Study Responsibilities

“Pfizer was responsible for study design and conduct; data collection, analysis, and interpretation; and writing of this manuscript. Both Pfizer and BioNTech manufactured the vaccine and placebo.
BioNTech was the regulatory sponsor of the study and contributed to data interpretation and writing of the manuscript. All data were available to the authors, who vouch for its accuracy and completeness and to adherence of the study to the protocol.”

The above statement was buried within the supplementary material of the recently released vaccine “safety” study for 5-11 year olds. It revealed that Pfizer controlled how the study was designed, how the process was conducted, how the data was analyzed and interpreted, and how the manuscript was written. On top of that, they not only determined what the make-up of the vaccine is, they also got to create the placebo as well. Their investor Biotech also had a prominent role in interpreting all of the data you are hearing about all over the MSM. But don’t you worry, Pfizer, Biotech, and the authors all vouche for the accuracy of the information. That should make you feel comfortable and confident in allowing them to inject your children with a “vaccine” that has proven to lead to more severe reactions and fatalities in its short time of use than any other vaccine on the market.

Trust Pfizer. It’s not like they have ever been prosecuted for criminal wrongdoing and/or fraud, right?

Justice Department Announces Largest Health Care Fraud Settlement in Its History

Pfizer to Pay $2.3 Billion for Fraudulent Marketing

WASHINGTON – American pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. (hereinafter together “Pfizer”) have agreed to pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products, the Justice Department announced today.

Pharmacia & Upjohn Company has agreed to plead guilty to a felony violation of the Food, Drug and Cosmetic Act for misbranding Bextra with the intent to defraud or mislead.”

https://www.justice.gov/opa/pr/justice-department-announces-largest-health-care-fraud-settlement-its-history

Drug Maker Pfizer Agrees to Pay $23.85 Million to Resolve False Claims Act Liability for Paying Kickbacks

“Pharmaceutical company Pfizer, Inc. (Pfizer), based in New York, NY, has agreed to pay $23.85 million to resolve claims that it used a foundation as a conduit to pay the copays of Medicare patients taking three Pfizer drugs, in violation of the False Claims Act, the Justice Department announced today.”

https://www.justice.gov/opa/pr/drug-maker-pfizer-agrees-pay-2385-million-resolve-false-claims-act-liability-paying-kickbacks

Oregon has recouped over $10 million in civil settlements from Pfizer since 2003

AG Rosenblum Announces Large Settlement with Pfizer for Misleading Drug Pricing Coupons

“Attorney General Rosenblum today announced a $975,000 settlement with the pharmaceutical company, Pfizer, for distributing misleading marketing materials and coupons to Oregon consumers.”

Pharmaceutical Giant Pfizer To Pay $785 Million In Settlement Of Qui Tam Lawsuit Alleging Subsidiary Wyeth Engaged in Fraudulent Drug Rebate Scheme

“Department of Justice (DOJ) recently entered into a settlement of a qui tam lawsuit against Pfizer, Inc. and its subsidiary Wyeth LLC.  Pursuant to the settlement, Pfizer will pay $784.6 million. According to the allegations of the case, from 2001 to 2006, Wyeth engaged in healthcare fraud by failing to inform Medicaid about the discounts that it offered to its private purchasers, such as hospitals, on two medications that are commonly used to treat acid reflux disease. Wyeth’s deceptive practices led to the company’s underpayment of millions of dollars in drug rebates to Medicaid.”

https://www.google.com/amp/s/www.natlawreview.com/article/pharmaceutical-giant-pfizer-to-pay-785-million-settlement-qui-tam-lawsuit-alleging%3famp

I stand corrected. But hey, it’s just normal corporate politics and practices. “Boys will be boys,” so to speak…especially in the name of profit, am I right? That’s all water under the bridge and I’m positive these slaps on the wrist for bad behavior surely gave Pfizer the wake-up call it needed, especially during a “pandemic” no less:

Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

“Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight.

In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their hopes in a safe and effective covid-19 vaccine to end the pandemic. “As I’ve said before, we are operating at the speed of science,” Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorised in the United States.1

But, for researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails.”

“Since Jackson reported problems with Ventavia to the FDA in September 2020, Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials (covid-19 vaccine in children and young adults, pregnant women, and a booster dose, as well an RSV vaccine trial; NCT04816643, NCT04754594, NCT04955626, NCT05035212). The advisory committee for the Centers for Disease Control and Prevention is set to discuss the covid-19 paediatric vaccine trial on 2 November.”

https://www.bmj.com/content/375/bmj.n2635

Well then, there are just no two ways around it. This is a blatant pattern of illegal activities, fraud, and false advertisement. What is it that compels people to continually place trust in these criminal organizations in regards to their health, especially when a company like Pfizer, with a repeated history of fraudulent claims, has full control over every design and piece of information relating to the study outcomes for its experimental product? Why would anyone entrust this company with the health of their children?

