Report 6: “Safe and Effective? We Beg to Differ. Red Flags in the Pfizer Internal Documents.”

Pfizer released the documents on their early efficacy and safety trials of their vaccine. (Pfizer 2.7.3 SUMMARY OF CLINICAL EFFICACY). https://phmpt.org/wp-content/uploads/2021/12/STN-125742_0_0-Section-2.7.3-Summary-of-Clinical-Efficacy.pdf.

The results of these documents are used to justify the claim the vaccines are safe and effective. Examine the document! It is evident beyond any doubt. Pfizer lied and misled; and upon this foundational lie, Moderna, and public health authorities, built the lie so big that it is believed alongside continual repetition that the mRNA vaccines are ‘safe and effective.’

Herein we will examine these claims, deconstruct them, and prove them false, using well-established foundational science.

Why did Pfizer want the original documents sealed for 75 years, buried in the labyrinth of the governmental archives, hidden in plain sight? After 75 years, the documents may be forgotten; or if not forgotten lost, and if found by some future scholar, stripped of their legal implication. Released after everyone who received the vaccine is dead. Released after those responsible for bringing this plague upon the world are dead. So, we ask: If there is nothing to hide, why hide it? And this is so curious as they are already immune from legal action under the mantle of the EUA (with the profound power of the Federal Government protecting them). But the EUA immunity has an Achilles heel: If the EUA was granted on fraud, the Government is immune from legal action, but Pfizer is not.

This brings us to the essential question: Is the vaccine safe and efficacious? An in-depth look at Pfizer’s own documents challenges these assertions. The evidence is in plain sight. The vaccines are not proven safe nor effective. We need to know that they knew, and when they knew it. But as medical professionals, there is a higher burden. If they did not know, but they should have known because the knowledge was published in peer review literature, have they committed medical malfeasance?

First, we must look at the difference between vaccine efficacy and vaccine effectiveness. There is similarity. Vaccine efficacy and vaccine effectiveness measure the proportionate reduction in cases among vaccinated persons. Vaccine efficacy is used when a study is carried out under ideal conditions, for example, during a clinical trial. Vaccine effectiveness is used when a study is carried out under typical field (that is, less than perfectly controlled) conditions (Principles of Epidemiology | Lesson 3 – Section 6 (cdc.gov)). A vaccine may show efficacy in a clinical trial but be utterly ineffective when introduced at a societal level. This non-effectiveness may be due to unanticipated safety concerns (aka, excessive adverse reactions reported) or more subtle immunological reasons due to immune imprinting (aka, doctrine of original antigenic sin)( Monto, A. S., Malosh, R. E., Petrie, J. G., & Martin, E. T. (2017). The Doctrine of Original Antigenic Sin: Separating Good from Evil. J Infect D https://doi.org/10.1093/infdis/jix173). In all cases, a vaccine can only be declared effective after widespread deployment at a societal level, and a risk/reward benefit has been determined. For a vaccine against a disease such as COVID-19, where the risk from the disease is only to a segment of the population, and the overall risk to society is extremely low, there needs to be essentially no risk or adverse reactions from the vaccine. Pfizer’s need to hire 2,400 personnel to deal with the unexpected adverse reactions of the vaccines, essentially precludes the designation of the vaccine as “effective”.

We have historical precedent to help us understand this. The CDC uses two primary systems to monitor the safety of vaccines. Vaccine Adverse Event Reporting System (VAERS) and Vaccine Safety Datalink (VSD). VAERS is an early warning system that helps CDC and FDA monitor problems following vaccination. VSD is a collaboration between CDC and eight integrated health care organizations. (Vaccine Safety Datalink VSD | Monitoring | Ensuring Safety | Vaccine Safety | CDC). In 1967, the usual seasonal flu was replaced by a more virulent strain known as H1N1 swine flu. A vaccine was brought to market to combat this variant. The result was an unacceptably high level of Guillain-Barre (a neurological dysfunction of ascending motor paralysis). The vaccine was withdrawn as non-effective. (Guillain-Barré syndrome and Flu Vaccine | CDC).( Breman, J. G., & Hayner, N. S. (1984). Guillain-Barré syndrome and its relationship to swine influenza vaccination in Michigan, 1976-1977. Am J Epidemiol, 119(6), 880-889. https://doi.org/10.1093/oxfordjournals.aje.a113810)

