While the Public Was Distracted by “Cover Stories” a Court Ordered Release of FDA Docs Revealed that Pfizer's COVID Shot Caused 1,291 Different Adverse Events During Clinical Trials
From [CHD] and [HERE] and [HERE] An estimated 10,000-page set of documents released by the U.S. Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER), as ordered by U.S. District Judge Mark T. Pittman, allows the public to access data Pfizer submitted to FDA from its clinical trials in support of a COVID-19 vaccine license. Prior to Judge Pittman’s ruling, the FDA planned to suppress the data for the next 75 years which the agency claimed was necessary, in part, because of its “limited resources.”
A 38-page report included in the documents features an Appendix, “LIST OF ADVERSE EVENTS OF SPECIAL INTEREST,” that lists 1,291 different adverse events following vaccination. The list includes acute kidney injury, acute flaccid myelitis, anti-sperm antibody positive, brain stem embolism, brain stem thrombosis, cardiac arrest, cardiac failure, cardiac ventricular thrombosis, cardiogenic shock, central nervous system vasculitis, death neonatal, deep vein thrombosis, encephalitis brain stem, encephalitis hemorrhagic, frontal lobe epilepsy, foaming at mouth, epileptic psychosis, facial paralysis, fetal distress syndrome, gastrointestinal amyloidosis, generalized tonic-clonic seizure, Hashimoto’s encephalopathy, hepatic vascular thrombosis, herpes zoster reactivation, immune-mediated hepatitis, interstitial lung disease, jugular vein embolism, juvenile myoclonic epilepsy, liver injury, low birth weight, multisystem inflammatory syndrome in children, myocarditis, neonatal seizure, pancreatitis, pneumonia, stillbirth, tachycardia, temporal lobe epilepsy, testicular autoimmunity, thrombotic cerebral infarction, Type 1 diabetes mellitus, venous thrombosis neonatal, and vertebral artery thrombosis among 1,246 other medical conditions following vaccination.
“At least now we know why the FDA and Pfizer wanted to keep this data under wraps for 75 years,” said Children’s Health Defense (CHD) president and general counsel Mary Holland. “The clinical trial data released so far should put an immediate end to the Pfizer COVID vaccines. The potential for serious harm is very clear, and those injured by the vaccines are prohibited from suing Pfizer for damages.”
Pfizer hired about 600 additional full-time employees to process adverse event reports during the three months following theEmergency Use Authorization (EUA) of its COVID-19 vaccine, newly released documents reveal.
According to the documents, Pfizer said, "More are joining each month with an expected total of more than 1,800 additional resources by the end of June 2021."
The information was contained in a 10,000-page document cache released April 1 by the U.S. Food and Drug Administration (FDA) and made public as part of a court-ordered disclosure schedule stemming from an expedited Freedom of Information Act (FOIA) request.
The latest revelations appeared in a document, "Cumulative analysis of post-authorization adverse event reports" of the Pfizer-BioNTech vaccine, highlighting such adverse events identified through Feb. 28, 2021.
The document was previously released in November 2021, but was partially redacted. The redactions included the number of employees Pfizer hired and/or was planning to hire.
According to the unredacted document released April 1:
"Pfizer has also taken a multiple actions [sic] to help alleviate the large increase of adverse event reports. This includes significant technology enhancements, and process and workflow solutions, as well as increasing the number of data entry and case processing colleagues.
"To date, Pfizer has onboarded approximately 600 additional full-time employees (FTEs).
"More are joining each month with an expected total of more than 1,800 additional resources by the end of June 2021."
The unredacted version also revealed the number of Pfizer-BioNTech vaccine doses shipped worldwide between December 2020 and February 2021:
"It is estimated that approximately 126,212,580 doses of BNT162b2 [the Pfizer EUA vaccine] were shipped worldwide from the receipt of the first temporary authorisation for emergency supply on 01 December 2020 through 28 February 2021."
The number of shipped doses previously was redacted.
Remarking upon this newly revealed information, Brian Hooker, chief scientific officer of Children's Health Defense, told The Defender:
"The rollout of the Pfizer vaccine has led to an unprecedented number of adverse events reported — 158,000 adverse events in the first two-plus months of the rollout means that the rate of reported AE [adverse events] was approximately 1:1000, with many of the AEs graded as serious. This is based on a denominator of 125,000,000 vaccines distributed.
"It is no wonder that an army of 1,800 individuals was needed to process all of the information."
Hooker noted the total number (1,205,755) of COVID vaccine adverse events reported to the Vaccine Adverse Event Reporting System between Dec. 14, 2020 and March 25, 2022, now eclipses the total number (930,952) of adverse events reported in the 32-year history of the database.
Dr. Madhava Setty, a board-certified anesthesiologist and senior science editor for The Defender, previously reported on the same Pfizer document, before the unredacted version was released.
"In that piece, I alluded to Pfizer's admission that they needed more staff to process all of the adverse events being reported to them," Setty said.
"It seems this document has now been updated. 600 FTEs [full-time employees]! ... I wonder how many extra people the CDC [U.S. Centers for Disease Control and Protection] has hired? Given how they are operating, I would say zero."