It should come as no surprise that the recent November 2021 evidence for the “safety and efficacy” of Pfizers vaccine for use in 5-11 year olds contains some head-scratching revelations. These admittances should make anyone think twice before injecting their children with experimental synthetic lab-created toxic concoctions. Highlights below:

Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age

“BNT162b2 has been shown to have an acceptable safety profile characterized by transient mild-to-moderate injection-site pain, fatigue, and headache, was more immunogenic among 12-to-15-year-olds than among young adults, and was 95 to 100% efficacious in preventing Covid-19 illness from 7 days to approximately 2 months after the second dose.^3,4 Vaccine efficacy against Covid-19 from 7 days to 6 months after the second dose was 91%,⁶ with a similar estimated real-world effectiveness from 8 to 28 days after the second dose.⁷“

PARTICIPANTS AND OVERSIGHT

“This phase 1 dose-level identification study and ongoing phase 2–3 safety, immunogenicity, and efficacy trial investigate the administration of the BNT162b2 vaccine to healthy participants 6 months to 11 years of age. Herein we present the results for children 5 to 11 years of age through the cutoff date (September 6, 2021); results for children 2 to 4 years and 6 months to less than 2 years of age are not yet available. Participants will be followed for 2 years after receipt of the first dose, including monitoring for potential cases of Covid-19 and MIS-C.”

Phase 2–3 Randomized Trial among Children 5 to 11 Years of Age

“Through the use of an interactive Web-based system, participants were randomly assigned in a 2:1 ratio to receive two doses, 21 days apart, of either BNT162b2 at the dose level selected during phase 1 (10 μg) or saline placebo. In phase 2–3, all participants and study personnel, with the exception of those preparing or administering the injections, were unaware of group assignments. After 6 months, or after participants become eligible for Covid-19 vaccination according to local or national recommendations, placebo recipients will be offered the BNT162b2 vaccine.

SAFETY

Safety evaluations included assessment of reactogenicity events reported by a parent or guardian through the use of an electronic diary for 7 days after each dose. Data on unsolicited adverse events, including confirmed diagnoses of myocarditis or pericarditis, were collected from the first dose through 1 month after the second dose. Data on serious adverse events will be collected from the first dose through 6 months after the second dose.”

“Seroresponse was defined by an increase in titers by a factor of at least 4 from baseline or by titers that were at least 4 times the lower limit of quantitation if the baseline measurement was less than the lower limit of quantitation.”

“Effectiveness was inferred by an “immunobridging” approach, in which neutralizing titers elicited by BNT162b2 in 5-to-11-year-olds were compared with titers elicited by BNT162b2 in 16-to-25-year-olds (in whom efficacy had been demonstrated⁴), with formal noninferiority hypothesis testing.”

PHASE 1 SAFETY AND IMMUNOGENICITY

“Most local reactions were mild to moderate, and all were transient (Fig. S1A and Table S4). Fever was more common in the 30-μg dose-level group than in the 10-μg and 20-μg dose-level groups after the first and second doses (Fig. S1B). All four sentinel participants in the 30-μg dose-level group who received the second 30-μg dose had mild-to-moderate fever within 7 days; the remaining 12 participants in the 30-μg dose-level group received a 10-μg second dose approximately 1 month after the first dose, as recommended by the internal review committee after selection of the phase 2–3 dose. Adverse events from the first dose through 1 month after the second dose were reported by 43.8% of participants who received two 10-μg doses of BNT162b2, 31.3% of those who received two 20-μg doses, and 50.0% of those who received two 30-μg doses (Table S6). One severe adverse event (grade 3 pyrexia) in a 10-year-old participant began the day of the second 20-μg dose of BNT162b2, with temperature reaching 39.7°C (103.5°F) the day after vaccination and resolving the following day. Antipyretic medications were used, and the investigator considered the event to be related to receipt of the BNT162b2 vaccine.”

“BNT162b2 recipients reported more local reactions and systemic events than placebo recipients (Figure 2). The reactions and events reported were generally mild to moderate, lasting 1 to 2 days (Table S4). Injection-site pain was the most common local reaction, occurring in 71 to 74% of BNT162b2 recipients. Severe injection-site pain after the first or second dose was reported in 0.6% of BNT162b2 recipients and in no placebo recipients. Fatigue and headache were the most frequently reported systemic events. Severe fatigue (0.9%), headache (0.3%), chills (0.1%), and muscle pain (0.1%) were also reported after the first or second dose of BNT162b2. Frequencies of fatigue, headache, and chills were similar among BNT162b2 and placebo recipients after the first dose and were more frequent among BNT162b2 recipients than among placebo recipients after the second dose. In general, systemic events were reported more often after the second dose of BNT162b2 than after the first dose. Fever occurred in 8.3% of BNT162b2 recipients after the first or second dose. Use of an antipyretic among BNT162b2 recipients was more frequent after the second dose than after the first dose. One BNT162b2 recipient had a temperature of 40.0°C (104°F) 2 days after the second dose; antipyretics were used, and the fever resolved the next day.

From the first dose through 1 month after the second dose, adverse events were reported by 10.9% of BNT162b2 recipients and 9.2% of placebo recipients (Table S7). Slightly more BNT162b2 recipients (3.0%) than placebo recipients (2.1%) reported adverse events that were considered by the investigators to be related to the vaccine or placebo. Severe adverse events were reported in 0.1% of BNT162b2 recipients and 0.1% of placebo recipients. Three serious adverse events in two participants were reported by the cutoff date; all three (postinjury abdominal pain and pancreatitis in a placebo recipient and arm fracture in a BNT162b2 recipient) were considered to be unrelated to the vaccine or placebo. No deaths or adverse events leading to withdrawal were reported.

