Vaccins : débat en 3min
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En juin 2020, la FDA n'avait pas encore mené d'étude sur l'ARNm. Et le classait, effectivement à l'époque, dans la catégorie des "thérapies géniques". L'extrait présenté par (le complotiste et désinformateur) Idriss Aberkane est page 70 de ce rapport : Il semble de continuer la lecture du rapport afin de voir les compléments d'informations apportés par Moderna : https://www.sec.gov/Archives/edgar/data/1682852/000168285220000017/mrna-20200630.htm Some of our investigational medicines are classified as gene therapies by the FDA and the EMA, and the FDA has indicated that our investigational medicines will be reviewed within its Center for Biologics Evaluation and Research, or CBER. Even though our mRNA investigational medicines are designed to have a different mechanism of action from gene therapies, the association of our investigational medicines with gene therapies could result in increased regulatory burdens, impair the reputation of our investigational medicines, or negatively impact our platform or our business. (1/2) Suite : There have been few approvals of gene therapy products in the United States or foreign jurisdictions, and there have been well-reported significant adverse events associated with their testing and use. Gene therapy products have the effect of introducing new DNA and potentially irreversibly changing the DNA in a cell. In contrast, mRNA is highly unlikely to localize to the nucleus, integrate into the DNA, or otherwise make any permanent changes to cell DNA. Consequently, we expect that our investigational medicines will have a different potential side effect profile from gene therapies.
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