Traditional Vaccines
Traditional vaccines enter the blood stream and typically use a live, but weakened virus, or a dead virus, or a small, less-harmful segment of a live virus or bacteria, in order to stimulate the body’s natural immune response.
Experimental Gene Therapy Covid-19 Vaccines
The current Covid-19 “vaccines” all use novel mRNA or adenovirus technology to enter into cells in order to stimulate a genetic immune response in which the cell, using its own DNA, is programed to create the spike protein. In fact, the messenger RNA (mRNA) reprograms the user’s body to produce at least portions of the very same toxic spike proteins that constitute the pathogenic SARS-Cov-2 virus in an effort to arm the user’s immune defenses against a known enemy. Whereas adenovirus programing, such as found in the Johnson & Johnson (Janssen) vaccine uses nonenveloped DNA viruses (a DNA vaccine) or fragments to infect a wide range of the user’s cells to produce the same or similar spike proteins as the mRNA vaccines do. In the case of all three Covid 19 Vaccines, the injectables cause a user’s genome to produce abnormal S proteins (Spike Proteins), which are now known and demonstrated to cause mitochondrial damage and fragmentation. In short, all three Covid 19 Vaccines cause the user’s body to produce or over produce S-proteins which represent abnormal growth. On this basis alone, injury to the user’s genome may well be prospectively barred by the Americans with Disabilities Act (ADA), whether such user was disabled at the time of the injection or not.
NOTE: Both mRNA and Adenovirus vaccines have never been tested or used in humans until now.
NOTE: Both mRNA and Adenovirus vaccines have never been tested or used in humans until now.
How Experimental Gene Therapy mRNA Covid-19 Vaccines Work (Moderna/Pfizer)
Disclaimer: The video above includes unsubstantiated claims of safety and efficacy. Clinical trials on Covid-19 are still being conducted. The video above is only to be used educational purposes on how mRNA vaccine technology works.
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How Experimental Gene Therapy Adenovirus Covid-19 Vaccines Work (Johnson&Johson/Astrazeneca)
Disclaimer: The video above includes unsubstantiated claims of safety and efficacy. Clinical trials on Covid-19 are still being conducted. The video above is only to be used educational purposes on how Adenovirus vaccine technology works.
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Experimental Gene Therapy Vaccine Risks
Information Provided By Dr. Jane Ruby Via Military TRO against DOD HHS FDA Pages 37-58.
10. To demonstrate both safety and efficacy, the FDA “typically requires three phases of clinical trials” for vaccines. Phase I trials include small numbers of healthy volunteers, perhaps a few dozen to a hundred. Phase 2 studies usually involve a slightly larger cohort and looks for short-term reactions to the vaccine. Phase 3 studies are supposed to be the most robust, both in terms of numbers of participants and in the scientific rigor that the products are required to meet. All of these studies are planned in advance and submitted for approval to the FDA. In Phase 3 studies, hundreds or thousands of volunteers participate. Vaccinated people are compared with people who have received a placebo or another vaccine so researchers can learn more about the test vaccine’s safety and effectiveness and identify common side effects.
11. The Pfizer-BioNtech BNT162b Covid-19 vaccine (the “EUA Pfizer Vaccine”) conducted Phase 1 and 2 trials. After their completion, Pfizer submitted a protocol for a Phase III, blinded, placebo-controlled trial lasting two years and involving 44,000 volunteers. The study’s scheduled end date was in mid-2023, to allow adequate time to follow the vaccine recipients and determine if there were intermediate to long-term side-effects from the vaccine, particularly considering that the mRNA technology for a vaccine has (a) never been approved by the FDA in 3 CDC website, last accessed on Aug. 26, 2021 - https://www.cdc.gov/vaccines/hcp/conversations/ensuring-safe-vaccines.html this is also an oversimplification as there will always be pre-clinical animal studies before vaccines are ever tested on human beings. 4 Id. 5 Id. Case 1:21-cv-02228-STV Document 7 Filed 08/30/21 USDC Colorado Page 6 of 19 7 its history, and (b) never been used on large cohorts of people.
12. The COVID-19 genetic modification vaccines (Pfizer, Moderna, J&J) failed to test for genotoxicity, mutagenicity, teratogenicity, and oncogenicity. In other words, it is unknown whether or not these products will change human genetic material, cause birth defects, reduce fertility, or cause cancer. Of concern, one manufacturer publicly declares on their website the mechanism of action of their mRNA as follows: “[g]enerally, the only thing that changes from one potential mRNA medicine to another is the coding region – the actual genetic code that instructs ribosomes to make protein. Utilizing these instruction sets gives our investigational mRNA medicines a software-like quality. We also have the ability to combine different mRNA sequences encoding for different proteins in a single mRNA investigational medicine.” (Source: https://www.modernatx.com/mrna-technology/mrna-platform-enablingdrug-discovery-development ). To my knowledge, there is no informed consent to the public advising that they are submitting to a permanent change in their native genetic sequencing or any of their natural genetic material.
13. When compared to other, standard package inserts/labeling, there is an absence of a description of the molecular structure of the biologic. This is a further failure to disclose to medical prescribers the formula and molecular weight.
14. In the human trial for Pfizer-BioNTech Covid-19, the protocol lists a significant number of exclusions whereby subpopulations and those with certain conditions could not enter the trial; therefore there is no controlled trial data and this should render any mandates for those populations as contraindications. These populations or conditions are missing from the final Approval label (See Exhibit B).
