Revolver Exclusive: The Big Pharma “Shell Game” Tricking Our Military Into Mandatory Vaccinations

Commander Jay Furman alerting of deception and malfeasance within the government and pharmaceutical companies.

Reposted from Revolver and Commander Jay Furman
Original article written on September 25, 2021 (reprinted with permission)

Last month, Revolver exclusively published a paper by Navy CDR J.H. Furman, warning that the mandatory COVID-19 vaccination of the entire Navy could constitute a national security threat.

Now, Furman has produced another paper, describing what he calls a “shell game” by which other U.S. government agencies, and several pharmaceutical companies are tricking the Navy into embracing mandatory vaccination, at great risk to the United States.

 

His paper is reproduced below.

The views and opinions expressed in this paper do not in any way represent the United States Navy or the Department of Defense.

 

CDR Jay Furman, USN

At the turning point of the Spanish American War, a single American officer volunteered to hand carry a critical message through impossible enemy lines to a fateful ally named General Garcia, forever changing the course of that war and our country. Today, one million COVID-19 non-vaccinated brave military messengers would deliver a, no less, existential dispatch: the U.S. Military is being misled by the U.S. Food and Drug Administration (FDA), the Center for Disease Control (CDC), and the Pfizer and BioNTech drug companies, resulting in the current mandatory COVID-19 vaccination policies. While some media outlets reflexively cheer on the deadly shell game, is our military leadership prematurely mandating a vaccine that their personnel cannot, or should not, legally receive? Could that decision prove to be more detrimental to military readiness than the disease itself, thereby posing a greater threat to U.S. national security?

 

On August 23, 2021, news broke that Pfizer had obtained an FDA license for its COVD-19 vaccine. The contrived FDA announcement:

Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine [BioNTech’s COVID-19 Vaccine, mRNA, not Pfizer]. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine [Pfizer’s non-FDA licensed vaccine], and will now be marketed as Comirnaty (koe-mir’-na-tee) [only available in markets outside U.S.], for the prevention of COVID-19 disease in individuals 16 years of age and older (emphasis added).

 

The agency charged with the public’s health in pharmaceutical matters issued two related official letters confounding the announcement, above. Reconciling those letters and the ensuing policy is tedious, leaving the truth one-layer too deep for most media outlets. Unfortunately, the resulting confusion appears more goal than incidental. Bottom-line, the FDA did not license a COVID-19 vaccine physically available to consumers in the U.S.

In their first letter, the FDA issued the only COVID-19 vaccination license for COVID-19 Vaccine, mRNA (Comirnaty) owned by German company BioNTech (not Pfizer). It is not produced for a U.S.-licensed label anywhere in the FDA’s jurisdiction. In their second letter, the FDA re-issued the Emergency Use Authorization (EUA) for Pfizer-BioNTech COVID-19 Vaccine (not a FDA license). The letter officially designates Comirnaty as the licensed name for COVID-19 Vaccine, mRNA. This EUA explicitly states that Pfizer-BioNTech COVID-19 Vaccine “[…] has not been approved or licensed by the FDA, but has been authorized by emergency use [EUA] by the FDA […]” (emphasis added). It goes on to assert that Pfizer-BioNTech COVID-19 Vaccine and Comirnaty (COVID-19 Vaccine, mRNA) formulations are the same and thereby can be clinically substitutable. The FDA notes the abundant supply of Pfizer-BioNTech COVID-19 Vaccine and the non-availability of Comirnaty (COVID-19 Vaccine, mRNA) in the U.S. market. They then explicitly re-affirm that Pfizer-BioNTech COVID-19 Vaccine is, in fact, experimental and only covered by the EUA, not FDA licensed.

 

FDA License Letter:

 

EUA Re-issue Letter Excerpts:

Confused yet? The CDC did not help matters, either. On Monday, August 31, 2021, their Advisory Committee on Immunization Practices (ACIP) released an inaccurate statement. The committee’s public announcement unanimously endorsed the FDA license for the “Pfizer-BioNTech licensed vaccine.” They misstated the vaccine name and license holder, never mentioning the actual owner of the FDA license, BioNTech, conflating legal ownership of Comirnaty (COVID-19 Vaccine, mRNA) as Pfizer’s. They neglected to mention it is not available in the U.S. and therefore not possible for consumers here to receive. Those inaccuracies further aided the public misperception that Pfizer-BioNTech COVID-19 Vaccine is FDA licensed. Concurrently, two high-level career FDA officials resigned at the time of the CDC ACIP board announcement, citing frustration with overreach into FDA affairs by other parts of the Executive Branch.

 

The Pfizer company issued a “forward-looking” press release, that was also easily misinterpreted. Perhaps they were hoping the mundane went unnoticed, as the pharmaceutical giant intermingled complex terms and concepts: Pfizer, BioNTech, Comirnaty, COVID-19, mRNA, EUA, authorized, approved, licensed, manufacturer, legal owner, national markets, and etc. The corporate relationship between Pfizer and BioNTech is no less convoluted. The joint venture and vaccine names, also similar, only add to the confusion. All of which potentially prevented a clear understanding of important legal and regulatory nuances, and allowed a fearful U.S. public to believe an available vaccine was now regulatorily licensed for their safety and legal recourse, when in reality, it was not. In brief:

  • BioNTech is the marketing arm of the two company enterprise in the U.S., Europe, and UK.
  • Pfizer produced Comirnaty (COVID-19 Vaccine, mRNA) for BioNTech, while both submitted supporting material for the license.
    BioNTech, alone, received an FDA license for Comirnaty (COVID-19 Vaccine, mRNA).
  • Both Pfizer-BioNTech COVID-19 Vaccine and Comirnaty (COVID-19 Vaccine, mRNA) were covered, in-part, by the re-issued EUA.
  • Both Pfizer-BioNTech COVID-19 Vaccine and COVID-19 Vaccine, mRNA may be available in other countries. Yet, Comirnaty (COVID-19 Vaccine, mRNA) is not available anywhere under FDA jurisdiction.
  • If and when this occurs, Comirnaty (COVID-19 Vaccine, mRNA) will be “[…] manufactured, filled, labeled, and packaged at Pfizer.”
  • Both Pfizer produced vaccines are, at times, marketed as Comirnaty outside the U.S. While only COVID-19 Vaccine, mRNA) is officially recognized as Comirnaty in this country.

Recent U.S. military vaccine mandates look to be a direct result of the manufactured confusion. August 24, 2021 DoD guidance stated that the Department “[…] will only use COVID-19 vaccines that receive full licensure from the Food and Drug Administration (FDA) […]” (emphasis added). A fully FDA licensed COVID-19 vaccine is not available to U.S. service members. They are simply not able to legally comply with the DoD mandate.

By administrative and regulatory law, it appears that all public and private institutions are not allowed to mandate EUA medical products. In 21 U.S. Code 360bb-3-Authorization for medical products for use in emergencies for unapproved products (b)(2)(e)(1)(A)(ii)(III), it says that recipients have “[…] the option to accept or refuse administration of the product.” In the FDA’s own policy guidelines it is written that recipients “[…] have the option to accept or refuse the EUA product […].” Under U.S. Code 335(i)(4) and related regulations, “the informed consent process typically requires human subjects to agree to the receipt… upon a disclosure that the product in question is not yet FDA approved and that the receipt of such product is voluntary.” Informed consent is required to administer EUA vaccines with few exceptions.

