International Journal of Coronaviruses

International Journal of Coronaviruses

Current Issue Volume No: 4 Issue No: 1

Opinion-article Article Open Access
  • Available online freely Peer Reviewed
  • FDA Should Re-evaluate All MRNA Vaccines And Revoke Their Use Authorizations (The Short Version).

    Wu Jianqing 1
       

    1 Healthier World (Independent researcher for cause), P. O. Box 689, Beltsville, MD 20704. 

    Abstract

    Drug industry, controlling medical publishers and large media promote flawed medicine for their revenues by systematically laundering medical knowledge in decades. They maintain and promote flawed research models and suppress disruptive discoveries, thereby precluding reform of medicine. In this study, I will deeply explore how the wrong life model, population-based research model, misused clinical trials, flawed statistical models, the symptom based research methods, binary disease classification, failure to address the massive vital organ capacities, failure to correct biases caused by expected delay in realizing side effects, and failure to address the interference effects of non-controllable factors affect the conclusions of effectiveness and safety for mRNA vaccines. I will directly analyze three studies that have been relied upon by FDA in approving mNRA use authorizations: one BNT162b2 effectiveness study published in NEJM, one booster shot study published in NEJM and a Seven Integrated Health Care Organizations study published by CDC. I will expose fatal flaws in the frequency risk concept, effectiveness rate, and hazard reduction ratios, and show why 3% death rate, 95% effectiveness rate and 90% mortality reduction are all meaningless and misleading, and should never have been used as treatment guidance. I will also examine common biases that can be easily practiced by sponsors researchers to alter conclusions in favor of approval. By relying on laundered medical knowledge , FDA has consistently failed to predict latent drug side effects for any drugs and vaccines in its history. FDA approved disastrous DES in 1941, Swine Flu vaccine in 1976, and mRNA vaccines in 2020. The vaccines are used to deliver short-term benefits on a small percent of persons at the costs of damaging health, causing deaths that could be avoided, and shortening lifespans for all people in the population. I thus urge FDA to reevaluate all mRNA vaccines and revoke their use authorizations.

    Author Contributions
    Received Dec 25, 2021     Accepted Jan 18, 2022     Published Feb 23, 2022

    Copyright© 2022 Wu Jianqing.
    License
    Creative Commons License   This work is licensed under a Creative Commons Attribution 4.0 International License. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

    Competing interests

    The authors have declared that no competing interests exist.

    Funding Interests:

    Citation:

    Wu Jianqing (2022) FDA Should Re-evaluate All MRNA Vaccines And Revoke Their Use Authorizations (The Short Version). International Journal of Coronaviruses. - 4(1):16-66
    DOI 10.14302/issn.2692-1537.ijcv-21-4053

    Introduction

    Introduction

    In 1941, FDA approved DES for human use without considering data on its long- term safety and resulted in a big health crisis that has not been over yet. In 1976, FDA approved Swine Flu vaccine quickly and caused 24% of the population to receive dangerous Swine Flu vaccine, which was found to damage the nerve system. From 2020 to now, FDA approved multiple RNA vaccines without considering long-term safety study, pharmacodynamic and pharmacokinetic data, and even without doing any serious analysis of potential dangers to humans. As a U.S. citizen, I have explored flaws in medicine on and off since 2001, and in the last five years, I have found ways to prove key flaws in the foundation of medicine. In the last two years, I tried to have my findings published, but monopolistic medical publishers and large media systematically suppressed my findings to protect their revenue. From my further study, I discovered that monopolistic medial publishers and monopolistic media have jointly laundered medical science information for decades. Their practices were known several decades before, but societies, government agents, public entities, and private citizens have accepted laundered science as best science. As a result, medical literature is filled with junk science, trade articles, wrong disease theories, information on dangerous drugs, aggressive treatments, and revenue making medical practices, etc. When the life model, core research model, and risk evaluation method are all wrong, nearly all accepted medical knowledge on treatments of chronic diseases are wrong or grossly inaccurate. Due to the business model used in science publishing, science merit of any research is measured by the amount of revenue it would generate for sponsors and publishers. Under the laundered medical knowledge, anything that does not generate revenue is “junk science”; and drugs and vaccines are the best medicine because they can generate the largest amounts of revenue.

    Over the years, FDA routinely relies on laundered science to make its decisions that can affect health and life of millions of Americans to potentially billions of people in the world. By relying on laundered science, FDA approved mRNA vaccines. I will prove the foundation of medicine is deeply flawed and summarily prove that all key evidence that FDA had relied on, including, risk model or risk factor, treatment effectiveness rate, and hazard ratio (e.g., adjusted rate ratio) are irrelevant to any persons, and capable of being massively inflated by manipulating small probabilities and concealing real dangers. The inflated benefits-to-risk ratio of the vaccines are magnitudes higher than their real values. After adjusting the benefits-to-risk ratio against all identified flaws and data manipulations over small probabilities, I must find that vaccines (as well as any drug approved in the past) impose unreasonable dangers with little real benefits, and short-term benefits observed in a small number of recipients are far lower than the noted dangers and expected risks that will realize in their life times. I thus urge FDA to suspend all mRNA vaccines use authorizations, reevaluate all mRNA vaccines under a new life model and new analytic framework, revoke all use authorizations, and preferentially make a first ban on their uses on human population.

    Affiliations:
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