Documents show US regulators called COVID shots 'vaccines' in public, 'gene therapy' in private

The US Food and Drug Administration in 2020 told COVID-19 injection manufacturers their products were "gene therapy" while telling the public they were "vaccines" documents show.The DailyClout made the findings after analyzing documents disclosed by formal information requests, some made public sooner due to court orders. Authors David Shaw, Cassie Papillon, Dr. Chris Flowers, MD, and Loree Brittsay, recently reported on the vaccine/gene therapy controversy in the documents. They wrote that "much more than semantics is at issue" because proper definitions mean different review processes.Prior to September 2021, the US Centers for Disease Control and Prevention (CDC) defined a vaccine as, “a product that stimulates a person’s immune system to produce immunity to a specific disease, protecting the person from that disease.” The CDC defined vaccination as, “The act of introducing a vaccine into the body to produce immunity to a specific disease.”This is why, as late as June 30 2020, the FDA termed the developing COVID-19 mRNA shots as gene therapies. Moderna’s Q2 2020 quarterly report stated, “mRNA is considered a gene therapy product by the FDA."Publicly, however, the agency said repeatedly that the US government and its partners were working to develop an mRNA COVID “vaccine." The DailyClout probed the mixed messages."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?'” asked the authors."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 what was at stake. The company's Q2 2020 quarterly report stated, “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.”The report added, “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."David E. Martin, the CEO of an international intangible asset underwriting and analyst firm has stated, said the American agencies did just that.“We changed what the definition of a vaccine was, we mislabeled it, this is a clear and compelling Federal Trade Commission deceptive medical practices case because both BioNTech and Moderna said that ’mRNA injections were experimental gene therapies classified as such by the FDA,’” Martin explained, as reported by DailyClout.When considering a drug for emergency use authorization, the FDA selects an internal advisory committee to review data submitted by the pharmaceutical company about its new drug. The FDA usually follows the committee recommendations.Even though the FDA told Moderna that it considered its mRNA COVID drug to be gene therapy, the agency did not send Moderna's data to the usual committee for gene therapies — the Cellular, Tissue and Gene Therapies Advisory Committee. Instead, the Vaccine and Related Biological Products Advisory Committee was tasked for analysis."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," the DailyClout explained."At a time when the US 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.'"The DailyClout said the folly of this path is now plainly 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."The documents were disclosed by a court order and have been the subject of an ongoing series by DailyClout. Reports 95 and 96 on the gene therapy/vaccine controversy are available on their website.