 

The newly mandated Pfizer-BioNTech COVID-19 Vaccine is legally defined as an EUA and therefore cannot be mandated in the military unless informed consent is waived by a presidential waiver and, according to U.S. Code Section 1107a of Title 10 and DoDI 6200.02, only after meeting specific criteria. Two of these criteria apparently preclude its issuance in this case: 1) “[…] specified military operation presents a substantial risk that military personnel may be subject to a chemical, biological, nuclear, or other exposure likely to produce death or serious or life-threatening injury or illness […]” and; 2) “[…] no available satisfactory alternative therapeutic or preventive treatment in relation to the intended use of the investigational new drug.” In the first, a waiver of informed consent is limited to the support of a specific military operation. For the second, monoclonal antibody therapy is an FDA-authorized alternative COVID-19 treatment.

It does not matter that the FDA stated in their re-issued EUA, their website, or Fact Sheet that the vaccines are similarly formulated and can be clinically interchangeable. The simple fact is that the administration of an EUA vaccine, by law, requires informed consent. It is therefore illegal to mandate any of the three U.S. available COVID-19 vaccines that are not officially licensed. As the Department did not receive an informed consent waiver from the President to mandate the Pfizer-BioNTech CV-19 Vaccine, and the FDA licensed Comirnaty (COVID-19 Vaccine, mRNA) is not yet available in the U.S., it remains uncertain how the military can continue to incorrectly mandate COVID-19 vaccination.

Consequently, the Services’ mandatory vaccination orders are impossible to lawfully execute according to Uniform Code of Military Justice (UCMJ) Article 90. U.S. military officers take an oath to the Constitution, and not to those appointed over them in the event orders are unlawful (enlisted service members swear allegiance to both). An officer may find themselves duty bound to refuse an unlawfully mandated vaccination in support and defense of the law of the land, on the behalf of their troops.

 

Meanwhile in other countries, Pfizer has not provided any COVID-19 vaccines without explicit (and extreme) indemnity contracts in place. They are requiring not only protection from all future product harm civil lawsuits, but also protection from Pfizer’s “[…] fraud, gross negligence, mismanagement, failure to follow good manufacturing processes… or malice […].” The company is requiring some countries to fund foreign bank accounts, take out insurance, and put up sovereign assets such as their Embassies or military bases, according to global health law lecturer Mark Eccleston-Turner of the University of England and statnews.com.

The aforementioned regulatory charade may be a U.S. version of Pfizer’s COVID-19 global indemnity project. Unfortunately, the company has a history of misbranding “with the intent to defraud or mislead.” In a landmark DOJ case they were found guilty of a felony, and fined $2.3 billion (the largest such fine ever) for fraudulent marketing. Interestingly, the FDA receives almost half of its current funding from industry in the form of “regulatory fees,” a clear conflict of interest which should be strongly questioned.

If the vaccine is actually safe and effective, then why all this confusion? Why did they only license “Comirnaty (COVID-19 Vaccine, mRNA),” exclusively available outside of this country? Why did they not license the “Pfizer-BioNTech COVID-19 Vaccine,” the only label available in the U.S. Why does Pfizer not just import the approved label? Why are they so keen on some form of almost total indemnity everywhere their vaccines are available? Why are we told they are interchangeable, but their license and EUA are legally not? If what is in the vial is the same, then why the legal labyrinth? And what exactly was the cross-agency overreach into FDA licensing processes and why is there no formal Congressional inquiry?

 

Sen. Ron Johnson (R-Wis.) is asking questions. He recently wrote a letter to the FDA requesting “why they did not grant full licensure for the Pfizer-BioNTech vaccine that is already in use and available in the U.S., and how the agency will ensure that those being vaccinated under mandates will receive the FDA-approved version […].” Those concerned about our nation’s defense should consider asking their Congressmen and Senators to do the same.

The complex web of words, business structures, international legal agreements, and unforthright regulation may not collectively protect U.S. citizens. Rather, they enable a slight-of-hand scheme that increases global market-share, reduces expenses, and lowers potential legal exposure. All the while, this product (with no long-term studies and declining efficacy) is pushed on the consumer—at all costs—regardless of the potential harm. If the confusion were removed as it should be, informed citizens, their elected officials, and public servants would not stand for this carnival-like side show.

Nine months into the vaccination campaign, available evidence to-date does not look good for existing U.S. vaccines. The original “wild” version of SAR-CoV-2 is virtually dead and the increasingly immune variants dominate. Delta is highly contagious, but much less dangerous to the general population. The largest real-world analysis study, examining 700,000 records in Israel’s official health database, found that the COVID-19 vaccinated are 13 times more likely to be infected and 27 times more likely to demonstrate serious symptoms than those with recovered natural immunity. The Combined Vaccine Adverse Event Reporting System (VAERS), which tracks post-vaccination events for possible patterns, has through August recorded more than 600,000 events, including 81,000 serious or life-threatening events and about 13,000 deaths.

In contrast, as of 12 August, the COVID-19 mortality rate in the military was .001%, or 29 deaths in the almost 2.2 million-strong and exceptionally healthy U.S. service member population. Recent studies, meanwhile, indicate that teen boys and young men (the military’s dominant demographic) are more likely to suffer heart problems from vaccination than they are to be hospitalized from COVID-19 itself. It is not difficult at all to imagine that in a force as young and healthy as the military, universal vaccination could cause more harm than the disease itself.

We all, citizen, elected official and military, want to protect the Force, but the extent of national harm that could result from doing so in this way, with wrong or incomplete information, is staggering to contemplate. Industry, regulators, and media must be immediately cross-examined. We literally only get one shot at this, as these vaccines are irreversible experimental gene therapies. I have previously suggested a Department-wide safety pause to conduct further study, so as to not prematurely commit the entire U.S. fighting force to one permanent experimental group. Given all of the cross-agency confusion, Congressional inquiry may be necessary. A bipartisan body could better investigate the misperceptions informing national security decisions.

Until more is reliably known, DoD can still maintain a control group with almost half of the 2.2 million uniformed population still deciding not to vaccinate. We could easily commence prevention and treatment therapies like I-MASK+ currently used in nations around the world with great efficacy.

It would be a national calamity to “rush to failure” en masse with the entire U.S. troop strength, using vaccines that may be more harmful than the disease itself to this specific population entrusted with our nation’s defense. The pervasive misperception that Pfizer-BioNTech COVID-19 Vaccine is FDA licensed, thereby justifying mandatory vaccination policy, is a logical syllogism based on a false premise and, therefore, invalid. The FDA, CDC, Pfizer, BioNTech and the media must reveal what is under all of the “shells” for the sake of this Republic.

Many U.S. military service members are carrying these messages to Garcia in the strongest terms possible, by tendering resignations. I am aware of many seasoned officers and enlisted who have done so, or done the effective equivalent (early retirement or non-reenlistment). This mandatory vaccination decision may, in the end, squander billions in training and readiness. The sudden loss of even a fraction of the one million non-vaccinated force could expose critical capabilities at scale. The talent capable of separating, at this time, have completed all service obligations, are fully trained and highly experienced, constituting the best of our warfighter expertise and lethality. Many others are declining to visit the military recruiter’s office for the first time. The already difficult task of recruiting for our all-volunteer force may become nearly impossible with a mandatory vaccination policy.