They are as follows:
a. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
b. Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
c. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention(s).
d. Receipt of medications intended to prevent COVID 19. Case 1:21-cv-02228-STV Document 7-1 Filed 08/30/21 USDC Colorado Page 38 of 198
e. Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19.
f. Individuals at high risk for severe COVID-19, including those with any of the following risk factors:
h. Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (e.g., healthcare worker, emergency response personnel).
j. Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention.
k. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
l. Women who are pregnant or breastfeeding.
m. Previous vaccination with any coronavirus vaccine. (These did not exist at the time and, in my opinion, still do not exist).
n. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, e.g., for cancer or an autoimmune disease, or planned receipt throughout the study.
o. Regular receipt of inhaled/nebulized corticosteroids.
p. Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.
q. Participation in other studies involving study intervention within 28 days prior to study entry through and including 6 months after the last dose of study intervention, with the exception of non-Pfizer interventional studies for prevention of COVID 19, which are prohibited throughout study participation.
r. Previous participation in other studies involving study intervention containing lipid nanoparticles.
s. Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit. Case 1:21-cv-02228-STV Document 7-1 Filed 08/30/21 USDC Colorado Page 39 of 198
t. Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality.
u. Positive test for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs) at the screening visit.
v. SARS-CoV-2 NAAT-positive nasal swab within 24 hours before receipt of study intervention. w. Less than 12 years of age. this is particularly significant because PfizerBioNTech companies have requested EUA for <12 years of age, including 2- 11 year olds with no randomized, controlled study data and no proof of Human Subjects Review Board evaluation and approval.
15. The COVID-19 genetic modification vaccines (Pfizer, Moderna, J&J) failed to disclose or conduct and/or include any study results for standard pre-licensing safety that would adequately and at a minimum inform prescribers and patients of serious considerations. These findings are, by good standard practices, included in the package insert, commonly referred to as the Label. The missing studies and results include key information such as:
a. Pharmacokinetics – studies on the fate of the drug after administration:
18. The COMIRNATY product that has been deemed (https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-covid-19- vaccine-COMIRNATYr-receives-full) to “have the same formulation [as the Pfizer-BioNTech Covid-19 Vaccine] and can be used interchangeably to provide the Covid-19 vaccination series,” was granted full FDA approval, licensed, and labeled with the Indication “to prevent Covid-19 in individuals 16 years of age and older.” This is in contrast to the a priori primary endpoint in the study protocol (See Exhibit C). Case 1:21-cv-02228-STV Document 7-1 Filed 08/30/21 USDC Colorado Page 42 of 198
19. Relative to #17, the companies declare that the COMIRNATY product, while the same formulation, is currently “unavailable,” in direct contradiction to Pfizer’s statement that COMIRNATY was used in over 20,000 people in 2021. (See Exhibit B, Pfizer Package Insert).
20. The FDA approval letter for COMIRNATY, dated August 23, 2021, from RADM Denise Hinton to Pfizer that has been used by the Department of Defense to claim that there is now a “fully licensed vaccine”, constitutes a “deceptive or misleading statement” about a product as that term is used in regards to marketing or labeling a drug or vaccine. Until a vaccine has shown the requisite safety, efficacy, and potency requirements by rigorous scientific studies, the vaccine simply has not passed muster as a “fully licensed” or “fully FDA approved” product.
21. The FDA’s approval letter clearly states that a different vaccine, manufactured by BioNTech Manufacturing GmbH in Germany and known as COMIRNATY, is being approved as a fully licensed vaccine. In this same letter, RADM Hinton also extends the Emergency Use Authorization for the Pfizer BioNtech vaccine. Later in the same letter, RADM Hinton states that the BioNtech vaccine is the equivalent to the COMIRNATY vaccine, while they are “legally distinct”, that no safety or efficacy concerns are present, and that because of the lack of availability of the COMIRNATY vaccine that the Pfizer BioNtech is allowed to be substituted in place of the approved COMIRNATY vaccine. This is all done without any evidence as to how the BioNtech vaccine can be declared safe or effective when it has not even completed a successful Phase III trial. (See Exhibit E for FDA Guidance Document on requirements for Phase 3 trials; https://www.fda.gov/media/87621/download
22. There are four phases to human trials in drug development and Phase 3 is most critical as it comprises the last phase of testing to be completed before the drug's details and clinical trial results are submitted to the regulatory authorities for approval of the drug's release on the open market. While Phase 1 focuses on tolerability and safety in a small number of healthy subjects and Phase 2 establishes efficacy and optimal dosing regimen, Phase 3 should demonstrate and confirm the preliminary evidence gathered in the previous trials that the entity is, a safe, beneficial and effective treatment for the intended indication. The absence of findings from this part of the study as well as from the missing elements enumerated in Sections 15 and 16 violate FDA Guidance Expectations for proper review submission and approval.
23. The COVID-19 genetic vaccine companies (Pfizer, Moderna, J&J) have not provided complete FDA or the public disclosure on their vaccine boxes, package inserts or labels for all of the ingredients within these injection vials. Vis a vis fundamental human rights, governed by International Law and the Nuremberg Code of 1947, the vaccine-specific ingredient information is critical, required and necessary to know so that any human can make an informed decision whether or not to consent to inoculation. Case 1:21-cv-02228-STV Document 7-1 Filed 08/30/21 USDC Colorado Page 43 of 198
24. The Pfizer, Moderna, and J&J vaccines are considered “genetic vaccines”, or vaccines produced from gene therapy molecular platforms which, according to US FDA regulatory guidance, are classified as gene delivery therapies and should be under a fifteen-year regulatory cycle with annual visits for safety evaluation by the research sponsors. (Long Term Follow-up After Administration of Human Gene Therapy Products. Guidance for Industry. FDA-2018-D2173. 2020. Accessed July 13, 2021, at https://www.fda.gov/regulatory-information/search-fdaguidance-documents/long-term-follow-after-administration-human-gene-therapy-products.