The interesting thing about COVID-19 is that we are told that the VAERS system is unreliable (Gorski, D. (2022, January 7). As 2021 shambles to a close, the misuse of VAERS by anti vaxxers continues apace. Science-Based Medicine. https://sciencebasedmedicine.org/as-2021-shambles-to-a-close-the-misuse-of-vaers-by-antivaxxers-continues-apace/). And yet, it is sponsored by the CDC and despite a multi-billion-dollar budget, never upgraded to fix its deficiencies. How does the CDC see the VAERS database? Healthcare providers are required by law to submit any adverse events following vaccination. (CDC) COVID-19 vaccination requires its own reporting. (CDC). VAERS system is seen as underreporting not overreporting adverse events. (CDC). So, which is it? Government incompetence, government malfeasance of the highest official public health figure in the land, or the current VAERS system is highly valuable? The only valid conclusion is that the CDC sees the current VAERS system as incredibly valuable.

Is the Pfizer vaccine (as well as Moderna and other vaccines) safe? There is a basic problem. Each vaccine has its own proprietary formula. The conflation of all the vaccines into the single heading “the vaccines are safe” is not warranted and care must be taken to designate which vaccine is under discussion.

There is a very high standard to declare a vaccine safe. This standard is higher for a vaccine than for a medication. (Santa Clara University, & Burrell, A. (2021, March 11). First, do harm: The ethics of human challenge trials for COVID-19 vaccine development. Markkula Center for Applied Ethics. Retrieved April 29, 2022, from https://www.scu.edu/ethics/healthcare-ethics-blog/first-do-harm-the-ethics-of-human-challenge-trials-for-covid-19-vaccine-development/) This is derived from the first principle of medicine “First, do no harm.” The physician assesses the patient, renders a diagnosis, and then prescribes medication. In the decision to prescribe a medication, the physician must balance the good of the medication against the harm of the medication against the disease of the individual. Several situations demonstrate the issue. A patient is suffering from cancer. The use of a chemotherapeutic agent may save the patient’s life but also may have serious and life-threatening side effects. A common dilemma for a physician is the patient suffering from a cold who demands an antibiotic. The physician knows the cold is due to a virus and will not respond to the antibiotic and so will not prescribe it for the cold. But he/she may reason that a cold often leads to a bacterial infection and an antibiotic will prevent that and so prescribes the antibiotic. If a healthy patient comes to a physician requesting medication, but in which the physician cannot find reasonable grounds to prescribe the medication, the physician is obligated not to give that patient medication as it violates the first principle. The reason is obvious. Every medication has a potential negative side effect. If the patient is healthy, and any medication is given, there is the potential to do harm. In the case of a vaccine the situation is fundamentally different. The patient is healthy and there is a desire to prevent disease. But the vaccine itself may have undesirable side effects. Any harm to the patient is now weighed against the good to society. If the vaccination is for a terrible plague such as smallpox or polio the answer is clear: Everyone is at risk. The diseases are devastating to everyone, and the side effects are minimal. Not giving the vaccine is harmful and so the first principle is violated. As such, the vaccination is offered to healthy people.

In the case of COVID-19, this standard is not reached. The disease is only harmful to a small segment of the population and that harm must be weighed against the potential harm of a vaccine to a much larger segment of the population not at risk. The question now presents itself: is there sufficient evidence that the COVID-19 vaccine is essentially harmless to the general population? The answer presents itself as it is summed up in the idiom, “the facts speak for themselves”. The demand of vaccine manufacturers against legal liability of their vaccines indicate that the manufacturers do not consider the vaccines safe. The need for Pfizer to hire 2400 full-time employees to evaluate adverse effects from the vaccine speaks for itself. The action by public medical officials to impeach the VAERS reporting system speaks for itself. The only valid conclusion: The Pfizer vaccine is not safe.

