2007-2010, which found that “less than 0.3% of all adverse drug events and 1-13% of serious events are reported to the FDA.”
As another cause for alarm, Elijah noted the in-house upheaval caused by the flood of adverse event reports: “[T]here has been such a large volume of adverse events, classified as ‘serious cases’ in that short period of time, that Pfizer has had to take on more full-time employees and make significant technology changes to cope with the processing of the voluminous reports while also meeting regulatory reporting timelines.” Even so, Elijah concluded that “the FDA and Pfizer have appeared to conceal the full extent of the Pfizer-BioNTech vaccine side effects from the public.”
MANY ERRORS AND ANOMALIES
Pfizer’s case report forms included many apparent “errors and anomalies”:2
- Patients entered into the “healthy population” group who were not healthy
- Serious adverse event numbers left blank;
- Suspicious-looking start and end dates for serious adverse events
- Missing sample barcodes, making it impossible to match samples to participants
- Review of adverse event reports (for signs of Covid-19 cases and assessment of Covid-19 case severity) conducted by unblinded teams
- Illogical dating related to side effects and medical visits
- Uniformity of post-injection observation period recorded, suggesting automated data entry rather than individualized observation of possible reactions
- Adverse events listed as “not serious” despite extended hospitalization
- Dismissal of health problems as “unrelated” to the injection
Although roughly half of the reported adverse events were “serious adverse events,” Pfizer chose to unblind the placebo groups and offer them the experimental injections as soon as the shots received EUA status, thus destroying any ability to assess long-term injuries between the “vaccinated” and unvaccinated groups.12 (“Vaccinated” is in quotes because the injections are a form of gene therapy—they are not vaccines.)
Meanwhile, author and former Democratic political advisor Naomi Wolf has organized highly trained teams of volunteer experts— including researchers, biostatisticians and lawyers—to scrutinize the Pfizer documents as they are released.13 An immediate observation by one of her teams was that Pfizer’s 5.3.6 report is missing information about outcomes for almost half of the cases. Out of the over forty-two thousand case reports received by the company through the end of February, Pfizer listed the case outcome as either “not recovered” or “unknown” for nearly half (almost twenty-one thousand). As Wolf emphasized in late April, “We don’t know what happened to them.” Wolf’s “Team #5” explained, “This number [of missing outcomes] dwarfs the reported deaths number so finding out the eventual outcome is vitally important.”14
That death number, let’s recall, showed that over twelve hundred people died within three months of taking the injection (through the end of February 2021). Despite this extraordinary number of deaths, Dr. Mace Rothenberg, who stepped down as Pfizer’s chief medical officer in March 2021 after twelve years with the company,15 told C-SPAN’s Washington Journal the next month, “I can tell you that no corners were cut” when developing the injections, also stating, “there have been no deaths that have occurred directly as a result of the vaccine alone.”16
TrialSiteNews’s Elijah noted the logical contortions employed by those “defending the safety of the Pfizer vaccine,” including the favored claim that “correlation does not imply causation.”4 Although Pfizer’s analysis indicated that nine reported fatalities were due to anaphylaxis—with four of those deaths occurring on the very day of injection—the company’s response was “that these individuals had underlying medical conditions”—never mind that its clinical trial eligibility criteria emphasized recruitment of “healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion” as well as baseline screening for history of anaphylaxis.17 Underscoring the relevance of the temporal association between injection and adverse event, Elijah also pointedly noted that 50 percent of the cardiovascular “adverse events of special interest” reported to Pfizer, including one hundred thirty-six cardiac deaths, occurred within twenty-four hours of receiving the shot, again suggesting “vaccine death causality.”
MORE ANOMALIES
Interestingly, Pfizer’s report appeared to show that women were three times more affected by adverse events generally, and by cardiovascular events and anaphylaxis specifically. According to Pfizer, 71 percent of the cumulative case reports it received were for women, while just 22 percent were for men (and, oddly, data on sex were missing for the remaining 7 percent). Yet, Elijah wrote, “nowhere in Pfizer’s analysis does the company comment on this data,” instead “confidently” asserting that its case review raised no safety issues.4
Although sex-specific “vaccine” risks are a real possibility, Naomi Wolf has noted that in the context of a randomized controlled trial, the skewed ratio of females to males smacks of “cherry-picking.” Rhetorically asking why Pfizer might want to leave out some of the men, she suggests one “obvious” answer—“men get myocarditis [heart muscle inflammation] disproportionately.”14
In the original analysis submitted to FDA, Pfizer excluded data associated with use of its injection in pregnancy and lactation. However, the 5.3.6 document discloses four hundred thirteen case reports of adverse events in pregnant and lactating women—eighty-four classified as “serious.” Nonetheless, Pfizer’s conclusion is that “there were no safety signals that emerged from the review of these cases of use in pregnancy and while breast feeding.”
