United States Armed Forces Use ‘Restrictions” to Compel COVID-19 Vaccination
| Restrictions based on Information Bias & “Efficacy” Data | | the Law & Ethics |
In a disturbing pattern across numerous United States Military Bases and other Department of Defense (DOD) Installations - military and civilian personnel are being ‘incentivized’ into taking the Emergency Use Authorization (EUA) COVID-19 vaccines.
The implied message is that ‘immunity’ is near 95% once ‘vaccinated’. These same agencies have failed to explain what the statistical results from the Moderna and Pfizer ‘vaccine’ trials actually mean.
“Immunity” is not conferred once ‘fully’ ‘vaccinated’.
The trial results demonstrated a 95% efficacy rate of symptom reduction.
Moderna did not choose ‘death’, ‘hospitalization’, ‘cessation of transmission’ or ‘prevention of infection’ as their primary efficacy endpoint.
Despite the information bias (seeking to report only positive percentages without context) in the reporting of the clinical trial outcomes, a range of misleading statements, deceptive marketing practices, manipulation, restrictions and peer pressure type measures are being applied to service members who do not take the COVID-19 vaccines.
Some of these measures include restrictions on an otherwise healthy population such as restrictions on travel outside a state, limitations on leave approvals and other forms of civil liberties restrictions. Emotive messaging such as “Duty”, “Protect your Family” “#killthevirus” “#stopthespread” are just some examples of this pressure.
Neither the Moderna or Pfizer products were approved based on any trial protocols or results that demonstrated that the ‘vaccine’ would prevent infection or prevent transmission. In other words, you can receive the COVID-19 ‘vaccine’ and can still become infected, still transmit and the only results, based on the clinical trials' own protocols, demonstrate that you may have a statistical chance at having “a” symptom reduction.
The Bottom-Line Up Front
Based on the actual clinical trial protocol and data submitted to the FDA for Emergency Use Authorization (EUA) --- ‘immunity’ --- was not a primary efficacy endpoint.
Moderna did not choose ‘death’, ‘hospitalization’, ‘cessation of transmission’ or ‘prevention of infection’ as their primary efficacy endpoint.
“Unreported absolute risk reduction measures of 0.7% and 1.1% for the Pfzier/BioNTech and Moderna vaccines, respectively, are very much lower than the reported relative risk reduction results.
Reporting absolute risk reduction measures and results is essential to prevent outcome reporting bias in evaluation of COVID-19 vaccine efficacy.” Brown RB. Outcome Reporting Bias in COVID-19 mRNA Vaccine Clinical Trials. Medicina. 2021; 57(3):199. https://doi.org/10.3390/medicina57030199 https://www.mdpi.com/1648-9144/57/3/199/htm
“Immunity” will not be achieved via the statistical chance that one might have “a” symptom reduced should they develop the COVID-19 disease.
The implications of directives, public messaging campaigns and other forms of information bias that have ensued are significant and without legal precedent.
There are numerous legal violations that may apply as they relate to the leaders, medical professionals and agencies engaged in deceptive advertising practices. These violations included (but are not limited to) the following:
FTC Act, 15 U.S.C. § 41 et seq., [re: deceptive medical advice]
It is unlawful under the FTC Act, 15 U.S.C. § 41 et seq., to advertise that a product or service can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. As a result, every party promoting the use of this mRNA technology with the implied statement that ‘immunity’ or #killthevirus is conferred or that getting this mRNA technology will prevent COVID-19 is violating the FTC Act.
There is no waiver of liability for deceptive practices (#killthevirus marketing, #preventthespread, ‘duty’) even in a state of emergency per FTC Act, 15 U.S.C. § 41 et seq..
21 CFR 50.23 et seq, the FDA informed consent for experimentation requires a review board constituted with members who have no financial interest in the outcome of the trialed technology. Further the EUA doesn’t waive consentrequirements. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.c fm?CFRPart=50&showFR=1&subpartNode=21:220.127.116.11.20.1
(1) Emergency Use Authorizations (EUA): Illegal to Mandate Products Under EUA PCR testing and COVID vaccines are not fully licensed products. They are EUA products, (Decl. Varma ecf 19 P.43.) which by their very nature are legally considered investigational. As these are experimental medical products, it is unlawful and unethical to mandate either the RT-PCR test or any currently available COVID vaccine. Federal law confirms explicitly that an EUA product must be voluntary because the federal statute requires “the option to accept or refuse administration of the product.”
