Informed Consent? AFLD Lawsuit Seeks Halt to EUA and FDA Approval

• (i)  for the under-18 category;
• (ii)  for those, regardless of age, who have been infected with SARS-CoV-2 prior to vaccination; and
• (iii)  until such a time as the Defendants have compiled their obligation to create and maintain the requisite "conditions of authorization" under Section 546 of the Food, Drugs, and Cosmetics Act, 21 U.S.C. § 360bbb-3(e), thereby enabling Vaccine candidates to give truly voluntary, informed consent.

Migration of the SARS-CoV-2 "Spike Protein" in the Body

The spike protein, which is that catalyst that enables the virus to infect other bodies, is a "pathogenic protein" and a toxin that causes damage. It enters the bloodstream and circulates throughout the body, severely damaging the cardiovascular system. It causes platelets to clump, causing heart inflammation, bleeding, and clotting. It crosses the blood-brain barrier to cause neurological damage while accumulating in several tissues, including the liver, spleen, bone marrow, adrenal glands, and ovaries. It can be transferred to infants through breastmilk, with VAERS reporting incidents of "infants sucking from vaccinated mothers experiencing bleeding disorders in the gastrointestinal tract."

Because of the lack of safety studies to rush the quickly designed vaccines, no one knew where these spike proteins would travel in the body once injected or how long they would last. For this reason, talk about booster shots fluctuates back and forth.

Increased Risk of Death from Vaccines

The government database VAERS (Vaccine Adverse Event Reporting System), established in 1986, is designed to serve as an "early warning" system for potential health risks caused by vaccines. Approximately 1% to 19%, at best, of all vaccine adverse events are reported to VAERS, leaving it highly inadequate, as pointed out by the plaintiff. Remarkably, "of the 262,000 total accumulated reports in VAERS, only 1,772 are not related to COVID-19. According to the database, the total reported vaccine deaths in the first quarter of 2021 represent a 12,000% to 15,000% increase in vaccine deaths year-on-year. From 2009 to 2019, there were 1,529 total vaccine deaths. In the first quarter alone of 2021, there have been over 4,000. The CDC's parallel COVID-19 side-effect reporting system, an app called "V-Safe," is inaccessible and controlled exclusively by the CDC.

Reproductive Health

The spike proteins our bodies are taught to produce by the mRNA shots are in the same family as other reproductive proteins found in sperm, ova, and placenta. Antibodies created to fight the spike protein may interact with similar naturally occurring proteins in the reproductive system, and there is no data provided on this by the manufacturers. The lawsuit points to a study in the New England Journal of Medicine that found pregnant women receiving the vaccine during the first or second trimester suffer an 82% spontaneous abortion rate, killing 4 out of 5 unborn babies. A leaked Pfizer document shows that an extraordinarily high number of nanoparticles accumulate in the delicate ovarian tissues, more so than in other tissues. With no manufacturer studies on this troubling discovery, the suit notes it is a cause of great concern. 

Furthermore, every female is born with the total number of eggs she will have for her entire life. By design, the reproductive system is arguably the most "delicate hormonal and organ balance in all our systems." With billions of aggressive mRNA spike proteins accumulating in the ovarian tissue, this is a great cause for concern. To this day, scientists and doctors do not fully understand all of the contributing factors to infertility. Evidence also suggests the vaccines could cause "permanent autoimmune rejection of the placenta." In essence, the body would attack the placenta as though it were an invader, ultimately making pregnancy impossible. 

Vascular Disease

Research shows that the spike proteins themselves damage vascular cells, causing strokes and many other problems. As is well documented, all of the COVID-19 vaccines are causing clotting disorders in all ages. The spike proteins are also known to cause clotting that the body cannot repair, like thrombocytopenia and brain thrombosis. 

Autoimmune Disease

The human immune system perceives the spike proteins from the vaccines as foreign invaders and initiates an immune response to fight them. This nature-intended scenario also causes any cell in our body that is expressing spike proteins to become a target for destruction by our own immune system, causing an immune disorder affecting virtually any organ in the body. AFLDS asserts it is likely "that some proportion of the spike protein will become permanently fused to the long-lived human proteins, and this will prime the body for prolonged autoimmune diseases," which can take years to show up. 