MIXED MESSAGES IN PFIZER COVID DOCUMENTS
In a trenchant piece in The Defender on March 15, 2022,18 Dr. Meryl Nass (an internal medicine physician and member of the scientific advisory board of Children’s Health Defense) outlined a variety of ways in which the official Covid “vaccine” safety narrative contradicts the legal documents that FDA relied on to make its EUA and licensing decisions. Dr. Nass asked, “Is this fraud?”
As one example, Nass noted that “messaging around vaccine safety in pregnancy conflicts with what is known.” Pfizer chose to hedge its bets in the language used on its Comirnaty label, which reads, “Available data on Comirnaty administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy”—a “pretty clear ‘We don’t know’” according to Nass; however, that has not stopped the Centers for Disease Control and Prevention (CDC) and its director Rochelle Walensky,19 or National Institute of Allergy and Infectious Diseases (NIAID) director Anthony Fauci, or the physician trade group American College of Obstetricians and Gynecologists (ACOG) from repeating, ad nauseum, that the shots are safe for pregnant women and their babies. Nass also noted the contrast between the CDC’s January 7, 2022 admission in Morbidity and Mortality Weekly Report that data are insufficient to make any determination of Covid “vaccine” safety in the first trimester20 and ACOG’s recommendation in favor of vaccination “in any trimester” and “emphasis. . . on vaccine receipt as soon as possible to maximize maternal and fetal health.”21
Nass called attention to several other inconsistencies between CDC’s guidance to the general public and the statements found on the Comirnaty label or in the package insert. These include mixed messages regarding anaphylaxis, myocarditis, cancer and fertility problems. Where myocarditis is concerned, said Nass, CDC’s website gives the impression that episodes “are mild and resolve quickly,” yet the Comirnaty label expressly states: “Information is not yet available about potential long-term sequelae.” Likewise, whereas CDC and manufacturers claim Covid injections (Pfizer’s and others) will not cause cancer or fertility problems, the Comirnaty label admits the product “has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility.”18
In the same article, Nass also raised questions about the Pfizer injection’s professed efficacy. [Editor’s note: The concept of “vaccine efficacy” is problematic in and of itself, premised as it is on underlying and unproven assumptions about germ theory and vaccination as a route to health.] Nass points out that around the time when FDA granted EUA status to Pfizer’s injection, the agency also issued a memorandum stating that “‘very few cases of confirmed COVID-19 [had] occurred’ among the 3% of clinical trial participants who had evidence of prior infection”—what many refer to as “natural immunity.” In other words, FDA admitted that the clinical trials could not meaningfully assess the injections’ benefits for individuals who had already had Covid. Nevertheless, those individuals were later “encouraged and sometimes forced” to receive the injections.
The EUA granted by FDA to Pfizer covered everyone age sixteen and older, even though FDA’s memorandum described only one “confirmed” Covid case in the age group of sixteen- to seventeen-year-olds. Nass explained, “there were no data to support efficacy in this age group. No wonder four members of the FDA advisory committee voted no, and one abstained from supporting authorization.”
Nass and others have speculated that authorization for teenagers was needed to lay the groundwork for eventually putting Covid injections on the CDC’s childhood vaccine schedule. Such a move would guarantee permanent liability protection under the umbrella of the 1986 National Childhood Vaccine Injury Act (NCVIA), and would open the door to mandating the injections for school attendance. Currently, the liability protections granted to EUA Covid-19 injections under the Public Readiness and Emergency Preparedness (PREP) Act are scheduled to expire on October 1, 2024.22
Nass forcefully concluded: “The bottom line is that the CDC, FDA, and National Institutes of Health [NIH] have not been working to protect the public during the COVID pandemic, but instead to protect themselves (in the case of the FDA) and to broadcast false information to the public regarding vaccine safety (in the case of the NIH and CDC).”18
DISTURBING BIODISTRIBUTION FINDINGS
The 5.3.6. report was just one document among thousands of pages from the first court-ordered cache of Pfizer documents. Others pertain to animal studies and study protocol amendments, as well as the original Pfizer-BioNTech application to market the injections to the Department of Health and Human Services (HHS).8
One especially disconcerting final report (A Tissue Distribution Study of a [3H]-Labelled Lipid Nanoparticle-mRNA Formulation Containing ALC-0315 and ALC-0159 Following Intramuscular Administration in Wistar Han Rats) describes an animal study carried out on rats that focused on biodistribution of the lipid nanoparticles (LNPs) in Pfizer’s injection.23 LNPs, functioning as “delivery systems,” are the pharmaceutical industry’s answer to the unique challenges posed by mRNA “vaccines” which, “under physiological conditions,” are prone to instability and mRNA degradation.24 According to Jessica Rose, PhD, who holds degrees in applied mathematics, immunology, computational biology, molecular biology and biochemistry, analysis of the Pfizer data confirms biodistribution to the liver, spleen, adrenal glands and ovaries. In other words, and contrary to what we have been told, Pfizer’s LNPs transport the injection’s ingredients—the mRNA components as well as other active and inactive ingredients, both disclosed and undisclosed—around the body rather than staying at the injection site.8 Rose notes that Japanese researchers have come up with similar biodistribution findings.
