Index Entries

Siguna Mueller
February 5, 2023

Mueller is an interdisciplinary, independent researcher with a PhD in Mathematics (summa cum laude, University of Klagenfurt) and a PhD in Biomedical Sciences (University of Wyoming).

"This book offers an analytical look at the much debated risks and benefits of the newly developed COVID-19 mRNA-vaccines. As such, it is one of the first books to give a comprehensive overview of mRNA vaccines against COVID-19 and the only one that addresses this topic from a broad multidisciplinary background. It brings together insights from various underlying disciplines on the challenges of developing and evaluating the most suitable vaccines for mass vaccination programs enrolled throughout the world - focusing on safety and efficacy. This book should not be missing on the shelf of any biomedical researcher, epidemiologist, public health professional or clinical researcher interested in SARS-CoV2 or virology and vaccine development in general." (source)

"Foreword

It all began on March 11, 2020, when WHO director general in his opening remarks at the media briefing on COVID-19.1 stated the following: 'In the past two weeks, the number of cases of COVID-19 outside China has increased 13-fold, and the number of affected countries has tripled. There are now more than 118,000 cases in 114 countries, and 4291 people have lost their lives... The area became even more demanding when an entire novel type of vaccine was introduced to fight the disease: mRNA vaccines.

The idea of writing this book came as an imperative to convey basic and applied scientific knowledge in a clear and organized form contributing to the understanding of the many open issues concerning this new medical initiative intended to save millions of people’s lives. Therefore, it is not a conventional book to be read only. It is rather a book that would act as a compass for the journey undertaken by anybody concerned or interested to understand the novel groundbreaking technology...

This book provides a clear guide to understand the basics and the applications of this new vaccine establishment and production technology. It offers necessary complementary reading material for a wide array of (semi-)professional and interested people involved in these aspects of vaccinology.

As a medical scholar and lifelong learner, I wish to thank Dr. Siguna Mueller sincerely for undertaking a Herculean task to walk the difficult path of loads of numerous published information, showing the way out through the challenges and opportunities of these mRNA vaccines in a clear and organized form.

Prof. Dr. P. Nicolopoulou Stamati, MD, PhD...

What This Book Is All About

... Overall, this book offers a comprehensive overview of mRNA vaccines that addresses the most important issues known so far but also highlights additional challenges and questions that to date have not received a lot of attention...  Again, it needs to be stressed that while the topic is complex, it is treated in a rational and unbiased way via the most rigorous scientific logic.

Much emphasis is also placed on how risks and benefits are evaluated, and the most critical component that is missing—the use of technology, and how it scales both benefits and harm...

Also included in the book are challenging issues involving attribution, diagnostics, reporting, transience of vaccine immunity, and causality assessment...

Later chapters in particular analyze which outcomes have been formally measured in trials and studies (and over how much time), which outcomes have been inferred, and what is known so far about the (in)effectiveness of vaccines to prevent SARS-CoV-2 infection, severe disease, and death."

(source)

Contents include: 

2 Appraisal of Some of the Key Postulates Underlying mRNA Vaccines

  • 2.3 The Assumption “Vaccine mRNAs do not integrate into the human genome”

3 Relevance for mRNA Vaccine Safety

  • 3.1 Detrimental Consequences of Type I IFN Stimulation and New Disease Patterns
  • 3.2 Cross-Reactivities, Vaccine Self-Adjuvancy, and Adverse Immune Responses
  • 3.3.1 Impairment of the Adaptive Immune System
  • 3.4 Contaminants of IVT Processing
  • 3.5 Dichotomous Immune Response and Attribution of Adverse Events
  • 3.6 The Real Potential of Creating Genetically Modified Humans

4 From Challenges to Opportunities and Open Questions

  • 4.1 Differentiating Whether Adverse Reactions Are Geared Against the Lipid Nanoparticles or Against Vaccine RNAs and Their Byproducts
  • 4.3 Guarding Against Cross-Reactivities and Aberrant Immune Responses
  • 4.4 Guarding Against Other Medium and Longer-Term Side Effects
  • 4.12 RNA Vaccines Need to Be Classified as Gene Therapies, with Corresponding Testing, Surveillance, and Long-Term Follow-up Practices

5 The Challenge of Evaluating Vaccine Safety and Effectiveness

6 Safeguarding Against the Analog of Antimicrobial-Resistance Development

  • 6.2.2 Selection by Neutralizing Antibodies May be a Key Driver to Induce a Viral Escape Mutant

7 Scales, Pseudoscales, the Human Factor, and a Way Forward

  • 7.2.1 The Pseudoscale PCR Positiveness
  • 7.2.6 Natural Immunity Versus Vaccine-Induced Immunity
  • 7.3.1 Contamination and Quality Control Are Distinctive Scaling Concerns 
  • 7.3.4 Scaling of Antibody-Driven Selection Pressure Leading to the Emergence of Viral Variants in Immune-Compromised Individuals
  • 7.3.5 Scaling of Antibody-Driven Selection Pressure Leading to the Emergence of New VOCs [variants of concern] In Vitro

8 mRNA Vaccine Safety and Efficacy—Official Criteria When AEs Are Caused by the Injection

9 mRNA Covid-19 Vaccines Best Reflect Effective Pharmaceuticals—Basic Considerations and LNPs

  • 9.4.1 LNPs Used for Preclinical Studies Are Highly Inflammatory and May Be Key Drivers of the Antibody Response

10 mRNA Covid-19 Pharmaceuticals and the Spike Antigen

  • 10.2.1 Spike Protein Fragments and Entire Spike Protein Detected in the Plasma of mRNA-1273 Vaccine Recipients
  • 10.2.3 Vaccine Spike and mRNA Found to Persist in Lymph Node Germinal Centers and Confirmed in the Blood of Vaccinated Individuals
  • 10.2.4 More Evidence That the Vaccine mRNA Is Not Degrading But Continues to Produce Protein
  • 10.3 Vaccine-Derived Products Are Not Limited to the Cytosol But Found in the Nucleus
  • 10.3.1 Reverse-Transcriptase Activity Following SARS-CoV-2 Infection or Injection
  • 10.3.2 In vitro, Pfizer Vaccine mRNA Becomes DNA in Liver Cells
  • 10.3.3 Spike Protein Goes to the Nucleus and Impairs DNA Repair

11 Other Facets of SARS-CoV-2 Immunity, the Risk of Immune Tolerance and T Cell Exhaustion

  • 11.2.3 mRNA Injections May Be Subject to Suppressor Functions of the Mucosal Immune System
  • 11.2.5 The Opposite: Boosters Evoking Hyperinflammatory Immune Responses
  • 11.3 T Cell Exhaustion
  • 11.3.1 The EMA Concern of Boosters Potentially Weakening the Immune System
  • 11.3.2 Plausibility of the Concern

 

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adverse events,COVID-19,gene therapy,immunodeficiency and immunopathological disorders,lipid nanoparticles,mRNA,natural immunity,polymerase chain reaction (PCR) testing issues,reverse transcription,SARS-CoV-2 spike protein,vaccine (or viral) immune escape (VIE),vaccine biodistribution,vaccine composition,vaccine ingredients,vaccine quality control,vaccines