25. The FDA has “advised sponsors to observe subjects for delayed adverse events for as long as fifteen years following exposure to the investigational gene therapy product, specifying that the long-term follow-up observation should include a minimum of five years of annual examinations, followed by ten years of annual queries of study subjects, either in person or by questionnaire.” (emphasis added). Thus, the administration of the Moderna, Pfizer, and J&J vaccines should not be undertaken without the proper consent and arrangements for long-term follow-up which are currently not offered in the US. (See, EUA briefing documents for commitments as to follow up: Moderna, Pfizer, J&J).
26. The “vaccines” have a dangerous mechanism of action, as indicated by the inventor of the technology, Dr. Robert Malone, who has stated that they force the body to make an uncontrolled quantity of a computer-generated facsimile of the pathogenic wild-type spike protein from the SARS-CoV-2 virus for an indefinite period of time. This is unlike any and all other vaccines in the entire history of immunization, which have always contained a partial antigen or live-attenuated virus. This means that, with respect to the Pfizer, Moderna, and J&J vaccines, there is no way to predict among patients who will produce more or less of the spike protein because this measure was not included in any preclinical or clinical safety studies.
27. The spike protein itself has been demonstrated to injure vital organs such as the brain, heart and lungs, as well as damage blood vessels and directly cause blood clots. Additionally, because these vaccines infect cells within these organs, the generation of spike protein within heart and brain cells, in particular, causes the body’s own immune system to attach to these organs. This is abundantly apparent with the burgeoning number of cases of myocarditis or heart inflammation among individuals below age 30 years. See, infra ¶ 48 - 54.
28. Because the US FDA and CDC have offered no methods of risk mitigation or proof of continued safety surveillance for these serious adverse effects which can lead to permanent disability or death, no one should be pressured, coerced, receive the threat or reprisal, or be mandated to receive one of these investigational products against their will. Because the vaccine centers, CDC, FDA, and the vaccine manufacturers ask for the vaccine recipient to release them from all liability and agree to full indemnification in their favor on the consent form before injection, all injuries incurred by the person are at their own cost which can be prohibitive depending on the needed procedures, hospitalizations, rehabilitation, and medications. Case 1:21-cv-02228-STV Document 7-1 Filed 08/30/21 USDC Colorado Page 44 of 198
29. In general, it is never good, nor standard, nor reasonable clinical practice to widely utilize novel biological products in populations who have not been tested in registration trials. With respect to the COVID-19 vaccines, these unstudied populations include COVID-19 survivors, those with prior suspected COVID-19 infection, those with positive SARS-CoV-2 serologies, pregnant women, and women of childbearing potential who cannot assure contraception.
30. It is never good, nor standard, nor reasonable research practice to perform a largescale clinical investigation without the necessary structures in place to ensure the safety and protection of human subjects. These structures include a critical event committee, data safety monitoring board and human ethics committee. These groups in large studies work to objectively assess the safety of the investigational product and research integrity. The goal is to mitigate risk and protect human subjects. It is my understanding that the COVID-19 vaccine program sponsored by the CDC and FDA has implemented none of these crucial safety structures which, to my knowledge, have never before been omitted from any large-scale clinical investigation, not to mention that the subject clinical investigation is of far greater and unprecedented magnitude and complexity than any of its predecessors. It is my assessment that the COVID-19 clinical investigation has provided no meaningful risk mitigation for subjects (restricting groups, a special assessment of side effects, or follow-up visits) to ensure or improve the safety of the program. COVID-19 Vaccine Risks and Reporting
31. The COVID-19 public vaccination program operated by the CDC and the FDA is a clinical investigation and not scheduled to conclude until mid-2023 and under no circumstance can any person, including the military servicemen who protect and defend this country, receive pressure, coercion, or threat of reprisal with respect to their free choice of participation. Violation of this principle of autonomy by any entity constitutes reckless endangerment with a reasonable expectation of causing personal injury resulting in damages.
32. In 1990, the Vaccine Adverse Event Reporting System (“VAERS”) was established as a national early warning system to detect possible safety problems with U.S. licensed vaccines. VAERS is a passive reporting system, meaning it relies upon individuals to voluntarily send in reports of their experiences to the CDC and FDA. VAERS is useful for detecting unusual or unexpected patterns in adverse event reporting that might indicate a possible safety problem with a vaccine. It is known to err on the side of under-reporting as demonstrated by the Harvard Pilgrim Health System study (See Exhibit E) that found “less than 1% of vaccine adverse events were reported” to VAERS. Case 1:21-cv-02228-STV Document 7-1 Filed 08/30/21 USDC Colorado Page 45 of 198
33. The total safety reports in VAERS for all vaccines up to 2019 was 16,320. The total safety reports in VAERS for COVID-19 vaccines alone through June 18, 2021, was 387,288. Based on VAERS, as of July 16, 2021, there were 11,405 COVID-19 vaccine deaths and 36,117 hospitalizations reported for the COVID-19 vaccines (Pfizer, Moderna, J&J). Currently, as of August 20, 2021, VAERS has reported an astounding 623,343 adverse events and 13,627 deaths. By comparison, from 1999 until December 31, 2019, VAERS received 3,167 death reports (158 per year) for all vaccines combined. Thus, the COVID-19 mass vaccination is associated with at least a 39-fold increase in annualized vaccine deaths reported to VAERS.
34. The COVID-19 vaccines are not safe for general use and cannot be deployed indiscriminately or supported, recommended, or mandated among any group; this is particularly dangerous for the military who are the frontline of protection and preservation for this nation.