In response to a separate FOIA lawsuit against HHS, the American conservative activist group Judicial Watch announced on May 2, 2022 that it had received four hundred sixty-six pages of records regarding biodistribution studies and other data for Pfizer’s Covid injections.25 These pages again confirm that LNPs were found outside the injection site in test animals within eight to forty-eight hours of injection. One of the reports included in the batch, a February 2021 report titled 2.4 Nonclinical Overview, describes the testing of “boosted immunizations” in rats, explaining that “Vaccine-related microscopic findings at the end of dosing for BNT162b2 were evident in injection sites and surrounding tissues, in draining iliac lymph nodes, bone marrow, spleen, and liver.”26
SHORTCUTS: PAR FOR THE COURSE
Various sections of the “nonclinical overview” refer to World Health Organization (WHO) guidelines on vaccine development from 2005, which, as summarized by Judicial Watch, apparently justify the following:
- Not conducting safety pharmacology studies (“as they are not considered necessary for the development of vaccines”)
- Not evaluating drug interactions with BNT162b2 (same reason)
- Not assessing genotoxicity (“as components of the vaccine constructs are lipids and RNA and are not expected to have genotoxic potential”)
- Not conducting carcinogenicity studies (as the lipids and RNA “are not expected to have carcinogenic or tumorigenic potential”)
To this, Judicial Watch president Tom Fitton commented, “These documents show why many Americans have concerns about whether the novel COVID vaccines that were developed at such an accelerated pace were tested properly and thoroughly.”25
Another court case worthy of mention was brought by whistleblower Brook Jackson, a former regional director at the Ventavia Research Group. Responsible for clinical trial oversight, Jackson emailed concerns to FDA about the poor management of the trials; within hours, she was fired. An article by investigative journalist Paul Thacker in The BMJ, published on November 2, 2021, describes Jackson’s shock at witnessing potential data falsification, the unblinding of approximately one thousand participants during the study and various deviations from protocol.27 Even after Jackson’s serious allegations, Ventavia continued to run clinical trials for Pfizer’s Covid injections.8 Her False Claims Act lawsuit against Pfizer, Ventavia and another company called ICON alleges that the three defendants “deliberately withheld crucial information from the United States that calls the safety and efficacy of their vaccine into question.”28 After being under seal for over a year, the court in January 2022 unsealed her four-hundred-page complaint, making it publicly available.
