"2.1. The Mode of Action of mRNA Anti-COVID-19 Defines Them as GTP and Their Destiny as Vaccines
Although incompletely defined, the mode of action of mRNA vaccines should classify them as gene therapy products (GTP); they are nucleic acids intended to make the cells of the vaccinee produce an antigen, inducing the production of antibodies. This mode of action corresponds exactly to the regulatory agencies’ definition of a GTP.
According to the EMA CHMP report (Committee for Medicinal Products for Human Use): 'The active substance consists of mRNA that is translated into the spike protein antigen of SARS-CoV-2; the LNP protects the RNA and enable transfection of hosts cells after IM delivery; the S protein induces an adaptive immune response'.
According to the FDA, gene therapy is a medical intervention based on the modification of the genetic material of living cells. Cells may be altered in vivo by gene therapy given directly to the subject.
According to EMA 2009, a GTP: (a) contains an active substance which contains or consists of a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replacing, adding or deleting a genetic sequence; and (b) in its therapeutic, prophylactic or diagnostic effects, relates directly to the recombinant nucleic acid sequence it contains, or to the product of the genetic expression of this sequence."
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