Report 96: mRNA COVID-19 Shots – ‘Vaccines’ or Gene Therapy Products? – Part 2

 

Report 96: mRNA COVID-19 Shots – ‘Vaccines’ or Gene Therapy Products? – Part 2

February 20, 2024 • by David Shaw; Cassie Papillon; Dr. Chris Flowers, MD; and Loree Britt

When considering a drug for emergency use authorization (EUA), the Food and Drug Administration (FDA) selects an internal advisory committee to review information and data submitted to the FDA by the pharmaceutical company about its new drug. These influential FDA advisory committees, based on that information and data, make recommendations regarding the granting or denial of EUA, subsequently determining if a drug will become publicly available. While the FDA is not obligated to follow the committee recommendations, it typically does. The health of the American public, as well as billions of dollars, hinges on FDA advisory committee recommendations and, ultimately, the FDA’s related authorization. Given the significance of advisory committee recommendations, it is crucial to select the appropriate committee based on the type of drug under consideration. However, as demonstrated, the FDA disregarded the fact that mRNA COVID-19 drugs are gene therapies and, consequently, did not choose the logical advisory committee to oversee and make recommendations about these “vaccines.”

Despite the FDA communicating to Moderna that it considered its mRNA COVID drug to be gene therapy, the agency chose the Vaccine and Related Biological Products Advisory Committee (VRBPAC) to review mRNA COVID drugs’ clinical trial data and vote on whether EUAs should be granted. To informed observers, the selection of VRBPAC, a vaccine committee, seemed illogical, as mRNA drugs are gene therapies. The FDA has a specific committee for gene therapies — the Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC). To fulfill its mission of protecting public health, the FDA must meticulously choose the committee of experts advising it on novel drugs. So, why was the wrong committee selected for mRNA COVID-19 shots? While we cannot ascertain the answer with absolute certainty, an educated guess can be made based on available information.

When the U.S. government developed and promoted COVID countermeasures, “vaccine” was a familiar and generally non-threatening concept to most Americans. In contrast, “gene therapy” products were unfamiliar to most. At a time when the U.S. government was focused on achieving widespread uptake of the new COVID drug, it made sense for it to stick with the familiar term “vaccine” rather than try to persuade the population to accept a type of drug — a gene therapy — that had not been used before. It appears that the government and its agencies chose the path of least resistance, which unfortunately involved deception about the type of drug being used, to ensure widespread acceptance of the “vaccine.” Now, over three years since EUA was granted by the FDA and mRNA COVID-19 shots began being administered to millions of Americans, the extensive adverse events associated with these novel drugs are becoming evident. The decision to take the easy route has led to significant portions of the population losing trust in these entities and needlessly suffering adverse events.

Read Part 2 of “mRNA COVID-19 Shots – ‘Vaccines’ or Gene Therapy Products?” series below.