
Ten red flags in the FDA’s risk-benefit analysis of Pfizer’s EUA application to inject American children 5 to 11 with its mRNA product
🚩 COVID-19 rates in children ages 5 to 11 are so low that there were ZERO cases of severe COVID-19 and ZERO cases of death from COVID in either the treatment (n= 1,518) or control group (n= 750). So any claims you see in the press about the Pfizer vaccine being “90% effective” in children are meaningless because they are referring to mild cases from which children usually recover quickly (and then have robust broad spectrum immunity). So there is literally no emergency in this population for which one could apply for Emergency Use Authorization. Pfizer’s application should be dead on arrival if the FDA actually followed the science and their own rules. We will return to this topic below.
🚩 Pfizer’s clinical trial in kids was intentionally undersized to hide harms. This is a well known trick of the pharmaceutical industry. The FDA even called them out on it earlier this summer and asked Pfizer to expand the trial and Pfizer just ignored them because they can. (Pfizer fudged it by importing data from a different study but this other study only monitored adverse outcomes for 17 days so if anything the new data polluted rather than clarified outcomes). To put it simply, if the rate of particular adverse outcome in kids as a result of this shot is 1 in 5,000 and the trial only enrolls 1,518 in the treatment group then one is unlikely to spot this particular harm in the clinical trial. Voilà “Safe & Effective(TM)”.
🚩 Pfizer only enrolled “participants 5-11 years of age without evidence of prior SARS-CoV-2 infection.” Does the Pfizer mRNA shot wipe out natural immunity and leave one worse-off than doing nothing as shown in this data from the British government? Pfizer has no idea because children with prior SARS-CoV-2 infection were excluded from this trial. This was by design. Toxic polluters have learned to not ask questions that they do not want the answers to, lest they wind up staring at their own smoking gun in a future court case.
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