Thanks for this survey of Moderna statements about mRNA injections being classified as gene therapy by the FDA. From the comment I made to the Trialsite News article you cited, here is how the European Union defines "gene therapy" - to include these mRNA treatments.
The 2003 EU definition of "gene therapy", which still current: https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX%3A32003L0063 classifies mRNA and other such methods (viral vector) of programming a cell's ribosomes to create specific proteins as "gene therapy" even though such treatments are not expected to alter the actual genes, in the chromosomes, of the cell.
Select the EN PDF. Find page 88, by the "159/nn" numbers at the top of each page. This PDF starts with page 46 by that system, so we want the physical PDF page 43. Part IV 1:
"For the purposes of this Annex, gene therapy medicinal product shall mean a product obtained through a set of manufacturing processes aimed at the transfer, to be performed either in vivo or ex vivo, of a prophylactic, diagnostic or therapeutic gene (i.e. a piece of nucleic acid), to human/animal cells and its subsequent expression in vivo. The gene transfer involves an expression system contained in a delivery system known as a vector, which can be of viral, as well as non-viral origin. The vector can also be included in a human or animal cell."
"a piece of nucleic acid" includes DNA or RNA. "to human/animal cells and its subsequent expression in vivo". This includes mRNA introduced by a lipid nanoparticle delivery system or viral RNA or DNA from a viral vector which, in either case, programs ribosomes to manufacture the protein according to the amino acid sequence contained in that RNA or DNA.
Nowhere does this definition of "gene therapy" require that the therapy alter the genes in the chromosomal DNA of the cell.
We know transfection to permanently alter DNA has occurred in in vitro in studies of the mRNA gene therapy in at least one Swedish study. We know from the Almara study the spike concentrates in ovaries and testes, we see the vast reproductive harms worldwide. There is no longer any doubt, whatsoever, that these shots are gene therapy masquerading as vaccines.
JOIN LOCAL REPUBLICANS TO BAN JABS. It started in Florida.
https://covidandvaxfaqs.substack.com/p/join-local-republicans-to-ban-jabs
Thanks for this survey of Moderna statements about mRNA injections being classified as gene therapy by the FDA. From the comment I made to the Trialsite News article you cited, here is how the European Union defines "gene therapy" - to include these mRNA treatments.
The 2003 EU definition of "gene therapy", which still current: https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX%3A32003L0063 classifies mRNA and other such methods (viral vector) of programming a cell's ribosomes to create specific proteins as "gene therapy" even though such treatments are not expected to alter the actual genes, in the chromosomes, of the cell.
Select the EN PDF. Find page 88, by the "159/nn" numbers at the top of each page. This PDF starts with page 46 by that system, so we want the physical PDF page 43. Part IV 1:
"For the purposes of this Annex, gene therapy medicinal product shall mean a product obtained through a set of manufacturing processes aimed at the transfer, to be performed either in vivo or ex vivo, of a prophylactic, diagnostic or therapeutic gene (i.e. a piece of nucleic acid), to human/animal cells and its subsequent expression in vivo. The gene transfer involves an expression system contained in a delivery system known as a vector, which can be of viral, as well as non-viral origin. The vector can also be included in a human or animal cell."
"a piece of nucleic acid" includes DNA or RNA. "to human/animal cells and its subsequent expression in vivo". This includes mRNA introduced by a lipid nanoparticle delivery system or viral RNA or DNA from a viral vector which, in either case, programs ribosomes to manufacture the protein according to the amino acid sequence contained in that RNA or DNA.
Nowhere does this definition of "gene therapy" require that the therapy alter the genes in the chromosomal DNA of the cell.
Top notch reporting on this issue!! I had not seen this coverage before, anywhere. Thank you so much for sharing.
We know transfection to permanently alter DNA has occurred in in vitro in studies of the mRNA gene therapy in at least one Swedish study. We know from the Almara study the spike concentrates in ovaries and testes, we see the vast reproductive harms worldwide. There is no longer any doubt, whatsoever, that these shots are gene therapy masquerading as vaccines.