The Stages in Understanding the modRNA Jabs

my journey in understanding the totality of the multi-layered, complex structure and multiple activities of the jab

I thought I’d share my journey in understanding these complex products. I am not sure I quite understand everything, but I am not sure anyone else does frankly. Including Moderna and Pfizer. And that is pretty scary.

In my journey I made a conscious decision to not examine the protein expressed in detail, that is what the spike protein does in the body. This is well covered by others, so I concentrated on what I call the pharmacological phase (after all, it is my training), and present this mostly in point form.

Stage 1: it is a ‘vaccine’

1. injection and draining into the lymph nodes

2. regular ordinary mRNA goes into cells

3. something something something

4. spike protein is produced

5. epitopes on cells

6. immune response and lovely lovely ANTIBODIES, SCHMANTIBODIES

Well I wasn’t in this stage long, if at all, but it is mind boggling to me that many docs still are, and have no curiosity regarding the “something, something, something” phase. This product has a pharmacological phase and an immunological phase and each phase is multilayered and complex. But we need to understand this first. I was struggling to explain this concept until I heard the term “pro-drug” which leads to the next stage. Oh and I knew from the beginning that the jab does not stay in the arm due to the lipid coating. All drugs given IM eventually drain into the vascular system and are eliminated.

Stage 2: the mRNA as a drug

• drug substance and drug product concept

  • drug substance is the modRNA

  • drug product is the final product injected into people

• modRNA as a drug

  • I applied the concepts of structure-activity relationships

  • each part does something and how does it differ from the original or natural form?

  • codon-optimization and its risks

  • N-1-methylpseudouridine and other changes (3’UTR and poly (A) tail, etc)

• synthetic nature of the modRNA

  • how does it break down? I could not find an answer

  • how long does it last?

• purity and manufacturing

  • fragmented and truncated modRNA what do they do?

  • contaminants especially dsRNA (DNA was not on my radar then)

  • endotoxin

• Process 1 vs Process 2

  • lack of comparability and possible effects

  • guidelines for assessing such changes in manufacturing were not applicable to the modRNA vaccines? Implications?

• protein expression

  • this was a big one, spent weeks learning about Western blots

  • what protein was being produced? Errors and risks for autoimmunity

  • protein produced was considered “proprietary” and we are only NOW obtaining evidence of frameshifting etc when this risk and others were identified at approval

  • how long does it last?

Stage 3: it is a gene therapy product

• review of federal and international guidelines

  • discovery that GTP for vaccines excluded from the GTP

• necessary non-clinical and clinical studies avoided using WHO 2005 guidelines

• what are known and unknown risks from the synthetic mRNA

• biodistribution issues and how it differs from normal kinetics

  • what are the requirements if the vaccine was reviewed as a GTP for biodistribution?

• Onpattro, and approved GTP with LNPs used as a template

  • what was studied and how

  • what I discovered specifically that exosomes are formed and extruded into the environment

  • need for shedding studies

I remember telling people about Onpattro as a template and that exosomes form and are shed and that this is likely happening with the vaccine in early 2022 but was ignored or disbelieved. I already had a good idea about the biodistribution issues and that the studies done to date were unreliable.

Stage 4: the LNPs as a carrier for the synthetic mRNA

• learning that the A plus B concept was incorrect

  • the LNPs were not an inert carrier for the mRNA, they were integral and had pharmacological activity on its own (other than as a transfection agent), AND in combination with the modRNA

• toxicity and manufacturing

  • the nature of the synthetic lipids and how they are manufactured

  • their intrinsic toxicity and biodegradability

  • contamination issues

  • molar ratios and its implications

  • stability, agglomeration, particle size

  • risk of CARPA and other effects from the pegylated lipids

• adducts and safety

  • contamination with metals including arsenic

  • discovery of Moderna’s paper regarding late migrating peaks and adducts

  • implications for cancer

• biodistribution in detail, and lies, lies, lies uncovered

• beginning of understanding the LNPs and their properties

Stage 5: DNA/SV40 contamination

• already in stage 2 I was looking at manufacturing, batch analysis, and contamination

  • did this explain the variability in patient response and toxicity?

• but here was objective proof that the products were contaminated and adulterated

• guidelines or DNA measurement, risk analysis

• obtaining vials and arranging for analysis and subsequent reporting and preprint

• review of analytical methodology issues for DNA as well as all other contaminants, and quality parameters

• compendial standards and further structured training from United States Pharmacopoeia (which was excellent)

  • review of changes in methodology from Process 1 to Process 2

  • RNA measurement and poly (A) tail measurement in particular

Stage 6: Transfection

• how transfection makes this product a GMP and how DIFFERENT this is from all other drug therapies and technologies

• cellular distrubances

• the steps from transfection to modRNA translation in detail

• discovery that release from endosomes is the rate limiting step

  • storage in endosomes and toxicity

  • only 2% of all LNPs result in protein expression, what happens to the other 98%?

• shedding is real and environmental risk and how this was known beforehand and laws changed to avoid required studies

How to explain what transfection really is?

Stage 7: Nanoparticles

• the nature of nanoparticles

  • quantum effects!!

  • optical effects (likely the cause of the ‘glowing’ in the vials due to the optical effects of concentrated LNPs)

  • physical and chemical effects

• analytical methodology still debated; no one knows how to measure the LNPs

  • Moderna freely admits they have no idea what the LNPs look like, their activity in the body

  • each LNP is different? LNPs with blebs, multilamellar structure, amorphous mix all exist at the same time in the same vial?

• the biomolecular corona

  • provides a biological identity

  • changes what is happening inside the LNPs

  • unpredictable and can’t be measured in vivo

• nanoparticle toxicity as a nanoparticle separate from toxicity due to the lipids themselves

• almost sentinent, unpredictable, unknowable, unmeasurable

Stage 8: The jabs are synthetic viruses

• stealth nature of biocorona coated particles

  • body sees the particles as “natural”

• snythetic biology in the cell; reaction to synthetic nature of both the modRNA and lipids

• structure of the LNPs mimic a virus with a protein coating, lipid shell and nucleic acid material within

• unknown effects

  • possibility that the reponse to the jabs are as variable or more so than the variability in the manufacturing

  • combining both the “pharmacological” aspect and the batch variability could result in the an adverse rate of 0 to death with no predictability (like age, sex, weight etc)

I am here

Whew.

There are other chunks I’ve reviewed and discussed but are not mentioned here. Where is everyone in this journey? Have I missed any other big black holes?

And at this point, we have not even talked about the spike protein and any post translational modifications, presentation on the cell surface, whether a trimer is ever made etc etc.

Discuss

Oh and pray the rosary