35. According to expert medical opinion, there are emerging trends demonstrating that any Covid-19 vaccine is especially risky for those in the 12 – 29 year-old demographic, with resulting complications in the cardiovascular, neurological, hematologic, and immune systems. (See, Rose J, et al). Increasingly, the medical community is acknowledging the possible risks and side effects inclusive of myocarditis, Bell’s Palsy, Pulmonary Embolus, Pulmonary Immunopathology and severe allergic reaction causing anaphylactic shock. See Chien-Te Tseng, Elena Sbrana, Naoko Iwata-Yoshikawa, Patrick C Newman, Tania Garron, Robert L Atmar, Clarence J Peters, Robert B Couch, Immunization with SARS coronavirus vaccines leads to pulmonary immunopathology on challenge with the SARS virus, https://pubmed.ncbi.nlm.nih.gov/22536382/ (last visited June 21, 2021); Centers for Disease Control and Prevention, Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine—United States, December 14–23, 2020 (Jan 15, 2021), https://www.cdc.gov/mmwr/volumes/70/wr/mm7002e1.htm (last visited June 26, 2021).
36. The Centers for Disease Control has held emergency meetings on this issue and the medical community is responding to the crisis. It is known that myocarditis causes injury to heart muscle cells and may result in permanent heart damage culminating in heart failure, arrhythmias, and cardiac death. These conditions could call for a lifetime need for multiple medications, implantable cardio defibrillators, and heart transplantation. Heart failure has a fiveyear 50% survival and would markedly reduce the lifespan of a child or young adult who develops this complication after vaccine-induced myocarditis (McCullough PA, Philbin EF, Spertus JA, Kaatz S, Sandberg KR, Weaver WD; Resource Utilization Among Congestive Heart Failure (REACH) Study. Confirmation of a heart failure epidemic: findings from the Resource Utilization Among Congestive Heart Failure (REACH) study. J Am Coll Cardiol. 2002 Jan 2;39(1):60-9. doi: 10.1016/s0735-1097(01)01700-4. Case 1:21-cv-02228-STV Document 7-1 Filed 08/30/21 USDC Colorado Page 46 of 198
37. COVID-19 vaccine-induced myocarditis has a predilection for young males below age 30 years, a substantial demographic of the US military. The Centers for Disease Control has held emergency meetings on this issue, the medical community is responding to the crisis, and the US FDA has issued a warnings on the Pfizer and Moderna vaccines “Fact Sheet for Patients and Caregivers,” the apparent substitute for an official, and comprehensive Informed Consent document, for myocarditis. Given the prevalence of this event in younger males, no individual under age 30 under any set of circumstances should feel obliged to take this risk with the current genetic vaccines, particularly the Pfizer and Moderna products. https://www.fda.gov/newsevents/press-announcements/coronavirus-COVID-19-update-june-25-2021.
38. Multiple recent studies and news reports detail young adults, ages 18-29, dying from myocarditis after receiving the COVID-19 vaccine. According to the CDC, 475 cases of pericarditis and myocarditis have been identified in vaccinated citizens aged 30 and younger. See FDA, Vaccines and Related Biological Products Advisory Committee June 10, 2021, Meeting Presentation, https://www.fda.gov/media/150054/download#page=17 (last visited June 21, 2021).
39. The FDA found that young people ages 12-24 account for 8.8% of the vaccines administered; yet this demographic comprises 52% of the cases of myocarditis and pericarditis reported through May 31, 2021. Id. Table 5: VAERS Report
40. Furthermore, the CDC announced on June 24, 2021, that the vaccine is “likely linked” to myocarditis. “Advisory Board, CDC panel reports ‘likely association’ of heart Case 1:21-cv-02228-STV Document 7-1 Filed 08/30/21 USDC Colorado Page 47 of 198 inflammation and mRNA COVID-19 vaccines in young people,” (June 24, 2021) https://www.advisory.com/daily-briefing/2021/06/24/heart-inflammation.
41. On July 12, 2021 the US FDA sent out an additional warning for Guillain-Barre Syndrome or ascending paralysis for the J&J vaccine which is not predictable and, when it occurs, can result in ascending paralysis, respiratory failure, the need for critical care and death. Not all cases completely resolve, and some vaccine victims may require long term mechanical ventilation, or become quadra- or paraplegics. Prolonged neurological rehabilitation is commonly required, and this will call for time away from school and studies for those children injured from the J&J vaccine with Guillain-Barre Syndrome. https://www.fda.gov/media/150723/download Risks of COVID-19 Vaccines for Those Recovered from COVID-19
42. There is recent research demonstrating that the COVID-19 vaccine is dangerous for those who have already had COVID-19 and recovered with inferred robust, complete, and durable immunity. These patients were excluded from the FDA-approved clinical trials performed by Pfizer, Moderna, and J&J. From these trials the safety profile was unknown when the products were approved for Emergency Use Authorization in 2020. There has been no study demonstrating clinical benefit with COVID-19 vaccination in those who have well documented or even suspected prior COVID-19 illness.
43. To my knowledge, there are no studies that demonstrate the clinical benefit of COVID-19 vaccination in COVID-19 survivors or those with suspected COVID-19 illness or subclinical disease who have laboratory evidence of prior infection.
11. The Pfizer-BioNtech BNT162b Covid-19 vaccine (the “EUA Pfizer Vaccine”) conducted Phase 1 and 2 trials. After their completion, Pfizer submitted a protocol for a Phase III, blinded, placebo-controlled trial lasting two years and involving 44,000 volunteers. The study’s scheduled end date was in mid-2023, to allow adequate time to follow the vaccine recipients and determine if there were intermediate to long-term side-effects from the vaccine, particularly considering that the mRNA technology for a vaccine has (a) never been approved by the FDA in 3 CDC website, last accessed on Aug. 26, 2021 - https://www.cdc.gov/vaccines/hcp/conversations/ensuring-safe-vaccines.html this is also an oversimplification as there will always be pre-clinical animal studies before vaccines are ever tested on human beings. 4 Id. 5 Id. Case 1:21-cv-02228-STV Document 7 Filed 08/30/21 USDC Colorado Page 6 of 19 7 its history, and (b) never been used on large cohorts of people.