Neurological Damage

The brain, which is unique in structure and function, is usually protected with an amazing feature called "the blood-brain barrier." This complex and multi-layered barrier prevents nearly everything from reaching the brain and allows it to function without interruptions from the rest of the body. Sadly, unlike any other vaccine ever used, the COVID-19 vaccines can breach this barrier through different routes, including through the nerve structure in the nasal passages and through the blood vessel walls. The lawsuit says the vaccines are programmed to produce the S1 subunit of the spike protein in every cell in every Vaccine recipient. Still, this subunit causes brain damage and neurological symptoms, with the elderly at an increased risk.

To explain further, the S1 subunit of the spike protein (which can cross the blood-brain barrier) is the part of the SARS-CoV-2 virus that produces COVID-19 and is in the vaccines. Considering the high number of ACE2 receptors in the brain (the portion of the cell that allows the spike protein to attach to human tissue), this is even more alarming. The VAERS database shows a significant increase in reporting of neurological damage following the vaccine.

Effect on the Young

The immune responses in the young and healthy are more vigorous than in others. The lawsuit points out "the vaccines are more deadly or harmful to the young than the virus, and that is excluding the unknown future effects on fertility, clotting, and autoimmune disease." In fact, the vaccines may induce—in the very people who need immune assistance the least—a powerful and potentially harmful immune response which includes damage to their own cells and tissues. According to CDC data, those under 18 face statically ZERO chance of death from SARs-CoV-2. However, there are reports of heart inflammation in young men and at least one documented case of a fatal heart attack in a healthy 15-year-old boy two days after receiving the Pfizer vaccine. Since April 2021, the CDC has admitted increased cases of myocarditis and pericarditis after the mRNA vaccines, particularly in young adults and adolescents. 

AFLDS asserts in the claim that it is a virtual certainty that healthy children, whose birthright is decades of a healthy life, will face premature death or decades of chronic disease, facing challenges around antibody-dependent enhancement, neurological disorders, autoimmune disease, and reproductive problems.

Antibody Dependent Enhancement

Antibody Dependent Enhancement ("ADE") occurs when SARS-CoV-2 antibodies created by the vaccine—instead of protecting the vaccinated person—cause a more severe or lethal case of COVID-19 when the person is later exposed to SARS-CoV-2 in the wild. Rather than preventing damage—the vaccine amplifies the infection. This paradoxical reaction may only be visible after months or years of using the vaccine in populations worldwide. ADE was observed in the original SARS-CoV-1 epidemic in 2003, which is reportedly 78% similar to the current SARS-CoV-2 virus responsible for COVID-19. 

Blood Supply

Right now, individuals who have received COVID-19 vaccines are permitted to donate their spike protein-laden blood into the blood supply, projecting all of the risks previously discussed. The lawsuit notes that healthcare professionals and scientists around the globe are frantically appealing to the FDA to halt the vaccines. Fifty-seven top scientists and doctors from Central and South America call for an immediate end to all COVID-19 vaccine programs. 

Seeing the catastrophic and deadly results of the rushed vaccines, other physician-scientist groups—who point out that in the past government has ended vaccine trials on far less than the facts presented now—have made similar calls, among them: Canadian Physicians, Israeli People's Committee, Frontline COVID-19 Critical Care Alliance, World Doctors Alliance, Doctors 4 Covid Ethics, and Plaintiff America's Frontline Doctors.  

The scientists all agree that the spike protein produced by the vaccines causes disease even without the virus.

The Vaccines are Not Approved by the FDA, but Merely Authorized for Emergency Use

AFLDS asserts in its lawsuit that the Defendants have failed to educate the American public that the FDA has neither "approved" the vaccines nor has the DHHS Secretary determined they are "safe and effective." Instead, using "weasel language" of the EUA statute, the Defendants have decided it is "reasonable to believe" that the vaccines "may be" effective and that the benefits outweigh the risks. Instead of educating the American people, the Defendants have bombarded them with messages from all levels of the federal and state government, the private sector, and the media. The President himself recently stated:

"The bottom line is this: I promise you they are safe. They are safe. And even more importantly, they're extremely effective. If you're vaccinated, you are protected."     