WHITING OUT EXCESS MORTALITY
Incredibly, the mainstream media are not reporting the information emerging from the Pfizer documents. It does not appear that even one legacy news source has published a story mentioning the significant adverse event findings or the potential clinical trial fraud. Meanwhile, just hours after FDA authorized a fourth Pfizer injection for people aged fifty and older, Dr. Peter Marks—director of FDA’s Center for Biologics Evaluation and Research (CBER)— said a fifth shot could be needed by the fall.29
How can Marks say this when high-quality epidemiological data demonstrate that Covid-19 injections provide none of the benefits they are alleged to offer?30 On the contrary, real-world data suggest that rates of illness are highest in the triple-jabbed, with the lowest rates in the uninjected. In the United Kingdom, “vaccine” effectiveness has been rated as low as minus 300 percent for thirty- to seventy-year-olds who received three jabs, with triple-injected individuals in their sixties faring the worst.31 The UK has also conveyed in its weekly surveillance the fact that nine in ten Covid deaths are in fully “vaccinated” people, and a similar pattern holds true for those hospitalized for Covid.32 For UK residents who received a second dose at least six months earlier, the risk of death (from all causes) appears to be almost 300 percent greater.33
U.S. mortality patterns for the “vaccinated” and uninjected and for Covid-19 versus Covid injections are somewhat harder to ascertain due to extensive data manipulation by HHS and CDC.34 In early January 2022, for example, HHS quietly disseminated new reporting guidelines for hospitals that instructed the health care facilities to stop recording the “previous day’s COVID-19 deaths.”35 In March, CDC erased over seventy-two thousand deaths linked to Covid-19 illness from its data tracker, citing “coding logic errors.”36 Commenting on the shenanigans, Dr. Nass suggested that CDC hides much of its data and selects only those data that advance its “health policies”; it then “blames its ‘outdated’ IT [information technology] systems for the problems if it gets caught.”36
A report FDA had in its possession before reaching its August 2021 decision to grant full approval for Comirnaty showed the all-cause mortality rate in the “vaccinated” group to be 24 percent higher (twenty-one deaths) than in the placebo group (seventeen deaths).37 FDA’s response: “None of the deaths were considered related to vaccination.”38 Nonetheless, excess mortality in the U.S. has been rising steadily since the injections’ widespread rollout.33 Insurance companies are describing an increased death rate of working-age Americans—anywhere from 40 to 54 percent higher than pre-pandemic levels.39,40 Other estimates put excess U.S. mortality in individuals twenty-five to sixty-four years of age even higher, at approximately 85 percent.41 In 2021, coinciding with the injections, funeral homes reported a surge in funerals and cremations.42 In patients examined in autopsy studies conducted by renowned German pathologist Dr. Arne Burkhardt, the injections were clearly implicated in 93 percent of the deaths.43
INCONVENIENT TRUTHS
While public health agencies continue to deceive by withholding and burying vital information, people the world over are discovering the inconvenient truths about Covid-19 injections. Although we were told it could never happen, we now have studies, for example, showing that mRNA from the Pfizer injections can transcribe into DNA, permanently changing the DNA of affected cells.44 Incredibly, in response to a FOIA request made by the Informed Consent Action Network (ICAN) to CDC on April 28, 2021, CDC admitted it does not have any documents to support its claim that Covid-19 shots do not integrate into DNA.45 F DA a nd Pfizer, too, are holding steadfast to their assertions that the injections do not alter the human genome, though a study published in February 2022 (“Intracellular reverse transcription of Pfizer BioNTech COVID-19 mRNA vaccine BNT162b2 in vitro in human liver cell line”)46 showed that in the liver—one of the organs “preferred” by Pfizer’s synthetic mRNA—the injections’ genetic code can reverse transcribe into the DNA, raising questions about the potential for subsequent liver cancer.44 Stated in simpler language, an observer described “vaccinated” individuals’ DNA as having been “hacked and modified by Pfizer.”47
The noticeable rise of myocarditis, pericarditis (inflammation of the heart lining) and myopericarditis (both combined)—especially among young and otherwise healthy teenagers—is another inconvenient truth. Study after study shows that far from being a “mild” condition, as purported by CDC, these are very serious conditions. In one study, two-thirds of adolescents who developed myopericarditis after Covid injection showed elevated serum troponin levels indicative of heart damage and persistent abnormalities.48 Another study showed that 60 to 70 percent of teenagers with vaccine-induced myocarditis might have permanent heart scarring.48
Among other inconvenient truths, Stephanie Seneff, PhD, senior research scientist at the Massachusetts Institute of Technology (MIT), says we can expect to see a dramatic increase in prion diseases, autoimmune diseases, younger-onset neurodegenerative diseases and blood disorders such as clotting, hemorrhaging, strokes and heart failure in the next ten to fifteen years,49 and at least eight studies show adrenal insufficiency after mRNA injections.50 Others are anticipating severe intellectual disabilities in the aftermath of Covid injections.51
PFIZER PRESSURES FDA CHILD VACCINE INJECTIONS
In April, 2022, Pfizer signaled its plans to request another EUA from FDA for a third dose of its mRNA injection for five- to eleven-year-olds;52 in May, FDA expeditiously authorized the “booster” for that age group without even consulting with its own advisory panel.53 FDA had already, in January, allowed an EUA booster dose of the Pfizer shot for adolescents twelve through fifteen years of age.54 Pfizer trumpeted the merits of a booster dose in five- to eleven-year-olds based on a study of only one hundred forty children—an unpublished study at that, not evaluated by independent experts. Pfizer also intends to seek emergency authorization for a kids’ booster dose from the European Medicines Agency and regulatory agencies in other countries, agencies that typically follow FDA’s lead.
