Why did the FDA assign the review and recommendation responsibilities to the Vaccines and Related Biological Products Committee instead of the Cellular Tissue and Gene Therapy Advisory Committee? CTGTAC was the logical FDA advisory committee for such a product.
The FDA insisted on calling the COVID-19 gene therapy injections 'vaccines' and assigned them to VRBPAC. In September 2021, the Centers for Disease Control and Prevention changed the definitions of 'vaccine' and 'vaccination' to match the output measurement of the mRNA products.
The Cellular, Tissue and Gene Therapy Advisory Committee reviews data for drugs that are gene therapies, and the Vaccine and Related Biological Products Advisory Committee is responsible for the scientific data review of prospective vaccines and related biological products.
Table 1 compares the roles of the two advisory committees: the Vaccines and Related Biological Products Advisory Committee and the Cellular, Tissue, and Gene Therapy Advisory Committee.
If the vaccine versus gene therapy distinctions presented in this report had been openly and publicly discussed when the COVID-19 shots became available, would the general public have lined up as enthusiastically and confidently to take multiple injections of what is clearly a gene therapy product?
In his address to the attendees, Oelrich said, "Ultimately the mRNA vaccines are an example for that cell and gene therapy. I like to say that if we had surveyed two years ago, in the public, 'Would you be willing to take gene or cell therapy and inject it into your body?' we would have probably had a 95% refusal rate."
Searching the FDA's guidance regulations for vaccines versus gene therapy products, we found Section 610.15 of the Code of Federal Regulations on General Biological Product Standards, which states that vaccine products "Shall meet generally accepted standards of purity and quality."
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