The Pfizer company is acting as if they are 100% legit and approved for manufacturing and purchasing COVID jabs, especially for younger people and children, when in fact, what they did was manipulation with study data.
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According to The Daily Expose,
“Analysis and comparison of the review document submitted by Pfizer to the US Food and Drug Administration, on the basis of which the FDA gave the green light to expand the emergency permit for vaccination, as well, for children aged 12-15, as opposed to the study protocol in children, reveal concerning findings.
These include violations of the protocol established by Pfizer itself, and no less serious, designing the trial protocol in a way that will allow the company to present as positive findings as possible in terms of vaccine safety in children, and to include as little as possible serious side effects in the review submitted to the FDA.”
“According to the review document submitted by Pfizer to the FDA, four of the 1131 children in the study arm who received Pfizer-BioNTech COVID-19 Vaccine suffered from serious adverse events (“SAEs”) – that is, events in which at least one criterion was met: caused death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, a congenital anomaly/birth defect.
Of these four children, three had such severe depression, that they were hospitalized shortly after vaccination (in the first 7 days after the first dose, in the second only one day after the second dose, and in the third 15 days after the first dose, respectively).”
The consequence of this finding is extremely worrying, as it means that one in every 350-400 children who are vaccinated might suffer from severe depression and need hospitalization.
“Worsening suicidal ideas with initial SSRI treatment in adolescents”, they explain, “is a recognized risk and provides a reasonable alternative explanation for depression exacerbation in these BNT162b2 recipients”. So here you go – why blame the vaccine, when there is a perfectly reasonable and logical alternative explanation for the exacerbation of their depression?
There are two major problems with this certain explanation.
“1. The claim that the SSRIs the children received is an alternative explanation for the deterioration of the children’s mental state is doubtful. According to the scientific literature, exacerbation of suicide and mental state occurs right at the beginning of treatment with antidepressants, usually in the first two weeks, and certainly not more than a month after starting treatment – which is the time when you start to see improvement. In fact, the opposite is true: if there is no improvement within four weeks, a medication is usually replaced.
2. More importantly, according to the study protocol – participants with a previous psychiatric diagnosis should never have been included in the study in the first place (see page 41 in the protocol). It turns out that one of the exclusion criteria in the study is: “Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study“.
Furthermore, there were major violations even before…
“In the Pediatric Study Protocol (see table on page 12), Pfizer undertook that the duration of follow-up for serious adverse events (SAEs) would be “from Dose 1 to 6 months after the second dose”.
A six-month follow-up period is considered to be very short compared to the usual follow-up time in Phase 3 studies for vaccines. According to the FDA, Phase 3 in vaccine studies should last between one and four years.
Yet it turns out from Pfizer’s review document that the company did not complete even this relatively short follow-up period, and in fact was content with only 30 days of follow-up of the severe adverse events. This fact emerges from the chapter dealing with the date of analysis (page 30, under the heading of the SAEs chapter): “12-15-year-olds: SAEs from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 0.4% of BNT162b2 recipients and 0.1% of placebo recipients“.
This has been made possible because the protocol appears to be designed in such a way that the review submitted to the FDA will only include the serious adverse events that appeared during the first month after vaccination.
Despite all being said and proven, beyond the severe criticism towards Pfizer, the analysis and comparison raise serious questions for the FDA itself…
It’s all a huge lying bunch of proposters!