The most tragic are those already in the Service who have a remaining obligation (contracts or enlistments) and cannot choose to leave for risk of legal or financial ruin. Continue down this path, and our military will almost certainly suffer a heretofore-unseen morale deficit, further reducing overall fighting capability. If we run off or demoralize fully half of our armed force, then the defense of this nation will be significantly crippled.

And for what? To protect 0.001% of those in service? We would wreck our military, just after wrecking our economy, at the worst possible time, when U.S. soft power and perceived hard power are arguably at their lowest levels in half a century. This unnecessary vaccine mandate comes at a moment when strategic competitors are demonstrably more capable, more aggressive, and more able to project their will against U.S. interests than ever before.

If the mandatory COVID-19 vaccine policy is truly a military readiness initiative, then the reality is it will cause a far graver impact to our national defense posture than this disease. America’s foes do not care the reason why our Soldiers, Sailors, Airmen, Marines, Coast Guard or Guardians are not on duty to prevent attack. Mandatory vaccination’s enterprise-level damage to recruiting, retention, and trust and confidence within the ranks could make us all more vulnerable than COVID-19 ever could alone. It has been said that this great nation can only be conquered from within. If the military self-inflicts a strategic sized wound (by persecuting half the troops), then it is possible we could gift this nation’s enemies our own mortal blow.

To review, the FDA licensed vaccine is not available to consumers in the U.S. and even DoD cannot mandate any emergency vaccine without a specifically conditional, presidential waiver of a service member’s informed consent. To do otherwise is unlawful. The way I see it, service members have three choices: 1) choose to receive the EUA shot; 2) submit a religious and/or medical waiver, or; 3) refuse the EUA shot, as only a fully licensed vaccine labeled Comirnaty, not available at your U.S. clinic, can be mandated at present.

As we do best, service members are helping service members. More information can be found at COVID-19 educational information hub: thecontrolgroup.us

Commander Furman is a career United States naval officer, naval aviator and foreign area officer with extensive experience advising senior military, diplomatic and international organization’s leadership. The Commander has spent years serving throughout Africa, Asia, Europe and the Middle East at sea, ashore and airborne. He holds a Master of Arts in Security Studies from the Naval Postgraduate School.

NOTE FROM EXPANDING AWARENESS RELATIONS:
Thank you to Commander J.H. Furman and The Revolver for bringing these incredibly important issues to our attention. The amount of deception and manipulation that these “medical/health agencies”, government/politicians and pharmaceutical companies have employed to vaccinate everyone cannot in common sense terms be deemed as a beneficial goal and/or for health reasons. There is something else at work here.

Thank you again to Commander J.H. Furman and everyone else speaking up during these perilous times. Your bravery and integrity in coming forward is greatly appreciated and much needed to bring this awareness to the population.

God bless.

Are These Findings the Death Blow for Vaccine Passports?

“COVID shots do not prevent infection or spread of the virus”

This article has been cross-posted from globalresearch.ca
Written by Joseph Mercola (September 17, 2021)

All Global Research articles can be read in 51 languages by activating the “Translate Website” drop down menu on the top banner of our home page (Desktop version).

Visit and follow us on Instagram at @crg_globalresearch.

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More than 15 studies now show the natural immunity you get after recovering from COVID-19 is far superior and more long-lasting than what you get from the COVID shot

Lawsuits challenge vaccine requirements that fail to accept natural immunity as an alternative to the COVID injection

Todd Zywicki, a law professor at George Mason University in Virginia, sued over the school’s vaccine mandate, which did not recognize natural immunity. The school settled out of court, granting Zywicki a medical exemption. They did not, however, change their general policy to recognize other staff and students who have natural immunity

Some of the plaintiffs in a lawsuit filed against Rutgers University in New Jersey also object to the vaccine mandate on the basis that they have natural immunity. This lawsuit is still pending

Since COVID shots do not prevent infection or spread of the virus, and COVID-jabbed individuals carry the same viral load when symptomatic as unvaccinated individuals, the argument that vaccine passports will identify and separate “public health threats” from those who are “safe” to be around simply falls apart

*

While governments around the world are going full steam ahead with plans for vaccine passports, two key things have occurred that blow irreparable holes in the whole argument.

First, more than 15 studies now show the natural immunity you get after recovering from COVID-19 is far superior and longer-lasting than what you get from the COVID shot, and secondly, lawsuits have challenged vaccine requirements that fail to accept natural immunity as an alternative to the COVID injection. Other lawsuits highlighting the illegalities of vaccine mandates have also been filed.

The Zywicki Case

As reported by the New York Post,1 August 4, 2021, when George Mason University in Virginia decided to implement a vaccine mandate, law professor Todd Zywicki sued.2 Mason recovered from COVID-19 in 2020 and has natural immunity, as demonstrated by several antibody tests. One of his attorneys, Harriet Hageman, stated:

Common sense and medical science should underpin GMU’s actions. Both have gone missing with this latest effort to force a distinguished professor to take a vaccine that he does not need — not for his own protection nor for anyone else’s safety at Scalia Law School.”

The lawsuit pointed out that people with natural immunity have an increased risk of adverse reactions to the COVID shot — according to one study3 up to 4.4 times the risk of clinically significant side effects — and that the requirement not only violates due process rights and the right to refuse unwanted medical treatment, but is not compliant with the Emergency Use Authorization.4

A Win for GMU Professor but No Legal Precedent

August 17, 2021, George Mason University caved before the case went to trial and granted Zywicki a medical exemption to the vaccine requirement.5 Unfortunately, and irrationally, the school did not revise its general policy. As reported by Citizens Journal:6

“The school’s acknowledgment of natural immunity is significant given the serial case of amnesia that seems to have overtaken the world on this basic point of biology.

However, the school still maintains the vaccination requirement for all other members of the GMU community, regardless of naturally acquired immunity. At the time of this writing, the same medical exemption has not been offered on a broader scale.

Furthermore, the lawsuit would have served as an interesting test case for vaccine mandate-related litigation, which will become more prevalent as time goes on. Regardless, the victory still serves as a sliver of hope that some universities will entertain reasonable arguments and that individuals can fight back with litigation …

With the GMU case resolved without trial, many critical legal arguments went untested. For example, does the 14th Amendment’s Due Process Clause apply to vaccine mandates, or does the state have the ability to suspend such rights when responding to a public health emergency?

How does the reliability of natural immunity affect the constitutionality of policies that fail to recognize it? Can the government simply cherry-pick whatever science it wants to justify its policies? According to the court filing,7

‘The Supreme Court has recognized that the Ninth and Fourteenth Amendments protect an individual’s right to privacy. A ‘forcible injection … into a nonconsenting person’s body represents a substantial interference with that person’s liberty[.]’ Washington v. Harper, 494 U.S. 210, 229 (1990).’

Given this precedent, as well as the state’s police powers to suspend individual rights under compelling circumstances, how will this apply to Covid-19 in a low-risk environment such as a college campus?

If the right still holds, how will it apply to city-wide vaccine passport programs, given that Covid-19 is a relatively mild disease? … The move is also mysterious, given the relevance of the matter. As a result, it did not create a binding legal precedent.”