Lymphadenopathy was reported in 10 BNT162b2 recipients (0.9%) and 1 placebo recipient (0.1%). No myocarditis, pericarditis, hypersensitivity, or anaphylaxis in BNT162b2 recipients was reported. Four rashes in BNT162b2 recipients (observed on the arm, torso, face, or body, with no consistent pattern) were considered to be related to vaccination; the rashes were mild and self-limiting, and onset was typically 7 days or more after vaccination. No safety differences were apparent when the data were analyzed according to baseline SARS-CoV-2 infection status.”

“This study describes immunization against SARS-CoV-2 infection with an mRNA vaccine in children younger than 12 years of age and documents the safety, immunogenicity, and efficacy of a Covid-19 vaccine in this population; trials of other vaccines are under way. Limitations of the study include the lack of longer-term follow-up to assess the duration of immune responses, efficacy, and safety. However, longer-term follow-up from this study, which will continue for 2 years, should provide clarification. This study was also not powered to detect potential rare side effects of BNT162b2 in 5-to-11-year-olds. However, the safety of BNT162b2 observed in the study combined with widespread use of BNT162b2 in older populations should provide reassurance. Moreover, an expanded cohort of 5-to-11-year-olds is being assessed in the present study, and additional safety assessments are in progress. Further limitations are that concomitant administration of BNT162b2 with other vaccines was not assessed, and cell-mediated responses to immunization are not yet available.”

https://www.nejm.org/doi/full/10.1056/NEJMoa2116298

Does it fill anyone with confidence when the company which designs, funds, creates, and runs the vaccine safety trial deems its own product to have an “acceptable” safety profile? By what measurement are they determining this? What is the definition they are applying to “acceptable?” It is telling that they can only estimate a “real-world effectiveness” for their “acceptable” product. How will they know it’s “safe and effective?” Well, it definitely won’t be through a 2 year follow-up with their controls as anyone given the placebo during the trial will be given the vaccine as they are now eligible to receive it. Thus, any long-term comparison data is already tarnished.

But don’t worry, the researchers inferred effectiveness through an “immunobridging” approach. This is where they look to the correlates of protection of antibodies to determine whether an intervention is effective. The researchers did so by looking at neutralizing titers of antibodies elicited by BNT162b2 in 5-to-11-year-olds and compared them with titers elicited by BNT162b2 in 16-to-25-year-olds. They then used formal noninferiority hypothesis testing to complete their efficacy assessment. This is a study design where they attempt to demonstrate that their vaccine is more effective and not substantially worse than a product currently in use…which in this case was Pfizer’s saline placebo. In other words, the researchers looked at a rise in theoretical antibodies levels for which they have no known correlation of protection in order to determine that their vaccine was more effective than their own saline placebo creation. What could go wrong with that?

Well, a lot actually. The idea that a saline placebo is some inert substance which causes no harm upon injection is blatantly false. The dangerous side effects of this practice has been known about since at least the early 1900’s. This study from 1911 provides some startling revelations about the horrible side effects from injected saline. Excerpts below:

TIIE DANGERS OF SALINE INJECTIONS.

“In recent years the practice of injecting hot solutions of saline into a vein, or under the skin, has greatly increased. The use of these injections in the prevention or treatment of operative shock, in the treatment of cholera or severe haemiorrhage, or as a vehicle for salvarsan or anaesthetics has futlly proved their value. It appears, however, to be widely believed that the intravenious or subcutaneous injection of large quantities of saline is an entirely innocent procedure. On looking for trustworthy evidelnce in support
of this belief, one is met ‘witlh two striking facts: (1) The great variation in the quantities of liquid injected, together with absence of aniy serious attempt to graduate the volume of injection according to the body weight; (2) the wide variation in the absolute quantities of salt injected.