US Bases in California: Mandating the RT-PCR and experimental COVID vaccines also violates California State law (CA Health & Safety Code § 24172). 10 Federal and State law on this matter rest on the first principle of the Nuremberg Code requiring that the human subject be “so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress or other forms of constraint or coercion.”
Specific laws such as the US Federal Regulations, notably the National Research Act [Title II, Public Law 93-348], https://www.govinfo.gov/content/pkg/STATUTE- 88/pdf/STATUTE-88-Pg342.pdf#page=5 Regulations for the Protection of Human Subjects of Biomedical and Behavioral Research [45 CFR 46] https://www.ecfr.gov/cgi- bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719& n=pt45.1.46&r=PART&ty=HTML and revisions of various regulations, rules, and laws ([21 CFR 50]https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=5 0&showFR=1&subpartNode=21:18.104.22.168.20.1 , [21 CFR 56]https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart =56 , [45 CFR 46 Subpart D] https://www.hhs.gov/ohrp/regulations-and- policy/guidance/special-protections-for-children/index.html [10 CFR 745]https://www.govinfo.gov/app/details/CFR-2011-title10-vol4/CFR-2011-title10-vol4- part745 , [45 CFR 46 Subpart B] https://www.ecfr.gov/cgi- bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML#sp45.1.46.b , [45 CFR 46 Subpart D] https://www.hhs.gov/ohrp/regulations-and-policy/guidance/special-protections-for- children/index.html specifically and permanently guarantee that all persons in the United States are entitled to exercise the right of informed consent to accept or to refuse to enroll in any medical experiment.
Mandating products approved for emergency use violates federal and state law since Emergency Use Authorization (EUA) means the products are investigational and experimental. Federal and state law is very clear that mandates are illegal for EUA products. Both the RT-PCR test and all COVID vaccines are not FDA- approved; they are available under an EUA. 21 USCS § 360bbb-3 Authorization for medical products for use in emergencies.
For those Air Forces Bases located in California: Mandating the RT-PCR and experimental COVID vaccines also violates California State law (CA Health & Safety Code § 24172).https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?sectionNum=241 72.&lawCode=HSC
Federal and State law on these matters rest on the first principle of the Nuremberg Code requiring that the human subject be “so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress or other forms of constraint or coercion.
Note, that while vaccine manufacturers may be shielded from liability by 42 USC 300aa-11 and 42 USC 300aa-22, other institutions are not protected. https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42- section300aa-22&num=0&edition=prelim
Examples of the USAF Vaccine Directives and Memorandums:
Colonel Anthony Mastalir, USAF recently signed, in part, the Directive that included the following: “Any person who refuses to comply or otherwise violates its provisions may be detained and turned over to military or civilian authorities. For military members, violations are punishable under the UCMJ. For all personnel, violations are punishable under the United States Code (USC), to include 18 USC 1001, 18 USC 1382, and 42 USC 271. Additionally, any personnel who fail to adhere to this memorandum or subsequent orders may be subject to debarment (denied access to the installation)”.
Vandenberg, AFB included the following in their Directive: “This Directive is effective immediately, and applies to all military members of Vandenberg AFB regardless of location, as well as civilian employees, dependents, retirees, contractors, and any persons on the installations for any
reason. Public Health Directives 1-7 are hereby rescinded and replaced by this Directive. The following measures are mandatory.”
Travel. Please use discretion when making travel arrangements. Travel- related infections remain the most prevalent threat vector for the virus among the non-vaccinated population.
i. Unofficial Travel (leave and pass). The local area for Vandenberg AFB is defined as San Luis Obispo County and Santa Barbara County. However, effective immediately, fully vaccinated individuals are exempt from this local area definition and, therefore, may resume leave and pass processes consistent with unit policies and AFI 36-3003, Military Leave Program. The Secretary of Defense STOP MOVEMENT guidance directs all military members must have Sq/CC or Director approval to travel outside the local area, whether on leave or on pass. Sq/CCs and Directors have the authority to determine when their approval is required for unofficial travel for fully vaccinated personnel. While civilian travel cannot be restricted, civilian employees should report to their supervisor and the MCC if they believe they were exposed toCOVID-19 during their travel.
