by Lora Hammill et al, Daily Clout:
COVID-19 ‘vaccine’ drugs are modified mRNA gene therapy products. So, why did the FDA assign the review and recommendation responsibilities to the Vaccines and Related Biological Products Committee (VRBPAC) instead of the Cellular Tissue and Gene Therapy Advisory Committee (CTGTAC)? CTGTAC was the logical FDA advisory committee for such a product. Yet the FDA insisted on calling the COVID-19 gene therapy injections ‘vaccines’ and assigned them to VRBPAC.
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In September 2021, the Centers for Disease Control and Prevention (CDC) changed the definitions of ‘vaccine’ and ‘vaccination’ to match the output measurement (i.e., antibody titers) of the mRNA products. To date, the CDC has not logically justified its changes to those definitions, and the FDA has not explained why it selected a vaccine advisory committee to review and approve gene therapy products.
What are the roles and purposes of the various FDA committees? Are they in place to support Big Pharma or to protect the American people?
All drug products must undergo scrutiny by the Food and Drug Administration (FDA) before they can be used in clinical trials or marketed to the general public. The FDA utilizes advisory committees of selected scientific experts to review information about drug products and to assess whether or not the drug is authorized/approved for human use. The type of drug product determines the committee assigned the task of safety and efficacy data review, and the responsibility for voting to recommend or reject authorization or approval of the drug.
The Cellular, Tissue and Gene Therapy Advisory Committee (CTGTAC) reviews data for drugs that are gene therapies, and the Vaccine and Related Biological Products Advisory Committee (VRBPAC) is responsible for the scientific data review of prospective vaccines and related biological products. Pfizer and Moderna presented drug products —BNT162b2 and mRNA-1273 respectively —to the FDA for consideration as treatments in response to the SARS-CoV-2 virus. Both drug product candidates were made from modified messenger ribonucleic acid (modRNA, often incorrectly referred to as ‘mRNA’) sequences wrapped in lipid nanoparticles. These two drugs are genetically modified mRNA products, but they were labelled by the FDA as “vaccines” and assigned to VRBPAC for evaluation.
Were the correct “experts” advising the FDA on the authorization of modified mRNA drug products?
What Is Gene Therapy?
From the FDA’s website:
“Gene therapy is a technique that modifies a person’s genes to treat or cure disease. Gene therapies can work by several mechanisms:
- Replacing a disease-causing gene with a healthy copy of the gene.
- Inactivating a disease-causing gene that is not functioning properly.
- Introducing a new or modified gene into the body to help treat a disease.
Gene therapy products are being studied to treat diseases including cancer, genetic diseases, and infectious diseases.” [Emphasis added.] [https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/what-gene-therapy]
Pharmaceutical companies manufacture the COVID-19 “vaccine” drug products using modified mRNA. Modified mRNA is taken up and utilizes a cellular mechanism to produce spike proteins for immune recognition. There is a greater potential risk of delayed adverse events following exposure to human Gene Therapy (GT) products. Per the FDA website:
“The possibility of site-specific changes in the human genome raises the potential for
- malignancies (cancer),
- impairment of gene function
- prolonged exposure to the protein produced and the potential for autoimmune-like reactions.
For these reasons, GT products require more rigorous evaluation before receiving approval for use. Studies must answer long-term effect questions as well as assess risk to cells, tissues, and/or organs targeted by the GT product. Such studies take time to gather statistically relevant data.” [https://www.fda.gov/vaccines-blood-biologics/biologics-guidances/cellular-gene-therapy-guidances]
Why Did the CDC Change the Definition of ‘Vaccine’ and ‘Vaccination’ in September 2021, 10 Months After EUA Was Granted to Pfizer and Moderna for Their COVID-19 Drugs?
We are unsure as to why the CDC changed the definitions for vaccine and vaccination or why the definitions were changed at that particular time. Ten months passed between the initial emergency use authorizations (EUAs) for Pfizer and Moderna and the CDC’s “vaccine” definition change. Was this for commercial reasons? Did the FDA’s approval of COMIRNATY® (the Pfizer-BioNTech COVID-19 “vaccine”) in August 2021, and the fact that the original definition of a “vaccine” did not fit the CDC’s new definition, influence this decision?
The Pfizer and Moderna COVID-19 drug products were labelled as “vaccines” well before the “vaccine” definition changed, and the FDA assigned VRBPAC as the advisory committee reviewing the COVID “vaccines”-related data as early as May of 2020. But, are these COVID drugs truly “vaccines,” or are they gene therapies, as defined by the FDA? The distinction matters since it drives the review and approval processes for the drugs.