For some considerable time we lhave been studying the effects on animals of injection of saline solutions of various strengths, of distilled-water, and of other liquids. Though our experimiients were undertaken for a very different purpose, the results may have some value in helping us to determiine how far the adminiistration to man of saline injections can be safely carried. We have, tlherefore, briefly summarized those points that bear on this question. We find that the injection of large quantities of normal or slightly hypertonic saline solutions into a vein or under the skin is not nearly so innocuous a proceeding as is often supposed. The quantities injected were uisually far smaller than the quantities, relatively to body weight, that are frequently given in man. The undesirable effects that we encountered include fever, rigors, subnormal temperatures, diarrhoea, intestinal hemorrhage, Cheyne Stokes breathing, convulsions, and sudden death. The last two we have only met with after inijection of strongly hypertonic solufions, and, except in the case of young animals, only when the injection lhas beeni giveni rapidly. For all practical purposes of injection in man these accidents may probably be neglected, thouglh their occurrence in animals accentuates the need for caution in human injections. The otlher accidents mentioned occur very frequently after injection into a vein or under the skin of normal or slighitly hypettonic solutions. The grave sequel to large saline injections (in man) of pulmonary edema has recenitly been noted in this JOURNAL. To this list of clinical drawbacks to saline injections in animals may be added the onset of glycosuiria recorded by Martin Fischer and quoted by Bingel. We must also note the histological changes observed by other workers on this subject. Raum, for example, showed that intravenous injection of the dog with normal saline was followed by vacuolation of the liver cells. Allbrecht found that the red cells of animals were darmaged by large injections of normal saline; Rossle observed degenerative, changes in the heart muscle and capillary walls of animals similarly injected, and Hossli found that saline injections caused in animals fatty changes in the heart muscle and kidneys. We cannot here discuss in detail all of these effects of saline injections, but one result-namely, fever-we may refer to, because it illustrates the poinlts on which we wish to lay stress. It has long been known that injections of saline into a vein or under the skin in man or animals may set up fever. In the last two years several papers have appeared on this subject in Germany, and in them it is often assumed that the fever which follows injection of salilne is solely due to the salt injected and not to the water in which the salt is dissolved. In consequence, therefore, of the absence of proper controls, no constant attention has been paid to any relation between the extent of the fever produced by injection and the ratio of the volume of water injected to the weight of the animal receiving the injection.”

“To conclude, we think:

1. That saline injections as at present administered are by no means free from risk, especially when they are large.
2. That the cause of the toxicity of distilled water that is allowed to stand in sealed sterile vessels is not yet explained.
3. That neitlher centrifuging, filtration tllrough cotton-wool or bacterial filters, nor boiling, is sufficient to prevent the fever that follows saline injections.
4. That distillation in a sterile Jena retort of all water used in the preparation of saline solutions, followed by immediate injection, is at present the only reliable method of ensuring that no fever follows the injections.

doi: 10.1136/bmj.2.2659.1589

It is made very clear that the injection of “normal” saline solution into the veins can have severe and serious consequences. Not only were there dangerous and life-threatening clinical symptoms noted in 1911 but also damaging histiological changes found upon autopsy. While the researchers believed that the side effects were due to a lack of distilled water, it is obvious that these issues have not faded as even today, these same side effects are seen in patients given injectable saline:

What Are Side Effects of Normal Saline?

“Normal Saline may cause serious side effects including:

• fast heartbeat,
• fever,
• rash,
• joint pain, and
• shortness of breath

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Normal Saline include:

• fever,
• injection site swelling,
• redness, and
• infection

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Normal Saline. For more information, ask your doctor or pharmacist.”

https://www.rxlist.com/normal-saline-side-effects-drug-center.htm

While I won’t go in-depth, this study from 2016 went through the various reasons why saline is not “normal” nor physiological. I recommend reading the entire study sometime as it details many of the dangerous side effects as well. Here are a few pivotal excerpts:

0.9% saline is neither normal nor physiological

“0.9% saline (sodium chloride (NaCl), henceforth referred to as saline) was first described by Dr. Hartold Jacob Hamburber (Dutch physiological chemist, 1859–1924) in the 1890s. Having a similar freezing point to human serum and causing no visible erythrocyte lysis, the solution was initially named by Dr. Hamburber “indifferent fluid” (Awad et al., 2014). Over the years, the name has morphed into what is more commonly called “normal saline” or “physiological saline” despite no additional evidence or rationale for the relabeling. The implied normalcy and physiological property have perpetuated indiscriminate use of saline in medical practice.”

“Despite its name, saline is neither “normal” nor “physiological”. Compared to human serum, saline has a nearly 10% higher Na concentration and 50% higher Cl concentration.”

“Despite the availability of safer and more physiologically balanced solutions and despite not a single study demonstrating saline to be superior to balanced solutions, saline continues to be used frequently, if not the most commonly used resuscitative fluid, in medical practice. Evidence suggests that high Cl-containing fluids (such as saline) are associated with multiple adverse effects including an increased occurrence of kidney dysfunction with possible reduced survival. Although large randomized controlled trials comparing saline and balanced fluids are necessary, the time has come to at least recognize that saline is neither normal nor physiological. Saline administration should be considered to have the same status as a drug prescription.”

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4794509/#__ffn_sectitle

It is clear that there is nothing normal about “saline” solution nor is it the inert placebo that they want you to believe that it is. The adverse events associated with its use should be more than enough to caution anyone thinking this is a proper control to compare against an experimental vaccine. In fact, injecting anything into a child should not be considered a proper control, especially when the substance used is also created by the same company who developed the drug, designed the study, interpreted the data, and vouched for its accuracy. The only true control would be to compare the vaccinated against the unvaccinated but obviously this will never occur as the differences in adverse events would be striking.