There are two paths that both lead to the conclusion that the Pfizer vaccine is not safe and effective. The first is the construction of the vaccine and the second is the construction of the study to evaluate the vaccine.

To start, let’s look at the vaccine. It is a marvel of biotechnology. It consists of four separate components. (Pardi, N., Hogan, M. J., Porter, F. W., & Weissman, D. (2018). mRNA vaccines – a new era in vaccinology. Nat Rev Drug Discov, 17(4), 261-279. https://doi.org/10.1038/nrd.2017.243). A mRNA core, surrounded by a lipid nanoparticle (ALC 0315 for Pfizer or SM-102 for Moderna; see diagram). This lipid nanoparticle is positively charged and will attach itself to the mRNA. It is surrounded by negatively charged PEG coating, and an emulsifier. The mRNA directs the cell to make the spike protein of the virus. The lipid nanoparticle, PEG and emulsifier helps get the mRNA into the cell. (Schlich, M., Palomba, R., Costabile, G., Mizrahy, S., Pannuzzo, M., Peer, D., & Decuzzi, P. (2021). Cytosolic delivery of nucleic acids: The case of ionizable lipid nanoparticles. Bioeng Transl Med, 6(2), e10213. https://doi.org/10.1002/btm2.10213),( Lipid Nanoparticle – Creative Biolabs (creative-biolabs.com), (Kowalski, P. S., Rudra, A., Miao, L., & Anderson, D. G. (2019). Delivering the Messenger: Advances in Technologies for Therapeutic mRNA Delivery. Mol Ther, 27(4), 710-728. https://doi.org/10.1016/j.ymthe.2019.02.012) Each component has its own use and its own potential hazard. Each component must be assessed for safety. And then the entire combination must be assessed for safety.

Verbeke, R., Lentacker, I., de Smedt, S. C., & Dewitte, H. (2019). Three decades of messenger RNA vaccine development. Nano Today, 28, 100766. https://doi.org/10.1016/j.nantod.2019.10076

Figure 1. Lipid components used in mRNA vaccine formulations

Source cited in report: CAS, Understanding Nanotechnology in COVID-19 Vaccines

Figure 2. mRNA lipid nanoparticle formulation

Source cited in report: Verbeke et al. (2019)

The basic dictum of toxicology, the study of body toxins, is that all things are potentially toxins, and it is the dose that makes the difference.( Grandjean, P. (2016). Paracelsus Revisited: The Dose Concept in a Complex World. Basic Clin Pharmacol Toxicol, 119(2), 126-132. https://doi.org/10.1111/bcpt.12622), (Frank, P., & Ottoboni, M. A. (2011). The dose makes the poison (3rd ed.). Wiley.). From this, two things follow: The mRNA directs the cell to make the spike protein of the virus (without making the entire viral particle). It is essential to demonstrate that the spike protein is innocuous. It is essential to demonstrate that the lipid nanoparticle delivery system is harmless.

Evaluation of the lipid nanoparticle delivery system: The lipid nanoparticle delivery system used for vaccines was initially designed to deliver medicines and for gene therapy. It is the mechanism used to deliver chemotherapy for brain tumors and is designed to penetrate the blood brain barrier. The blood brain barrier (BBB) protects the brain from environmental hazards, including medicines and pathogens, such as bacterial and viruses. This barrier is overcome by lipid nanoparticles.( Shankar, R., Joshi, M., & Pathak, K. (2018). Lipid Nanoparticles: A Novel Approach for Brain Targeting. Pharm Nanotechnol, 6(2), 81-93. https://doi.org/10.2174/2211738506666180611100416)