In a statement, lead counsel Jenin Younes with the New Civil Liberties Alliance, said:8

“NCLA is pleased that GMU granted Professor Zywicki’s medical exemption, which we believe it only did because he filed this lawsuit. According to GMU, with the medical exemption, Prof. Zywicki may continue serving the GMU community, as he has for more than two decades, without receiving a medically unnecessary vaccine and without undue burden.

Nevertheless, NCLA remains dismayed by GMU’s refusal — along with many other public and private universities and other employers — to recognize that the science establishes beyond any doubt that natural immunity is as robust or more so than vaccine immunity.”

Other Lawsuits Challenging Schools’ Vaccine Mandates

While not specifically centered around the validity of natural immunity, a lawsuit filed by more than a dozen students and Children’s Health Defense against Rutgers University in New Jersey does include this aspect, as some of the plaintiffs object to the mandate on the basis that they have natural immunity. This lawsuit was filed in mid-August 20219 and is still pending.

Earlier this year, in April 2021, the Los Angeles Unified School District was sued over its vaccine requirement by California Educators for Medical Freedom and the Health Freedom Defense Fund.10July 27, a California court dismissed the lawsuit without prejudice, as it concluded the LAUSD had voluntarily abandoned its mandatory vaccine requirement. As reported by The Defender:11

“This is a BIG win — because of the lawsuit, LAUSD represented to the court on the record that it does not have a policy requiring vaccination with EUA products. Since the court has now confirmed the absence of any policy requiring vaccination at LAUSD, all teachers and staff are safe to return to work without vaccination or furnishing proof of vaccination in the fall.”

Time will tell if the Children’s Health Defense case against Rutgers University will bring the legal precedent needed to more effectively thwart this tyrannical trend. Still, even smaller wins like Zywicki’s are important and demonstrate there are ways we can fight back, if only we’re willing.

Natural Immunity Surpasses Vaccine-Induced Protection

While vaccine passports are immoral and unconstitutional in and of themselves, medical science is also proving them useless and irrational. As reported by Daniel Horowitz in an August 25, 2021, article in The Blaze,12 there are at least 15 studies that show natural immunity from previous infection is more robust and longer-lasting than what you get from the COVID shot. He writes:

“The debate over forced vaccination with an ever-waning vaccine is cresting right around the time when the debate should be moot for a lot of people. Among the most fraudulent messages of the CDC’s campaign of deceit is to force the vaccine on those with prior infection, who have a greater degree of protection against all version of the virus than those with any of the vaccines.

It’s time to set the record straight once and for all that natural immunity to SARS-CoV-2 is broader, more durable, and longer-lasting than any of the shots on the market today. Our policies must reflect that reality.”

We now have data showing vaccine immunity rapidly wanes regardless of variants, but especially when a new variant becomes predominant. According to the Mayo Clinic, as of July 2021, Pfizer’s COVID injection was only 42% effective against infection,13 which doesn’t even meet the Food and Drug Administration’s requirement of 50% efficacy14 for COVID vaccines.

This matches Israeli data, which show Pfizer’s shot went from a 95% effectiveness at the outset, to 64% in early July 2021 and 39% by late July, when the Delta strain became predominant.15,16 Pfizer’s own trial data also demonstrate rapidly waning effectiveness. BMJ associate editor Peter Doshi discussed this in an August 23, 2021, blog.17

By the fifth month into the trial, efficacy had dropped from 96% to 84%, and this drop could not be due to the emergence of the Delta variant since 77% of trial participants were in the U.S., where the Delta variant didn’t emerge until months later. So, even without a predominance of a new variant, effectiveness drops off. In an August 20, 2021, report, BPR noted:18

“‘The data we will publish today and next week demonstrate the vaccine effectiveness against SARS COVID 2 infection is waning,’ the CDC director [Rochelle Walensky] began … She cited reports of international colleagues, including Israel ‘suggest increased risk of severe disease amongst those vaccinated early’ …

‘In the context of these concerns, we are planning for Americans to receive booster shots starting next month to maximize vaccine induced protection. Our plan is to protect the American people and to stay ahead of this virus,’ Walensky shared …

The CDC director appears to all but admit that the vaccine’s efficacy rate has a strict time limit, and its protections are limited in the ever-changing environment.”

You’re Far Safer Around a Naturally Immune Person

Add to this a) the fact that the COVID shots do not prevent infection or spread of the virus and b) the fact that COVID-jabbed individuals carry the same viral load when symptomatic as unvaccinated individuals,19,20 and the whole argument that vaccine passports will identify and separate “public health threats” from those who are “safe” to be around simply fails miserably.

As noted by Horowitz, anyone capable of rational thought understands that a person with natural immunity from a previous infection is “exponentially safer to be around than someone who had the vaccines but not prior infection.”21

As for the unvaccinated who do not have natural immunity from prior infection, well, their status poses no increased risk to anyone but themselves. Conversely, since the COVID shot cannot prevent infection or transmission, and only promises to reduce your risk of serious illness, the only one who can benefit from the shot is the one who got it. It protects no one else.

In fact, you may actually pose an increased risk to others, because if your symptoms are mild or nonexistent, but your viral load high, you’re more likely to walk around as usual. Rather than staying home because you suspect you’re infected and infectious, you’re out spreading the virus around to others, vaccinated and unvaccinated alike.

What Does the Research Say?

In his article, Horowitz reviews 15 studies that should, once and for all, settle the debate about whether people who have had COVID are now immune and whether that immunity is comparable to that of the COVID shots. Here’s a select handful of those studies. For the rest, please see the original Blaze article.22

  • Immunity May 202123 New York University researchers concluded that while both SARS-CoV-2 infection and vaccination elicit potent immune responses, the immunity you get when you’ve recovered from natural infection is more durable and quicker to respond.

The reason for this is because natural immunity conveys more innate immunity involving T cells and antibodies, whereas vaccine-induced immunity primarily stimulates adaptive immunity involving antibodies.

  • Nature May 202124 This research dispels fears that SARS-CoV-2 infection might not produce long-lasting immunity. Even in people with mild COVID-19 infection, whose anti-SARS-CoV-2 spike protein (S) antibodies levels might rapidly decline in the months’ post-recovery, persistent and long-lived bone marrow plasma cells start churning out new antibodies when the virus is encountered a second time.

According to the authors, “Consistently, circulating resting memory B cells directed against SARS-CoV-2 S were detected in the convalescent individuals. Overall, our results indicate that mild infection with SARS-CoV-2 induces robust antigen-specific, long-lived humoral immune memory in humans.”

  • Nature July 202025 The Nature findings above support findings from Singapore published in July 2020, which found patients who had recovered from SARS in 2002/2003 had robust immunity against SARS-CoV-2 17 years later.
  • Cell Medicine July 202126 Here, they found that most previously infected patients produced durable antibodies and memory B cells, along with durable polyfunctional CD4 and CD8 T cells that target multiple parts of the virus.

According to the authors: “Taken together, these results suggest that broad and effective immunity may persist long-term in recovered COVID-19 patients.” The same clearly cannot be said for vaccine-induced immunity.

  • BioRxiv July 202127 Echoing the Cell Medicine findings above, University of California researchers concluded that “Natural infection induced expansion of larger CD8 T cell clones occupied distinct clusters, likely due to the recognition of a broader set of viral epitopes presented by the virus not seen in the mRNA vaccine.”

