"Comirnaty has the same formulation as the FDA-authorized Pfizer-BioNTech COVID-19 vaccine and can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness."
Service members are refusing the SARS-CoV-2 vaccine mandate based on an illegal order because the EUA BioNTech is voluntary, while an FDA-approved and licensed Comirnaty vaccine can be mandated — yet the Comirnaty vaccine does not exist in the U.S. yet. The FDA also prohibits labeling one drug as another drug by a different name. The FDA has not published an exception to a policy that BioNTech labeled drugs can be relabeled with a Comirnaty label. Even if both drugs are made by Pfizer, and hypothetically have the same exact formulation, they are legally distinct. Pfizer has also yet to publish where and when people could obtain the Comirnaty-labeled product in the U.S. Officers-in-Charge of military vaccine clinics have written affidavits that they do not have Comirnaty-labeled vaccines, and available EUA drugs are voluntary. Service members are within their rights to refuse a BioNTech labeled drug. 2. John Doe, Jane Doe v. DOD, HHS, Air Force, Navy, FDA, Army (Reyes, Defending the Republic) Defending the Republic in October filed a lawsuit against the U.S. government — including Secretary of Defense Lloyd Austin, III, Department of Human Services Secretary Xavier Becerra and FDA Acting Commissioner Dr. Janet Woodcock — on behalf of 16 active-duty military service members in support of their right to refuse the unconstitutional and unlawful COVID-19 vaccine mandate. According to Defending the Republic:"The core claims raised in the lawsuit ask the court to bar the FDA and DOD from using deceptive 'bait-and-switch' tactics and to uphold the constitutional right of every citizen to refuse an unwanted, unnecessary and unproven vaccine. The 'bait-and-switch' involves the FDA's approval of the Comirnaty vaccine, which is not available, while the FDA and DOD instead seek to administer the experimental, unapproved version of the vaccine (which cannot be mandated) to trick service members to forfeit their rights to informed consent and to refuse an experimental vaccine.
This lawsuit challenges the FDA's unlawful "approval" of the Comirnaty Vaccine. This approval violated the Administrative Procedure Act, contradicted the FDA's own rules, was based on flawed and incomplete scientific studies, and was made despite unprecedented numbers of adverse events — including deaths — related to the vaccine.
The complaint also alleges the FDA acted in an "arbitrary and capricious" manner, in that it excluded certain groups from clinical trials, including those with previous COVID-19 infection and pregnant women.
DOD adamantly claims BioNTech and Comirnaty are the same product. However, a trove of evidence shows not only are the two products different in formulation, but Comirnaty has not even begun production, and Pfizer has no intention to begin production until pandemic stockpiles of the liability-free EUA products are exhausted.
As a matter of due diligence, it would be simple for DOD to confirm or deny this lack of FDA-approved drug supply by demanding clarification from the FDA and Pfizer, to ensure that service members' rights are not being railroaded by an industry with a monopoly acting with the collusion of captured agencies.
Instead, the chain of command complies without any resistance to a force-reduction crisis, and holds disciplinary hearings for separation using the convenient industry-provided mantra of "interchangeable."
In documentation of the fraud that is occurring, a TRICARE physician wrote the following email communication:"Per the memo attached, On September 13, 2021, the National Library of Medicine within the National Institutes of Health (NIH), reported, '[a]t present, Pfizer does not plan to produce any product with these new [Comirnaty National Drug Codes] and labels over the next few months while EUA-authorized product is still available and being made available for U.S. distribution.' Therefore, Pfizer has not made any Comirnaty. There is no expected date when we will receive Comirnaty."
