Interesting Studies and Documents

21 July 2020
Army Contracting Command — New Jersey, ACC-NJ, Building 9, Picatinny Arsenal, NJ 07806
SUBJECT: Technical Direction Letter for Medical CRBN Defense Consortium (MCDC), Request for Prototype Proposals (RPP) 20-11, Objective PRE-20-11 for “COVID-19 Pandemic — Large Scale
Vaccine Manufacturing Demonstration” (Pfizer, Inc.)
REF: Prizer Request for Technical Direction Letter, RPP 20-11 under OTA W15QKN-16-9-1002 for
Objective PRE-20-11, dated 20 July 2020

The total approved cost to the Government for the Operation Warp Speed (OWS) Prototype Projects, to deliver “Large Scale Vaccine Manufacturing Demonstration” by Pfizer, Inc., is not to exceed $1,950,097,500.00:
– $1,950,000,000.00 to perform project efforts included in the SOW
– $97,500.00 for the Consortium Management Firm (CMF) Administrative Cost
DATED AS OF 30 March 2021
“Purchaser acknowledges that the Vaccine and materials related to the Vaccine, and their
components and constituent materials are being rapidly developed due to the emergency
circumstances of the COVID-19 pandemic and will continue to be studied after provision
of the Vaccine to Purchaser under this Agreement. Purchaser further acknowledges that
the long-term effects and efficacy of the Vaccine are not currently known and that there
may be adverse effects of the Vaccine that are not currently known
. Further, to the extent
applicable, Purchaser acknowledges that the Product shall not be serialized” (Page 23)
FOOD AND DRUG ADMINISTRATION (FDA) Center for Biologics Evaluation and Research (CBER)
162nd Vaccines and Related Biological Products Advisory Committee (VRBPAC) Meeting
OPEN PUBLIC MEETING, December 10, 2020

In the record of a meeting in December 2020, Food and Drug Administration adviser Dr. Patrick Moore stated, “Pfizer has presented no evidence in its data today that the vaccine has any effect on virus carriage or shedding, which is the fundamental basis for herd immunity.”
Pfizer BNT162B2 vaccine post-marketing safety report. Listing of Adverse EffectsOut of 50 pregnant women, who participated in Pfizer’s mRNA COVID vaccine post-marketing trial, 22 (44%) suffered miscarriages.
CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021After the initial distribution of 126,212,580 doses, there were a total of 182,138 adverse event reports received, including 1.223 deaths, and 1291 adverse side effects of special interest comprising a 9 pages long list.
Taking into account a typical underreporting rate (98%) and generously assuming that all 130M doses distributed were also administered, yields a very conservatives ~ 0.05% (1 in every 2000) fatality rate caused by Pfizer, according to Pfizer itself.
Why a Judge Ordered FDA to Release Covid-19 Vaccine Data Pronto
Kerr L, Baldi F, Lobo R, et al. (August 31, 2022) Regular Use of Ivermectin as Prophylaxis for COVID-19 Led Up to a 92% Reduction in COVID-19 Mortality Rate in a Dose-Response Manner: Results of a Prospective Observational Study of a Strictly Controlled Population of 88,012 Subjects. Cureus 14(8): e28624. doi:10.7759/cureus.28624Regular Use of Ivermectin as Prophylaxis for COVID-19 Led Up to a 92% Reduction in COVID-19 Mortality Rate. Non-use of ivermectin was associated with a 12.5-fold increase in mortality rate and a seven-fold increased risk of dying from COVID-19 compared to the regular use of ivermectin.
Formiga, Fabio Rocha, et al. “Ivermectin: An Award-Winning Drug with Expected Antiviral Activity against COVID-19.” Journal of Controlled Release, vol. 329, 10 Jan. 2021, pp. 758–761,, 10.1016/j.jconrel.2020.10.009.Ivermectin is an FDA-approved broad-spectrum antiparasitic agent with demonstrated antiviral activity against a number of DNA and RNA viruses, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Ivermectin was also identified as a promising agent against the alphaviruses chikungunya, Semliki Forest and Sindbis virus, as well as yellow fever, a flavivirus [5]. Moreover, a new study indicated that ivermectin presents strong antiviral activity against the West Nile virus, also a flavivirus, at low (μM) concentrations [6].
Tuvali, Ortal et al. “The Incidence of Myocarditis and Pericarditis in Post COVID-19 Unvaccinated Patients-A Large Population-Based Study.” Journal of clinical medicine vol. 11,8 2219. 15 Apr. 2022, doi:10.3390/jcm11082219Post COVID-19 infection was not associated with either myocarditis (aHR 1.08; 95% CI 0.45 to 2.56) or pericarditis (aHR 0.53; 95% CI 0.25 to 1.13). We did not observe an increased incidence of neither pericarditis nor myocarditis in adult patients recovering from COVID-19 infection.