Matthew A. Leard, Colonel, USAF, Commander recently signed a memorandum for all Air Force personnel on Altus Air Force Base (AFB) Oklahoma that identified, in part, restrictions for those not vaccinated. The title of the memorandum “97 AMW Policies and Directives Regarding Coronavirus Disease 2019 (COVID-19)” included restrictions for those vaccinated and not vaccinated.
“Vaccinated Personnel: Paragraph 2 of this policy applies only to those personnel who have received both doses of a COVID-19 vaccine, and at least 5 days have passed since the receipt of the second dose. Paragraphs 3, 4, 5, 9 and 10 of this policy do not apply to COVID19-vaccineated personnel, subject to the conditions in paragraph 2.d. All Personnel who have not received both doses of the vaccine are subject to paragraphs 3-10 below.”
The memorandum goes on to put in place restrictions on those personnel who have not been vaccinated and also adds that “...vaccinated individuals may be required to provide proof they are vaccinated against COVID-19 in order to avail themselves of these policies for vaccinated personnel. Individuals who decline to provide proof of COVID-19 vaccination will not be granted the privileges of paragraphs 2.a and are required to abide by paragraphs 3-10 ...”.
Lt. Gen. Dorothy A. Hogg, Surgeon General of the United States Air Force, made a number of misleading statements during her statements with the 59th Medical Wing. In the transcript, posted on its website a transcript of the U.S. Air Force Surgeon General’s there is a mandatory video briefing for airmen at the Lackland Air Force Base in Texas. In the video, Lt. Gen. Dorothy A. Hogg narrates several unsubstantiated statements about the safety of the COVID vaccine — and then conveys to airmen that it is their “duty” rather than their choice to take
an experimental mRNA injection. Pressure. (Additional Details on her statements in Post Script.)
Clinical Trial End-Points and the Data
It is worth restating. Neither the Moderna or Pfizer/BioNtech clinical trial protocols were designed to test for the prevention of transmission of SARS-CoV-2 and neither trial was designed to establish whether the ‘vaccines’ would prevent one from becoming infected.
Stated differently, the majority of news outlets, and public health officials have touted a poorly understood 95% efficacy data point for both the Moderna and Pfizer/BioNtech ‘vaccines’. There have been numerous ‘interpretations’ of the dataand numerous flawed assessments of what a ‘vaccine’ does and does not do specifically with regard to ‘immunity’.
The mRNA technology used in the Moderna and Pfizer/BioNtech roll-out does not confer ‘immunity’ – rather the clinical trials were designed to determine symptom reduction.
As an aside – but related - numerous traditional vaccinations do not prevent transmission of infection post vaccination. The Diphtheria, Tetanus, and Pertussis (DTaP), Measles, Mumps, and Rubella (MMR), the live Polio Vaccine https://www.cdc.gov/flu/professionals/acip/safety-vaccines.htm are three such examples of ‘shedding’ post vaccination where numerous outbreaks of the disease, that the vaccination alleges to prevent, have been caused by the vaccine strain themselves. To reiterate this, more polio cases are now caused by the vaccine than by the wild virus as 4 African countries report them.
Is the DOD ready to now restrict all personnel based on vaccine strain
Dr. Anthony Fauci admitted in October, 2020 the goal of COVID vaccines is to provide personal protection only, not to prevent death, or person to person transmission. Fauci said he and his colleagues would “settle for ... the primary endpoint to prevent clinically recognizable disease.” https://finance.yahoo.com/news/fauci-vaccines-will-only-prevent- symptoms-not-block-the-virus-195051568.html
Moderna Chief Medical Officer Tal Zaks stated “our trial will not demonstrate prevention of transmission, because ... you have to swab people twice a week for very long periods, and that becomes operationally untenable,” citing the need for a five-to-ten times longer trial length and even higher costs. https://www.bmj.com/content/371/bmj.m4037
[Read this statement again]
Tal Zak tells BMJ that “...the trial is precluded from judging [hospital admissions], based on what is a reasonable size and duration to serve the public good
Moderna Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT04470427 https://www.fda.gov/media/144434/download#page=37
For the primary efficacy endpoint, the case definition for a confirmed COVID-19 case was defined as: At least two of the following systemic symptoms: Fever (≥38oC), chills, myalgia, headache, sore throat, new olfactory and taste disorder(s), or At least one of the following respiratory signs/ symptoms: cough, shortness of breath or difficulty breathing, OR clinical or radiographical evidence of pneumonia; and NP swab, nasal swab, or saliva sample (or respiratory sample, if hospitalized) positive for SARS-CoV-2 by RT-PCR.”