12. The COVID-19 genetic modification vaccines (Pfizer, Moderna, J&J) failed to test for genotoxicity, mutagenicity, teratogenicity, and oncogenicity. In other words, it is unknown whether or not these products will change human genetic material, cause birth defects, reduce fertility, or cause cancer. Of concern, one manufacturer publicly declares on their website the mechanism of action of their mRNA as follows: “[g]enerally, the only thing that changes from one potential mRNA medicine to another is the coding region – the actual genetic code that instructs ribosomes to make protein. Utilizing these instruction sets gives our investigational mRNA medicines a software-like quality. We also have the ability to combine different mRNA sequences encoding for different proteins in a single mRNA investigational medicine.” (Source: https://www.modernatx.com/mrna-technology/mrna-platform-enablingdrug-discovery-development ). To my knowledge, there is no informed consent to the public advising that they are submitting to a permanent change in their native genetic sequencing or any of their natural genetic material.
13. When compared to other, standard package inserts/labeling, there is an absence of a description of the molecular structure of the biologic. This is a further failure to disclose to medical prescribers the formula and molecular weight.
14. In the human trial for Pfizer-BioNTech Covid-19, the protocol lists a significant number of exclusions whereby subpopulations and those with certain conditions could not enter the trial; therefore there is no controlled trial data and this should render any mandates for those populations as contraindications. These populations or conditions are missing from the final Approval label (See Exhibit B).
They are as follows:
a. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
b. Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
c. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention(s).
d. Receipt of medications intended to prevent COVID 19. Case 1:21-cv-02228-STV Document 7-1 Filed 08/30/21 USDC Colorado Page 38 of 198
e. Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19.
f. Individuals at high risk for severe COVID-19, including those with any of the following risk factors:
- i. Hypertension ii. Diabetes mellitus iii. Chronic pulmonary disease iv. Asthma v. Current vaping or smoking vi. History of chronic smoking within the prior year vii. BMI >30 kg/m2 g. Anticipating the need for immunosuppressive treatment within the next 6 months.
h. Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (e.g., healthcare worker, emergency response personnel).
- i. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
j. Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention.
k. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
l. Women who are pregnant or breastfeeding.
m. Previous vaccination with any coronavirus vaccine. (These did not exist at the time and, in my opinion, still do not exist).
n. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, e.g., for cancer or an autoimmune disease, or planned receipt throughout the study.
o. Regular receipt of inhaled/nebulized corticosteroids.
p. Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.
q. Participation in other studies involving study intervention within 28 days prior to study entry through and including 6 months after the last dose of study intervention, with the exception of non-Pfizer interventional studies for prevention of COVID 19, which are prohibited throughout study participation.
r. Previous participation in other studies involving study intervention containing lipid nanoparticles.
s. Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit. Case 1:21-cv-02228-STV Document 7-1 Filed 08/30/21 USDC Colorado Page 39 of 198
t. Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality.
u. Positive test for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs) at the screening visit.
v. SARS-CoV-2 NAAT-positive nasal swab within 24 hours before receipt of study intervention. w. Less than 12 years of age. this is particularly significant because PfizerBioNTech companies have requested EUA for <12 years of age, including 2- 11 year olds with no randomized, controlled study data and no proof of Human Subjects Review Board evaluation and approval.
15. The COVID-19 genetic modification vaccines (Pfizer, Moderna, J&J) failed to disclose or conduct and/or include any study results for standard pre-licensing safety that would adequately and at a minimum inform prescribers and patients of serious considerations. These findings are, by good standard practices, included in the package insert, commonly referred to as the Label. The missing studies and results include key information such as:
a. Pharmacokinetics – studies on the fate of the drug after administration:
- i. Drug Half Life
- ii. Drug-Drug Interactions (against standard metric drugs)
- iii. Absorption
- iv. Elimination
- v. Receptor Affinity
- vi. Tissue and Body Fluid Mass and Volume
- vii. Drug Metabolism
- viii. Maximum Drug Concentration
- ix. Time to Concentration
- x. CYP450 Isoenzyme Impact on Liver and Drug: Identification of the microsomes in this system that are affected by this biologic and how that may interfere with or enhance effect on liver function
- i. Receptor Binding
- ii. Drug Effect at Receptor Binding, particularly Angiotensin Converting Enzyme-2 Receptors, the key receptor for the resulting Subunit 1 pathogen, the Spike Protein resulting from the Pfizer, Moderna, and J&J self-proclaimed mechanism of action (MOA). iii. Concentration of the Drug at the Receptor Sites Case 1:21-cv-02228-STV Document 7-1 Filed 08/30/21 USDC Colorado Page 40 of 198 16. The COVID-19 genetic vaccines (Pfizer, Moderna, J&J) failed to study the following standard good practice subpopulations for the effects enumerated in no.’s 13 and 14 sufficiently with a placebo control arm:
- a. Age
- b. Gender
- c. Race
- d. Liver Impairment
- e. Kidney/Renal Impairment
- a. Prior to COMIRNATY’s full FDA approval, the FDA issued a Warning regarding the rates of heart inflammation and heart failure in teenagers; but that Warning did not translate equally to the product labeling, no Black Box Warning transferred to the Label, and in fact did not even translate to Contraindications Section for these products.
- b. It is good standard practice to include studies for any entity administered concomitantly with monoamine oxidase inhibitors (MAOIs) and/or include a contraindication for simultaneous use.
- c. Prescribers and medical providers are not only not discouraged, but they are affirmatively encouraged, to proceed with injecting this series into populations that were either excluded in the study or who subsequently reported serious life threatening adverse events as reported by the federal government’s tracking sites Vaccine Adverse Reporting System (VAERS) and V-Safe.