Increasingly, the public is being made aware of the severe conflicts of interest that weigh on Dr. Fauci, the National Institute of Allergies and Infectious Diseases (NIAID), and the Vaccines and Related Biological Products Advisory Committee, which advises and consults Defendants regarding vaccine EUAs. The lawsuit maintains the public cannot assess the reliability of the information they are being given due to the conflicts of interest of the authorities providing it to them.

The Significant Known and Potential Risks of the Vaccines

According to the complaint, both the Pfizer and Moderna vaccines do not meet the CDC guidelines—they do not stimulate the body to produce immunity from a disease. No peer-reviewed studies demonstrate they give immunity or prevent transmission. The lawsuit alleges of the shots:

"They are a synthetic fragment of nucleic acid embedded in a fat carrier that is introduced into human cells, not for the purpose of inducing immunity from infection with the SARS-CoV-2 virus, and not to block further transmission of the virus, but in order to lessen the symptoms of COVID-19."

As pointed out in the case, information is propagandized and censored on every level—including medical journals—thus, the public is uninformed about the gene therapy technology behind the Pfizer and Moderna vaccines. In its SEC filings, Moderna admits "the novel and unprecedented nature of this new class of medicines." The company also recognizes that the FDA classes its vaccine as a form of "gene therapy." Admittedly, not being a vaccine at all, the document states:

"Rather, instructions, via a piece of lab-created genetic code (the mRNA) are injected into your body that tells your body how to make a certain "spike protein" that is purportedly useful in attacking the SARS-CoV-2 virus."     

The claim alleges the population is enslaved to an offensive, coordinated $1 billion government-funded media campaign, including Biden's door-to-door scheme, pushing the vaccines. The media campaign is reinforced by a draconian system of coercive rewards and penalties intended to convince vaccination. Even the federal government is offering a range of incentives, which include free childcare. Simultaneously, legacy news agencies and social media oligarchy across the board promote the agenda, agreeing not to publish any negative news about the vaccines—individual physicians and certain medical journals are being censored. Dr. Philippe Douste-Blazy, cardiologist and former France Health Minister and 2017 candidate for Director of the WHO and former Under-Secretary-General of the United Nations, described the horrifying censorship:

The Lancet boss said, “Now we are not going to be able to, basically, if this continues, publish any more clinical research data, because the pharmaceutical companies are so financially powerful today and are able to use such methodologies, as to have us accept papers which are apparently, methodologically perfect but in reality, which manage to conclude what they want to conclude.” … one of the greatest subjects never anyone could have believed … I have been doing research for 20 years in my life. I never thought the boss of The Lancet could say that. And the boss of the New England Journal of Medicine too. He even said it was “criminal” — the word was used by him. That is, if you will, when there is an outbreak like the COVID-19, in reality, there are people … us, we see “mortality” when you are a doctor or yourself, you see “suffering.” And there are people who see “dollars” — that’s it."

The Option to Accept or Refuse the Vaccines

Using fear to manipulate the public is a strategy often used in public health. After a year of constant psychological manipulation, the claim notes that society is now scared, vulnerable, and desperate for a return of its freedoms. The pressure on the defenseless to take the vaccine is unprecedented. The plaintiff argues Americans are especially vulnerable to guilt, shame, coercion, and the threat of penalties. The suit contends the unvaccinated are threatened and warned with false fears and anxiety about COVID-19, including children who aren't at any statistical risk, and the removal of the constitutional rights of the unvaccinated, including:

o Being prohibited from working
o Being prohibited from attending school or college
o Being limited in the ability to travel in buses, trains, and planes
o Being prohibited from traveling outside the United States
o Being excluded from public and private events, such as performing arts venues