3. Robert & Mulvihill v. DOD, HHS, FDA (Callender, America's Frontline Doctors) In this case, two active duty service members seek a temporary restraining order from the DOD vaccine mandate based on prior COVID infections and naturally acquired immunity. The case cites that AR40-562 has a longstanding exemption for vaccines when service members demonstrate natural immunity with serologic testing. In an unprecedented unilateral decision, the U.S. Secretary of Defense Lloyd Austin has redefined immunity by vaccine only, and thereby denies science in the validity of natural immunity in a new policy for the vaccine mandate. The case demonstrates potential harm to the plaintiffs by incomplete clinical trials ending in 2023, a new experimental technology of mRNA without general population data on long-term effects and the 837,595 adverse events reported to the Vaccine Adverse Event Reporting System (as of Oct. 22). The United States Military Academy at West Point has already discharged Army cadets with natural immunity for refusing the vaccine. West Point only has a few young, healthy cadets seeking vaccine exemptions, and yet has created a policy of expulsion and separation that denies a >95% vaccinated population at the academy can protect the few unvaccinated. This is a denial of science; herd protection was originally established that 60% natural immunity would protect vulnerable elderly and infants. The affidavit of Lt. Col. Theresa Long, MD, MPH, FS, in support of this case as a military whistleblower makes compelling arguments that the SARS-CoV-2 vaccine is putting all service members at serious health risks, with toxic ingredients not previously used in humans Long recommended the Secretary of Defense ground all vaccinated pilots until they can be evaluated for cardiac symptoms. 4. Church v. Biden (Yoder, Temporary restraining order granted Oct. 29 in favor of military and federal employees) This case exposes that the Nov. 8 deadline for vaccine mandates imposed on military and federal employees was created by President Biden’s Safer Federal Workforce Task Force in a scheme to use the deadline as a "forcing function" to coerce vaccine uptake, to collect data on the scope of how many religious exemptions would be requested, to collect extensive information on religious beliefs and to ultimately refuse all religious accommodations with any criteria an agency chooses. This case outlines the longstanding protections in the Free Exercise Clause of the First Amendment, the Equal Protection Clause of the Fifth Amendment, and the Religious Freedom and Restoration Act. The case articulates the sincerely held religious objections to aborted fetal cells in all of the SARS-CoV-2 vaccines. The case highlights the preferential exemptions for federal employees in the federal Executive Branch (White House, Centers for Disease Control and Prevention, National Institutes of Health, National Institute of Allergy and Infectious Diseases and select federal agents. The Federal Food, Drug, and Cosmetic Act also protects the plaintiffs because the FDA-approved Comirnaty is not available to anyone in the U.S. Mike Yoder, attorney for the plaintiffs, said: "The DOD OIG COVID-19 Coordinator has confirmed that the Pentagon does not have COMIRNATY and does not know when COMIRNATY will be available." Yoder referenced a letter addressed to Pfizer, in which the FDA clarifies any uncertainty that BioNTech is labeled as EUA and therefore voluntary: "The Pfizer-BioNTech COVID-19 Vaccine vial label and carton labels are clearly marked for 'Emergency Use Authorization.'" Ultimately, the case argues the federal vaccine mandate violates fundamental rights without a compelling governmental interest using the least restrictive means: right to freely exercise religion, right to earn a living and right to remain free from the forcible injection of a medication, such as a vaccine to a nonconsenting person’s body. 5. Costin v. Biden (Yoder) This case also represents various federal and military plaintiffs. It details the fraud of agencies misinforming employees that BioNTech is FDA-approved and mandatory, and reports that DOD is falsifying medical records with "Comirnaty" for service members who received "BioNTech." From the lawsuit:"93. On August 23, 2021, the FDA approved Pfizer's COMIRNATY® (COVID-19 vaccine, mRNA) ("COMIRNATY"), which is legally distinguishable from the Pfizer-BioNTech vaccine ("BioNTech") as evidenced by the FDA's COMIRNATY vaccine approval announcement published on August 23, 2021.
"94. The FDA approval letter only states that COMIRNATY is FDA-approved; Pfizer-BioNTech, is not, nor has it ever been approved by the FDA.
"95. It could not be clearer that BioNTech is not FDA-approved and therefore, the vaccine remains subject to the EUA provisions of the federal Food, Drug, and Cosmetic Act ("FDCA").
