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“By claiming that these substandard, demonstrably misbranded and adulterated products are ‘BLA licensed vaccines,’ the FDA is abrogating its duty.”
~ Sasha Latypova
Much ink has been spilled—notably by meticulous researchers Sasha Latypova and Katherine Watt at Substack—about the stealthily constructed legal architecture that allowed the U.S. government to carry out a mass atrocity on the population, via Covid injection, without any option for citizen redress.
Members of the public now have an opportunity, by adding their comments to a citizen petition filed by Children’s Health Defense (CHD), to loudly draw attention to one aspect of the government’s criminal behavior—namely, the sleight of hand by which FDA “jumped tracks” and misbranded the Emergency Use Authorization (EUA) Covid shots as “BLA-licensed” vaccines.
Biologics License Application approval legally requires a variety of steps that FDA illegally chose to ignore when it granted BLAs to the Pfizer and Moderna mRNA injections. The bypassed requirements include “Institutional Review Board (IRB) oversight, documented informed consent, validated manufacturing processes, good laboratory practice in preclinical testing, and representative clinical trial data.”
Latypova and Watt have explained at length how the 2005 PREP Act legally enables the adulteration and misbranding of EUA products, but BLA products are a different story—misbranding them is a “severe violation” of federal law. As the petition explains, “The vaccines—labeled today as fully licensed—are in fact EUA products ‘in disguise,’ bearing BLA labels without satisfying the statutory standards those labels require.”
CHD and Latypova are encouraging “hundreds of thousands of people” to flood the FDA’s website with comments. And as of December 11, almost 101,000 people had already done so!
Latypova provides some guidance on how to submit comments:
Let’s make sure the FDA continues to hear an earful!
Breaking: Citizen Petition to the FDA Filed by Children’s Health Defense with My Input (Sasha Latypova)
Citizen Petition from Children’s Health Defense (link for submitting comments)
Petition for Administrative Action Regarding COVID-19 Vaccine Licensure (PDF)
Due Diligence and Art (Sasha Latypova)
Bailiwick News Archives (Katherine Watt)
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