When it comes to mRNA injections for COVID, Americans are 100% dependent on the FDA and vaccine manufacturers to assess and confirm purity and consistency. That might be okay if the testing methodologies that manufacturers and the FDA were still fully transparent, but they’re not anymore. Not only are the test results confidential, even the methodology used hasn’t been made public. The world just has to take manufacturers’ word that there’s no contamination or variability with the mRNA sequence or its lipid nanoparticle components—even though published epidemiology data indicate otherwise. Secrecy abounds despite the vaccine manufacturers receiving billions of U.S. taxpayer dollars to conduct their R&D efforts. Transparency should be non-partisan, especially when it comes to the quality of America’s pharmaceuticals. On top of that, both the Trump and Biden administrations have proposed lifting COVID mRNA intellectual property rights for mRNA injections. Yet both the FDA and manufacturers are tightly protecting the ingredient information as proprietary/trade secret. But is it really appropriate to label it “proprietary/trade secret” if the research/development/product was funded with hundreds of millions of taxpayer dollars? >>> Are Safety Reports From COVID mRNA Shots Due to Lack of FDA Ingredient Clarity? A transparent, publicly accountable FDA should be eager to prospectively test most or all of its regulated products for qualitative and quantitative consistency—and make those findings publicly available. A transparent FDA would also share its testing methodology for mRNA COVID products for scientists who wish to confirm. But anyone trying to access this information will find it embargoed via an FDA report rendered useless by ludicrous redactions of not just the methodology, but the FDA’s critique of the methodology. FIGURE 1: Around 75% of information from the official FDA Chemistry Manufacturing and Controls report are redacted to the point that nobody other than the FDA or manufacturers could ever independently test COVID mRNA shots using validated FDA testing methodology. Without a list of ingredients or testing methodology, it is impossible for anyone else outside the FDA or manufacturers to know precisely how to check for product consistency. It is especially troublesome since new, preliminary data using independent methodology has produced troubling evidence of contamination in mRNA COVID product. FDA’s Improper Quality Testing Methodology Also troubling is the fact that in 2021, the FDA opted to start monitoring America’s pharmaceutical quality via a remote collection of “mailed-in” drug samples—a far less reliable process than testing samples directly collected at manufacturing plants or distribution points by FDA officials. This “mail-in” sampling methodology is absurd. It would be akin to a state health department monitoring restaurants by requesting them to periodically mail in various items from their menu to be tested for potential food-born contamination or asking restaurants to promise to test the items themselves. >>> Should Lipid Nanoparticles Used in mRNA COVID Injections Have Received More Vigilant Regulatory Scrutiny? Lack of Specific Dosing Transparency Has No Precedence Unlike every other FDA-approved pharmaceutical, including a previously approved RNA-based products including patisiran (Onpattro®), none of the COVID injections provide the sequence, molecular weight and milligram strength on its official FDA package label. Normally, official FDA package labeling provides specifics of the actual ingredients in that volume, including the structure/sequence and specific concentration. That is not the case for COVID mRNA labels. Look up whatever pharmaceuticals you can think of in the Drugs.com database, and you’ll see how all labels provide structure and/or molecular weight in their official package labeling. COVID mRNA shots are a conspicuous exception to the historical FDA approval practice and “truthful label” rule. FIGURE 2: Blue = batches with a high number of adverse events reported. Green = batches with a low number of events reported. Yellow/Amber = batches with little or no adverse events reported, where each batch represents tens of thousands to hundreds of thousands of injections. The study raises a number of critically important questions, which can’t begin to be answered without the consistency being verified beforehand—and “mail-in” sampling is not the way to do it. Providing ingredient transparency and assuring quality via an appropriate sampling methodology is a core mission of the FDA. In fact, it was the primary reason for establishing the agency back in 1906. Americans today deserve complete transparency and improved quality control oversight when it comes to our pharmaceuticals. Our health may depend on it. This piece originally appeared in RealClear Health
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