Pfizer/BioNtech Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT04368728 https://www.fda.gov/media/144245/download?fbclid=IwAR3FNVjqWO1lmPCcskScF n4u-KWIyrD0NUQp6XRyq76dwhSVXYHgo-VVxqQ
“For the primary efficacy endpoint, the case definition for a confirmed COVID-19 case was the presence of at least one of the following symptoms and a positive SARS-CoV-2 NAAT within 4 days of the symptomatic period: Fever; New or increased cough; New or increased shortness of breath; Chills; New or increased muscle pain; New loss of taste or smell; Sore throat; Diarrhea; Vomiting.”
Digging deeper into the data:
Source: Vaccines and Related Biological Advisory Committee, December 17, 2020 | FDA Briefing Document | Moderna COVID-19 Vaccine | https://www.fda.gov/media/144434/download
Table 21, page 34 (the frequency of solicited local adverse events) is used to critically review the data.
1. Table 21, page 34: There is an over representation of pain, erythema, swelling, lymphadenopathy.
In the COVID Symptoms Table: see https://www.fda.gov/media/144434/download Additionally --- See Table 23, page 37 (frequency of solicited adverse events for
specific COVID Symptoms):
105 in the vax group, 39 in the placebo. Dose Two
1,806 in the vax group, 38 in the placebo.
c. Headache Dose One
4031 in the vax group, 3303 in the placebo
d. Myalgia (a clinical protocol identified as the single most important symptom outside of respiratory)
2698 in the vax group, 1626 in the placebo
6353 in the vax group, 1312 in the placebo.
***A NEAR FIVE-FOLD DIFFERENCE (GREATER) in the vaccine group than the placebo. ****
Stated differently, you are nearly five times more likely to have a COVID-like Symptom from the Vaccine that from a placebo.
In both the Moderna and Pfizer/BioNtech clinical trials, the number of symptoms culminates as a ‘case’. If one or more symptoms were solicited the data was used to inform the final results. However, the numbers (denominator) matter. The number of 170 ‘cases’ (Pfizer/BioNtech) and 196 ‘cases’ (Moderna) were used to generate the
‘efficacy’ result. The calculation or the denominator is important here. efficacy’ must be understood.
As an example:
8 ‘cases’ in vaccine group
162 ‘cases’ in placebo group
8/162 = 5%
Thus, the claim of 95% efficacious.
Why the denominator matters. If one is to assess the absolute risk reduction (ARR) versus the relative risk reduction (all statistical assessments) the overall clinical trial denominator should be included. This must be understood.
For those not familiar with the risk assessment protocols in clinical trials a review of the process is here: https://www.ncbi.nlm.nih.gov/books/NBK63647/
The Other Questions of Ethics
The issue of ethics and the question of the mechanisms of how the mRNA technology works must be included in this letter. Let’s be clear...it is not a Vaccine
Throughout this letter the word ‘vaccine’ has been put in quotes. Why? Because in the words of the manufacturers themselves it is a gene therapy technology. Their words.
The Moderna and Pfizer “alleged vaccine” trials have explicitly acknowledged that their gene therapy technology has no impact on viral infection or transmission whatsoever and merely conveys to the recipient the capacity to produce an S1 spike protein endogenously by the introduction of a synthetic mRNA sequence. Emphasis on the word ‘synthetic’.
Therefore, the basis for any claims that there will be ‘immunity’ protections is moot in this case.
There is no “general comfort, health, and prosperity,” derived from the ‘encouraged’ application of gene therapy on a population in which it has already induced pain, suffering, failure to perform activities of daily living...and death.
Details of the mRNA Technology Platform
From Moderna’s website https://www.modernatx.com/mrna-technology/mrna- platform-enabling-drug-discovery-development “Recognizing the broad potential of mRNA science, we set out to create an mRNA technology platform that functions very much like an operating system on a computer. It is designed so that it can plug and play interchangeably with different programs. In our case, the ‘program’ or ‘app’ is our mRNA drug – unique mRNA sequence that codes for a protein”.