This is our first area of concern. Lipid based nano therapy is acceptable for chemotherapy to target highly malignant brain tumors because the inherent disease is so deadly to the patient that any negative side effect of the delivery system, except the immediate death of the patient, can be ignored. In this setting, they are considered less toxic than alternatives, but this does not mean they are not toxic to the brain. (Shankar, 2018, et al). The situation for a vaccine is fundamentally different. The recipient is healthy. Any evaluation of the safety of this delivery system for a vaccine needs to evaluate whether penetration of the blood brain barrier by the lipid nanoparticle delivery system conveys its own harm. Studies have proven that ENMs (engineered nanomaterials) that can cross or bypass the blood–brain barrier and then access the central nervous system, carry the potential of neurotoxicity (Ge D, Du Q, Ran B, et al. The neurotoxicity induced by engineered nanomaterials. Int J Nanomedicine. 2019;14:4167-4186. Published 2019 June 6. doi:10.2147/IJN.S203352). This evaluation was never done in the Pfizer safety and efficacy trials. Therefore, it is impossible to know whether the vaccine is safe in this arena. Pfizer did not prove the safety of the nano-lipid delivery system for the brain.

A second question is whether the COVID-19 virus can hitch a ride on the delivery vehicle to penetrate the brain during the period when someone may be infected, full of replicating virus, but asymptomatic. It is known that a carrier is likely to be infectious during the asymptomatic replication phase of the virus. It is also known that the virus is capable of directly infecting cells. This question remains unanswered as such an evaluation is never done by Pfizer.

We were told ad nauseam that the injection would stay at the injection site. However, it was known since the inception of lipid nanoparticle delivery systems that they enter the systemic circulation and can find their way to many end points.( Christensen, J., Litherland, K., Faller, T., van de Kerkhof, E., Natt, F., Hunziker, J., . . . Swart, P. (2014). Biodistribution and metabolism studies of lipid nanoparticle-formulated internally [3H]-labeled siRNA in mice. Drug Metab Dispos, 42(3), 431-440)

Figure 3. Extra- and intracellular barriers for mRNA delivery

Source cited in report: Kowalski et al. (2019)

This property of the mRNA/lipid nanoparticle delivery is utilized in many medications, and in fact, forms the basis of utilizing such delivery systems for chemotherapy for brain tumors, melanomas, and potentially other cancers(Lainé, A. L., Gravier, J., Henry, M., Sancey, L., Béjaud, J., Pancani, E., . . . Passirani, C. (2014). Conventional versus stealth lipid nanoparticles: formulation and in vivo fate prediction through FRET monitoring. J Control Release, 188, 1-8. https://doi.org/10.1016/j.jconrel.2014.05.042) (Kowalski, P. S., Rudra, A., Miao, L., & Anderson, D. G. (2019). Delivering the Messenger: Advances in Technologies for Therapeutic mRNA Delivery. Mol Ther, 27(4), 710-728. https://doi.org/10.1016/j.ymthe.2019.02.012) It is known almost from inception that the size of the lipo-nanoparticle and the exact chemical composition determine the distribution throughout the body and various tissues.(Lainé et al., 2014),( Hirsjärvi, S., Dufort, S., Gravier, J., Texier, I., Yan, Q., Bibette, J., . . . Coll, J. L. (2013). Influence of size, surface coating and fine chemical composition on the in vitro reactivity and in vivo biodistribution of lipid nanocapsules versus lipid nanoemulsions in cancer models. Nanomedicine, 9(3), 375-387. https://doi.org/10.1016/j.nano.2012.08.005). Therefore, it was known that the vaccine injection would not stay at the injection site. Stating that the vaccine would stay at the injection site is a lie of commission. As this information was not evaluated, it could not be concluded that the vaccine was safe.

The mRNA lipid nanoparticle is wrapped with PEG (also known as ALC 0159). PEG is utilized in many medications, as well as foodstuffs and cosmetics. The incidence of severe allergic reaction to PEG (known as anaphylaxis, a life-threatening event) is rising as PEG is becoming more common in the environment. (Troelnikov, A., Perkins, G., Yuson, C., Ahamdie, A., Balouch, S., Hurtado, P. R., & Hissaria, P. (2021). Basophil reactivity to BNT162b2 is mediated by PEGylated lipid nanoparticles in patients with PEG allergy. J Allergy Clin Immunol, 148(1), 91-95. https://doi.org/10.1016/j.jaci.2021.04.032),(Erdeljic Turk, V. (2021).

