by David Shaw; Cassie Papillon; Dr. Chris Flowers, MD; and Loree Britt, Daily Clout:
To this day — more than three years after Pfizer and Moderna’s mRNA COVID-19 drugs received Emergency Use Authorization (EUA) — television, radio, and the Internet still inundate the public with ads, messages, and stories about COVID vaccines. But, are the mRNA COVID-19 shots genuinely vaccines? These products never aligned with the pre-September 2021 definitions of “vaccine” and “vaccination,” as defined by the Center for Disease Control and Prevention (CDC). At that time, a vaccine was defined as, “A product that stimulates a person’s immune system to produce immunity to a specific disease, protecting the person from that disease.” And, the CDC then defined vaccination as: “The act of introducing a vaccine into the body to produce immunity to a specific disease.” [Emphasis added.] Abundant evidence now shows that mRNA COVID drugs did not produce immunity protecting a person from contracting or transmitting the SARS-CoV-2 virus, which causes COVID-19. So why do the Food and Drug Administration (FDA) and CDC still assert that the COVID injections are vaccines, and does it matter?Much more than semantics is at issue when public health and regulatory agencies refer to the mRNA COVID drugs.
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The way in which the FDA defines a drug — as a vaccine or a gene therapy — drives which advisory committee reviews the product and what steps the drug approval process involves. Through at least June 30, 2020, the FDA termed these COVID-19 mRNA drugs gene therapies. Moderna’s Q2 2020 quarterly report stated, “mRNA is considered a gene therapy product by the FDA…” [Emphasis added.] [https://d18rn0p25nwr6d.cloudfront.net/CIK-0001682852/dfd10d54-ff56-40f1-b2e6-c4fc887b6afc.pdf, p. 70.] Despite the FDA telling Moderna it considered mRNA a gene therapy, the agency told the public repeatedly that the U.S. government and its partners were working to develop an mRNA COVID “vaccine,” and this message persists. Why would the FDA, along with the CDC, misinform Americans about the type of drugs they were taking by the millions of doses? The answer becomes clearer when one understands that there are vastly different approval processes and, thus, approval timelines in place for vaccines and gene therapies.
Moderna realized this early on. In its Q2 2020 quarterly report, the company mentioned, “No mRNA drug has been approved in this new potential class of medicines and may never be approved as a result of efforts by others or us. mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented nature of this new class of medicines.” [Emphasis added.] It also stated, “The number and design of the clinical trials and preclinical studies required for the approval of these types of medicines have not been established, may be different from those required for gene therapy products, or may require safety testing like gene therapy products.” [Emphasis added.] Clearly, gene therapy drug development comes with a lot of unknowns. However, vaccine drug development and the related approval processes are well-established. Did the FDA pull a ‘vaccine bait-and-switch’ on the American people to develop an anti-COVID-19 drug, one that Americans would accept, at “warp speed?” Evidence supports that that is, indeed, what happened; and this series of reports, starting with Part 1 below, will present facts showing this to be the case.
