Preface A

[michael edward badolato jr]

Preface: Covid 19 Vaccines, Not for Sissies

Widespread comorbidity exists: largely degenerative disease resulting from specified junk food (SJF), lack of weight bearing (walk, run) exercise (LE), air pollution, and drug use; with COVID 19 infection and vaccine toxicity: higher rates of illness and fatality.

COVID 19 earlier (2020) overall infection fatality rate estimated .35 (1 in 280), mostly concerns those having comorbidity; leaving many people in a risk category 1 in 1500 or less; most have little or no symptoms from COVID 19; however, the vaccine lipid nanoparticle delivery with encased mRNA is designed to persist in circulation, resisting the immune system as it penetrates cells of a healthy person, and may cause mortality or shortened life expectancy. On contrast, with  comorbidity compromising immune response, COVID 19 may exceed the hazard of vaccination. It makes sense that a healthy person can resist COVID 19, but not the vaccine side effects, because vaccine delivery is designed to defeat the healthy immune system.

COVID 19 Vaccine Mortality Rate (VMR) and Infection Fatality Rate (IFR) 

A general observation, the COVID 19 infection fatality rate is clustered in high risk older age comorbidity categories; and vaccine mortality rate may be high, strongly suggesting that healthy people may be better off not taking the vaccine.

While other factors may have contributed to increased all cause mortality exceeding that attributed to direct COVID infection, it appears that vaccine caused death may be part of the increase. Death is when the heart stops beating due to a variety of causes that may be spurred on by the vaccine: it doesn't carry a sign "vaccination caused death". Vaccine mortality rate (VMR) can be estimated when more hearts stop beating in correlation with the number and timing of vaccination doses and reported adverse events. It is much more difficult to estimate vaccine caused shortened life expectancy. It is widely known that drug use side effects are among the leading causes of death in the US.

It is also true that many vaccinated people are classified as dying of COVID; partly because there are great numbers of vaccinated people, but also comorbidity has such a big role that it is often difficult to tell if an individual died of comorbidity while having tested positive for COVID, or because of COVID. 

Vaccines Do Not Prevent CommunityTransmission 

If a COVID vaccine prevents illness requiring hospitalization, that helps reduce exposure to health care workers, however, a July 2021 CDC study of a holiday gathering in Barnstable, MA reported a majority of COVID infections were among fully vaccinated people in an area with majority vaccination coverage, with similar viral loads between vaccinated and unvaccinated. The US CDC has officially recognized the vaccines do not prevent transmission or spread of the virus. 

Vaccination: An Individual Risk Level Decision

The Moderna coauthored safety profile below (Hou 2021), published after the vaccine rollout, admits safety concerns. Taken together with the Ndeupen 2021 independent animal study at Thomas Jefferson University, may suggest the mRNA lipid nanoparticle vaccines, and perhaps the others, have a high VMR since concerns include mRNA and resulting spike protein common to all. Hou 2021 also included review of mRNA lipid nanoparticle (LPN) development with invasive procedures such as direct injection into heart or brain. These are last resort applications; an individual risk level decision, the mRNA LPN delivery system may not be appropriate for the wider public in low COVID IFR risk categories. 

The mRNA-LNP Platform is Reported Highly Inflammatory

Ndeupen 2021:

The nucleoside-modified mRNA-LNP vaccine platform used by Pfizer/BioNTech and Moderna in their SARS-CoV-2 vaccines has been widely tested in preclinical studies, and its effectiveness in supporting Tfh cells and protective humoral immune responses matches or surpasses other vaccines (Alameh et al., 2020). These vaccines’ mRNA component is nucleoside modified to decrease potential innate immune recognition (Kariko´ et al., 2005; Kariko´ et al., 2008). The LNP was chosen as a carrier vehicle to protect the mRNA from degradation and aid intracellular delivery and endosomal escape. The LNPs consist of a mixture of phospholipids, cholesterol, PEGylated lipids, and cationic or ionizable lipids. The phospholipids and cholesterol have structural and stabilizing roles, whereas the PEGylated lipids support prolonged circulation. The cationic/ionizable lipids are included to allow the complexing of the negatively charged mRNA molecules and enable the exit of the mRNA from the endosome to the cytosol for translation (Samaridou et al., 2020)...

