The rushed “warp speed” development and approval of completely novel Covid-19 mRNA and DNA vaccines pushed on millions of people has resulted today in millions of reported injuries and thousands of deaths according to public health databases such as VAERS (US), Eduravigilance (EU), Yellow Card (UK) and others. This article reviews some of the publicly available documents on Pfizer’s non-clinical development program and points to its deficiencies, omissions and gaps that were clearly visible, yet never questioned by the regulators or other health authorities. The cursory nature of the entire preclinical program can be briefly summarized as “we did not find any safety signals because we did not look for them”. The omissions of standard safety studies and glaring scientific dishonesty in the studies that were performed are so obvious that they cannot be attributed to the incompetence of the manufacturers and regulators. Rather, the question of wilful negligence should be raised.
The focus of my review was the scope and adequacy of the program of non-clinical assessment for a novel gene therapy vaccine with a brief discussion of 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 previously known to be rigorous ethical drug development process, as well as the shocking negligence on the part of the regulatory agencies that are supposed to keep the pharmaceutical manufacturers honest. It turns out that both were highly dishonest and pushed an entirely novel technology and product on millions of people without a single well designed safety assessment.
In summary, I have identified the following:
- Finding 1: Pfizer’s program did not include a comprehensive end-to-end test of all components of the final approved product. The studies included in the approval package were for a variety of versions of the product with no comparability assessments, thus no comprehensive assessment of product safety can be made.
- Finding 2: The toxicity of the Covid 19 vaccine’s mRNA active ingredient was never studied!
- Finding 3: Pfizer claimed absence of potential for enhanced covid illness based on the animal study where no covid illness was observed.
- Finding 4: CDC, FDA and Pfizer lied about “vaccine staying in the injection site”.
- Finding 5: Pfizer skipped major categories of safety testing altogether.
- Finding 6: Pfizer used dishonest and self-serving interpretation of regulatory guidelines to avoid routine safety testing.
- Finding 7: Both FDA and Pfizer knew about major toxicities associated with gene therapy class of medicines, and therefore cannot claim lack of anticipatory knowledge of these risks. This points to intentional fraud and collusion between Pfizer and the regulators to push this untested dangerous product on the market.