Vaccine Adverse event Reporting System (VAERS) Data and the Ethics of compelling a population to assume a risk, up to and including Death.
The Department of Defense, USAF Col. Leard other Senior Leaders, making statements not based in fact, are encouraged to look at the reporting and the VAERS data for the most current data on the adverse events. https://vaers.hhs.gov/
If you are not familiar with the steps needed to query the VAERS database the following:
As of February 12, 2021, the data indicates that there were 929 deaths, 1869 hospitalizations, 3451 urgent care visits, 2191 office related visits, 190 anaphylaxis, and 198 cases of Bell’s Palsy following inoculation. There have been over 15K adverse events in VAERS to include pulmonary embolism, pulmonary infarction, and myocarditis, pericarditis, or heart attacks.
Per the CDC the claims of deaths (1170) received a COVID-19 vaccine. Countries around the world are reporting similar numbers. The European EudraVigilance Database, as of Feb 13th 2021 shows a total number of adverse reactions increased 45% while serious cases increased by 51%. http://www.adrreports.eu/en/search_subst.html?s=03
In the European database, there were over 10 thousand nervous systems disorders, 240 cardiac disorders and other grave adverse events.
Across the United States, in some verified cases, deaths were reported within minutes to hours after receiving the injection. It is important to add that VAERS has traditionally represented approximately 1% of all adverse
reactions. https://digital.ahrq.gov/sites/default/files/docs/publication/r18hs017045- lazarus-final-report-2011.pdf There is (to date) and based on VAERS reporting alone a 4.10% rate of reactions to COVID-19 vaccinations, including deaths.
Late-term Miscarriages and stillbirths, within hours of receiving the ‘vaccine’, are also reported in VAERS.
In the limited rat studies (female Sprague Dawley CD rats) conducted by Moderna, the vaccine led to more pregnancy loss in rat studies (the only study done). Vaccinated rats lost 16% of pregnancies, double those that got the ‘placebo’ (another vaccine). (pg. 50-51/169) https://www.ema.europa.eu/en/documents/assessment- report/covid-19-vaccine-moderna-epar-public-assessment-report_en.pdf
Regrettably, none of these findings led to a full toxicology study yet based on
incomplete and suppressed data, DOD is enabling its senior leaders to make unsubstantiated claims that the COVID-19 shot can be safely taken by pregnant women.
Revisiting the pregnancy and safety issues. European drug regulators stated that Moderna never ran an adequate toxicological study on its COVID ‘vaccine in animals.
In the limited and poorly designed ‘rat’ studies toxicity studies revealed “...hepatic alterations (increased liver weights, hepatocyte vacuolation, hypertrophy of Kupffer-cells, centrilobular degeneration, characterized by the presence of mixed inflammatory cell in sinusoids with single cell necrosis or degeneration of hepatocytes) and corresponding changes in clinical chemistry (statistically significant increases in AST, ALP, triglyceride, cholesterol, bilirubin, urea nitrogen) were frequently – but not consistently –
observed”. “The product specific study 2308-123 was not conducted in GLP- compliance, and exhibits major procedural/methodological limitations. In principle these aspects would render this study inadequate for evaluation the repeated dose toxicity of mRNA-1272 to the extent recommended in relevant guidance on non-clinical development of vaccine products” and the studies it did submit showed serious hematological impact – yet the application went ahead anyway. Procedure No. EMEA/H/C/005791/0000
The Department of Defense is now beyond the claims of information bias in reporting the trial results -- and has now moved into the realm of statements that would suggest significant pressure is being put on service members to take the‘vaccine. “Incentives” to regain permission to travel or other ‘liberties’ is in play!
What does this mean for the Department of Defense?
An mRNA synthetic strand (gene technology) does NOT fall within the definition of a biologic and falls well outside the federal regulation definition of “vaccine” in State statutes.
Further, in the case of the trial outcomes – these products do not confer “immunity”.
The pressure and messaging being used to induce personnel of the Armed Forces population to take a risk with the mRNA technology for the benefit of a liberty or a call to ‘duty’ for the ‘exchange’ of a reduction in restrictions is beyond the pale.
Nowhere in the Department of Defense guidance has it been stipulated that pressure or incentives of ‘less restrictions’ are allowed and the medical ‘apartheid’ of personnel endorsed.