Using complementary techniques, we show that in mice intradermal, intramuscular, or intranasal delivery of LNPs used in preclinical studies triggers inflammation characterized by leukocytic infiltration, activation of different inflammatory pathways, and secretion of a diverse pool of inflammatory cytokines and chemokines. Thus, the inflammatory milieu induced by the LNPs could be partially responsible for reported side effects of mRNA-LNP-based SARS-CoV-2 vaccines in humans and are possibly  contributory to their reported high potency for eliciting antibody responses...

In summary, using different techniques, we show that LNPs, alone or complexed with control noncoding poly-cytosine mRNA, are highly inflammatory in mice, likely through the engagement and activation of various distinct and convergent inflammatory pathways...

In a matter of hours, the lungs turned red in color in the LNP-inoculated group... As was observed for the skin and muscle, flow cytometric analyses revealed significant leukocytic infiltration dominated by neutrophils and eosinophils and a decrease in macrophages and certain dendritic cell (DC) subsets...Thus, intranasal delivery of LNPs leads to massive inflammation in the lungs...

People often present with more severe and systemic side effects after the booster shot. This raises the possibility that the adaptive immune response might somehow amplify side effects induced by the vaccine. One culprit identified so far is PEG, which is immunogenic. Antibodies formed against PEG have been reported to support a so-called anaphylactoid, complement activation-related pseudoallergy (CARPA) reaction (Kozma et al., 2020; Szebeni, 2005, 2014)...
Although mRNA mainly transfects cells near the injection site, it could hypothetically reach any cell in the body (Maugeri et al., 2019; Pardi et al., 2015). The resulting translated protein could be presented on MHC-I in the form of peptides, or displayed as a whole protein in the cell membrane. In both cases, cells with the vaccine peptide/ protein on their surfaces could be targeted and killed by cells of the adaptive and innate immune system: CD8+ T, and natural killer (NK) cells (via antibody-dependent cellular toxicity [ADCC]), respectively.

It has been reported that the mRNA from Moderna’s mRNA-LNP vaccine injected intramuscularly could be detected in very low levels in the brain, potentially indicating that the mRNA-LNP platform might cross the blood-brain barrier and reach the CNS (Moderna 2021)...

it will be necessary to strike a balance between positive adjuvant and negative inflammatory properties as LNP-associated vaccines move forward..."

Preface: Covid 19 Vaccines, Not for Sissies

Moderna Refers to Safety Concerns

Hou 2021:

"...The safety profile of lipid nanoparticle–mRNA formulations correlates with the lipid components and mRNA molecules. Lipid components may activate host immune responses following systemic or local administration; for example, PEG-lipids could induce hypersensitivity reactions by stimulating the complement system (127,169). Moreover, anti-PEG antibodies could result in fast systemic clearance of subsequently administered PEGylated nanoparticles by accelerated blood clearance (127,169). The accelerated blood clearance phenomenon may change the bioavailability and biodistribution of the drug encapsulated in PEGylated nanoparticles and, thus, cause side effects (127,169). To ameliorate safety concerns, numerous natural and synthetic polymers have been investigated as alternatives to PEG, of which several are under evaluation in clinical trials (127,169).
Cationic and ionizable lipids have also been reported to stimulate the secretion of pro-inflammatory cytokines and reactive oxygen species (170–173). Although the immunogenicity of these lipids has not yet been fully understood, complement system and Toll-like receptors may participate in innate immune activation (170,173–175).