Kerr L, Baldi F, Lobo R, et al. (August 31, 2022) Regular Use of Ivermectin as Prophylaxis for COVID-19 Led Up to a 92% Reduction in COVID-19 Mortality Rate in a Dose-Response Manner: Results of a Prospective Observational Study of a Strictly Controlled Population of 88,012 Subjects. Cureus 14(8): e28624. doi:10.7759/cureus.28624Ivermectin has been proposed as potential prophylaxis and therapy for coronavirus disease 2019 (COVID-19) due to its previously reported anti-viral [1-4], metabolic [5-10], and anti-inflammatory [11-19] actions, with strong plausibility [20,21] and positive in vitro, in vivo, and epidemiological findings [22-24] in preliminary studies, as well as extensive, well-established safety profile and known absence of risks with long-term use.
Fraiman, Joseph et al. “Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults.” Vaccine vol. 40,40 (2022): 5798-5805. doi:10.1016/j.vaccine.2022.08.036Moderna lowered the chance of COVID hospitalization by -6.4 per 10,000, but INCREASED the risk of a serious adverse event by +15.1 per 10,000. Therefore, vaccine net risk of a bad outcome increased by +8.7 per 10,000 by taking the Moderna shot.
Pfizer lowered the chance of COVID hospitalization by -2.3 per 10,000, but INCREASED the risk of a serious adverse event by +10.1 per 10,000. Therefore, vaccine net risk of a bad outcome increased by +7.8 per 10,000 by taking the Pfizer shot.
Yamamoto, Kenji. “Adverse effects of COVID-19 vaccines and measures to prevent them.” Virology journal vol. 19,1 100. 5 Jun. 2022, doi:10.1186/s12985-022-01831-0…immune function among vaccinated individuals 8 months after the administration of two doses of COVID-19 vaccine was lower than that among the unvaccinated individuals.
The decrease in immunity can be caused by several factors such as N1-methylpseudouridine, the spike protein, lipid nanoparticles, antibody-dependent enhancement, and the original antigenic stimulus. These clinical alterations may explain the association reported between COVID-19 vaccination and shingles.
Irrgang P, Gerling J, Kocher K, Lapuente D, Steininger P, Habenicht K, Wytopil M, Beileke S, Schäfer S, Zhong J, Ssebyatika G, Krey T, Falcone V, Schülein C, Peter AS, Nganou-Makamdop K, Hengel H, Held J, Bogdan C, Überla K, Schober K, Winkler TH, Tenbusch M. Class switch towards non-inflammatory, spike-specific IgG4 antibodies after repeated SARS-CoV-2 mRNA vaccination. Sci Immunol. 2022 Dec 22:eade2798. doi: 10.1126/sciimmunol.ade2798. Epub ahead of print. PMID: 36548397.High levels of neutralizing SARS-CoV-2-antibodies are an important component of vaccine-induced immunity. Several months after the second vaccination, SARS-CoV-2-specific antibodies were increasingly composed of non-inflammatory IgG4, which were further boosted by a third mRNA vaccination and/or SARS-CoV-2 variant breakthrough infections. IgG4 antibodies among all spike-specific IgG antibodies rose on average from 0.04% shortly after the second vaccination to 19.27% late after the third vaccination… Importantly, this class switch was associated with a reduced capacity of the spike-specific antibodies [IgG1 and IgG3] to mediate antibody-dependent cellular phagocytosis and complement deposition.
Kisielinski, Kai, et al. “Possible Toxicity of Chronic Carbon Dioxide Exposure Associated with Face Mask Use, Particularly in Pregnant Women, Children and Adolescents – a Scoping Review.” Heliyon, Mar. 2023, p. e14117Fresh air has around 0.04% CO₂, while wearing masks for more than 5 minutes causes chronic exposure to carbon dioxide levels between 1.41% to 3.2% in mask-filtered air. Repeated exposure to higher levels of CO₂ increase the risks of a long list of serious problems including stillbirths, low sperm production, cognitive impairment, and permanent mental declines, especially in children.

The results are remarkably consistent with another mask study, which concluded that long COVID symptoms might actually be “long mask” syndrome, which they dubbed MIES, or “mask-induced exhaustion syndrome.”