Anaphylaxis associated with the mRNA COVID-19 vaccines: Approach to allergy investigation. Clin Immunol, 227, 108748. https://doi.org/10.1016/j.clim.2021.108748) (Sellaturay, P., Nasser, S., Islam, S., Gurugama, P., & Ewan, P. W. (2021). Polyethylene glycol (PEG) is a cause of anaphylaxis to the Pfizer/BioNTech mRNA COVID-19 vaccine. In Clin Exp Allergy (Vol. 51, pp. 861-863). https://doi.org/10.1111/cea.13874),( Kim, M. A., Lee, Y. W., Kim, S. R., Kim, J. H., Min, T. K., Park, H. S., . . . Chang, Y. S. (2021). COVID-19 Vaccine-associated Anaphylaxis and Allergic Reactions: Consensus Statements of the KAAACI Urticaria/Angioedema/Anaphylaxis Working Group. Allergy Asthma Immunol Res, 13(4), 526-544. https://doi.org/10.4168/aair.2021.13.4.526). Although the consent form for the vaccine mentions the possibility of severe allergic reaction and anaphylaxis, it does not overtly tell the recipient that this is in the vaccine. If a person knows they have a PEG allergy, such a warning would warn them against receiving the vaccine. Likewise, the emulsifiers used in the vaccine delivery system may also induce an anaphylactic-like reaction. The vaccine is clearly not safe for someone who has an allergy to PEG and or related emulsifiers. The warning should be more overt.

The heart of the vaccine is modified mRNA. (Kim, S. C., Sekhon, S. S., Shin, W. R., Ahn, G., Cho, B. K., Ahn, J. Y., & Kim, Y. H. (2022). Modifications of mRNA vaccine structural elements for improving mRNA stability and translation efficiency. Mol Cell Toxicol, 18(1), 1-8. https://doi.org/10.1007/s13273-021-00171-4). mRNA tells the cell to produce the spike protein. The foundational technology for the vaccine was developed by Malone, et al. (Park, J. W., Lagniton, P. N. P., Liu, Y., & Xu, R. H. (2021). mRNA vaccines for COVID-19: what, why and how. Int J Biol Sci, 17(6), 1446-1460. https://doi.org/10.7150/ijbs.59233) mRNA produced by the body is rapidly degraded in the body. The vaccine mRNA is modified to resist the degradation mechanisms of the body.( Schoenmaker, L., Witzigmann, D., Kulkarni, J. A., Verbeke, R., Kersten, G., Jiskoot, W., & Crommelin, D. J. A. (2021). mRNA-lipid nanoparticle COVID-19 vaccines: Structure and stability. Int J Pharm, 601, 120586. https://doi.org/10.1016/j.ijpharm.2021.120586) Nevertheless, the mRNA vaccines are unstable. A special feature of mRNA is that even one change (strand break, or oxidation of the bases) in the long mRNA strand (typically between 1000 and 5000 nucleotides long) can stop translation.( Klauer, A. A., & van Hoof, A. (2012). Degradation of mRNAs that lack a stop codon: a decade of non stop progress. Wiley Interdiscip Rev RNA, 3(5), 649-660. https://doi.org/10.1002/wrna.1124). This makes mRNA vaccines quite different from other vaccines in which small changes of the antigens do not necessarily have a measurable effect on their efficacy. Consequently, for mRNA vaccines, it is critical to monitor the integrity of the full molecule and that the strict guidelines are followed when administering the vaccine. This is an impossible standard, given the large number of facilities and different level personnel administering the vaccine. The failure to set up routine quality assurance standards in the huge number of facilities administering the vaccine precludes an assessment of the appropriate handling of the vaccine to ensure stability. Therefore, it Is not correct to state that the vaccines are safe, as this aspect is not monitored.