Cytotoxicity of lipid materials is also a safety concern, depending on the dose, lipid properties and cell types (176,177). In vivo application of lipid nanoparticles has been reported to induce liver and lung injuries in rodents (170,173), which may be attributed to the cytotoxicity of the materials and the induction of pro-inflammatory factors (171,178).
To improve the biocompatibility of lipid nanoparticles, biodegradable lipids can be applied (76–78,108,179). The immunogenicity of IVT mRNA is another safety concern, although eliciting cellular and humoral immunity may be advantageous for vaccination. Nevertheless, immune responses to IVT mRNA may also suppress antigen expression and negatively affect vaccine efficacy (175,180,181). Moreover, immune activation is undesirable for some mRNA applications, such as protein replacement therapies and genome editing. 

To minimize the immunogenicity of mRNA, two approaches are commonly used. Chemical modifications of specific IVT mRNA nucleotides, such as pseudouridine (ψ) and N1 -methylpseudouridine (m1ψ), can reduce innate immune sensing of exogenous mRNA  translation (2,4,7,182, [Nucleosides have a nitrogenous base and a five-carbon carbohydrate group, usually a ribose molecule. Nucleotides are a nucleoside with one or more phosphate groups attached]).

Chromatographic purification can remove doublestranded RNA, an analogue of viral genome, in IVT mRNA preparations, diminishing immune activation and increasing translational efficiency (2,4,7,183).

The IVT mRNA molecules used in the mRNA-1273 and BNT162b2 COVID-19 vaccines were prepared by replacing uridine with m1ψ (17,19,21), and their sequences were optimized to encode a stabilized pre-fusion spike protein with two pivotal proline substitutions (17,19,21)..."

Codon Optimization May Have Side Effects

Mauro 2018: 

"...An unintended consequence of codon optimization is that it disrupts different types of information that overlap coding regions, which can affect local rates of translation elongation, lead to alterations in protein conformation, and increase immunogenicity...

...Numerous studies indicate that the scientific bases for codon optimization in mammals (chemical modifications of specific IVT mRNA nucleotides as mentioned above) are poorly supported; because of this, it is difficult to justify the use of codon optimization as a tool for bioproduction of therapeutic proteins. The question that therefore needs to be asked is why is codon optimization still commonly used? One possible reason is that in some cases, higher levels of protein expression are required for clinical trials and commercialization, and these expression levels can sometimes be obtained by using codon-optimized mRNAs—regardless of the underlying mechanism. Unfortunately, some of the potential problems associated with codon optimization, which can affect protein function and increase immunogenicity, may not be seen until the drug is in late stage clinical trials, or after the drug is on the market [99]..."

Be Intentional About Health

Seeing a doctor is sometimes essential, but often life threatening. Do not take medical advice unless fully understanding and in agreement. Make it your decision. Medications, a leading cause of death, are overused in the United States. Improving lifestyle is preferred: most conditions result from a touch of genetics combined with diet/exercise habits (SJF, LE), and an ambient combustion aerosol (ACA) promoting insidious neurodegeneration. Details and overall context matter. You want to learn and be intentional about health. Taking good care is our responsibility.

^{Hou X. et al. Lipid nanoparticles for mRNA delivery. Nature Reviews/Materials 6:1078-84 2021}

^{Mauro P.M. Codon Optimization in the Production of Recombinant
Biotherapeutics: Potential Risks and Considerations. BioDrugs 32:69-81 2018 Ndeupen S. et al. The mRNA-LNP platform’s lipid nanoparticle component used in preclinical vaccine studies is highly inflammatory. https://doi.org/10.1016/j.isci. 2021.103479 iScience 24, 103479, December 17, 2021 ª 2021} 

Preface Data on the Following Pages

USDA SR28 Page Reports:

Collards, Kale, Brussels Sprouts, Broccoli, Cauliflower,

Brown Rice, Light Tuna canned in water

Nationwide mapping of Airport, County, National Park visibility and pollutant measurements