Beyond the fact that mRNA is gene therapy technology – not vaccination – the encouragement of the leadership on the Altus AFB to gain a ‘pressured’ benefit post vaccination - must be challenged. The uptake of this medical device - an unproven medical countermeasure - is without any judicial precedent.
“...must become unwell for the purpose of this medical experiment...and assume a personal risk from an indemnified pharmaceutical industry”
No law has been passed that says that a healthy population must become unwell for the purpose of a medical experiment.
For those that still fail to understand what it means to ‘...become unwell for the purpose of a medical experiment’ – look to the technology of the mRNA and the data used to describe the process.
The mRNA will cause disease in the body – first – then the person’s immune system will generate a protein to attack the ‘disease’ that was generated in the body. Thus – you will become unwell as a part of the ‘incentivized’ statements being made by Lt. Gen. Dorothy A. Hogg and the Altus Commander, among just a few of the DOD Leadership.
To recap the actual language used in the mRNA submissions:
“...The BioNTech/Pfizer vaccine is based on messenger RNA (mRNA) technology. This allows cells to manufacture harmless fragments of viral proteins that the human body uses to build an immune response to prevent or fight subsequent, natural infection. When a person is given the vaccine, their cells will read the genetic instructions and produce fragments of the ‘spike protein', a protein on the outer surface of the virus which it uses to enter the body's cells, to replicate, and cause disease. The person's immune system will then treat this protein as foreign and produce natural defences — antibodies and T cells — against
it.” https://ec.europa.eu/commission/presscorner/detail/en/ip_20_ 2466
Emerging Ethical Questions
There is one other key ethical precedent that is emerging, unstated, yet simmering within a new precedent to afford those that have been vaccinated with additional liberties and those not with additional restrictions in order ‘achieve’ a statistical result of a symptom suppression should one become infected.
Aside from the fact that there are legitimate personal religious, philosophical and medical concerns about the safety, efficacy and adverse events – there has been a new more insidious and emerging dilemma.
A new question “...are we now setting a precedent to mandate the suppression of symptoms’ and are we now setting a binding precedent to restrict liberties based on flawed data interpretation?
Is the Department of Defense, and our defense medical establishment taking a precarious step toward mandating (incentivizing or pressuring) someone to take medications or therapeutics for a symptom(s) of an illness or condition that they do not have?
Is the DOD setting precedent with the trend for symptom reduction via a therapeutic, biologic, gene therapy technology and/or medications with known and unknown risks, to ensure a statistical chance at symptom suppression?
How much longer will the DOD Leadership allow for the information bias in the reporting of the trial results to drive pressured and incentivized rewards?
How far can this precedent extend? What other symptom ‘only’ prevention of illnesses will be treated via mandated medical prophylactic interventions? Any reasonable person should ask these questions.
The Department of Defense has relied on information reporting bias to report the ‘benefits’ of ‘vaccination’ and is now resorting to forms of pressure and ‘incentives’ to compel compliance on the uptake of an untested gene therapy technology that is still in clinical trial status. Significant adverse events have already been documented – up to and including death. These actions are without legal precedent.
In order to have a healthy debate, in the public square, with members and families of the Department of Defense, Veterans, caregivers and with our health care representatives, issues like the term effectiveness, efficacy, and ‘liberties’ gained post vaccination - plus mandates and medical ethics must be thoroughly communicated, debated and understood.
The Department of Defense leadership must address the concerns raised in this letter.
The statement by Col. Leard that “...five days post ‘vaccination’ after the second dose” being touted as a valid metric to be used to exempt personnel from certain restrictions is flawed and no ‘immunity’ is conferred.
| 5 March 2021 | P .S.
More Detail: Measures used by Lt. Gen. Dorothy A. Hogg – Surgeon General of the Air Force.
The video training starts with the following unsupported statement:
“Research has shown more than 75% of Americans need to be vaccinated from COVID-19 in order for the U.S. to get back to normal.”
In fact, there are zero published research studies that support Lt. Gen Hogg’s statement that 75% of Americans must be vaccinated for COVID.
Historically, natural acquired immunity has indicated a needed 60% immunity of the median age groups of the bell curve to protect infants and elderly on the tails of an age distribution bell curve. The fact that just this year the WHO changed the definition of herd immunity is suspect (being legally challenged) and has been widely challenged across national and international scientific communities.