The mRNA component was to be degraded within 48 hrs., but subsequent studies showed that it may persist for up to 8 weeks in draining lymph nodes(Turner, J. S., O’Halloran, J. A., Kalaidina, E., Kim, W., Schmitz, A. J., Zhou, J. Q., . . . Ellebedy, A. H. (2021). SARS-CoV-2 mRNA vaccines induce persistent human germinal center responses. Nature, 596(7870), 109-113. https://doi.org/10.1038/s41586-021-03738-2), (Röltgen, K., Nielsen, S. C. A., Silva, O., Younes, S. F., Zaslavsky, M., Costales, C., . . . Boyd, S. D. (2022). Immune imprinting, breadth of variant recognition, and germinal center response in human SARS-CoV-2 infection and vaccination. Cell, 185(6), 1025-1040.e1014. https://doi.org/10.1016/j.cell.2022.01.018) and continue to direct cells to make spike protein. The spike protein spills into the blood (coming from both spike protein production and the natural killing of cells making the spike protein by the immune system). The amount of spike protein in the blood is found in almost all vaccinated people after 1 to 2 days and in some maybe thousands of times higher than the spike protein reached by natural infection. ( (Röltgen K), 2022) In about 63% of the vaccinated the spike protein is still present after 7 days and may persist up to 28 days. After the second dose, the spike protein in the blood may bind to the antibody to form a complex and then attach to a cell surface and at normal blood barriers (blood vessels, kidney, blood brain barrier). The result is a type III hypersensitivity reaction. This results in inflammation and injury to the cells. If the reaction is at a joint, the result is arthritis. If the injury is directed against the kidney, it is glomerulonephritis. If the blood vessel is damaged the result is endotheliosis (inflammation of the cells lining the blood vessel or the blood vessel walls (vasculitis). Note due to antigen/antibody interaction, the spike protein may not be readily detectable in the blood. Evaluation of such injuries may take weeks to months and individuals receiving the vaccine should be alerted to these types of injuries, especially if they have an underlying immune condition. Failure to evaluate these adverse reactions and correct for the inability to detect the spike protein in the blood prior to marketing makes it impossible to declare the vaccination safe for such individuals.

At the heart of the vaccine is the spike protein. COVID-19 uses the spike protein to attach to and invade cells through the ACE2 receptor. The mRNA vaccines direct the body to make the spike protein, without making the entire virus, and thus initiate an immune response. The immune response is fundamentally different from natural infection. In natural infection the virus replicates in the upper respiratory tract (nose, nasopharynx, and throat). During this process the virus is attacked by the mucosal based immune system to make secretory IgA and simultaneously the virus is swallowed and initiates an IgM and then IgG response against the spike protein and other viral proteins. The mRNA vaccines only direct a response against the spike protein. The amount of spike protein initiated by the viral vaccines is significantly higher in some patients (thousands of times higher than natural infection), without the IgM and IgA components. This high level of spike protein in the protein can initiate antigen/antibody interactions and type III immune reactions, especially after the second dose. The failure to evaluate the inherent toxicity of the spike protein, and thus violate the prime principle of toxicology, precludes the statement that the vaccines are safe.

This begs the essential question: is the spike protein inherently toxic and is this toxicity dependent on the dose (level or titer) achieved? The fundamental rule in toxicology is “the dose makes the toxin.” (The dose makes the poison concept | toxicity. (2022, March 25). ChemicalSafetyFacts.Org. Retrieved April 30, 2022, from https://www.chemicalsafetyfacts.org/dose-makes-poison-gallery). The exact quote is from Paracelsus who said, “All things are poison, and nothing is without poison; only the dose makes a thing not a poison.” Why is this important? The failure to account for variation in dose and the difference in biological effect of the level of spike protein attained precludes a statement as to the safety of the vaccine for general use. The failure to assess the effect of the spike dependent on the level obtained strikes at the very heart of the principle of toxicology. If the vaccine induces a spike protein level several thousand times that of a natural infection, then the biological effect, “the toxin”, is likely to be profoundly different.