The lawsuit, in referencing the absence of the option to accept or refuse the vaccine after being given accurate information, reminds that the combined effect of the suppression and censorship of information about vaccine risks along with the failure to inform the public of the novel and experimental nature of the mRNA vaccines and alternative treatments is unacceptable. Furthermore, the experts failed to disclose and properly educate the public that the vaccines are neither FDA approved nor has the DDHS Secretary determined that they are "safe and effective." Instead, the agency has only determined it is "reasonable to believe" the vaccines "may be effective" and that the benefits outweigh the risks. Certainly, the lawsuit maintains:

"The sustained psychological manipulation of the public through official fear-based messaging regarding COVID-19, draconian countermeasures and a system of rewards and penalties, is to remove any possibility that Vaccine recipients are giving voluntary informed consent to the Vaccines. They have no real option to accept or refuse the Vaccines. They are unwitting, unwilling participants in a large-scale, ongoing non-consensual human experiment."

The Under-18 Age Category

Plaintiff expert Dr. Angelina Farella is a fully licensed board-certified pediatrician for over 25 years. She has vaccinated over 10,000 patients. Dr. Farella points out that it is not only the number of people tested but the length of time that is important when creating new vaccines. Emergency Use Authorization was granted prematurely for adolescents before ANY trials were completed. Declaring that children are not at risk in the pandemic and should not be part of the experiment, Dr. Farella states:

"Vaccines take years to safely test. It's not only the number of people tested but the length of time that is important when creating new vaccines. Emergency Use Authorization was granted prematurely for adolescents before ANY trials were completed. Moderna is scheduled to complete trials on October 31, 2022, and Pfizer is scheduled to complete trials on April 27, 2023. There were no trial patients under the age of 18. The FDA and these pharma companies are currently allowing children 12 years old to receive this shot when they were never studied in the trials. Never before in history have we given medications that were not FDA approved to people who were not initially studied in the trial."

Local governments are recklessly passing laws eliminating the requirement for parental consent or even knowledge of medical treatments given to children as young as 12. The lawsuit contends these moves are intended to set the stage for children to be vaccinated at school at the government's will. Lacking the complete brain development capable of giving voluntary, informed consent to vaccines, children already have a well-known and scientifically studied vulnerability to peer pressure. In this case, the lawsuit points out that with the COVID-19 vaccine, this age group—the under-18 subpopulation —is particularly susceptible to being injected with the vaccine "for the sake of other people and society," threatening them with immediate and potentially life-threatening harm. 

Those Previously Infected with SARS-CoV-2

A recent Cleveland Clinic study shows that natural immunity acquired through prior infection with COVID-19 is more robust than the benefits one would gain from the vaccine, rendering it unnecessary. The claim reveals that previously infected individuals had 96.4% immune protection from COVID-19, versus 94.4% in those injected with the vaccine.

Moreover, an Israeli study showed that less than 1% of new cases are in people who had been previously infected with COVID-19. By comparison, 40% of new COVID-19 cases are in those infected for the first time despite being vaccinated. Some argue the CDC's recent elimination of the reporting of breakthrough cases could be because of this information.

Those previously infected with COVID-19 who then received the vaccine are also prone to "Vaccine-driven disease enhancement." A person who gets the shot after having the disease mounts an immune response that is between 10-20% stronger than the response of a previously uninfected person. A study published in the New England Journal of Medicine noted antibody titers 10-45 times higher in those with preexisting COVID-19 immunity after the first Vaccine injection, with 89% of those seropositive reporting adverse side effects. As the lawsuit notes, this substantial risk is suppressed in mainstream national news. 

Whistleblower Testimony: 45,000 Deaths Caused by the Vaccines

The lawsuit includes expert testimony from an anonymous whistleblower name "Jane Doe," a computer programmer in the healthcare data analytics field. This witness, who writes fraud detection algorithms, has access to Medicare and Medicaid data maintained by the Centers for Medicare and Medicaid Services (CMS). In her expert opinion, VAERS "under-reports deaths resulting from the Vaccines by a conservative factor of at least 5, indicating the true number of deaths caused by the Vaccines is at least 45,000."