Nonsensical, Procedurally Invalid Vaccine Trial Results, by statistician-warrior Mathew Crawford of Rounding the Earth Substack:
Earlier this week on Monday I had a great conversation with Nutrition Scientist Chris Masterjohn. Our conversations have been extremely important for me in a way that I will explain later in this article. I believe that our observations led to something that vaccine experts likely knew from the start: the trials were designed so that the results are functionally meaningless, but serve as procedural illusions.
I posted a comment, slightly revised here:
Another path to the same conclusion is that legally, none of the pharma companies was ever required by FDA or any other regulatory agency to conduct valid clinical trials or produce valid clinical data.
Instead, the statutory framework for medical countermeasures, security countermeasures, pandemic products, epidemic products and Emergency Use Authorization products, requires no valid safety data, and only an HHS secretary declaration that a product “may be effective.” That simple statement by HHS secretary is enough to authorize procurement contracts, bulk manufacturing, distribution, mass injection and blanket liability shields for everyone involved.
If Pfizer and Moderna and the other contractors were never required to do valid clinical trials, they didn't do valid clinical trials.
21 USC 360bbb-3(c)(2)(A), added to Food Drug and Cosmetics Act (FDCA) in 1997, amended in 2004, means that there are no federally-required safety or efficacy standards for EUA products. The only requirement for "efficacy" claims, is that the HHS Secretary make a declaration that a product "may be effective." That declaration is to be "based on the totality of scientific evidence available to the Secretary, including data from adequate and well-controlled clinical trials, if available." But if no such data is available because it's a declared emergency and there's no time, the HHS declaration that it "may be effective" can be made anyway.