Did Pfizer Perform Adequate Safety Testing for its Covid-19 mRNA Vaccine in Preclinical Studies? Evidence of Scientific and Regulatory Fraud

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From [HERE]  

by Sasha Latypova

Abstract

The rushed “warp speed” development and approval of completely novel Covid-19 mRNA and DNA vaccines pushed on the people of the world has resulted until today in millions of reported injuries and thousands of deaths according to public health databases such as VAERS (US), EudraVigilance (EU), Yellow Card (UK) and others. This article reviews some of the publicly available documents on Pfizer’s non-clinical development program and points out its deficiencies, omissions and gaps, which were very obvious, yet were never questioned by the regulators or other health authorities. The cursory nature of the entire preclinical program can be summed up as “we did not find any safety signals because we did not look for them.” The omission of safety studies which are considered standard or even mandatory, and the scientific dishonesty in those studies which were performed are so obvious and glaring that they cannot be attributed to the incompetence of the manufacturers and regulators. Rather, the question of wilful negligence must be raised.

The focus of my review is the scope and adequacy of the program of non-clinical assessment for a novel gene therapy vaccine, combined with a brief discussion of the relevant regulatory frameworks. I did not dive deeply into the review of the results of specific studies. My goal is to illustrate the complete breakdown of the regular process of drug development and approval, previously known to be rigorous and ethical, as well as the shocking negligence on the part of the regulatory agencies which are supposed to keep the pharmaceutical manufacturers honest. In carrying out this review, I have made the following findings:

  1. Pfizer’s program did not include a comprehensive end-to-end test of all components of the final approved product (the mRNA COVID-19 vaccine). Instead, the studies included in the document package submitted to the FDA employed several variants and analogues of the product, whose comparability to the actual COVID-19 vaccine was not demonstrated or evaluated. Thus, no comprehensive assessment of product safety can be made on the basis of these studies.

  2. A key determinant of a drug’s toxicity is its distribution within the body. However, with the mRNA active ingredient of Pfizer’s COVID-19 vaccine, this crucial aspect was never studied!

  3. Pfizer claimed absence of potential for “vaccine-elicited disease enhancement” based on studies of an animal species that does not get sick from SARS-CoV-2.

  4. The CDC, the FDA and Pfizer all lied about “vaccine staying at the injection site”; they knew all along that distribution of the vaccine throughout the body had to be expected.

  5. Pfizer skipped major categories of safety testing altogether.

  6. Pfizer used dishonest and self-serving interpretation of regulatory guidelines to justify the shortcuts it took in routine safety testing.

  7. Both FDA and Pfizer knew about major toxicities associated with gene-therapy medicines in general, and they therefore cannot claim lack of anticipatory knowledge of these risks with the particular gene therapy medicine that is Pfizer’s COVID-19 vaccine. This points to intentional fraud and collusion between Pfizer and the regulators, who conspired to push this untested dangerous product on the market.

Overall, therefore, both the manufacturer and the regulators behaved in a highly dishonest manner and conspired to push an entirely novel technology and product on millions of people without carrying out a single well designed safety assessment.