In addition, Pfizer is pressuring FDA to authorize injection of children ages six months through five years, notwithstanding clinical trials that flopped—twice—in this age group.22 Even worse, the eighteen million children under five who could be affected by this decision would likely be told to receive three doses of BNT162b2 because “two shots didn’t prove quite strong enough.”55 FDA could approve Pfizer’s injections for the nation’s youngest as soon as early June, 2022. Moderna, too, is seeking FDA authorization to give its mRNA shots to children age six and under.
CDC’s own data show that the five-and-under age group accounts for less than 0.1 percent of Covid deaths and just 3 percent of alleged “cases.”56 As Nass has stated, around the world, “practically no children under the age of 5 have died from COVID”; as an example, she points to data from the UK and Wales showing that only one comorbidity-free child had died from Covid in the entire two years. A study from Johns Hopkins University that monitored forty-eight thousand Covid-diagnosed children under eighteen likewise found zero deaths in children free of comorbidities.57
On the other hand, as of April 29, 2022, U.S. submissions to the Vaccine Adverse Event Reporting System (VAERS) included over ten thousand adverse events in five- to eleven-year-olds, including five deaths, and another thirty-one thousand adverse events in adolescents twelve to seventeen years of age, including forty-four deaths.58 By that date, total adverse events reported just in the U.S. to VAERS amounted to over eight hundred thirteen thousand across all age groups, including nearly thirteen thousand deaths.
CRIMINAL NEGLIGENCE?
The Pfizer documents thus far released by FDA beg the question: how did Pfizer get FDA’s permission to unleash the company’s experimental biologic on the American public, when the documents in FDA’s possession revealed flawed clinical trial methods, distorted efficacy reporting, glaring safety concerns and more? FDA surely knew that the trials had failed and that the injections were neither safe nor effective. Furthermore, why did other health systems and regulatory agencies around the globe follow suit? Did these other agencies forgo their own due diligence and rubber-stamp the injections simply because FDA did so? As Lawyers For Justice, a group of attorneys and associated professionals committed to achieving justice and equality for the Irish people, has pointed out, “If so the granting of authorisations by each of these health systems and entities have [sic] been criminally negligent.”8
The simple truth is that Pfizer executives and scientists must have known their injections would result in a wave of morbidity and mortality. They must have been fully aware of the dangers associated with their mRNA injections—and they did not care. There is little doubt they also knew, well before applying for the first EUA, that their injections could not meet their claims of being “effective.” Pfizer’s CEO Albert Bourla, acting FDA commissioner Janet Woodcock, Fauci, Walensky and many more members of the Covid criminal sect appear to have lied to the American public from day one.
The White House, for its part, allocated over one billion dollars to the corporate media to tell the public to get “vaccinated” with a dangerous and experimental product, ignoring what the risk-benefit analysis in Pfizer’s own documents had revealed.66 Adverse events and deaths from the injections are now widespread and irrefutable, yet somehow, the crimes against humanity persist. Outside the U.S., similar lies have led to people in Shanghai being locked and fenced into their homes and left, in some cases, to starve to death.59 Every Covid criminal the world over should be placed under oath and made to testify. These villains suppressed vital information from the public, making informed consent impossible. For that alone, they deserve to be jailed.
Presumably, the most controversial Pfizer documents will not emerge until toward the end of the court-ordered discovery period. In the meantime, experts will continue to sift through thousands of pages each month. In the end, perhaps those responsible for the heinous crimes committed will be convicted. In the meantime, we must do what we can to “red pill” everyone we know and love. Share the Pfizer documents that are publicly available far and wide; they are easily accessed at Naomi Wolf’s website, Daily Clout, where qualified individuals can go a step further and sign up to volunteer to help analyze Pfizer’s documents.60 Together we can act, expose the truth and help save lives.
SIDEBARS
PFIZER’S “ADVERSE EVENTS OF SPECIAL INTEREST”
Nine of the thirty-eight pages of the Pfizer report on post-authorization adverse event case reports through February, 2021 are devoted to an appendix listing one thousand two hundred ninety-one “adverse events of special interest” (AESIs)—“events of interest due to their association with severe COVID-19 and events of interest for vaccines in general.”9 The company noted that the AESI list “can be changed as appropriate based on the evolving safety profile of the vaccine.”
