The idea that mRNA vaccine technology is “gene therapy” has been continually dismissed as a crazy conspiracy theory by mainstream media sources and public officials alike. However, SEC documents reveal that the FDA considers mRNA technology to be “gene therapy” Moderna’s SEC form S-1 goes into great detail on this subject.
Highlights from our reporting:
Moderna’s form S-1 mentions “gene therapy” 23 times in relation to mRNA
Filing documents go into detail about how their products will likely be subject to FDA testing that is applied against gene therapy drugs
Admits that serious adverse reactions to it’s mRNA vaccines could stonewall any regulatory approvals in the US
Worth noting: Moderna has been in business since 2010 and has never received an FDA approval.
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Sourced directly from the Moderna, INC form S-1 filed with the SEC. On page 3/195, this statement can be found.
Currently, mRNA is considered a gene therapy product by the FDA. Unlike certain gene therapies that irreversibly alter cell DNA and could act as a source of side effects, mRNA based medicines are designed to not irreversibly change cell DNA; however, side effects observed in gene therapy could negatively impact the perception of mRNA medicines despite the differences in mechanism. In addition, because no product in which mRNA is the primary active ingredient has been approved, the regulatory pathway for approval is uncertain. The number and design of the clinical and preclinical studies required for the approval of these types of medicines have not been established, may be different from those required for gene therapy products or may require safety testing like gene therapy products. Moreover, the length of time necessary to complete clinical trials and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one pharmaceutical product to the next, and may be difficult to predict.
On page 7/195 of the SEC document this elaboration referencing “approvals of gene therapy products in the United States”, stating additionally that “Gene therapy products have the effect of introducing new DNA and potentially irreversibly changing the DNA in a cell”
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.
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 because they lack risks associated with altering cell DNA irreversibly. Further, we may avail ourselves of ways of mitigating side effects in developing our investigational medicines to address safety concerns that are not available to all gene therapies, such as lowering the dose of our investigational medicines during repeat dosing or stopping treatment to potentially ameliorate undesirable side effects.
On page 16/196 of Moderna’s SEC form S-1, additional statements are made relating mRNA to “gene therapy” and “gene editing”.
As a potential new category of medicines, no mRNA medicines have been approved to date by the FDA or other regulators. Adverse events in clinical trials of our investigational medicines or in clinical trials of others developing similar products and the resulting publicity, as well as any other adverse events in the field of mRNA medicine, or other products that are perceived to be similar to mRNA medicines, such as those related to gene therapy or gene editing, could result in a decrease in the perceived benefit of one or more of our programs, increased regulatory scrutiny, decreased confidence by patients and clinical trial collaborators in our investigational medicines, and less demand for any product that we may develop.
Also, while we’re talking about this subject, this video is memorable at the least.