Pfizer downplayed adverse reactions in request for full FDA license
The April 1 document release also included "request for priority review" — the documentation Pfizer in May 2021 submitted to the FDA for full licensure of its Comirnaty COVID vaccine.
In this document, Pfizer described its vaccine as fulfilling an "unmet medical need," claiming:
"Mass immunization with a safe and effective vaccine against COVID-19 can dramatically alter the trajectory of the pandemic.
"According to policy briefing by the Institute for Health Metrics and Evaluation published on 31 March 2021, COVID-19 remains a leading cause of death in the US with up to 100,000 additional deaths projected in the US between March and July 2021, many of which can likely be prevented with COVID-19 vaccination."
Comment: No, COVID-19 was not a "leading cause of death" at any point. The official death toll from COVID-19 was massively inflated in most Western countries:
COVID-19 death toll will be 'much lower' than projected, top officials say
Johns Hopkins University Reveals Manipulated Covid Death Figures
'The numbers are skewed': Colorado officials warn of inflated COVID death statistics
And now that the COVID-19 fear-campaign has almost run its course... we are seeing governments and health agencies backtrack on their "official" numbers:
California county cuts death toll after finding fatalities 'clearly not' caused by COVID-19
Oops? UK to reduce Covid deaths by 10% because of 'counting errors'
CDC removes 24 percent of child COVID-19 deaths, thousands of others
Pfizer expressed "concerns" about lifting COVID-related measures, such as lockdowns, on the basis that the lifting of such restrictions would "counteract the impacts of this vaccination effort."
The documentstates:
"Vaccination against COVID-19 began with EUA/conditional approvals in December 2020, in a phased rollout defined by national/regional guidance.
However, there continue to be concerning trends that may counteract the impacts of this vaccination effort, including: [L]imitations in access to obtaining a vaccine due to infrastructure challenges (ie, clinic and appointment capacity and systems)[I]ncreasing viral transmission fueled by relaxed compliance with mitigations as the pandemic surpasses the 1-year mark (ie, masks, physical distancing, limiting travel)[I]ncreasing circulation of emerging variants of concern (which are currently driving continued spread of viral infection in Europe despite extensive mitigation mandates)."
Pfizerjustifiedits request for full licensure of its COVID vaccine on the following basis:
"A vaccine program must be implemented expediently and rapidly expanded to have a significant impact on the pandemic course.
"Licensure of BNT162b2 is likely to enhance vaccine uptake by facilitating supply of vaccine from Pfizer/BioNTech directly to pharmacies and healthcare providers/facilities.
"The greatest impact of BNT162b2 licensure may be direct supply to healthcare providers who serve vulnerable populations such as elderly patients and those who live in rural and underserved communities (ie, individuals who might be unable to navigate the challenges of securing vaccine access using the systems in place for EUA).
"Expansion of vaccine via licensure would ultimately improve the prospect of achieving population herd immunity to bring the pandemic under control."
Comment: It is in Pfizer's interest to maintain the facade that COVID-19 poses an on-going threat to public health. After all, the only thing they care about is selling more vaccines.
The same document glossed over the adverse effects for which the company previously admitted it hired a significant number of new employees to process, claiming:
"Based on Phase 1 data from the FIH Study BNT162-01, BNT162b1 and BNT162b2 [various vaccines tested during the trial period] were safe and well-tolerated in healthy adults 18 to 55 years of age, with no unanticipated safety findings.
"Phase 2/3 safety data were generally concordant with safety data in Phase 1 of the study, both overall and with regard to younger and older participants."
This is despite hard figures regarding adverse reactions provided later in the document:
"Through 28 February 2021 (data lock point aligned with Pharmacovigilance Plan), there were a total of 42,086 case reports (25,379 medically confirmed and 16,707 non-medically confirmed) containing 158,893 events. Cases were received from 63 countries.
"Consistent with what was seen in Phase 2/3 of Study C4591001, most reported AEs were in System Organ Classes (SOCs) with reactogenicity events: general disorders and administration site conditions (51,335), nervous system disorders (25,957), musculoskeletal and connective tissue disorders (17,283), and gastrointestinal disorders (14,096).
"Post-authorization data have also informed the addition of adverse drug reactions (ADRs) related to the experience of reactogenicity to the product labeling." [MORE]
The U.S. government has already purchased 50 million doses of the Pfizer vaccine intended for children under five years of age to be delivered by April 30, 2022 although the FDA has yet to grant an Emergency Use Authorization (EUA) for this age group. The risk of serious injury or death from COVID to healthy children is practically nil and so far, the vaccine is not effectivewhen used in young children.
“It would be criminal to expose infants and young children to this extremely risky product,” said Holland. “VAERS data show the catastrophic health impacts the vaccine is having on millions of people, yet Pfizer and other vaccine makers are raking in billions of dollars with no fear of being held accountable for injuries and deaths from their vaccines.”
The FDA’s attempt to suppress these data in support of the pharmaceutical industry’s bottom line isn’t a new phenomenon in this country’s public health system. For more information on pharmaceutical corruption and the tight relationship the industry has with government regulatory agencies, read The Real Anthony Fauci: Bill Gates, Big Pharma and the Global War on Democracy and Public Health by CHD Chair and lead counsel Robert F. Kennedy, Jr.