Uversky, V.N.; Redwan, E.M.; Makis, W.; Rubio-Casillas, A. IgG4 Antibodies Induced by Repeated Vaccination May Generate Immune Tolerance to the SARS-CoV-2 Spike Protein. Vaccines 202311, 991. [R]ecent investigations have found abnormally high levels of IgG4 in people who were administered two or more injections of the mRNA vaccines… [E]merging evidence suggests that the reported increase in IgG4 levels detected after repeated vaccination with the mRNA vaccines may not be a protective mechanism; rather, it constitutes an immune tolerance mechanism to the spike protein that could promote unopposed SARS-CoV2 infection and replication by suppressing natural antiviral responses. Increased IgG4 synthesis due to repeated mRNA vaccination with high antigen concentrations may also cause autoimmune diseases, and promote cancer growth and autoimmune myocarditis in susceptible individuals.
SARS-CoV-2 Uses CD4 to Infect T Helper LymphocytesWe demonstrated that SARS-CoV-2 spike glycoprotein (S) directly binds to the CD4 molecule, which in turn mediates the entry of SARS-CoV-2 in T helper cells. This leads to impaired CD4 T cell function and may cause cell death. SARS-CoV-2-infected T helper cells express higher levels of IL-10, which is associated with viral persistence and disease severity. Thus, CD4-mediated SARS-CoV-2 infection of T helper cells may contribute to a poor immune response in COVID-19 patients.
McKernan, Kevin, et al. “Sequencing of Bivalent Moderna and Pfizer Mrna Vaccines Reveals Nanogram to Microgram Quantities of Expression Vector Dsdna Per Dose.” OSF Preprints, 10 Apr. 2023. Web.Besides being extremely problematic due to large quantities of DNA found in the vials, the most alarming finding was the SV40 promoter in the DNA plasmid sequence. This part was not disclosed by Pfizer to the regulators.
Pfizer encoded an undisclosed “gene” into the DNA matrix from which mRNA is being made for covid injections. Then they left this raw material in the final product. The purpose of this undisclosed component is to ensure that whatever it is attached to is delivered not just into the cell, but into the cell’s nucleus (where the human DNA resides).
Biodistribution of mRNA COVID-19 vaccines in human breast milk – eBioMedicine“Our findings demonstrate that the COVID-19 vaccine mRNA is not confined to the injection site but spreads systemically and is packaged into breast milk extracellular vesicles.”
“Initially, it was thought that the vaccine mRNA encapsulated in LNPs would remain localized at the injection site and quickly degrade. However, several reports suggest that the LNPs/mRNA can enter the bloodstream and accumulate in distant tissues.”
What the data says [sic], by Steve KirschNo vaccine was ever needed. They make things worse
Nobody could name a single study proving that ANY vaccine given today in the US is safe, i.e., it kills fewer than 1 person per 1 million doses.
Not a single state will voluntarily release the record-level data needed to determine safety and efficacy
Child mask mandates for COVID-19: a systematic reviewWe screened 597 studies and included 22 in the final analysis. The six observational studies reporting lower infection rate had critical (n=5) or serious (n=1) risk of bias confounded by important differences between masked and unmasked groups and two were shown to have non-significant results when reanalysed. Sixteen other observational studies found no association between mask wearing and infection or transmission.
Conclusions Real-world effectiveness of child mask mandates against SARS-CoV-2 transmission or infection has not been demonstrated with high-quality evidence. The current body of scientific data does not support masking children for protection against COVID-19.
Foreign DNA in mRNA vaccineThe debate over DNA contamination in mRNA vaccines, as summarized in this paper, underscores the urgent need for further investigation into the reliability of the technological production process, the standardization of measurement methods and quality assurance thresholds, as well as the assessment of the long-term effects of such therapeutics.
For products designed for future global use, diligence and thoroughness should be paramount.
And questions remain:
Why are mRNA vaccine manufacturers silent on this issue?
Why aren’t the authorities taking action to refute or gain more clarity on the results and concerns raised by independent labs and scientists through their own manufacturer-independent experimental investigations?
Parry, Peter I et al. “’Spikeopathy’: COVID-19 Spike Protein Is Pathogenic, from Both Virus and Vaccine mRNA.” Biomedicines vol. 11,8 2287. 17 Aug. 2023, doi:10.3390/biomedicines11082287Key problem areas appear to be (1) the toxicity of the spike protein—both from the virus and also when produced by gene codes in the novel COVID-19 mRNA and adenovectorDNA vaccines [1,2], hence the novel term ‘spikeopathy’; (2) inflammatory properties of certain lipid-nanoparticles used to ferry mRNA [3]; (3) N1-methylpseudouridine in the synthetic mRNA that causes long-lasting action [4]; (4) widespread biodistribution of the mRNA [5] and DNA [6,7] codes via the lipid-nanoparticle and the viral-vector carrier matrices, respectively and (5) the problem of human cells producing a foreign protein in our ribosomes that can engender autoimmunity [8,9].
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