Brownstone | Contrary to popular belief that pharmaceutical companies drove the COVID vaccine development programs, the US FDA’s website (FDA, 2020) reveals that the United States Department of Defence (DoD) has been in full control of the Covid Vaccine development program since its beginning. The DoD has been responsible for development, manufacturing, clinical trials, quality assurance, distribution and administration, since that time (FDA, 2020; Rees and Latypova, 2022; KEI, 2022; Medical Defense Consortium, 2022; Rees, 2022). The major pharmaceutical companies have been involved as “Project Coordination Teams” effectively performing as subcontractors to the DoD. The Chief Operating Officer for the Warp Speed vaccine program is the US Department of Defence, and the Chief Science Advisor is the US Department of Health and Human Services (HHS).
The Nature of Gene-based Vaccines
The true nature of the COVID-19 ‘vaccines’ has been largely misrepresented by mainstream media, big pharmaceutical companies and governments and is poorly understood by the population at large. Referring to these products as “vaccines” led most people to consider them as relatively safe and well-researched and readily accept their widespread use. However, they are not really vaccines – they are serious gene-based interventions which have never been deployed widely in any population, especially never to healthy individuals including children, infants and pregnant women. In this sense they should be considered experimental.
COVID-19 ‘vaccines’ fall into a special class of therapeutic agents under the US FDA Office of Cellular, Tissue and Gene Therapies’ defined as “gene therapy products,” which involve “introducing a new or modified gene into the body to help treat a disease” (FDA, 2018). Heretofore, use of gene therapy products has been limited to the treatment of usually rare, serious and debilitating disease or genetic conditions. They have potential to cause permanent intergenerational genetic damage, cancer and interfere with reproductive capacity.
The FDA and other drug regulatory agencies have specific rules and guidelines to direct manufacturers in development and testing of such products, for both preclinical (FDA, 2013) and clinical (FDA, 2015) research. However, the FDA did not evaluate these COVID-19 “vaccines” according to these gene therapy guidelines.
Instead, there was a concerted effort to avoid referring to them as gene therapy products, based, in part, on the argument that the genetic material in the COVID-19 vaccines was not intended to be incorporated into an individual’s DNA, nor to modify gene expression. There was no prior short-term safety information and no long-term data on which to predict future effects. No similar therapeutic products have been previously approved anywhere in the world. Their widespread administration globally with no historical safety experience was an unprecedented risk in human health.
Accelerating Development
Messenger RNA platform technology has been researched by DARPA (Defense Advanced Projects Research Agency) since at least 2012 (McCullough, 2022). In early 2020, in the panic to develop the COVID-19 vaccines, certain critical research and development procedures were omitted, bypassed, curtailed, or not done in a logical sequential manner, or to established laboratory or manufacturing standards. Although the spike protein is the active drug and is directly responsible for the immune response, its pharmacology and toxicology have not been studied in animals or in humans as would normally have been required.
Other notable deficiencies include lack of critical research on carcinogenicity, mutagenicity, genotoxicity and reproductive toxicology in appropriate animal species. In particular, the potential for reverse transcription of mRNA genetic material into an individual’s DNA was not investigated. Furthermore, scale-up manufacturing was premature and lacked adequate quality control to ensure that product made in large batches is the same as made in smaller batches.
Without such research, the potency, mRNA integrity, presence of contaminants and stability of the “vaccines” cannot be guaranteed. Such oversights are directly responsible for the failure to predict the serious adverse drug reactions and mortality which have now been reported in association with these vaccines.
To mitigate risk, the plan in vaccine development was to use multiple technologies, multiple facilities and redundancy. Leverage of existing facilities would also take place. In the interest of expediency, the plan was to avoid using traditional pathways from early development to large-scale production. Avoidance of quality standards and guidelines such as Good Manufacturing Practice and Good Laboratory Practice guidelines was necessary to speed development, and conventional New Drug Application (NDA) and Biologics License Application (BLA) approvals were bypassed.
Instead, the process moved rapidly using compressed timelines and overlapping stages of development towards Emergency Use Authorization (EUA). Scale-up and large volume manufacturing was planned in parallel with, instead of before, clinical trials which, again, may have contravened accepted codes of Good Manufacturing Practices. These approaches were probably a recipe for potential disaster. (Latypova, 2022; Watt and Latypova, 2022).
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