Lt. Gen Hogg highlights that racial and ethnic minorities were included in the vaccine trials, and then she shares a shocking anecdotal testimonial that vaccinating in pregnancy is safe without any research on developmental and reproductive toxicity:
“I was hesitant to receive the vaccine, but after talking to my OBGYN, I realized vaccinating was the safest option for myself and my little boy. You might see claims that the COVID-19 vaccine can make someone infertile, harm a developing fetus in the womb, make the immune system attack the placenta or hurt a baby who is breastfeeding from a recently vaccinated mother. There is no scientific reason to think any of these are true.”
The Pfizer-BioNTech COVID-19 vaccine FDA Fact Sheet does not demonstrate the vaccine is safe or low-risk in pregnancy. In fact, pregnant women were excluded from Pfizer’s vaccine trials. As the fact sheet states: “All pregnancies have a risk of birth defect, loss, or other adverse outcomes;” “Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy;” and “Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milkproduction/excretion.”
Under the medical ethics of “Do No Harm,” the UK advises against the COVID vaccine for pregnant women. In the U.S., the Vaccine Adverse Event Reporting System (VAERS) contains 17 reports of miscarriages after the COVID-19 vaccine, as of February 5, 2021.
But by far the most inexcusable part of Lt. Gen Hogg’s presentation, which neither upholds the ethics of “Do No Harm” with pregnant women nor follows informed consent guidelines, is that a General Officer is using her position with undue influence, patriotic “pressure’ and emotional manipulation to persuade airmen that it is their duty to participate in a Phase 3 clinical trial of an experimental medical intervention:
Military leaders are using messages, videos, personal photos, deployments, squad leader meetings and officer sensing sessions to persuade service members to take the new “vaccine”. As in earlier statements made by Col. Leard – they are also incentivizing the uptake with a promise of less restrictions based on zero clinical trial evidence.
This reporting of misinformation and flawed data, and bias in favor of the new COVID-19 vaccine is evident by Lt. Gen Hogg’s statements regarding the COVID-19 vaccine. Regrettably – like Col Leard the Air Force is now being represented by these personnel who are resorting to - in part – peer pressure and positions or authority when it comes to the uptake of the experimental gene therapy technology.
Who takes responsibility for this?
What is the mRNA ‘vaccine’
This annex is provided to add additional detail to the topic of ‘gene therapy technology and the mRNA therapy. Numerous references will be provided in this letter to aid in your research.
This is an open letter to you and Senior Leaders of the Department of Defense (DOD) who are actively promoting and encouraging the uptake of the mRNA-based technology. Any efforts to encourage the uptake of the mRNA medical device and technology must address the requirement to call mRNA for what it is and is not – namely – mRNA is not and should not be called a “vaccine”.
A Closer Look at FTC Act, 15 U.S.C. § 41 et seq., and Deceptive Labeling Practices
When one is using terms with the intent to use deceptive medical advice the FTC Act, 15 U.S.C. § 41 et seq., applies. Both Pfizer and Moderna (and DOD) have been promoting what is alleged to be a ‘vaccine’. There is an attempt to suggest that with this ‘vaccine’ you will be immune from the pathogen. This is not the case with the mRNA technology. Both Pfizer and Moderna are, in point of fact, promoting a ‘gene-therapy’ technology yet deceptively using the term ‘vaccine’.
Further, and to put this in the simplest terms, the mRNA medical device and technology is a synthetic fragment (being injected) and is used as a form of gene-therapy. Again, it is not a vaccine and promoting it as such does not serve the best interests of those seeking true and informed consent or for those seeking a means to seek compensation due to injuries from this experimental mRNA technology device.
Immunity: Protection from an infectious disease. If you are immune to a disease, you can be exposed to it without becoming infected.
(4) Vaccine: A product that stimulates a person’s immune system to produce immunity to a specific disease, protecting the person from that disease.
Vaccines are usually administered through needle injections, but can also be administered by mouth or sprayed into the nose.
By the CDC definition and by Pfizer and Moderna’s own definition mRNA technology is not a vaccine. Or stated otherwise, immunity via mRNA technology is not conferred.
Let’s be clear...it is not a Vaccine
“This is mRNA packaged in a fat envelope that is delivered to a cell. It is a medical device designed to stimulate the human cell into becoming a pathogen creator. It is not a vaccine.