It is worth remembering that Pfizer, along with everyone else involved with this madness, is entirely exempt from liability and legal recourse regarding the use of their product. Below are some highlights from a sidebar on the PREP Act which provided this immunity:

The PREP Act and COVID-19: Limiting
Liability for Medical Countermeasures

Updated September 23, 2021

“To encourage the expeditious development and deployment of medical countermeasures during a public health emergency, the Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (HHS) to limit legal liability for losses relating to the administration of medical countermeasures such as diagnostics, treatments, and vaccines. In a declaration effective February 4, 2020 (the HHS Declaration), the Secretary of HHS (the Secretary) invoked the PREP Act and declared Coronavirus Disease 2019 (COVID-19) to be a public health emergency warranting liability protections for covered countermeasures. Under the HHS Declaration and its amendments, covered persons are generally immune from legal liability (i.e., they cannot be sued for money damages in court) for losses relating to the administration or use of covered countermeasures against COVID-19. The sole exception to PREP Act immunity is for death or serious physical injury caused by “willful misconduct.” However, individuals who die or suffer serious injuries directly caused by the administration of covered countermeasures may be eligible to receive compensation through the Countermeasures Injury Compensation Program.

Courts have characterized PREP Act immunity as “sweeping.” It applies to all types of legal claims under state and federal law. For example, under state tort law, individuals who suffer injuries caused by the intentional or negligent acts or omissions of another person may generally sue that person to recover monetary compensation. Thus, in the health care context, if a health care provider negligently administers a drug or device that causes a foreseeable injury to a patient, the injured person may be able to sue the provider for compensation under state tort law.

Federal laws such as the PREP Act may preempt state tort laws—as well as other state and federal laws—in certain contexts. Preemptive federal legislation displaces state law to alter the usual liability rules or immunize certain individuals from liability. In the PREP Act, Congress made the judgment that, in the context of a public health emergency, immunizing certain persons and entities from liability was necessary to ensure that potentially life-saving countermeasures will be efficiently developed, deployed, and administered. This Sidebar reviews the structure of the PREP Act and the HHS Declaration to explain the scope of this liability immunity as it applies to COVID-19 countermeasures.”

If within the scope of the declaration, the PREP Act immunizes a covered person from legal liability for all claims for loss relating to the administration or use of a covered countermeasure. The requirements for PREP Act immunity thus break down into four elements: (1) the individual or entity must be a “covered person”; (2) the legal claim must be for a “loss”; (3) the loss must have a “causal relationship” with the administration or use of a covered countermeasure; and (4) the medical product that caused the loss must be a “covered countermeasure.”

First, the PREP Act defines a covered person to include (i) the United States; (ii) manufacturers and distributors of covered countermeasures; (iii) “program planners”; and (iv) “qualified persons” who prescribe, administer, or dispense covered countermeasures. Program planners include Indian Tribes, state governments, and local governments who supervise programs that dispense, distribute, or administer covered countermeasures, or provide policy guidance, facilities, and scientific advice on the administration or use of such countermeasures. Qualified persons include licensed health professionals and other individuals authorized to prescribe, administer, or dispense covered countermeasures under state law, as well as other categories of persons identified by the Secretary in a PREP Act declaration. Employees and agents of all these persons and entities are also covered persons.

Second, PREP Act immunity reaches “all claims for loss” under federal and state law. Loss is broadly defined to mean “any type of loss,” including (i) death; (ii) physical, mental, or emotional injury, illness, disability, or condition; (iii) fear of such injury, including medical monitoring costs; and (iv) loss of or damage to property, including business interruption loss. This language seemingly includes, at a minimum, most state law tort, medical malpractice, and wrongful death claims arising from the administration of covered countermeasures.

Third, the loss must have a causal relationship to the administration and use of a covered countermeasure. As with the other elements, the PREP Act’s causation language sweeps broadly. PREP Act immunity applies to any claim for loss that has “a causal relationship with the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, or use” of a covered countermeasure.

Fourth, the medical product at issue must be a covered countermeasure. The PREP Act specifies four types of covered countermeasures: (i) a qualified “pandemic or epidemic product”; (ii) a “security countermeasure”; (iii) a drug, biological product, or device that the U.S. Food and Drug Administration (FDA) has authorized for emergency use; and (iv) a “respiratory protective device” that is approved by the National Institute for Occupational Safety and Health (NIOSH).”

The “Willful Misconduct” Exception

If a claim is within the PREP Act’s scope, a covered person is generally immune from legal liability. The “sole exception” to immunity is when a covered person proximately causes death or serious physical injury to another person through willful misconduct. A serious physical injury must be life threatening, permanently impair a body function, permanently damage a body structure, or require medical intervention to avoid such permanent impairment or damage. Willful misconduct requires that the covered person acted (i) intentionally to achieve a wrongful purpose; (ii) knowingly without legal or factual justification; and (iii) in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.

The process by which injured persons (or their representatives) may prove willful misconduct under the PREP Act is limited in several ways. Before filing a lawsuit claiming willful misconduct, injured persons must first seek compensation through the Countermeasures Injury Compensation Program (see below), and they cannot sue if they elect to receive that compensation. If they choose to file a lawsuit, injured persons may sue only in the U.S. District Court for the District of Columbia. Such lawsuits must meet
heightened standards for pleading and discovery, and are subject to procedural provisions generally favorable to defendants. Injured persons must prove willful misconduct by clear and convincing evidence (a higher standard than in a typical civil case), and recovery for noneconomic damages such as pain and suffering is limited.