We’re Creating a Pandemic of the Vaccinated

If natural immunity is better than vaccine-induced antibodies, you’d expect to see fewer reinfections among those who have already had COVID-19, compared to breakthrough infections occurring among those who got the COVID shot. And that’s precisely what we see.

In a preprint titled “Necessity of COVID-19 Vaccination in Previously Infected Individuals,”28 the researchers looked at reinfection rates among previously infected health care workers in the Cleveland Clinic system.

Of the 1,359 frontline workers with natural immunity from previous infection, not a single one was reinfected 10 months into the pandemic, despite heavy exposure to COVID-19-positive patients.

A second preprint,29 posted August 25, 2021, compared SARS-CoV-2 natural immunity to vaccine-induced immunity by looking at reinfection and breakthrough rates. Four outcomes were evaluated: SARS-CoV-2 infection, symptomatic disease, COVID-19-related hospitalization and death.

Results showed that, compared to those with natural immunity, SARS-CoV-2-naïve individuals who had received a two-dose regimen of Pfizer’s COVID shot had:30

  • A 5.96-fold increased risk for breakthrough infection
  • A 7.13-fold increased risk for symptomatic disease
  • A 13.06-fold increased risk for breakthrough infection with the Delta variant
  • A higher risk for COVID-19-related-hospitalizations

After adjusting for comorbidities, SARS-CoV-2-naïve individuals who had received two Pfizer doses were 27.02 times more likely to experience symptomatic breakthrough infection than those with natural immunity.31 No deaths were reported in either of the groups. In closing the authors concluded:32

“This study demonstrated that natural immunity confers longer lasting and stronger protection against infection, symptomatic disease and hospitalization caused by the Delta variant of SARS-CoV-2, compared to the BNT162b2 two-dose vaccine-induced immunity.”

Majority of Hospitalizations Are Actually in the Vaccinated

The oft-repeated refrain is that we’re in a “pandemic of the unvaccinated,” meaning those who have not received the COVID jab make up the bulk of those hospitalized and dying from the Delta variant. However, we’re already seeing a shift in hospitalization rates from the unvaccinated to those who have gotten one or two injections.

For example, in Israel, the fully “vaccinated” made up the bulk of serious cases and COVID-related deaths in July 2021, as illustrated in the graphs below.33 The red is unvaccinated, yellow refers to partially “vaccinated” and green fully “vaccinated” with two doses. By mid-August, 59% of serious cases were among those who had received two COVID injections.34

new hospitalizations

new severe covid 19 patients
deaths trend

Data from the U.K. show a similar trend among those over the age of 50. In this age group, partially and fully “vaccinated” people account for 68% of hospitalizations and 70% of COVID deaths.35

COVID-19 delta variant hospital admission and death in England

Data36 from the U.S. Centers for Disease Control and Prevention also refute the “pandemic of the unvaccinated” narrative. Between July 6,2021, and July 25, 2021, 469 COVID cases were identified in a Barnstable County, Massachusetts, outbreak.

Of those who tested positive, 74% had received two COVID injections and were considered “fully vaccinated.” Even despite using different diagnostic standards for non-jabbed and jabbed individuals, a whopping 80% of COVID-related hospitalizations were also in this group.37,38

COVID Shot May Harm Immunity in Those Previously Infected

While the authors of that August 25, 2021, preprint39 claim in their abstract that “Individuals who were both previously infected with SARS-CoV-2 and given a single dose of the vaccine gained additional protection against the Delta variant,” in the body of the article they admit they “could not demonstrate significance in our cohort.”

Unless significance is demonstrated, the finding is basically irrelevant, so I would not rely on this paper if I wanted to argue for vaccination of those with preexisting natural immunity. Besides, there’s research40 showing the COVID shots may actually harm the superior T cell immunity built up from prior infection, especially after the second dose. As reported by Horowitz in The Blaze:41

“Immunologists from Mount Sinai in New York and Hospital La Paz in Madrid have raised serious concerns. In a shocking discovery after monitoring a group of vaccinated people both with and without prior infection, they found ‘in individuals with a pre-existing immunity against SARS-CoV-2, the second vaccine dose not only fail to boost humoral immunity but determines a contraction of the spike-specific T cell response.’

They also note that other research has shown ‘the second vaccination dose appears to exert a detrimental effect in the overall magnitude of the spike-specific humoral response in COVID-19 recovered individuals.’”

Arguments for Vaccine Passports Are Null and Void

FEE.org reported the August 25 findings under the headline, “Harvard Epidemiologist Says the Case for COVID Vaccine Passports Was Just Demolished”:42

“Harvard Medical School professor Martin Kulldorff said research showing that natural immunity offers exponentially more protection than vaccines means vaccine passports are both unscientific and discriminatory, since they disproportionately affect working class individuals.

‘Prior COVID disease (many working class) provides better immunity than vaccines (many professionals), so vaccine mandates are not only scientific nonsense, they are also discriminatory and unethical,’ Kulldorff, a biostatistician and epidemiologist, observed on Twitter …

Vaccine passports would be immoral and a massive government overreach even in the absence of these findings. There is simply no historical parallel for governments attempting to restrict the movements of healthy people over a respiratory virus in this manner.

Yet the justification for vaccine passports becomes not just wrong but absurd in light of these new revelations. People who have had COVID already have significantly more protection from the virus than people who’ve been vaccinated.

Meanwhile, people who’ve not had COVID and choose to not get vaccinated may or may not be making an unwise decision. But if they are, they are principally putting only themselves at risk.”

Positive Signs

arihasanaj tiktok video

While we still have a long and likely hard fight ahead of us, there is reason to be optimistic. In a recent TikTok video,43 a young man named Ari Hasanaj who lives in New York City describes how he printed up posters that say:

“We do not discriminate against ANY customer based on sex, gender, race, creed, age, vaccinated or unvaccinated. All customers who wish to patronize are welcome in our establishment.”

He then went around the city, from one store to the next, asking each owner if they would agree to post the sign on their door to protest NYC’s vaccine passport requirement. A majority said yes. He is now asking others to join him in this effort.

In Denmark, vaccine passports will no longer be used to restrict movement as of September 10, 2021. The health minister, Magnus Heunicke, has stated, though, that the passport system may be reinstated if rising infection rates threaten important functions.

Denmark was among the first to announce the development of a digital vaccine passport, which came into effect in April 2021.44 For months, Danes repeatedly demonstrated against the COVID passes, and it seems the protests eventually had the desired effect. It just goes to show that if enough people resist, tyrannical overreach can be reined in.

