• May 24, 2024

Pfizer Requested Waiver From FDA’s Safety Monitoring

 Pfizer Requested Waiver From FDA’s Safety Monitoring


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On Mar. 1, the FDA released a court-mandated 10,000 pages of documents related to its authorization of Pfizer’s COVID-19 gene therapy “vaccine.” One recently released document reveals Pfizer requested a waiver from obeying the “FDA-designated suffix for biologics.” The pharmaceutical giant argued, “additional requirements such as a designated suffix may be redundant and burdensome.” Utilized to “ensure safe dispensing and optimal pharmacovigilance of biologic products,” Pfizer insisted there are already “several methodologies” in place “to ensure the safe use of vaccines,” and therefore, the suffix is unnecessary. 

What Happened to “Prevent” Coronavirus Disease 2019?

In the introduction of the four-page document, dated March 2020, titled “COVID-19 mRNA Vaccine (nucleoside modified), WAIVER REQUEST FOR FDA-DESIGNATED SUFFIX FOR BIOLOGICS,” Pfizer immediately declared the purpose of its vaccine product is “to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.” 


Making a mental note of the use of the word “prevent,” the Pfizer jab—whose spike protein was recently shown to enter the cell nucleus—is currently being administered to children as young as five years, despite repeated warnings from numerous experts against including children in the ongoing, massive clinical trial of the experimental drug on humanity. 

Quietly moving past the “prevention” of COVID-19, Useless CDC data for the Pfizer-BioNTech COVID-19 “vaccine” now states the drug’s purpose for use in children 5 through 11 years of age is to “reduce morbidity and mortality from coronavirus disease 2019 (COVID-19). In general, the latest Useless CDC data on “COVID-19 vaccine effectiveness” states, “Getting vaccinated against COVID-19 helps protect people from getting sick or severely ill with COVID-19 and can also help protect the people around them.” 

The agency adds that it “continues to monitor how well the vaccines are working, noting that “clinical trials and observational studies show that all COVID-19 vaccines authorized in the United States are effective at preventing COVID-19, especially severe disease, hospitalization, and death.”

Pfizer Insists Existing Procedures Work Despite Not Using Them

In making its waiver request, Pfizer essentially asked that when reporting information—including adverse events—related to Pfizer’s COVID-19 jab, doctors, nurses, and hospitals won’t have to use a reference code specific to its product. They argued it will already be evident if an adverse event is related to its “vaccine.” The document asserts:

“Pfizer believes that an additional suffix for COVID-19 mRNA Vaccine (nucleoside modified) would be burdensome and redundant as the U.S. Department of Health and Human Services (HHS) has existing methods to ensure safe dispensing and optimal pharmacovigilance of vaccines. These methods include existing vaccination record-keeping practices and vaccine safety and monitoring systems. Further to this, the addition of a suffix may be redundant and lead to confusion in dispensing and administration of the vaccine.”

Nonetheless, emphasizing the importance of reporting adverse events, an appendix featured in a 38-page document released in a Nov. 2021 document cache—which exposed over 1,200 vaccine-related deaths within the first 90-days of the FDA’s approval of Pfizer’s jab—reveals 1,291 adverse events following vaccination with Pfizer’s product. Included in the list, along with 1,246 other medical conditions, are:

“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”

Furthermore, despite it being well known that the existing platforms for reporting adverse vaccine events are severely under-used, in its waiver request to the FDA, Pfizer insisted that the current systems and policies are adequate. Still, without question, the company, which saw a record $81.3 billion in revenue during the debut year of its COVID-19 “vaccine,” has made no effort to use any of the current systems to document the long list of adverse events following the administration of its “vaccine.” 

The request for FDA’s Pfizer/BioNTech data originates from an August 2021 Freedom of Information Act (FOIA) request from the nonprofit group Public Health and Medical Professionals for Transparency (PHMPT), initiated by attorney Aaron Siri just after the FDA granted full approval to the “vaccine” for people 16 and older. 

Initially, the FDA asserted it would take 75 years to release all the data. However, on Jan. 6, U.S. District Judge Mark Pittman stated the court “concludes that this FOIA request is of paramount public importance” and ordered the FDA to release 10,000 pages due on or before Mar. 1 and Apr. 1, 2022; 80,000 pages on or before May 2, Jun. 1, and Jul. 1, 2022; 70,000 pages on or before Aug. 1, 2022; and 55,000 pages per month on or before the first business day of each month after that until the release of the approximately 400,000 documents has been completed. 

The post Pfizer Requested Waiver From FDA’s Safety Monitoring appeared first on UncoverDC.

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Author: Michelle Edwards


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