Grouping the forty-two-thousand-plus case reports received into various AESI categories, Pfizer reported its intent to evaluate the following:
- Anaphylactic reactions
- Cardiovascular events
- Covid-19-related events
- Dermatological (skin) reactions
- Facial paralysis
- Hematological (blood) disorders
- Hepatic (liver) disorders
- Immune-mediated/autoimmune disorders
- Musculoskeletal disorders
- Neurological disorders
- “Other” (e.g., multiple organ dysfunction)
- Pregnancy-related events
- Renal (kidney) dysfunction or failure
- Respiratory (e.g., pulmonary hemorrhage)
- Thromboembolic (blood clotting) events
- Stroke
- Vasculitic events (blood vessel inflammation)
SHODDY MANUFACTURING AT McPHERSON PLANT
According to Naomi Wolf, a contracting letter from FDA shows that the ingredients for Pfizer’s injections were manufactured in Belgium and Germany before being shipped for packaging and distribution at two U.S. facilities, including a plant in McPherson, Kansas.61 For nearly a decade prior to the pandemic, FDA had criticized the McPherson plant (in detailed letters and reports) for quality control failures; in 2017, it characterized Pfizer’s process for manufacturing sterile injectable drugs at the facility as “out of control.”62 According to Wolf, FDA also accused Pfizer of “neglect[ing] to properly sample drugs for excess levels of certain toxins.”
In January 2020, FDA investigators again cited the McPherson plant for mold and bacterial contamination and for releasing drugs without quality inspections.63 A journalist who followed up on the matter in March 2021 stated, “It is unclear whether FDA investigators have returned to check on production practices in McPherson or plan to visit before vaccine production begins,” also noting that FDA did not respond to journalistic inquiries and quoting an FDA compliance expert’s remarks that any “fixes” implemented were likely to be “little but ‘window dressing.’”63
As of September 2020, Pfizer’s German partner BioNTech had received the equivalent of four hundred forty-five million dollars from the German government to speed up work on the Covid injections and expand production in Germany.64 In addition to its partnership with Pfizer, BioNTech also collaborated with China’s Shanghai Fosun Pharmaceutical Group to develop the injections. The book China Rx, published in 2018, described extensive “lapses in safety standards and quality control in Chinese manufacturing” and “concerns of FDA officials and insiders within the pharmaceutical industry” about illnesses and deaths caused by contaminated medications.65 Wolf suggests that China’s participation in the development of Covid injections lacking proper quality controls and manufactured with iffy ingredients (lipid nanoparticles, synthetic mRNA and other undisclosed ingredients) should more than raise an eyebrow.
REFERENCES
- DeMarche E. FDA ordered to speed up release of approval data for COVID-19 vaccine. Fox News, Jan. 7, 2022.
- Mercola J. Newly released Pfizer documents reveal COVID jab dangers. Mar. 23, 2022. https://sustainablefreedomlab.org/2022/03/23/newly-released-pfizer-documents-reveal-covid-jab-dangers/
- https://phmpt.org/wp-content/uploads/2021/10/IR0546-FDA-Pfizer-Approval-FINAL.pdf
- Elijah S. FDA’s forced hand drops Pfizer’s bombshell safety document. TrialSiteNews, Dec. 14, 2021.
- Siri A. Why a judge ordered FDA to release Covid-19 vaccine data pronto. Bloomberg Law, Jan. 18, 2022.
- Greene J. We’ll all be dead before FDA releases full COVID vaccine record, plaintiffs, say. Reuters, Dec. 14, 2021.
- Public Health and Medical Professionals for Transparency v. Food and Drug Administration. Civil Action No. 4:21-cv-01058-P. https://fingfx.thomsonreuters.com/gfx/legaldocs/gdvzymjqrpw/FDA%20FOIA%20plaintiff%20brief. pdf
- Lawyers for Justice. Release of Pfizer documents. Mar. 20, 2022. https://lawyersforjusticeireland.wordpress.com/2022/03/20/release-of-pfizer-documents/
- Pfizer. 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports of PF-07302048 (BNT162B2) Received Through 28-Feb-2021. https://phmpt.org/wp-content/uploads/2021/11/5.3.6-postmarketing-experience.pdf
- Crawford M. Leaked Pfizer post-marketing safety report. Rounding the Earth Newsletter [Substack], Dec. 2, 2021.
- https://www.fda.gov/media/153716/download
- Skidmore M. How many people died from the Covid-19 inoculations? An estimate based on a survey of the United States population. Working paper. Lighthouse Economics, Feb. 15, 2022. https://mark-skidmore.com/2022/02/15/how-many-people-died-from-the-covid-19-inoculations/
- Giannotti J. Pfizer documents part one: the Wolf team’s findings so far. Daily Clout, May 5, 2022.