- d. In direct contradiction to the FDA/CDC Safety meeting in October 2020, prior to the vaccination roll out program, there are no warning or precautions included in the Label relative to the FDA’s known and prior warnings.
- e. The Serious Adverse Event Section in the Label is devoid of data already known to the public through the VAERS and V-SAFE reporting systems, both the only sources for the public to be informed of risks. This raises the question as to why the reported rates of cardiac injury, sudden cardiac death, blood clot caused strokes, teen heart attacks, paralysis and serious permanent motor impairment and blood dyscrasias (as demonstrated by numerous scientists including UK physician Dr. Philipe VanWelbergen, Dr. Barbel Ghitalla, and Dr. Robert Case 1:21-cv-02228-STV Document 7-1 Filed 08/30/21 USDC Colorado Page 41 of 198 Young among others) are absent from the Label. Dr. Robert Young has provided recent evidence that vials of Pfizer, Moderna, Johnson & Johnson, & AstraZeneca properly constituted for individual use per the manufacturers’ instructions yielded visual microscopy evidence of lethal parasites, stainless steel aggregations, graphene oxide, and “nanoparticles of bismuth, titanium, vanadium, iron, copper, silicon, aluminum embedded in Pfizer vials.” (See Exhibit D, Blood smears, Dr. VWB & Dr. BG); Source: https://www.drrobertyoung.com/post/transmission-electron-microscopyreveals-graphene-oxide-in-cov-19-vaccines
- f. Teratogenicity is a primary concern in all experimental medical interventions and drugs under review, and unless it is studied (after human subjects’ review board approval), it is a de facto contraindication to give, much less mandate, any medical intervention to a woman of child bearing years, a pregnant woman, or newborn baby. In fact, the reason there is no guidance in the Label for use in pregnant women is because pregnant women were not studied. Women of childbearing age were also excluded; therefore, no safety data is included in the Label and the Label only indicates that “Available data on COMIRNATY administered to pregnant women is insufficient to inform vaccine-associated risks in pregnancy.” If the data is insufficient by the Companies’ and the P-B Label, then it should be contraindicated in that population.
- i. Similarly, the Label states, “It is not known whether COMIRNATY is excreted in human milk.” Pursuant to good and standard clinical research practices this would constitute a de facto contraindication.
- g. There is no information or data to guide prescribers on whether to use this and if it is safe to use in those with concomitant illnesses, otherwise known as medical comorbidity. h. The Label is missing data and guidance information on Carcinogenesis, Mutagenesis, and Impairment on Fertility – despite the disclosure by Pfizer that researchers during the trial were warned to avoid contact between people of child-bearing age and those who have gotten this entity. (See Exhibit C, Pfizer Protocol, page 132).
18. The COMIRNATY product that has been deemed (https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-covid-19- vaccine-COMIRNATYr-receives-full) to “have the same formulation [as the Pfizer-BioNTech Covid-19 Vaccine] and can be used interchangeably to provide the Covid-19 vaccination series,” was granted full FDA approval, licensed, and labeled with the Indication “to prevent Covid-19 in individuals 16 years of age and older.” This is in contrast to the a priori primary endpoint in the study protocol (See Exhibit C). Case 1:21-cv-02228-STV Document 7-1 Filed 08/30/21 USDC Colorado Page 42 of 198
19. Relative to #17, the companies declare that the COMIRNATY product, while the same formulation, is currently “unavailable,” in direct contradiction to Pfizer’s statement that COMIRNATY was used in over 20,000 people in 2021. (See Exhibit B, Pfizer Package Insert).
20. The FDA approval letter for COMIRNATY, dated August 23, 2021, from RADM Denise Hinton to Pfizer that has been used by the Department of Defense to claim that there is now a “fully licensed vaccine”, constitutes a “deceptive or misleading statement” about a product as that term is used in regards to marketing or labeling a drug or vaccine. Until a vaccine has shown the requisite safety, efficacy, and potency requirements by rigorous scientific studies, the vaccine simply has not passed muster as a “fully licensed” or “fully FDA approved” product.
21. The FDA’s approval letter clearly states that a different vaccine, manufactured by BioNTech Manufacturing GmbH in Germany and known as COMIRNATY, is being approved as a fully licensed vaccine. In this same letter, RADM Hinton also extends the Emergency Use Authorization for the Pfizer BioNtech vaccine. Later in the same letter, RADM Hinton states that the BioNtech vaccine is the equivalent to the COMIRNATY vaccine, while they are “legally distinct”, that no safety or efficacy concerns are present, and that because of the lack of availability of the COMIRNATY vaccine that the Pfizer BioNtech is allowed to be substituted in place of the approved COMIRNATY vaccine. This is all done without any evidence as to how the BioNtech vaccine can be declared safe or effective when it has not even completed a successful Phase III trial. (See Exhibit E for FDA Guidance Document on requirements for Phase 3 trials; https://www.fda.gov/media/87621/download
22. There are four phases to human trials in drug development and Phase 3 is most critical as it comprises the last phase of testing to be completed before the drug's details and clinical trial results are submitted to the regulatory authorities for approval of the drug's release on the open market. While Phase 1 focuses on tolerability and safety in a small number of healthy subjects and Phase 2 establishes efficacy and optimal dosing regimen, Phase 3 should demonstrate and confirm the preliminary evidence gathered in the previous trials that the entity is, a safe, beneficial and effective treatment for the intended indication. The absence of findings from this part of the study as well as from the missing elements enumerated in Sections 15 and 16 violate FDA Guidance Expectations for proper review submission and approval.
