‘The studies provided by Pfizer/BioNTech to the FDA and other regulatory authorities were fundamentally flawed and insufficient to prove safety and efficacy. Pfizer/BioNTech failed to determine the concentrations and structure of the encoded spike protein in their nonclinical and clinical studies. Such studies are fundamental to determine the pharmacology, pharmacodynamics and pharmacokinetics of a “pro-drug” as represented by the Pfizer/ BioNTech vaccines. Pfizer/BioNTech did perform a biodistribution study using a surrogate mRNA coding for luciferase instead of the spike protein.
The study demonstrated that the LNPs were distributed to a variety of different tissues including the liver, spleen, adrenals, reproductive organs, and the brain. The assumption that the modRNA vaccine would reside at the injection site, i.e., the deltoid muscle, was known to be false. Pfizer/BioNTech’s own data showed the spike protein would also be expressed in these distal tissues. This data helps to explain the extent and variety of serious adverse effects to the modRNA vaccine observed in humans.’
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Author: Dr. Paul Alexander
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