Vaccines escape some of the controls required for human drugs (without scientific justification). However, mRNA vaccines, which represent a new class of vaccine, should be subject to more controls than conventional vaccines because they are based on several new technologies. Conventional vaccines could be replaced by mRNA vaccines and anti-cancer “vaccines” (actually therapies) are being announced. Moreover, mRNA vaccines can be considered as pro-vaccines (the injected substance is not the active substance).
The WHO tried unsuccessfully to regulate these new products in 2022. mRNA vaccines are not subject to regulation as gene therapy products (GTP) although they correspond to the definition of GTP and although for the EMA therapeutic mRNAs are considered as gene therapy products. Moreover, Moderna and BioNTech expected their products to be regulated as gene therapies.
Therefore, anti-covid mRNAs are subject to the EMA’s human drug regulations, which also apply to vaccines; there is even an EMA document that requires pharmacokinetic testing for DNA vaccines. The exclusion of anti-Covid mRNAs from the regulation of gene products is not justified by the regulatory agencies, which allows these products to avoid numerous controls, in particular concerning specific toxicity, integration in the genome, transmission in the germ line, toxicity linked to the expression of structurally altered proteins, reproductive toxicity, repeated toxicity and excretion in the environment.
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