23. The COVID-19 genetic vaccine companies (Pfizer, Moderna, J&J) have not provided complete FDA or the public disclosure on their vaccine boxes, package inserts or labels for all of the ingredients within these injection vials. Vis a vis fundamental human rights, governed by International Law and the Nuremberg Code of 1947, the vaccine-specific ingredient information is critical, required and necessary to know so that any human can make an informed decision whether or not to consent to inoculation. Case 1:21-cv-02228-STV Document 7-1 Filed 08/30/21 USDC Colorado Page 43 of 198
24. The Pfizer, Moderna, and J&J vaccines are considered “genetic vaccines”, or vaccines produced from gene therapy molecular platforms which, according to US FDA regulatory guidance, are classified as gene delivery therapies and should be under a fifteen-year regulatory cycle with annual visits for safety evaluation by the research sponsors. (Long Term Follow-up After Administration of Human Gene Therapy Products. Guidance for Industry. FDA-2018-D2173. 2020. Accessed July 13, 2021, at https://www.fda.gov/regulatory-information/search-fdaguidance-documents/long-term-follow-after-administration-human-gene-therapy-products.
25. The FDA has “advised sponsors to observe subjects for delayed adverse events for as long as fifteen years following exposure to the investigational gene therapy product, specifying that the long-term follow-up observation should include a minimum of five years of annual examinations, followed by ten years of annual queries of study subjects, either in person or by questionnaire.” (emphasis added). Thus, the administration of the Moderna, Pfizer, and J&J vaccines should not be undertaken without the proper consent and arrangements for long-term follow-up which are currently not offered in the US. (See, EUA briefing documents for commitments as to follow up: Moderna, Pfizer, J&J).
26. The “vaccines” have a dangerous mechanism of action, as indicated by the inventor of the technology, Dr. Robert Malone, who has stated that they force the body to make an uncontrolled quantity of a computer-generated facsimile of the pathogenic wild-type spike protein from the SARS-CoV-2 virus for an indefinite period of time. This is unlike any and all other vaccines in the entire history of immunization, which have always contained a partial antigen or live-attenuated virus. This means that, with respect to the Pfizer, Moderna, and J&J vaccines, there is no way to predict among patients who will produce more or less of the spike protein because this measure was not included in any preclinical or clinical safety studies.
27. The spike protein itself has been demonstrated to injure vital organs such as the brain, heart and lungs, as well as damage blood vessels and directly cause blood clots. Additionally, because these vaccines infect cells within these organs, the generation of spike protein within heart and brain cells, in particular, causes the body’s own immune system to attach to these organs. This is abundantly apparent with the burgeoning number of cases of myocarditis or heart inflammation among individuals below age 30 years. See, infra ¶ 48 - 54.
28. Because the US FDA and CDC have offered no methods of risk mitigation or proof of continued safety surveillance for these serious adverse effects which can lead to permanent disability or death, no one should be pressured, coerced, receive the threat or reprisal, or be mandated to receive one of these investigational products against their will. Because the vaccine centers, CDC, FDA, and the vaccine manufacturers ask for the vaccine recipient to release them from all liability and agree to full indemnification in their favor on the consent form before injection, all injuries incurred by the person are at their own cost which can be prohibitive depending on the needed procedures, hospitalizations, rehabilitation, and medications. Case 1:21-cv-02228-STV Document 7-1 Filed 08/30/21 USDC Colorado Page 44 of 198
29. In general, it is never good, nor standard, nor reasonable clinical practice to widely utilize novel biological products in populations who have not been tested in registration trials. With respect to the COVID-19 vaccines, these unstudied populations include COVID-19 survivors, those with prior suspected COVID-19 infection, those with positive SARS-CoV-2 serologies, pregnant women, and women of childbearing potential who cannot assure contraception.
30. It is never good, nor standard, nor reasonable research practice to perform a largescale clinical investigation without the necessary structures in place to ensure the safety and protection of human subjects. These structures include a critical event committee, data safety monitoring board and human ethics committee. These groups in large studies work to objectively assess the safety of the investigational product and research integrity. The goal is to mitigate risk and protect human subjects. It is my understanding that the COVID-19 vaccine program sponsored by the CDC and FDA has implemented none of these crucial safety structures which, to my knowledge, have never before been omitted from any large-scale clinical investigation, not to mention that the subject clinical investigation is of far greater and unprecedented magnitude and complexity than any of its predecessors. It is my assessment that the COVID-19 clinical investigation has provided no meaningful risk mitigation for subjects (restricting groups, a special assessment of side effects, or follow-up visits) to ensure or improve the safety of the program. COVID-19 Vaccine Risks and Reporting
31. The COVID-19 public vaccination program operated by the CDC and the FDA is a clinical investigation and not scheduled to conclude until mid-2023 and under no circumstance can any person, including the military servicemen who protect and defend this country, receive pressure, coercion, or threat of reprisal with respect to their free choice of participation. Violation of this principle of autonomy by any entity constitutes reckless endangerment with a reasonable expectation of causing personal injury resulting in damages.
32. In 1990, the Vaccine Adverse Event Reporting System (“VAERS”) was established as a national early warning system to detect possible safety problems with U.S. licensed vaccines. VAERS is a passive reporting system, meaning it relies upon individuals to voluntarily send in reports of their experiences to the CDC and FDA. VAERS is useful for detecting unusual or unexpected patterns in adverse event reporting that might indicate a possible safety problem with a vaccine. It is known to err on the side of under-reporting as demonstrated by the Harvard Pilgrim Health System study (See Exhibit E) that found “less than 1% of vaccine adverse events were reported” to VAERS. Case 1:21-cv-02228-STV Document 7-1 Filed 08/30/21 USDC Colorado Page 45 of 198
33. The total safety reports in VAERS for all vaccines up to 2019 was 16,320. The total safety reports in VAERS for COVID-19 vaccines alone through June 18, 2021, was 387,288. Based on VAERS, as of July 16, 2021, there were 11,405 COVID-19 vaccine deaths and 36,117 hospitalizations reported for the COVID-19 vaccines (Pfizer, Moderna, J&J). Currently, as of August 20, 2021, VAERS has reported an astounding 623,343 adverse events and 13,627 deaths. By comparison, from 1999 until December 31, 2019, VAERS received 3,167 death reports (158 per year) for all vaccines combined. Thus, the COVID-19 mass vaccination is associated with at least a 39-fold increase in annualized vaccine deaths reported to VAERS.
