After examined both the substantive evidence and approval process used by FDA’s in approving the mRAN vaccines, I showed that due to routine suppression of critical discoveries by controlling medical publishers and limitations in FDA’s approval process, FDA could consider only flawed and self-serving findings in context of flawed medical theories in favor of the approval. As reflected in the briefs for FDA advisory committee, FDA did not consider fatal flaws in clinical trials, the symptom-based research methods, interference effects of many factors on vaccine benefits/risks, and potential long-term side effects. While off-target expression of mRNA vaccines were known evils in mRNA vaccines, FDA did not even consider. FDA did not address three critical problems responsible for erratic targeting: coating variations among mRAN molecules, differences in local hydrodynamic properties in each person, and the massive differences in influencing variables among different persons. By relying on cherry-picked, self-servicing, and deeply flawed application data and flawed contextual knowledge promoted by controlling commercial publishers, FDA could not see plainly predictable acute personal injuries, failed to consider many latent side effects on certain individuals particularly pregnant women, fetuses, babies, and people with diminished vital functional capacities. Given the fact that the vaccines are imposed on the population, defectiveness of the vaccines can cause the worst catastrophes, FDA must change its review process to overcome suppression of evidence practiced by vaccines sponsors and influencing medical journals. A workable process must include proactively seeking and considering any relevant information from any source and conducting expanded analysis without being constrained by flawed research models. By using an improved review process, FDA should not have found that mRNA vaccines are effective and safe. I urge FDA to re-valuate all mRNA use authorization (EUA) for the sake of billions of human beings.
Amid the rapid mutation of SARS-Cov-2 virus, leaders in the world are under pressure to contain outbreaks. It has been suggested that boost shots are the solution. Based on available evidence from medical literature, anyone would be compelled to find that boost shots are the best option. However, discovered flaws in the foundation of medicine give me a different perspective. I have proved that population model, symptom-based side effect research method, reductionist treatment approach, etc. used in researches produce grossly inaccurate findings. I have proved that the population model underestimates lifestyle factors by several orders of magnitudes; and side effects rated by the symptom-based revaluation method are distorted by massive organ reserve; and the superimposed affects of multiple disease cause factors can further distort side effects. When medicine is controlled by journals mainly funded by drug industry, medical literature is full of obsolete models, theories, practices and treatments. I explored how population-based research model, symptom-based side-effect evaluation method, and multiple disease causes model alter vaccines’ benefit-to-risk ratios. Finally, I deeply examine three medical failures: the DES disaster, belated discovery of stress hormones’ roles, and poorly understood immune system balance and show that medicine is unable to determine latent adverse effects as a matter of course.
Jianqing Wu, Ph.D., J.D, hereby submits this citizen petition to the Commissioner of the U.S. Food and Drug Administration (FDA) under the federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 355, 21 U.S. § 564(g)(2), 21 U.S. Code § 379dd, 21 C.F.R. §§ 1.21, 7.40(b), 42 U.S. § 262(a)(2), and the Administrative Procedure Act (APA), 5 U.S.C. §553(e). Petitioner requests FDA to suspend all outstanding mRNA vaccine use authorizations, re-evaluate their effectiveness and safety, and revoke their use authorizations as soon as possible, and make a plan to systematically overhaul its approval framework.
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