In addition to these procedural and substantive limitations, the PREP Act contains two statutory defenses to claims of willful misconduct. First, program planners and qualified persons cannot be found to have engaged in willful misconduct if they “acted consistent with applicable directions, guidelines, or recommendations by the Secretary regarding the administration or use of a covered countermeasure,” and
notify either the Secretary or a state or local health authority of the injury or death allegedly caused by the countermeasure within seven days. Second, countermeasure manufacturers and distributors may rely on regulatory compliance as a complete defense to a willful misconduct allegation. When the act or omission alleged to be willful misconduct is “subject to regulation” under the Public Health Service Act or the Federal Food, Drug, and Cosmetic Act (e.g., by FDA), an injured person cannot succeed on a willful misconduct claim unless the Secretary or the Attorney General has brought certain enforcement actions against the manufacturer or distributor that result in the imposition of particular penalties.”

https://www.google.com/url?sa=t&source=web&rct=j&url=https://crsreports.congress.gov/product/pdf/LSB/LSB10443&ved=2ahUKEwjDgYm10ZX0AhXclmoFHVygAlsQFnoECAcQAQ&usg=AOvVaw1xA9S50dJ3BQfqo6czQCeF

Before the pandemic, there was legal recourse and Pfizer still committed fraud. What is to stop them from doing so now?

In Summary:

• Pfizer paid the largest settlement ever at $2.3 Billion for fraudulent marketing
• Pfizer also paid $23.85 Million to resolve False Claims Act Liability for paying kickbacks
• Pfizer paid a $975,000 settlement for distributing misleading marketing materials and coupons to Oregon consumers
• Pfizer paid $785 Million in settlement ff Qui Tam Lawsuit alleging subsidiary Wyeth engaged in fraudulent drug rebate scheme
• In September 2020, a regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial
• Since Jackson reported problems with Ventavia to the FDA in September 2020, Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials (covid-19 vaccine in children and young adults, pregnant women, and a booster dose, as well an RSV vaccine trial

• Pfizer was responsible for study design and conduct; data collection, analysis, and interpretation; and writing of this manuscript
• Both Pfizer and BioNTech manufactured the vaccine and placebo
• BioNTech was the regulatory sponsor of the study and contributed to data interpretation and writing of the manuscript
• All data were available to the authors, who vouch for its accuracy (well that’s a relief…) and completeness and to adherence of the study to the protocol
• BNT162b2 has been shown to have an acceptable safety profile (“acceptable” as determined by the makers of the vaccine)
• Vaccine efficacy against “Covid-19” from 7 days to 6 months after the second dose was 91%, with a similar estimated real-world effectiveness from 8 to 28 days after the second dose
• Participants will be followed for 2 years after receipt of the first dose, including monitoring for potential cases of “Covid-19” and MIS-C (i.e. assessing long-term safety which is UNKNOWN)
• Participants were randomly assigned in a 2:1 ratio to receive two doses, 21 days apart, of either BNT162b2 at the dose level selected during phase 1 (10 μg) or saline placebo (also made by Pfizer)
• After 6 months, or after participants become eligible for “Covid-19” vaccination according to local or national recommendations, placebo recipients will be offered the BNT162b2 vaccine (which lo and behold, is now as the vaccines for 5-!1 year olds were approved less than 2 months after the cut-off date in September 2021…so much for “controls”)
• “Safety” evaluation is broken down as such:
  1. Assessment of reactogenicity events reported by a parent or guardian through the use of an electronic diary for 7 days after each dose
  2. Data on unsolicited adverse events, including confirmed diagnoses of myocarditis or pericarditis, were collected from the first dose through 1 month after the second dose
  3. Data on serious adverse events will be collected from the first dose through 6 months after the second dose
• Seroresponse was defined by an increase in titers by a factor of at least 4 from baseline or by titers that were at least 4 times the lower limit of quantitation if the baseline measurement was less than the lower limit of quantitation (keep in mind, there is no known correlation of protection)
• Effectiveness was inferred by an “immunobridging” approach, in which neutralizing titers elicited by BNT162b2 in 5-to-11-year-olds were compared with titers elicited by BNT162b2 in 16-to-25-year-olds with formal noninferiority hypothesis testing (i.e. effectiveness was inferred by hypothesis…)
• Adverse events from the first dose through 1 month after the second dose were reported by 43.8% of participants who received two 10-μg doses of BNT162b2, 31.3% of those who received two 20-μg doses, and 50.0% of those who received two 30-μg doses
• One severe adverse event (grade 3 pyrexia) in a 10-year-old participant began the day of the second 20-μg dose of BNT162b2
• BNT162b2 recipients reported more local reactions and systemic events than placebo recipients
• Frequencies of fatigue, headache, and chills were similar among BNT162b2 and placebo recipients after the first dose and were more frequent among BNT162b2 recipients than among placebo recipients after the second dose
• Systemic events were reported more often after the second dose of BNT162b2 than after the first dose
• Fever occurred in 8.3% of BNT162b2 recipients after the first or second dose
• Use of an antipyretic (fever reducer) among BNT162b2 recipients was more frequent after the second dose than after the first dose
• From the first dose through 1 month after the second dose, adverse events were reported by 10.9% of BNT162b2 recipients and 9.2% of placebo recipients
• Slightly more BNT162b2 recipients (3.0%) than placebo recipients (2.1%) reported adverse events that were considered by the investigators to be related to the vaccine or placebo
• Lymphadenopathy (swelling of the lymph glands) was reported in 10 BNT162b2 recipients (0.9%) and 1 placebo recipient (0.1%)
• Four rashes in BNT162b2 recipients (observed on the arm, torso, face, or body, with no consistent pattern) were considered to be related to vaccination
• No safety differences were apparent when the data were analyzed according to baseline “SARS-CoV-2” infection status (so the very real adverse reactions were compared to a laundry list of conditions for the very fake disease…seems legit…)
• Limitations of the study include:
  • The lack of longer-term follow-up to assess the duration of immune responses, efficacy, and safety
  • Longer-term follow-up from this study will continue for 2 years
  • This study was also not powered to detect potential rare side effects of BNT162b2 in 5-to-11-year-olds
  • An expanded cohort of 5-to-11-year-olds is being assessed in the present study, and additional safety assessments are in progress (in other words, trust them it’s safe even though they won’t know for at least 2 or more years)
  • The concomitant administration of BNT162b2 with other vaccines was not assessed
  • Cell-mediated responses to immunization are not yet available

