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Pfizer Requested Waiver From FDA’s Safety Monitoring

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, 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 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.”


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