mRNA: vaccine or gene therapy? The safety issues of regulation

According to health agencies (EMA, European Medicines Agency, US-FDA, Food and Drug Administration-US, WHO), vaccines in general escape some of the controls required for human drugs and this without scientific justification: they are not generally subject to pharmacokinetic studies for example except in special cases. However, according to the EMA, vaccines are subject to the regulations for human drugs, which require pharmacokinetic studies when a new route of administration or a new adjuvant is used. However, mRNA vaccines, which represent a new class of vaccine, should undergo more scrutiny than conventional vaccines because they are based on several new technologies. mRNAs should also be considered as prodrugs because the injected substance is not the substance causing active immunization; according to the FDA it is necessary to study how a prodrug contributes to the final toxicity and how it is transformed into an active substance. In addition, mRNAs used for protection against infectious disease are excluded from the regulation of gene therapy products (GTPs); this exclusion is not scientifically justified by the regulatory agencies. GTPs are subject to controls that mRNA vaccines are not: studies on biodistribution, doses, potential target of toxicity, identification of the target organ to obtain biological activity, research on integration into the genome and transmission in the germ line, toxicity related to the expression of structurally altered proteins, reproductive toxicity, repeated toxicity, and excretion in the environment. This is of concern because conventional vaccines could be replaced by mRNA vaccines and anti-cancer "vaccines" (actually therapies) are being announced. The FDA and the EMA have evaluated anti-Covid mRNA vaccines but the heads of these agencies have been pressured to approve them. The state military's handling of the Covid health crisis needs to be discussed in terms of its consequences and may explain this lack of oversight. It should also be discussed in the future whether all mRNA products should be subject to the same regulations and controls whether they are considered vaccines or not: it is not justifiable to subject therapeutic mRNAs to strict controls when they are intended for patients representing a small proportion of the human population and to exclude mRNA vaccines intended for the majority of the healthy human population.