*

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Notes

1 New York Post August 4, 2021

2, 7 Zywicki vs George Mason University Case 1:21-cv-00894

3 JAMA Internal Medicine August 16, 2021 [Epub ahead of print]

4, 5, 6, 8 Citizens Journal August 25, 2021

9 Children’s Health Defense vs Rutgers Case 2: 21-cv-15333

10 The College Fix April 10, 2021

11 The Defender August 12, 2021

12, 21, 22, 41 The Blaze August 25, 2021

13 MedRxiv August 8, 2021 DOI: 10.1101/2021.08.06.21261707

14 FiercePharma June 30, 2020

15 CNBC July 23, 2021

16, 17 The BMJ Opinion August 23, 2021

18 BPR August 20, 2021

19, 36, 37 CDC MMWR July 30, 2021; 70

20 NBC News August 7, 2021

23 Immunity May 3, 2021

24 Nature May 24, 2021; 595: 421-425

25 Nature July 15, 2020; 584: 457-462

26 Cell Medicine July 20, 2021; 2(7): 100354

27 BioRxiv July 15, 2021 DOI: 10.1101/2021.07.14.452381

28 MedRxiv June 19, 2021 DOI: 10.1101/2021.06.01.21258176

29, 30, 31, 32, 39 MedRxiv August 25, 2021 DOI: 10.1101/2021.08.24.21262415

33 Twitter Alex Berenson July 18, 2021

34 Science August 16, 2021

35 Evening Standard August 20, 2021

38 CNBC July 30, 2021

40 BioRxiv March 22, 2021 DOI: 10.1101/2021.03.22.436441

42 FEE.org August 30, 2021

43 TikTok September 2, 2021

44 Sundhedsministeriet, August 27, 2021

Featured image is from NaturalNews.com

Pfizer-BioNTech/COMIRNATY Vaccine Is Still Under “STUDY” Runs to be Completed at Different Intervals Between 2022-2026

” – known serious risks of myocarditis and pericarditis”

In addition to the many debates and conflicts surrounding the “approval” of the Pfizer/BioNTech/Comirnaty vaccine, there is interesting information to glean from the documents involved surrounding this controversy.

The below documents, some from the FDA’s own website, sheds further light into what seems to be a product still in its experimental/study phase. Some of the revelations are chilling, and doesn’t quite give the reassurance that an “approved” drug of this magnitude is more beneficial to us than what it is purported to be saving us from.

Screenshot of the FDA NEWS RELEASE: FDA Approves First COVID-19 Vaccine
taken on August 31, 2021
[ https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine ]
Content current as of August 23, 2021

Selected quotes in gray text boxes are from the above document:

“Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.

Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.

More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.

The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.”

There are a couple of notes to take away from this document. In the above quote, it doesn’t quite specify how long the clinical trial lasted. Only that more than half of the clinical trial participants were followed for safety outcomes for 4 months after the second dose. It also states that 12,000 of the recipients were followed for at least 6 months.

Both of these numbers (4 and 6) are incredibly low quantities when taking into account pregnant women who are at the beginning of their pregnancy. The length of the clinical trial does not take into account the full 9 months needed to determine a healthy pregnancy, nor does it allow for any time to safely assess the development of the baby once born.

The data in this document also does not include differences between those of the placebo group compared to that of the “vaccine” group. In addition, if we are to only take the 12,000 participants into account, which from the wording of the document seems to allude that these are the recipients of the vaccine, that would still leave 10,000 participants unaccounted for. Just from the amount of vaccine recipients (22,000), this is 45% of their study that the data does not reflect. If we are to include the 22,000 of the participants who received the placebo, the data that was not tracked would rise to 72%.

There is also the challenge of how they determined that the vaccine actually prevented COVID. Were these recipients exposed to someone with COVID or were deliberately inoculated with the disease to see if they would get infected? Many people, myself included, have gone on for more than a year without developing COVID, or at least “COVID symptoms”. Since this data only involved a 4-6 month trial period, how many of us (vaccinated, placebo, or otherwise) can say that we have not contracted COVID during this time-frame either? Is this implying that unless you’re vaccinated, you will most likely get COVID every 4-6 months?

Another consideration to take into account are the many testimonies from well-respected and renowned doctors/scientists/virologists who are adamant in their assessment that these vaccines are unnecessary and instead further harms the immune system rather than help it.

In the same regard, those who are unvaccinated will obviously then not contract any of the possible side effects that are listed in this document as well as the many adverse events that are reported to VAERS. Which leaves one to wonder if the benefits really outweigh the risks of the COVID vaccines.

There is also the slight alteration on a different page of the FDA website that gives further clarification as to the efficacy of the COVID vaccines – which does not reflect that of what many people are influenced to believe:

Under the heading:

Q: What safety information did FDA evaluate to authorize the Pfizer-BioNTech COVID-19 Vaccine for emergency use and approve Comirnaty?

Screenshot of the Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions
taken on August 31, 2021
[ https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine-frequently-asked-questions ]
Content Current as of August 23, 2021

UPDATE on September 6, 2021: Since the FDA website decided to remove this particular section from their FAQ (as of 9/1/2021), here is a screenshot taken from the web archive showing its existence:

“While the vaccine may not prevent infection, symptoms or transmission of the virus from person to person – “

This seems to be the heart of the matter, and although it continues with, “it is effective in preventing hospitalization and death.” it is in direct conflict with what we were led to believe this whole time. Most of the mainstream media, big tech platforms, health agencies, etc. have insisted that vaccines are needed to stop transmission of the virus and to protect those around us. However, this one simple statement defies everything that people were coerced into believing.

And with the last part of the sentence concluding that it prevents hospitalization and death, which even that is debatable when looking at the scope of the situation, it leaves one to wonder why this would not be an option for people to decide to take that risk on their own account. When comparing data of young individuals as well and their extremely low risk of hospitalization and death in the COVID setting, there ARE acknowledged threats when they are injected with the vaccine.

“Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks.”

The FDA is also acknowledging that there are higher risks involved with the Pfizer-BioNTech COVID-19 vaccine and myocarditis and pericarditis, especially in males aged 12-17, and up to age 40.

“Information is not yet available about potential long-term health outcomes.”

“In addition, the FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty. These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Comirnaty. In addition, although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.”

The document is also stating that the possibility of myocarditis and pericarditis is an accepted issue and will continue to be monitored after the marketing of the Comirnaty vaccine.

And in a rather blunt admission, FDA states on their own website that Comirnaty is not required to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy. This would explain why the initial trial run was only monitored for 4-6 months. An outline in the BLA (Biologics License Approval) also states that Comirnaty will conduct studies on this group as we see in a later section.

BLA documents state Comirnaty vaccine studies to be conducted for the next several years

Screenshot taken from from the FDA BLA Approval on August 31, 2021
[ https://www.fda.gov/media/151710/download ]
Document dated August 23, 2021

Text below is page 5 of the FDA BLA Approval document

Your deferred pediatric studies required under section 505B(a) of the Federal Food,
Drug, and Cosmetic Act (FDCA) are required postmarketing studies. The status of
these postmarketing studies must be reported according to 21 CFR 601.28 and section
505B(a)(4)(C) of the FDCA. In addition, section 506B of the FDCA and 21 CFR 601.70
require you to report annually on the status of any postmarketing commitments or
required studies or clinical trials.

Label your annual report as an “Annual Status Report of Postmarketing Study
Requirement/Commitments”
and submit it to the FDA each year within 60 calendar
days of the anniversary date of this letter until all Requirements and Commitments
subject to the reporting requirements under section 506B of the FDCA are released or
fulfilled. These required studies are listed below:

1. Deferred pediatric Study C4591001 to evaluate the safety and effectiveness of
COMIRNATY in children 12 years through 15 years of age.

Final Protocol Submission: October 7, 2020

Study Completion: May 31, 2023

Final Report Submission: October 31, 2023

2. Deferred pediatric Study C4591007 to evaluate the safety and effectiveness of
COMIRNATY in infants and children 6 months to <12 years of age.

