Preface

[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; taken together with COVID 19 infection and vaccine toxicity: high rates of severe 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 mRNA 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 claims first place in causing mortality and possibly 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.

^{Vaccine-Induced Fatality is Equal to or Greater than the Risk of a COVID death?}
Hard to believe, but based on statistical analysis of published data, Dopp 2022 Dopp 2022 came to the following conclusion: 

"... Altogether, the data show a COVID inoculated person is more likely to die within 30 to 60 days of “vaccination” than an unvaccinated person is to die of COVID 19 within 60 days of a positive COVID test, in all age cohorts under 60 years old...

COVID vaccine inoculations increase risk of death and produce a net negative benefit, aka increased risk of death … for all age groups younger than 60 years old. In other words, the COVID inoculations cause a net increase, rather than decrease, in the likelihood of death for all persons under 60 years old. 

For those over 60 years old, the benefit of COVID inoculations is negligible, ranging from a 0.0016% reduction in likelihood of death for a 60- to 69-year-old persons to a 0.125% reduction in likelihood of death for those over 80 years old. Because preventative treatments are often given to well persons, a vaccine is supposed to provide very small risk compared to benefit

Thus, such high fatality risks (VFRs) versus low benefit of risk reduction (ARRs) from the COVID inoculations are not acceptable..."

COVID 19 Vaccine Mortality Rate (VMR) and Infection Fatality Rate (IFR) (Pantazatos 2021, Levin 2020)

Consistent with Dopp 2022,Pantazatos 2021 estimated vaccine mortality rate (VMR), also known as vaccine fatality rate (VFR), to be 0.04 (1 in 2500) adjusted from the CDC 0.002 (factor of 20 difference): compared to the .35 (1 in 280) infection fatality rate (IFR), making the vaccine only approx 9 times less fatal overall. 

Most age stratified VMR estimates are lower bound estimates compared to overall VMR of .04 (1 in 2500).

VMR and IFR converted to 1 over denominator rounded:

Age       VMR                Age       IFR                    VMR         IFR

0-17      1 / 22,000        0-34      1 / 25,000          .0045         .004

18-29    1 / 14,700                                               .0068        

30-39    1 / 11,000        35-44     1 / 1,470           .0091         .068 

40-49     1 / 9500          45-54     1 / 434              .105           .23

50-64     1 / 6300          55-64     1 / 133              .0157         .75

65-74     1 / 2240          65-74     1 / 40                .0445         2.5

75-84     1 / 1640          75-84     1 / 12                .0604         8.5

85+        1 / 1750           85+       1 / 4                  .0577         28.3

overall  1 / 2500           overall   1 / 280 

While other factors may have contributed to increased all cause mortality exceeding that attributed to direct COVID infection (CDC 2021), Panzatatos 2021 estimated 133,000-187,000 vaccine caused deaths during the Feb-Aug 2021 rollout.

The Dopp 2022, Panzatatos 2021 estimates could be held as controversial, however, 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 determined when more hearts stop beating in correlation with the number and timing of vaccination doses. 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.

Vaccines Do Not Prevent Spread 

Panzatatos 2021: "...A recent July CDC study in Barnstable, MA reported a majority (75%) of COVID infections were among fully vaccinated people in an area with 69% vaccination coverage, with similar viral loads between vaccinated and unvaccinated (50). The US CDC has officially recognized that the vaccines do not prevent transmission or spread of the virus (5). Given that vaccines do not reduce community spread and that the risks to the individual outweigh the benefits for most age groups, vaccine mandates in workplaces, colleges, schools and elsewhere are ill-advised..."

Vaccination: An Individual Risk Level Decision

The Moderna coauthored safety profile below (Hou 2021), published after the vaccine rollout, admits safety concerns; but accompanied with crafty language and promises. Taken together with the Ndeupen 2021 independent animal study at Thomas Jefferson University, there is less surprise that the mRNA vaccines may have a high VMR. 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; the mRNA LPN delivery system is not appropriate for the wider public in low COVID IFR risk categories. 

It is an individual risk level decision likely only appropriate for those having comorbidities. The data show that more vaccinated people die of COVID than unvaccinated people do; partly because there are greater numbers of vaccinated people, but also comorbidity has a big role so that it is often difficult to tell if an individual died of comorbidity while having tested positive for COVID, or because of COVID. VMR, IFR, and other information presented here may assist in making a decision.

The mRNA-LNP Platform is 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)...

Preface: Covid 19 Vaccines, Not for Sissies

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..."

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)..."

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)..."

Mauro P.M. Codon Optimization in the Production of Recombinant
Biotherapeutics: Potential Risks and Considerations. BioDrugs 32:69-81 2018

"...Numerous studies indicate that the scientific bases for codon optimization (chemical modifications of specific IVT mRNA nucleotides as mentioned above) in mammals 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]..."

^{Dopp K. & Seneff S.  COVID-19 and All-Cause Mortality Data by Age Group Reveals Risk of COVID Vaccine-Induced Fatality is Equal to or Greater than the Risk of a COVID death for all Age Groups Under 80 Years Old as of 6 February 2022 
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} 

^{Panzatatos S, & Seligmann H. COVID vaccination and age-stratified all-cause mortality risk. Research Gate Preprint 2021}