- Pfizer’s cases gone missing and cherry-picked subjects: data shows 71% of people tested were women. Red Voice Media, Apr. 23, 2022. https://www.redvoicemedia.com/video/2022/04/pfizers-cases-gone-missing-and-cherry-picked-subjects-data-shows-71-of-people-tested-were-women
- Goldberg P. Mace Rothenberg steps down as Pfizer CMO, replaced by Stanford’s Aida Habtezion. The Cancer Letter, Jan. 8, 2021.
- Dr. Mace Rothenberg on the development of the Pfizer vaccine. C-SPAN Washington Journal, Apr. 12. 2021. https://www.c-span.org/video/?510698-5/washington-journal-mace-rothenberg-discusses-development-pfizer-vaccine&event=510698&playEvent
- https://clinicaltrials.gov/ct2/show/NCT04368728
- Nass M. Pfizer, FDA documents contradict official COVID vaccine safety narrative—is this fraud? The Defender, Mar. 15, 2022.
- COVID-19 vaccines while pregnant or breastfeeding. Centers for Disease Control and Prevention (updated Mar. 3, 2022). https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/pregnancy.html
- Lipkind HS, Vazquez-Benitez G, DeSilva M, et al. Receipt of COVID-19 vaccine during pregnancy and preterm or small-for-gestational-age at birth—eight integrated health care organizations, United States, December 15, 2020–July 22, 2021. MMWR Morb Mortal Wkly Rep. 2022;71(1):26-30.
- COVID-19 vaccines and pregnancy: conversation guide. ACOG, n.d. https://www.acog.org/covid-19/covid-19-vaccines-and-pregnancy-conversation-guide-for-clinicians
- Rogers T. Urgent call to action! We have 15 days to convince the FDA to reject the Pfizer mRNA shot in kids under 5. Let’s go!!!!! uTobian [Substack], Mar. 15, 2022.
- A Tissue Distribution Study of a [3H]-Labelled Lipid Nanoparticle-mRNA Formulation Containing ALC-0315 and ALC-0159 Following Intramuscular Administration in Wistar Han Rats: Final Report. Test Facility Study No. 185350, Sponsor Reference No. ALC-NC-0552. Vancouver, BC: Acuitas Therapeutics Inc. https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M4_4223_185350.pdf
- Aldosari BN, Alfagih IM, Almurshedi AS. Lipid nanoparticles as delivery systems for RNA-based vaccines. Pharmaceutics. 2021;13(2):206.
- Judicial Watch. What Pfizer, J&J COVID vaccine animal trials reveal about shots’ potential impact on major organs. The Defender, May 2, 2022.
- Module 2.4 Nonclinical Overview. BNT162b2. https://www.judicialwatch.org/documents/jw-v-hhs-fda-pfizer-biontech-vaccine-prod-3-02418-pgs-3-36/
- Thacker PD. Covid-19: researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial. BMJ. 2021;375:n2635.
- Forseti R. Pfizer whistleblower Brook Jackson sues Pfizer for $2 billion over falsified mRNA data submitted to obtain FDA authorization for COVID-19 “vaccines.” ragnar_forseti’s newsletter [Substack], Feb. 19, 2022.
- Stieber Z. Fifth COVID-19 vaccine shot may be needed in fall: FDA official. The Epoch Times, Mar. 29, 2022.
- Nass M. COVID vaccines don’t prevent transmission, severe illness or deaths, data show. The Defender, Apr. 4, 2022.
- Amanuensis. Vaccine effectiveness hits as low as minus 300%—as UKHSA announces it will no longer publish the data. The Daily Skeptic, Mar. 20, 2022.
- Whilst you’ve been distracted by Russia’s invasion, the UK gov. released a report confirming the fully vaccinated now account for 9 in every 10 Covid-19 deaths in England. The Exposé, Mar. 1, 2022.
- Mercola J. Mortality rates are on the rise. Are COVID vaccines to blame? The Defender, May 6, 2022.
- Mercola J. Hospitals no longer required to report COVID deaths, HHS says. The Defender, Mar. 11, 2022.
- https://healthdata.gov/stories/s/COVID-19-Reporting-and-FAQS/kjst-g9cm/
- Redshaw M. CDC removes tens of thousands of deaths “accidentally” attributed to COVID. The Defender, Mar. 21, 2022. 37.
- https://www.fda.gov/media/151733/download
- Rosenberg D. FDA report finds all-cause mortality higher among vaccinated. Israel National News, Nov. 17, 2021.
- Children’s Health Defense. Diamond mine of data? Insurance companies report 40% increase in premature non-COVID deaths. The Defender, Jan. 5, 2022.