"96. As a result, a mass misinformation campaign has construed the two legally distinct vaccines to be considered by the public-at-large as a single "Pfizer vaccine" — this is not correct.
"97. The two Pfizer vaccines are legally distinct and include differences. For example, the two vaccines have different numbers of ingredients: COMIRNATY has eleven (11) ingredients while Pfizer-BioNTech has just ten (10) ingredients."
6. Navy Seals v. Biden (Gannam, Liberty Counsel) This case challenges the blanket refusal of religious accommodation of service members, federal employees and federal civilian contractors. The federal COVID-19 vaccine mandate violates the voluntary conditions of an EUA drug, the First Amendment and the Religious Freedom Restoration Act. According to the complaint:"Plaintiffs have demonstrated their commitments to the United States Constitution and the Nation’s future comfort, security and prosperity. This Court should demand that the Nation return the favor. Telling Plaintiffs they must accept or receive a shot they oppose according to their sincerely held religious beliefs, or face court-martial, dishonorable discharge, and other life-altering disciplinary measures, disgraces the sacrifices these heroes have made.
"Defendants' vaccine mandate, ostensibly responding to a public health crisis, has created a national emergency of much greater magnitude. The mandate attacks the military from within by removing brave servicemembers from defending the Nation by land, air and sea, and from without by eliminating the dedicated civilian defense contractors and employees providing everything from boots and uniforms, to cyber security, to the world's most advanced stealth fighter jet — the F-35 Raptor— solely because these protectors of our constitutional freedoms requested accommodation of their sincerely held religious beliefs under the same Constitution.
"The crisis created by Defendants' mandates, applied to two million federal employees, is unnecessary and completely avoidable, but nonetheless imminent and real."
Despite the willingness of applicants for religious accommodations to undertake reasonable protocols for public health as they did prior to the SARS-CoV-2 vaccine rollout, most Navy personnel are immediately removed from positions and declared "not physically qualified" while expected to take a risk of myocarditis even if they have natural immunity from a prior infection. The lawsuit states:"For example, on October 14, 2021, Vice Admiral William Galinis, Commander, Naval Sea Systems Command (NAVSEA), sent a warning to his entire command, comprising more than 85,000 civilian and military personnel: 'The Executive Order mandating vaccinations for all federal employees has provided clear direction. We are moving quickly toward a workforce where vaccinations are a condition of employment. Frankly, if you are not vaccinated, you will not work for the U.S. Navy.'"
7. Navy Seals v. DoD (Berry, First Liberty Institute) First Liberty reported the U.S. Navy has written a policy that discharged Seals can be required to pay back the cost of years of training:"Collectively, our clients have more than 350 years of military service and more than 100 combat deployments. But under the Pentagon's current policy, their careers —decades of experience, leadership and training — could be on the verge of destruction if they choose not to be vaccinated.
"Navy SEALs are brave and fierce fighters who dedicate years of their lives, sacrificing themselves physically and mentally to serve our nation and defend our liberties. Plus, it costs millions of taxpayer dollars in training — approximately $2 million per Navy SEAL — to prepare the most elite fighting force on the face of the earth.
"It's vindictive and punitive that the DOD is threatening to expel them from the Navy or even send them to jail. Even more shocking, the government could also force these elite fighters to repay the nation for their training — all for simply asking for a religious accommodation. Again, this is a right they have under both federal and military law."
"It's not only the Navy SEALs themselves who face harassment, but also their families. First Liberty has documentation from the DOD stating military service members and their dependents (who are not subject to military orders) cannot travel until they are vaccinated. That's unjustified and outrageous."
The Navy policy is to discharge all unvaccinated service members without an approved exemption on Nov. 28. Many of these lawsuits are taking donations to offset the cost of litigation to service member plaintiffs. The court precedents won in these military lawsuits will also benefit civilians facing similar employer mandates. "Even in a pandemic, the Constitution cannot be put away and forgotten." — Roman Catholic Diocese of Brooklyn v. Cuomo, 141 S. Ct. 63, 68 (2021) Read more at: ChildrensHealthDefense.org
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