Hulscher notes that "the proper conditions for market withdrawal have been met" and he lists the main points:
Regulatory Classification and Guidelines:
COVID-19 modRNA vaccines were misclassified as traditional vaccines rather than gene therapy products, bypassing stricter regulatory requirements.
WHO guidelines from 2005 were used for nonclinical assessments, despite being outdated and inapplicable to modRNA vaccines.
Spike Protein and Safety Concerns:
The spike protein produced by modRNA vaccines is toxic and can cause immune-related complications.
Studies on pharmacokinetics (how much spike protein is produced, where it distributes, and how long it persists) were not conducted as part of Pfizer's submission.
Spike protein production varies among individuals based on genetics, health status, and other factors, but this variability was never studied.
Biodistribution and LNP Behavior:
Pfizer's own biodistribution data showed lipid nanoparticles (LNPs) and modRNA were widely distributed throughout the body, including the liver, spleen, ovaries, and adrenal glands.
Contrary to claims, spike protein production was not limited to the injection site, raising concerns about off-target effects and toxicity.
Toxicology and Carcinogenicity Testing:
Pfizer did not conduct genotoxicity or carcinogenicity studies, despite the potential for the spike protein and LNPs to cause harm.
Wistar Han rats, which are not a relevant species for SARS-CoV-2 toxicity studies, were used inappropriately in preclinical testing.
Deficient Clinical Trials:
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