- Mercola J. U.K. data shows 9 in 10 Covid-19 deaths are among the fully vaccinated, but U.S. data is vastly different; is the CDC lying to the public? The Exposé, Mar. 16, 2022.
- Rogers T. All-cause mortality skyrockets in 2021. uTobian [Substack], Nov. 12, 2021.
- Shilhavy B. Life insurance companies suffered while the funeral industry prospered in 2021 after COVID vaccines were rolled out. Vaccine Impact News, Feb. 4, 2022.
- Kirsch S. Bhakdi/Burkhardt pathology results show 93% of people who died after being vaccinated were killed by the vaccine. Steve Kirsch’s newsletter [Substack], Dec. 28, 2021.
- Chudov I. DNA transcribed from Pfizer mRNA vaccine contains MUTANT gp130 tumor gene. Igor’s Newsletter [Substack], Feb. 27, 2022.
- Lee M. No documents to support CDC’s claims that COVID-19 vaccines do not integrate into DNA: advocacy group. [your]NEWS, Apr. 19, 2022.
- Alden M, Falla FO, Yang D, et al. Intracellular reverse transcription of Pfizer BioNTech COVID-19 mRNA vaccine BNT162b2 in vitro in human liver cell line. Curr Issues Mol Biol. 2022;44(3):1115-1126.
- Chudov I. Worst fears realized: Pfizer mRNA transcribes into DNA. Igor’s Newsletter [Substack], Feb. 25, 2022.
- Redshaw M. Heart damage found in teens months after second Pfizer shot, study shows. The Defender, Mar. 29, 2022.
- Mercola J. Unintended consequences of mRNA vaccines against COVID-19. The Epoch Times, Mar. 3, 2022.
- Mariette C, Lavaud J, Descamps V. Stress induced by messenger ribonucleic acid (RNA) vaccination may reveal acute adrenal insufficiency. Endocrine. 2022;75(2):659-660.
- Tenpenny S. 20 mechanisms of injuries (MOI): how COVID-19 injections can make you sick; even kill you. DrTenpenny.com, 2021. https://amigraineurslife.files.wordpress.com/2021/05/dr.-tenpenny-20-moi-list.pdf
- Redshaw M. Pfizer to ask FDA to allow 3rd COVID shot for healthy 5- to 11-year-olds, based on study of 140 kids. The Defender, Apr. 14, 2022.
- Redshaw M. FDA authorizes Pfizer booster for kids 5 to 11, bypasses advisory panel. The Defender, May 17, 2022.
- Redshaw M. Reports of COVID vaccine injuries pass 1 million mark, FDA signs off on Pfizer booster for kids 12 and up. The Defender, Jan. 3, 2022.
- Pfizer hopes to submit little-kid vaccine data by early June. Associated Press, May 3, 2022.
- Children’s Health Defense. FDA weighing Moderna vax for kids 6 and under, but experts say trials inadequate. The Defender, Apr. 1, 2022.
- Risk Factors for COVID-19 Mortality among Privately Insured Patients: A Claims Data Analysis. A FAIR Health White Paper in collaboration with the West Health Institute and Marty Makary, MD, MPH, from Johns Hopkins School of Medicine, Nov. 11, 2020.
- Redshaw M. More than 8,000 new COVID vaccine injuries reported to VAERS, CDC data show. The Defender, May 6, 2022.
- Shilhavy B. Destruction of food begins in Shanghai with fences installed to keep people locked down. Vaccine Impact News, Apr. 24, 2022.
- https://campaigns.dailyclout.io/invitation?type=brand&code=&brand=cc3b3e5a-6536-4738-8ed6-5ee368c67240
- The Pfizer investigation: COVID vaccine lacked proper quality controls. Bannons War Room, Apr. 23, 2022. https://rumble.com/v122tg3-the-pfizer-investigation-covid-vaccine-lacked-proper-quality-controls.html
- FDA warns Pfizer over contaminated drugs at Kansas plant. Reuters, Feb. 28, 2017.
- Tribble SJ. Pfizer’s newest vaccine plant has persistent mold issues, history of recalls. Kaiser Health News, Mar. 10, 2021.
- BioNTech wins $445 million German grant for COVID-19 vaccine. Reuters, Sep. 15, 2020.
- https://www.chinarxbook.com/china-rx
- https://www.businessinsider.com/white-house-launch-1-billion-ad-blitz-covid-vaccines-report-2021-3?op=1
This article appeared in Wise Traditions in Food, Farming and the Healing Arts, the quarterly journal of the Weston A. Price Foundation, Summer 2022
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