There are two issues at hand: the safety of the vaccine if it induced such a high level of spike protein and the efficacy of that antibody response. The spike protein is toxic to endothelial cells and to the blood brain barrier, without being part of the coronavirus. (Theoharides, T. C., & Conti, P. (2021). Be aware of SARS-CoV-2 spike protein: There is more than meets the eye. In J Biol Regul Homeost Agents (Vol. 35, pp. 833-838). Copyright 2021 Biolife Sas. www.biolifesas.org. https://doi.org/10.23812/theo_edit_3_21), (Dinetz, E. (2022). Case Series of Three Neurological Side Effects in Younger-Aged Individuals After Pfizer’s mRNA Vaccine. Cureus, 14(4), e23779. https://doi.org/10.7759/cureus.23779),( S, N. N., B, N. R., C, P., K, S. S., Ramakrishnappa, T., B, T. K., . . . Chandaragi, S. S. (2022). SARS-CoV 2 spike protein S1 subunit as an ideal target for stable vaccines: A bioinformatic study. Mater Today Proc, 49, 904-912. https://doi.org/10.1016/j.matpr.2021.07.163) This is the exact condition found with mRNA vaccination. Pfizer did not investigate the level of spike protein but only the neutralizing antibody response to the spike protein. The antibody response was equated to the effectiveness of the vaccine. This was never proven but taken as established fact. Many researchers pointed out that natural infection induced a T cell immunity not achieved by vaccination and measurement of the antibody response was insufficient to demonstrate immunity.

The spike protein consists of 2 subunits, called S1 and S2. S1 contains the RBD or Receptor Binding Domain that binds the ACE2 receptor. It is the target of the mRNA vaccine. (Dinetz, E. (2022). Case Series of Three Neurological Side Effects in Younger-Aged Individuals After Pfizer’s mRNA Vaccine. Cureus, 14(4), e23779. https://doi.org/10.7759/cureus.23779) (, N. N., B, N. R., C, P., K, S. S., Ramakrishnappa, T., B, T. K., . . . Chandaragi, S. S. (2022). SARS-CoV 2 spike protein S1 subunit as an ideal target for stable vaccines: A bioinformatic study. Mater Today Proc, 49, 904-912. https://doi.org/10.1016/j.matpr.2021.07.163) S1 is removed from the spike protein to allow activation of the S2 subunit which will allow the virus to fuse with the cell. The S1 subunit is then released into the circulation and ends up in an immune cell called a macrophage. In normal time, the job of the macrophage is to clean up the mess left after an immune response. But if the macrophage eats the S1 subunit, like Dr. Jekyll and Mr. Hyde, it transforms from short-lived cell that controls inflammation (the Dr. Jekyll) to a monstrous Mr. Hyde, that lives for a long time and initiates a vascular inflammatory response (Shirato, K., & Kizaki, T. (2021). SARS-CoV-2 spike protein S1 subunit induces pro-inflammatory responses via toll-like receptor 4 signaling in murine and human macrophages. Heliyon, 7(2), e06187. https://doi.org/10.1016/j.heliyon.2021.e06187). In turn, this initiates an inflammatory response against the endothelial cells, the cells that line the blood vessels, and results in an endothelialitis (Rotoli, B. M., Barilli, A., Visigalli, R., Ferrari, F., & Dall’Asta, V. (2021). Endothelial Cell Activation by SARS-CoV-2 Spike S1 Protein: A Crosstalk between Endothelium and Innate Immune Cells. Biomedicines, 9(9). https://doi.org/10.3390/biomedicines9091220) and vasculitis (Kar, B. R., Singh, B. S., Mohapatra, L., & Agrawal, I. (2021). Cutaneous small-vessel vasculitis following COVID-19 vaccine. In J Cosmet Dermatol (Vol. 20, pp. 3382-3383). https://doi.org/10.1111/jocd.14452).