Final Protocol Submission: February 8, 2021

Study Completion: November 30, 2023

Final Report Submission: May 31, 2024

3. Deferred pediatric Study C4591023 to evaluate the safety and effectiveness of
COMIRNATY in infants <6 months of age.

Final Protocol Submission: January 31, 2022

Study Completion: July 31, 2024

Final Report Submission: October 31, 2024

Submit the protocols to your IND 19736, with a cross-reference letter to this BLA STN
BL 125742 explaining that these protocols were submitted to the IND. Please refer to
the PMR sequential number for each study/clinical trial and the submission number as
shown in this letter.

Submit final study reports to this BLA STN BL 125742. In order for your PREA PMRs to
be considered fulfilled, you must submit and receive approval of an efficacy or a labeling supplement. For administrative purposes, all submissions related to these required
pediatric postmarketing studies must be clearly designated as:

• Required Pediatric Assessment(s)

As the document states, the completion study of Comirnaty postmarketing (after approval) is not due until May 31, 2023 / Novermber 20, 2023 / July 31, 2024 respective of older to lower age groups. There is also another important acronym to consider, which is the IND, which stands for Investigational New Drug.

With this knowledge in hand, it’s important to note that the clinical trial run was monitored for 4-6 months after the second dose on around 55% of the recipients, while the actual “approved” drug still in its investigational/study stages is set to be monitored for 2-3 years. This is a sizeable difference in the amount of time to determine safety and efficacy, especially when considering the many events already reported to VAERS. And according to the Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions page from the FDA website:

Screenshot taken from the FDA Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions
on August 31, 2021
[ https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine-frequently-asked-questions ]
Content current as of August 23, 2021

Q: Are vaccine providers required to report side effects?
A: Providers administering Comirnaty or Pfizer-BioNTech COVID-19 Vaccine must report to the Vaccine Adverse Event Reporting System (VAERS) and to Pfizer the following information associated with the vaccine of which they become aware:
  • Vaccine administration errors whether or not associated with an adverse event
  • Serious adverse events (irrespective of attribution to vaccination)
  • Cases of Multisystem Inflammatory Syndrome
  • Cases of COVID-19 that result in hospitalization or death

Acknowledged myocarditis and pericarditis issues being studied on children

” – known serious risks of myocarditis and pericarditis”

Screenshot taken from from the FDA BLA Approval on August 31, 2021
[ https://www.fda.gov/media/151710/download ]
Document dated August 23, 2021

Text in the gray box below are from pages 6-8 of the FDA BLA Approval documents
[ https://www.fda.gov/media/151710/download ]

We have determined that an analysis of spontaneous postmarketing adverse events
reported under section 505(k)(1) of the FDCA will not be sufficient to assess known
serious risks of myocarditis and pericarditis and identify an unexpected serious risk of
subclinical myocarditis.

Furthermore, the pharmacovigilance system that FDA is required to maintain under
section 505(k)(3) of the FDCA is not sufficient to assess these serious risks.

Therefore, based on appropriate scientific data, we have determined that you are
required to conduct the following studies:

4. Study C4591009, entitled “A Non-Interventional Post-Approval Safety Study of
the Pfizer-BioNTech COVID-19 mRNA Vaccine in the United States,” to evaluate
the occurrence of myocarditis and pericarditis following administration of
COMIRNATY.

We acknowledge the timetable you submitted on August 21, 2021, which states
that you will conduct this study according to the following schedule:

Final Protocol Submission: August 31, 2021

Monitoring Report Submission: October 31, 2022

Interim Report Submission: October 31, 2023

Study Completion: June 30, 2025

Final Report Submission: October 31, 2025

5. Study C4591021, entitled “Post Conditional Approval Active Surveillance Study
Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine,” to evaluate the occurrence of myocarditis
and pericarditis following administration of COMIRNATY.

We acknowledge the timetable you submitted on August 21, 2021, which states
that you will conduct this study according to the following schedule:

Final Protocol Submission: August 11, 2021

Progress Report Submission: September 30, 2021

Interim Report 1 Submission: March 31, 2022

Interim Report 2 Submission: September 30, 2022

Interim Report 3 Submission: March 31, 2023

Interim Report 4 Submission: September 30, 2023

Interim Report 5 Submission: March 31, 2024

Study Completion: March 31, 2024

Final Report Submission: September 30, 2024

6. Study C4591021 substudy to describe the natural history of myocarditis and
pericarditis following administration of COMIRNATY.

We acknowledge the timetable you submitted on August 21, 2021, which states
that you will conduct this study according to the following schedule:

Final Protocol Submission: January 31, 2022

Study Completion: March 31, 2024

Final Report Submission: September 30, 2024

7. Study C4591036, a prospective cohort study with at least 5 years of follow-up for
potential long-term sequelae of myocarditis after vaccination (in collaboration
with Pediatric Heart Network).

We acknowledge the timetable you submitted on August 21, 2021, which states
that you will conduct this study according to the following schedule:

Final Protocol Submission: November 30, 2021

Study Completion: December 31, 2026

Final Report Submission: May 31, 2027

8. Study C4591007 substudy to prospectively assess the incidence of subclinical
myocarditis following administration of the second dose of COMIRNATY in a
subset of participants 5 through 15 years of age.

We acknowledge the timetable you submitted on August 21, 2021, which states
that you will conduct this assessment according to the following schedule:

Final Protocol Submission: September 30, 2021

Study Completion: November 30, 2023

Final Report Submission: May 31, 2024

9. Study C4591031 substudy to prospectively assess the incidence of subclinical
myocarditis following administration of a third dose of COMIRNATY in a subset of
participants 16 to 30 years of age.

We acknowledge the timetable you submitted on August 21, 2021, which states
that you will conduct this study according to the following schedule:

Final Protocol Submission: November 30, 2021

Study Completion: June 30, 2022

Final Report Submission: December 31, 2022

It is interesting that the timing to be considered for approval of these vaccines was only a 4-6 month timeframe, however, known dangers/risks, identified as “serious”, are still allowed to be approved and to be studied for 2+ years.

The document also recognizes that myocarditis and pericarditis is enough of a concern to happen after administration of the Comirnaty vaccine, since it mentions several studies just for this specific adverse event, and to continue to assess these reports.

In addition to all of the substudies to be conducted, there is a study to be initiated on a select group of participants to administer a third dose of the Comirnaty vaccine.

All of this information leads credence to the fact that even though the Comirnaty vaccine has “officially been approved” by the FDA, it is still in the investigational stages and being experimented upon on the public. And it goes without saying, but if myocarditis and pericarditis (on top of other reported side effects) are serious risks especially in children (“The observed risk is highest in males 12 through 17 years of age.”), then for this known risk to be offered to infants/toddlers defies any ethically moral boundaries and is in direct violations of the Nuremberg Code.

The next section also provides further evidence that there have been NO studies in the safety/efficacy of the Pfizer-BioNTech/Comirnaty vaccine on pregnant women.

Pregnancy/Births were not studied during the initial Pfizer-BioNTech/Comirnaty trial runs

Another snippet from the FDA Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions website page, states the following:

Screenshot taken from the FDA Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions
on August 31, 2021
[ https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine-frequently-asked-questions ]
Content current as of August 23, 2021

Q: Can pregnant or breastfeeding women receive the Comirnaty or Pfizer-BioNTech COVID-19 Vaccine?