To recap on the terms above, vaccines actually are a legally defined term under public health law; they are a legally defined term under CDC and FDA standards. And the vaccine specifically has to stimulate both the immunity within the person receiving it and it also has to disrupt transmission.”
“...They (Moderna and Pfizer) have been abundantly clear in saying that the mRNA strand that is going into the cell is not to stop the transmission, it is a treatment. But if it was discussed as a treatment, it would not get the sympathetic ear of public health authorities because then people would say, “What other treatments are there?”
The Securities and Exchange Commission (SEC)
Within the same Moderna filing, as filed with the Securities and Exchange Commission on November 9, 2018, Moderna states “...Currently, mRNA is considered a gene therapy product by the FDA. Unlike certain gene therapies that irreversibly alter cell DNA and could act as a source of side effects, mRNA- based medicines are designed to not irreversibly change cell DNA; however, side effects observed in gene therapy could negatively impact the perception of mRNA medicines despite the differences in mechanism. In addition, because no product in which mRNA is the primary active ingredient has been approved, the regulatory pathway for approval is uncertain.” https://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473ds1.htm?s=03
It is also clear from this same SEC filing (pg.26) that Moderna is concerned with the use of the term ‘gene therapy’ and state, in part ‘...Some of our investigational medicines are classified as gene therapies by the FDA and the EMA, and the FDA has indicated that our investigational medicines will be reviewed within its Center for Biologics Evaluation and Research, or CBER. Even though our mRNA investigational medicines are designed to have a different mechanism of action from gene therapies, the association of our investigational medicines with gene therapies could result in increased regulatory burdens, impair the reputation of our investigational medicines, or negatively impact our platform or our business.
It is a Technology per the CDHR Definition of a Device
Lawyers “... refuse to stipulate in any conversations that this is in fact a vaccine issue. The only reason why the term is being used is to abuse the 1905 Jacobson case that has been misrepresented since it was written. And if we were honest with this, we would actually call it what it is: it is a chemical pathogen device that is actually meant to unleash a chemical pathogen production action within a cell. It is a medical device, not a drug because it meets the CDRH definition of a device. It is not a living system, it is not a biologic system, it is a physical technology - it happens to just come in the size of a molecular package.”
For additional references, the Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration (FDA) and has the responsibility for approval of all medical devices https://www.fda.gov/about-fda/fda-organization/center-devices-and-radiological- health.
To add to this discussion, it is important to consider that the ‘medical device’ definition is met when you consider that this is a nucleic acid sequence – not a viral fragment.
(a) Identification. Synthetic cell and tissue culture media and components are substances that are composed entirely of defined components (e.g., amino acids, vitamins, inorganic salts) that are essential for the survival and development of cell lines of humans and other animals.
A Technology Platform
From Moderna’s website https://www.modernatx.com/mrna-technology/mrna-platform-enabling- drug-discovery-development “Recognizing the broad potential of mRNA science, we set out to create an mRNA technology platform that functions very much like an operating system on a computer. It is designed so that it can plug and play interchangeably with different programs. In our case, the ‘program’ or ‘app’ is our mRNA drug – unique mRNA sequence that codes for a protein”.
In Layman’s terms - A Mechanical Device
For the layman tying to discern the core definition of mRNA technology the following:
“ This is a mechanical device in the form of a very small packet of technology – being inserted into the human system to activate the cell to become a pathogen manufacturing site.”
What does this mean for the Department of Defense and Possible Mandates?
A layman’s summary:
An mRNA synthetic strand is NOT within the definition of a biologic and falls well outside the FR definition of “vaccine” or “immunity” in State statutes.
Facebook Fact Checkers have taken issue with the legal definition of “Vaccine". In the Jacobson v. Massachusetts (1905) case, the court was clear that a PUBLIC BENEFIT was required for a vaccine to be mandated. Neither Pfizer nor Moderna have proved a disruption of transmission. In Jacobson v. Massachusetts, 197 U.S. 11 (1905), the court held that the context for their opinion rested on the following principle:
The Moderna and Pfizer “alleged vaccine” trials have explicitly acknowledged that their gene therapy technology has no impact on viral infection or transmission whatsoever and merely conveys to the recipient the capacity to produce an S1 spike protein endogenously by the introduction of a synthetic mRNA sequence. Therefore, the basis for the Massachusetts statute and the Supreme Court’s determination is moot in this case.