Since the 1950s and the disastrous experience with thalidomide that was used during pregnancy, along with knowledge of the rapid tissue development that occurs with pregnancy, the adage has been to avoid every known noxious substance (such as alcohol and smoking) during pregnancy. As defects may be subtle and take years to manifest, normal vaccination evaluation requires years of follow up. During the Pfizer safety evaluation, no pregnancy evaluation is done. It was impossible to declare the vaccine safe for pregnant women. Later studies purported to show the safety of vaccination, but a close evaluation of the data showed a high abortion rate, if the vaccine was delivered before the 20th week(Shimabukuro, T. T., Kim, S. Y., Myers, T. R., Moro, P. L., Oduyebo, T., Panagiotakopoulos, L., . . . Meaney-Delman, D. M. (2021). Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons. N Engl J Med, 384(24), 2273-2282. https://doi.org/10.1056/NEJMoa2104983). Yet, many women were not informed of the lack of safety evaluation. Reports in VAERS show infant death following maternal vaccination if the infant was breast fed.

So, is the vaccine safe? How would one know? There is no testing of penetration of the blood-brain barrier. There is no testing of pregnant women. There is no testing as to whether the spike protein itself may have noxious effect. The failure to indicate PEG and emulsifiers as components of the vaccine, certainly make it unsafe for those who have such allergies.

COVID-19 was declared to be an emergency. This was used to justify the lifting or sidestepping of normal safeguards that dictate vaccine development. As our understanding of the disease evolved, it rapidly became evident that it was only a risk to the elderly and the obese. We were promised a vaccine to prevent disease and thereby protect our vulnerable population. This was an admirable goal if the vaccine prevented infection. During the Pfizer Efficacy Trials , it unequivocally demonstrated that the vaccine did not prevent infection. Of the 40,000 plus participants in the trial, only 170 were evaluated for efficacy of the vaccine. Of these 170 in primary efficacy results ( Table 5 Page 36), 8 were fully vaccinated and developed the disease, while 162 of the placebo group developed the disease.

During the trials, many patients were unblinded. Given the small number of patients evaluated for efficacy of the vaccine, any unblinding is likely to have altered the results. During the trial, approximately 400 participants did not receive the second dose, and another 400 participants were not fully vaccinated. (Table 48 Page 145) The explanation for this is incomplete. It suggests that many participants had sufficient adverse reactions to drop out of the trial or avoid the second dose. The small number of evaluated patients, the lack of clarity over unblinding and its effect on evaluation of efficacy strongly suggests that at best, the results are compromised and an example of self-deception, and at worst, an overt act of fraud. This raises the additional question: of the 20,000 placebo participants, only 162 developed disease! How much of an emergency could this virus be?

During the trials it was also evident that between 5% and 20% of the population was already infected with COVID-19. This large number of infections indicated that lockdowns would be ineffective at controlling the disease. In a recent interview with Dr. Anthony Fauci, he acknowledged this fundamental truth of immunology and epidemiology. Dr. John Ioannidis, an eminent epidemiologist from Stanford University, early in the pandemic, told us that at least 5% of the population was already infected (and by implication, any lockdown would be ineffective). The three main authors of the Great Barrington Declaration, eminent and world-renowned epidemiologists told us so, and how best to address the issue.

The conclusions are evident. There are two types of sins: the overt sin of commission and the occult sin of omission The overt sin of commission is blatant lying. The occult sin of omission is more subtle but aptly summed up as “lying with the truth”. Both were committed by Pfizer, Moderna and public health authorities.

There was no evaluation of vaccine penetration on the brain or distant organs, such as the ovary, or whether it passed through the placenta to the baby in the mother’s womb, or in her breast milk to her infant. The evaluation of spike protein in the blood with the formation and effect of high levels of IgG antibody as a cause of Type III immunological injury was never done.

The failure to point out the deficiencies of the study that were likely to alter the results was never done. In the absence of such evaluation, it is impossible to conclude that the vaccine was safe. The vaccine was never demonstrated to be effective or efficacious. The vaccine did not prevent disease. And the disease itself was nowhere near as big a threat to population as promoted by public health authorities and echoed in the chambers of the media.