• It appeared in 1911 to be widely believed that the intravenious or subcutaneous injection of large quantities of saline is an entirely innocent procedure
• When looking at the evidence for this belief, two facts stood out:
  1. The great variation in the quantities of liquid injected, together with absence of aniy serious attempt to graduate the volume of injection according to the body weight
  2. The wide variation in the absolute quantities of salt injected
• The researchers found that the injection of large quantities of normal or slightly hypertonic saline solutions into a vein or under the skin is not nearly so innocuous a proceeding as is often supposed
• The quantities injected were uisually far smaller than the quantities, relatively to body weight, that are frequently given in man
• The undesirable effects that they encountered included:
  1. Fever
  2. Rigors
  3. Subnormal temperatures
  4. Diarrhoea
  5. Intestinal hemorrhage
  6. Cheyne Stokes breathing
  7. Convulsions
  8. Sudden death
• They believe that for all practical purposes of injection in man these accidents may probably be neglected, thouglh their occurrence in animals accentuates the need for caution in human injections
• The otlher side effects mentioned occurred very frequently after injection into a vein or under the skin of normal or slighitly hypettonic solutions
• Large saline injections in man resulted in pulmonary edema
• The onset of glycosuiria (excess sugar in the urine associated with diabetes) was recorded by Martin Fischer and quoted by Bingel
• Adding to the list of clinical drawbacks to saline injections in animals are evidence of histological changes which include:
  1. Raum showed that intravenous injection of the dog with normal saline was followed by vacuolation of the liver cells
  2. Allbrecht found that the red cells of animals were damaged by large injections of normal saline
  3. Rossle observed degenerative changes in the heart muscle and capillary walls of animals similarly injected
  4. Hossli found that saline injections caused in animals fatty changes in the heart muscle and kidneys
• It has long been known that injections of saline into a vein or under the skin in man or animals may set up fever
• The researchers conclude with four thoughts:
  1. That saline injections as at present administered are by no means free from risk, especially when they are large.
  2. That the cause of the toxicity of distilled water that is allowed to stand in sealed sterile vessels is not yet explained.
  3. That neitlher centrifuging, filtration tllrough cotton-wool or bacterial filters, nor boiling, is sufficient to prevent the fever that follows saline injections.
  4. That distillation in a sterile Jena retort of all water used in the preparation of saline solutions, followed by immediate injection, is at present the only reliable method of ensuring that no fever follows the injections.

• Today, it is noted that “normal” saline may cause serious side effects including:
  1. Fast heartbeat
  2. Fever
  3. Rash
  4. Joint pain
  5. Shortness of breath
• The most common side effects of “normal” saline include:
  1. Fever
  2. Injection site swelling
  3. Redness
  4. Infection
• These are not all the possible side effects of “normal” saline
• The name has morphed into what is more commonly called “normal saline” or “physiological saline” despite no additional evidence or rationale for the relabeling
• The implied normalcy and physiological property have perpetuated indiscriminate use of saline in medical practice
• Despite its name, saline is neither “normal” nor “physiological”
• Compared to human serum, saline has a nearly 10% higher Na concentration and 50% higher Cl concentration
• Despite the availability of safer and more physiologically balanced solutions and despite not a single study demonstrating saline to be superior to balanced solutions, saline continues to be used frequently, if not the most commonly used resuscitative fluid, in medical practice
• Evidence suggests that high Cl-containing fluids (such as saline) are associated with multiple adverse effects including an increased occurrence of kidney dysfunction with possible reduced survival
• Saline administration should be considered to have the same status as a drug prescription

