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A newly discovered document reveals the FDA was aware of the dangers of COVID-19 \u201cvaccines\u201d from the very beginning of the COVID-19 outbreak, but they hid them from us by omitting any mention of them in their public documents. The document is an SEC Registration<\/a> submitted by a German company, BioNTech SE<\/a>, on December 31, 2019. Like Moderna and Pfizer, BioNTech SE produces an mRNA gene modification product called iNeST, which is similar to the COVID-19 \u201cvaccines\u201d. These products are commonly known as gene therapy rather than gene modification to avoid calling attention to the dangers of modifying our genetic code, but that\u2019s exactly what they do.<\/p>\n The BioNTech SE<\/a> document was submitted to the SEC at about the same time as the first reports of COVID-19 started coming from China, proving that even before any COVID-19 \u201cvaccines\u201d were developed, the FDA was fully aware that mRNA products are gene modification products, as stated on page 16, “Currently, mRNA is considered a gene therapy product by the FDA.”<\/p>\n The FDA\u2019s awareness that mRNA is gene therapy is very important because, as shown in this same document, BioNTech SE<\/a> acknowledges that gene therapy products are \u201cwell-reported\u201d to have high levels of adverse side effects.<\/p>\n \u201cThere have been few approvals of gene therapy products in the United States and other 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.\u201d (page 26)<\/p>\n BioNTech SE\u2019s<\/a> statement that gene therapy products \u201chave been well-reported\u201d to have \u201csignificant adverse events\u201d indicates these dangers are well known in this industry, so I think it\u2019s safe to conclude that the FDA was also aware of them. And these dangers\u00a0are addressed repeatedly throughout this document, as shown in the examples below:<\/p>\n “Side effects observed in other gene therapies, however, could negatively impact the perception of immunotherapies…” (page 16)<\/p>\n \u201cWe also expect the centers using our product candidates, if approved, on a commercial basis could have similar difficulty in managing adverse events.\u201d (page 17)<\/p>\n \u201cAdverse events reported with respect to gene therapies or genome editing therapies could adversely impact one or more of our programs.\u201d (page 27)<\/p>\n \u201cProduct candidates we may develop may be associated with an adverse immune response or other serious adverse events, undesirable side effects or unexpected characteristics.\u201d (page 29)<\/p>\n Yet, despite the FDA\u2019s awareness of these dangers at the end of 2019, three months later, on March 27, 2020, they granted Emergency Use Authorization for producers Moderna and Pfizer to develop mRNA gene therapy products while completely whitewashing their Emergency Use Authorization to remove any mention of \u201cmRNA\u201d and \u201cgene therapy\u201d, renaming them as \u201cexperimental vaccines\u201d, even though they are not vaccines, as was explained in my previous post, Three Reasons Why the Covid-19 Vaccine is Not a Vaccine<\/a>.<\/p>\n The FDA\u2019s whitewashing campaign continues to this day. For example, on February 22, 2021, they released a 24-page Guidance Document as a follow up to a similar document released in October 2020. It\u2019s called Emergency Use Authorization for Vaccines to Prevent COVID-19<\/a>, but like their previous documents, all the dangers have been omitted so there is not a single mention of words like \u201cgene therapy\u201d or \u201cgene modification\u201d or even \u201cgene\u201d. They\u2019ve all been replaced with more acceptable words like \u201cvaccines\u201d. The other important descriptive word, \u201cmRNA\u201d, was also omitted from the main body of this document but I found it buried in a couple of references on pages 13 and 14 and it was mentioned once in parenthesis in Appendix 2 on page 17, but instead of warning about the \u201cwell-reported\u201d high levels of adverse events, it says it has \u201cbeen shown to be effective in clinical studies.\u201d Really? In what clinical studies? Perhaps they’re referring to all the clinical studies showing how effective it is in producing adverse side effects?<\/p>\n In summary, from the very beginning of the COVID-19 outbreak, the FDA has had full knowledge that mRNA products are gene therapy and the dangers of \u201csignificant adverse events\u201d caused by gene therapy products have been \u201cwell-reported\u201d, yet they have not mentioned these dangers anywhere in their documents, which should be enough to outrage the American people. Instead of a hundred million people getting injected, we should have a hundred million people marching on Washington DC to demand explanations for this blatant cover up, but it seems more likely that another hundred million will soon get their gene modification shots, ignorantly believing they\u2019re getting protected from COVID-19 because they didn\u2019t take the time to investigate.<\/p>\n