Pfizer/BioNTech’s COVID-19 modRNA Vaccines: Dangerous Genetic Mechanism of Action Released before Sufficient Preclinical Testing

"Introduction: Independent scientists and medical doctors jointly with the Public Health and Medical Professionals for Transparency filed a Freedom of Information Act (FOIA) request for data and reports
reviewed by the U.S. Food and Drug Administration (FDA) to license Pfizer/BioNTech’s COVID-19 modified mRNA (modRNA) vaccine (BNT162b2). This resulted in a court order to release a trove of documents that Pfizer/BioNTech submitted to the FDA for regulatory approval to be released in 8 months rather than 75 years. Pfizer/BioNTech’s regulatory submission must be reviewed independently to determine whether the COVID-19 modRNA vaccines were established as safe and effective products, as the public is led to believe by mainstream media and governmental authorities. This commentary provides a brief overview of the safety and efficacy of the Pfizer/BioNTech COVID-19 modRNA vaccines...

Discussion: 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 ... 

Given that the spike protein was known to be toxic, using Pfizer/BioNTech’s own data, the claim that the modRNA vaccine is safe is dubious. Additionally, the modRNA vaccine’s short-term safety, genotoxicity, carcinogenicity or excretion characteristics were not ascertained since vaccine regulatory guidance’s did not require it, and the long-term adverse effects such as cancer, neurological, or autoimmune diseases have yet to be determined. Finally, Pfizer/BioNTech could not adequately establish the short-term or long-term safety of the modRNA vaccines. The rolling review process used by regulatory authorities worldwide, including the FDA, the European Medical Agency, and Health Canada, revealed issues of concern, which were either ignored or downgraded in the published assessments of the COVID-19 vaccines, raising questions of effectiveness, veracity, and reliability of our regulatory agencies.

Conclusion: For any other medicinal product, the regulatory submission would have been considered incomplete and most probably rejected. Therefore, a moratorium on the use of Pfizer/BioNTech COVID-19 vaccines and boosters should be enacted at minimum, but ideally, they should be removed from the market and their use in humans should be stopped. It should be the responsibility of the pharmaceutical industry, not independent scientists, to determine whether a medical intervention is safe. Based upon Pfizer/BioNTech’s data, safety of their COVID-19 modRNA vaccine has not been proven."