34. The COVID-19 vaccines are not safe for general use and cannot be deployed indiscriminately or supported, recommended, or mandated among any group; this is particularly dangerous for the military who are the frontline of protection and preservation for this nation.
35. According to expert medical opinion, there are emerging trends demonstrating that any Covid-19 vaccine is especially risky for those in the 12 – 29 year-old demographic, with resulting complications in the cardiovascular, neurological, hematologic, and immune systems. (See, Rose J, et al). Increasingly, the medical community is acknowledging the possible risks and side effects inclusive of myocarditis, Bell’s Palsy, Pulmonary Embolus, Pulmonary Immunopathology and severe allergic reaction causing anaphylactic shock. See Chien-Te Tseng, Elena Sbrana, Naoko Iwata-Yoshikawa, Patrick C Newman, Tania Garron, Robert L Atmar, Clarence J Peters, Robert B Couch, Immunization with SARS coronavirus vaccines leads to pulmonary immunopathology on challenge with the SARS virus, https://pubmed.ncbi.nlm.nih.gov/22536382/ (last visited June 21, 2021); Centers for Disease Control and Prevention, Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine—United States, December 14–23, 2020 (Jan 15, 2021), https://www.cdc.gov/mmwr/volumes/70/wr/mm7002e1.htm (last visited June 26, 2021).
36. The Centers for Disease Control has held emergency meetings on this issue and the medical community is responding to the crisis. It is known that myocarditis causes injury to heart muscle cells and may result in permanent heart damage culminating in heart failure, arrhythmias, and cardiac death. These conditions could call for a lifetime need for multiple medications, implantable cardio defibrillators, and heart transplantation. Heart failure has a fiveyear 50% survival and would markedly reduce the lifespan of a child or young adult who develops this complication after vaccine-induced myocarditis (McCullough PA, Philbin EF, Spertus JA, Kaatz S, Sandberg KR, Weaver WD; Resource Utilization Among Congestive Heart Failure (REACH) Study. Confirmation of a heart failure epidemic: findings from the Resource Utilization Among Congestive Heart Failure (REACH) study. J Am Coll Cardiol. 2002 Jan 2;39(1):60-9. doi: 10.1016/s0735-1097(01)01700-4. Case 1:21-cv-02228-STV Document 7-1 Filed 08/30/21 USDC Colorado Page 46 of 198
37. COVID-19 vaccine-induced myocarditis has a predilection for young males below age 30 years, a substantial demographic of the US military. The Centers for Disease Control has held emergency meetings on this issue, the medical community is responding to the crisis, and the US FDA has issued a warnings on the Pfizer and Moderna vaccines “Fact Sheet for Patients and Caregivers,” the apparent substitute for an official, and comprehensive Informed Consent document, for myocarditis. Given the prevalence of this event in younger males, no individual under age 30 under any set of circumstances should feel obliged to take this risk with the current genetic vaccines, particularly the Pfizer and Moderna products. https://www.fda.gov/newsevents/press-announcements/coronavirus-COVID-19-update-june-25-2021.
38. Multiple recent studies and news reports detail young adults, ages 18-29, dying from myocarditis after receiving the COVID-19 vaccine. According to the CDC, 475 cases of pericarditis and myocarditis have been identified in vaccinated citizens aged 30 and younger. See FDA, Vaccines and Related Biological Products Advisory Committee June 10, 2021, Meeting Presentation, https://www.fda.gov/media/150054/download#page=17 (last visited June 21, 2021).
39. The FDA found that young people ages 12-24 account for 8.8% of the vaccines administered; yet this demographic comprises 52% of the cases of myocarditis and pericarditis reported through May 31, 2021. Id. Table 5: VAERS Report
40. Furthermore, the CDC announced on June 24, 2021, that the vaccine is “likely linked” to myocarditis. “Advisory Board, CDC panel reports ‘likely association’ of heart Case 1:21-cv-02228-STV Document 7-1 Filed 08/30/21 USDC Colorado Page 47 of 198 inflammation and mRNA COVID-19 vaccines in young people,” (June 24, 2021) https://www.advisory.com/daily-briefing/2021/06/24/heart-inflammation.
41. On July 12, 2021 the US FDA sent out an additional warning for Guillain-Barre Syndrome or ascending paralysis for the J&J vaccine which is not predictable and, when it occurs, can result in ascending paralysis, respiratory failure, the need for critical care and death. Not all cases completely resolve, and some vaccine victims may require long term mechanical ventilation, or become quadra- or paraplegics. Prolonged neurological rehabilitation is commonly required, and this will call for time away from school and studies for those children injured from the J&J vaccine with Guillain-Barre Syndrome. https://www.fda.gov/media/150723/download Risks of COVID-19 Vaccines for Those Recovered from COVID-19
42. There is recent research demonstrating that the COVID-19 vaccine is dangerous for those who have already had COVID-19 and recovered with inferred robust, complete, and durable immunity. These patients were excluded from the FDA-approved clinical trials performed by Pfizer, Moderna, and J&J. From these trials the safety profile was unknown when the products were approved for Emergency Use Authorization in 2020. There has been no study demonstrating clinical benefit with COVID-19 vaccination in those who have well documented or even suspected prior COVID-19 illness.
43. To my knowledge, there are no studies that demonstrate the clinical benefit of COVID-19 vaccination in COVID-19 survivors or those with suspected COVID-19 illness or subclinical disease who have laboratory evidence of prior infection.