• The PREP Act was implemented To encourage the expeditious development and deployment of medical countermeasures during a public health emergency and to limit legal liability for losses relating to the administration of medical countermeasures such as diagnostics, treatments, and vaccines
• Under the HHS Declaration and its amendments, covered persons are generally immune from legal liability (i.e., they cannot be sued for money damages in court) for losses relating to the administration or use of covered countermeasures against “COVID-19”
• Courts have characterized PREP Act immunity as “sweeping” as it applies to all types of legal claims under state and federal law
• Federal laws such as the PREP Act may preempt state tort laws—as well as other state and federal laws—in certain contexts
• Preemptive federal legislation displaces state law to alter the usual liability rules or immunize certain individuals from liability
• In the PREP Act, Congress made the judgment that, in the context of a public health emergency, immunizing certain persons and entities from liability was necessary to ensure that potentially life-saving countermeasures will be efficiently developed, deployed, and administered
• Within the scope of the declaration, the PREP Act immunizes a covered person from legal liability for all claims for loss relating to the administration or use of a covered countermeasure
• The PREP Act defines a covered person to include:
  • The United States
  • Manufacturers and distributors of covered countermeasures
  • “Program planners”
  • “Qualified persons” who prescribe, administer, or dispense covered countermeasures
• PREP Act immunity reaches “all claims for loss” under federal and state law
• Loss is broadly defined to mean “any type of loss,” including:
  1. Death
  2. Physical, mental, or emotional injury, illness, disability, or condition
  3. Fear of such injury, including medical monitoring costs
  4. Loss of or damage to property, including business interruption loss
• PREP Act immunity applies to any claim for loss that has “a causal relationship with the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, or use” of a covered countermeasure
• If a claim is within the PREP Act’s scope, a covered person is generally immune from legal liability
• The “sole exception” to immunity is when a covered person proximately causes death or serious physical injury to another person through willful misconduct
• Willful misconduct requires that the covered person acted:
  1. Intentionally to achieve a wrongful purpose
  2. Knowingly without legal or factual justification
  3. In disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit
• The process by which injured persons (or their representatives) may prove willful misconduct under the PREP Act is limited in several ways
• Before filing a lawsuit claiming willful misconduct, injured persons must first seek compensation through the Countermeasures Injury Compensation Program and they cannot sue if they elect to receive that compensation
• If they choose to file a lawsuit, injured persons may sue only in the U.S. District Court for the District of Columbia
• Such lawsuits must meet heightened standards for pleading and discovery, and are subject to procedural provisions generally favorable to defendants
• Injured persons must prove willful misconduct by clear and convincing evidence (a higher standard than in a typical civil case), and recovery for noneconomic damages such as pain and suffering is limited
• Program planners and qualified persons cannot be found to have engaged in willful misconduct if they “acted consistent with applicable directions, guidelines, or recommendations by the Secretary regarding the administration or use of a covered countermeasure,” and notify either the Secretary or a state or local health authority of the injury or death allegedly caused by the countermeasure within seven days
• Countermeasure manufacturers and distributors may rely on regulatory compliance as a complete defense to a willful misconduct allegation
• An injured person cannot succeed on a willful misconduct claim unless the Secretary or the Attorney General has brought certain enforcement actions against the manufacturer or distributor that result in the imposition of particular penalties

Pfizer has consistently been shown to be a corrupt criminal organization that has resorted to fraud, false advertisement, and kickbacks in order to push its products and agenda. This description could fit any pharmaceutical company as well as those that oversee the industry such as the FDA and CDC. When it comes to the study of an experimental vaccine to be tested on our children, Pfizer was able to control every aspect of its design and interpretation. They were able to make the determination that their own product was effective based on flawed inferred antibody results and noninferiority hypothesis testing. They get to claim that their product is “safe” by comparison with a toxic placebo of their own design while their data lacks long-term follow-up as the study will continue for at least two more years with unblinded controls who will be offered the very product they are evaluating for safety. They get to make these claims while facing absolutely no liability nor recourse for anyone who is subsequently injured or killed by their “safe and effective” experimental product.

What is it that continues to compel people to put blind faith in these evil institutions? When it comes to the abandonment of all logic and critical thought, there is usually one culprit to blame: FEAR. It is the power of fear that can make one act irrationally and against the best interests of themselves and, in this case, their children. The propaganda pushed out by the pharmaceutically-controlled WHO/CDC/FDA/MSM has been extremely effective at convincing people to turn themselves into human Guinea pigs at the expense of their own health and wellbeing. These villainous institutions now want us to turn our children into their unwilling subjects for their sick and twisted game of Russian Roulette.

There are six good reasons not to load a single bullet into the chamber:

1. “SARS-COV-2” has never been properly purified/isolated directly from a sick human nor ever proven pathogenic.
2. Without purified/isolated “SARS-COV-2,” the PCR tests can not be properly validated against the gold standard of purified/isolated “virus” and the results are thus scientifically meaningless.
3. There is no known correlation of protection for “SARS-COV-2” thus the antibody results are scientifically meaningless.
4. The mRNA vaccines are experimental and have a history of adverse reactions when tested against animals and humans.
5. Pfizer (and other manufacturers) has a proven track record of criminal activity including fraud, false advertisement, and kickbacks.
6. There is no liability for the manufacturers nor legal recourse for anyone injured or killed by their experimental toxic injection.

There would only ever be one reason to load a single bullet in that chamber, spin it around, and take the 1 in 6 chance that the chamber is empty. Do not let fear guide you to make a decision you may regret for the rest of your life. Your child needs you to be their voice. You owe it to them to cast away your fear, do your due diligence, and take the time to research this subject in order to make an informed, objective, and rational decision.