Researcher reveals Pfizer violated coronavirus trial protocol to obtain FDA emergency use authorization for children
By zoeysky // 2021-07-16
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Across the globe, Big Pharma and various governments have teamed up to accelerate the process for mandatory coronavirus (COVID-19) vaccination, despite data that shows the many negative side effects linked to different vaccines. One Israeli researcher and professor has recently revealed that Pfizer used questionable tactics to obtain the Food and Drug Administration's (FDA) authorization for Emergency Use Authorization (EUA) for children as young as 12.

Pfizer risking the health of young children for profit

Regardless of the many risks associated with coronavirus vaccines, mandatory vaccination programs are often quickly rolled out in many countries, As of writing, millions of doses of experimental vaccines have been administered while researchers have yet to determine the full extent of vaccine-related health risks to people of various ages. Even 12-year-old children are now allowed to get vaccinated because of Pfizer’s efforts to earn EUA for the age group. But Dr. Yaffa Shir-Raz, a researcher from Israel, warned that Pfizer violated its own protocol to ensure that its vaccine can be administered to young children. On June 8, Shir-Raz, a researcher and fellow at the University of Haifa and Interdisciplinary Center Herzliya in Israel, wrote an article detailing how Pfizer violated the company's own protocols. The article was published on America’s Frontline Doctors' website. In the article, Shir-Raz explained that Pfizer allowed children with pre-existing psychiatric conditions to be enrolled in the trial despite the fact that this was listed as exclusion criteria in the company's documentation. According to the review document Pfizer submitted to the FDA, four of the 1,131 children in the study given the Pfizer-BioNTech coronavirus vaccine experienced serious adverse events (SAEs) or events wherein "at least one criterion was met: caused death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, or congenital anomaly/birth defect." Because of Pfizer's decision, three children (out of 1,131) ended up requiring hospitalization for severe depression within one to 15 days of inoculation:
  • One child in the first seven days after the first dose
  • Another child in the second only one day after the second dose
  • And the last child in the third 15 days after the first dose
Pfizer admitted that all three children had pre-existing anxiety or depression. Additionally, the children started using a selective serotonin reuptake inhibitor (SSRI) one to two months before the study began. But instead of taking the blame, Pfizer claimed that the new SSRI was linked to depression among the young participants. But according to Shir-Raz says, "worsening suicidal ideation that would necessitate hospitalization typically occurs within two weeks and not more than a month after starting SSRIs." This suggests that Pfizer’s claim that the SSRIs are at fault instead of the vaccine is "doubtful." (Related: Pfizer pushes ahead with plans to push coronavirus vaccines on younger children, including toddlers and infants.) Pfizer also violated its own protocol by including these children in the trial. Shir-Raz warned that the consequence of the finding is "extremely worrying" since it suggests at one in every 350-400 children who are vaccinated could develop severe depression and require hospitalization.

Pfizer and Big Pharma must be held accountable for these manipulative tactics

But that's not all. Shir-Raz added that Pfizer used other questionable tactics for the trial.
  1. The trial only had a six-month follow-up in its entirety, which is less than the recommended one to four years of follow-up required by the FDA.
  2. Because of how the protocol was designed, Pfizer only needed to report serious adverse events occurring within the first month after inoculation to the FDA. This means adverse events occurring later wouldn't be considered in the FDA’s safety analysis and that Pfizer's findings would seem more positive than they actually are.
  3. Pfizer investigators were allowed to define the adverse events for themselves ("As elicited by investigative site staff") instead of relying on any diagnosis from medical professionals at a hospital.
Like other pharmaceutical companies only interested in profit, Pfizer has already paid billions in settlements for medical injuries and other matters.  In fact, Pfizer is known to have paid the largest fine ever ($2.3 billion) for a fraud lawsuit filed by the Department of Justice over illegal marketing claims. Shir-Raz also advised that the blame isn't solely on Pfizer. After all, the FDA allowed Pfizer to include only one month of data for its safety analysis. The public deserves to know why the FDA quickly approved the EUA for children. Finally, why did the FDA, which receives at least 45 percent of its funding from the drug companies that it regulates, approve the study protocol despite the potential dangers associated with coronavirus vaccines? Visit Vaccines.news to read more articles about how Big Pharma violates protocols and causes harm for profit. Sources include: NaturalHealth365.com AmericasFrontlineDoctors.org
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