A: While there have been no specific studies in these groups, there is no contraindication to receipt of the vaccine for pregnant or breastfeeding women. Pregnant or breastfeeding women should discuss potential benefits and risks of vaccination with their healthcare provider.

The acknowledgement above seems to indicate that the FDA and Pfizer-BioNTech/Comirnaty company have side-stepped this particular group in their vaccine studies, and have left it up to the healthcare provider to determine whether or not to administer this vaccine to pregnant women or women who are breastfeeding. This alone should be enough of a statement that there is no sufficient/professional data to analyze if the Comirnaty is safe during pregnancies/breastfeeding stages.

And if one were to consider the VAERS reporting system, in which the Pfizer-BioNTech company is required to report to, there have been numerous conditions of miscarriages/stillbirths/complications during pregnancy after administration of the COVID vaccine. While it is difficult to determine if these complications were a direct result of the vaccine, it is up to the scientific/healthcare community to investigate these cases in a thorough, unbiased and uninfluenced manner.

Another extremely alarming section of the FDA BLA Approval documents shows the following trial to be monitored in pregnant women:

Screenshot taken from from the FDA BLA Approval on August 31, 2021
[ https://www.fda.gov/media/151710/download ]
Document dated August 23, 2021

Text in the gray box below are from pages 9-10 of the FDA BLA Approval documents
[ https://www.fda.gov/media/151710/download ]
POSTMARKETING COMMITMENTS SUBJECT TO REPORTING REQUIREMENTS
UNDER SECTION 506B

We acknowledge your written commitments as described in your letter of August 21, 2021 as outlined below:

10. Study C4591022, entitled “Pfizer-BioNTech COVID-19 Vaccine Exposure during
Pregnancy: A Non-Interventional Post-Approval Safety Study of Pregnancy and
Infant Outcomes in the Organization of Teratology Information Specialists
(OTIS)/MotherToBaby Pregnancy Registry.”

Final Protocol Submission: July 1, 2021

Study Completion: June 30, 2025

Final Report Submission: December 31, 2025

There are a couple of key takeaways in this section that are of incredible importance. One major term to focus on is the word “NON-INTERVENTIONAL“.

According to What is a Non Interventional Study?, “In general, a non interventional study (NIS) (also called a non interventional trial) is where a patient takes regular medicine, prescribed according to the label. In an NIS, the researcher sets out to exert as little influence as possible on the patient’s condition while studying a medicine’s “…effectiveness, safety and tolerability under real life conditions” (Mishra & Vora, 2010).”

The article also reiterates multiple times that “non-interventional” studies are observational studies – the researchers are not to interfere with the dosages in any way but to prescribe them exactly as listed on the label. It also seems to imply that even if severe side effects show up, they are to still carry through with the “medicinal product” in that patient as prescribed. Another insinuation that one can make is that in order to not interfere with the study, it is not recommended to prescribe treatments that may help alleviate potential side effects. The term “tolerability” is implying to keep the patient going through the side effects in order to continue to study the long-term effects of the investigational new drug.

However, with the inclusion of “real life conditions”, it doesn’t indicate whether the patient can seek out physicians to investigate what is causing the side effects in their system and engage in therapeutic treatments to alleviate these effects. If a study is to be conducted in real life conditions, then it is to be expected that patients will seek treatments on their own while the researcher is only required to observe the patient to see how the alternative treatments interact with the drug/symptoms.

The same article goes on to state that the UK/EU have different definitions of what “non-interventional” means. “Aronson (2004) states… “the term ‘non-interventional’ in the Directive doesn’t mean non-interventional (i.e. non-interference) at all; it refers to an intervention with a licensed medicinal product.”

There is controversy and conflicts in this statement as another article, Interventional or Non-Interventional? Analyzing the Differences Between Clinical Studies Using Medicines in the European Union points out:

“Although defined in DIR 2001/20/EC, non-interventional studies are outside its scope. Due to the lack of harmonized regulation, some studies designed to be non‑interventional may be considered clinical trials by EU authorities. The two blinded studies described in Table 4 (see PDF) were considered clinical trials in the EU for planning on collection of data to support the marketing authorization application of experimental IMPs, despite no IMP being given and normal clinical practice being kept during the study period. Sponsors are thus advised to consult with authorities when planning studies under these conditions and/or whenever the objectives or design may raise questions.”

Further in the article, it states the following, which again, is not reassuring considering the policies/guidelines/mandates that authorities have been engaging in in order to mandate these investigational new drugs (COVID vaccines) onto the public:

“There is no centralized submission procedure for non-interventional studies with the exception of non-interventional PASSs, imposed as an obligation by an EU competent authority.{9} Because non-interventional studies do not have harmonized legislation, some Member States require submissions to regulatory authorities, while others do not. It is therefore important that sponsors are familiar with the regulatory framework of target EU Member States, and that they consult with local competent authorities and ethics committees (ECs) when justified.”

It’s sad to have to point this out, but the quote does specify “competent” authorities. And even the inclusion of “ethics committees” is not comforting seeing as how one of the leading figures in ethics study is Christine Grady, Chief of the Department of Bioethics at the National Institutes of Health Clinical Center, and wife of Anthony Fauci – Director of the National Institute of Allergy and Infectious Diseases and Chief Medical Advisor to the president, and who is also a large spokesperson for the experimental injections.

The other takeaway from section 10 of the FDA BLA documents is the term “TERATOLOGY“.

Definition of teratology
: the study of malformations or serious deviations from the normal type in developing organisms
merriam-webster/teratology

Teratology, branch of the biological sciences dealing with the causes, development, description, and classification of congenital malformations in plants and animals and with the experimental production, in some instances, of these malformations. Congenital malformations arise from interruption in the early development of the organism. Malformations in human infants, for example, may occur because the infant’s genotype contains mutant genes or includes an abnormal number of chromosomes; they also may occur if early in pregnancy the mother has had German measles (rubella), has taken some injurious drug, or has been exposed to an injurious dosage of radiation. Experimental studies suggest similar types of factors can cause malformations in animals and plants.”
britannica/teratology

Now when you combine the terms “non-interventional” and “teratology” together, it is suggesting that the ongoing studies (that were not conducted to begin with even in a clinical trial setting, as per the FDA’s own response) on pregnant women with Comirnaty and on the developing baby, will be monitored with as little intervention as possible and is mostly to be observed for malformations/genetic defects/miscarriages/etc.

In other words, safety and efficacy were never studied in this particular group, and neither was it studied in infants. It has also not been studied for long-term analysis, as the 4-6 month trial runs proves. The current “approval” it is undergoing now is an authorized experiment on the human population that is posing incredibly unnecessary risks when considering the many effective treatments that are already available to combat respiratory illnesses. And the insistent assertiveness to push this “investigational new drug” onto babies/children who are at extremely low risk for this illness is a disastrous decision from those in an “authoritative” position and should be investigated for malfeasance and misconduct.

This is also not the first time that government agencies/health industries/etc. have conducted experiments on the public.

The Tuskegee/Syphilis experiment was initiated onto a selection of African American men between 1932-1972. The study was only stopped (allegedly) after a publication was released on Associated Press in 1972 about the immorally unethical experiments being conducted on this group:

“Of about 600 Alabama black men who originally took part in the study, 200 or so were allowed to suffer the disease and its side effects without treatment, even after penicillin was discovered as a cure for syphilis. Treatment then probably could have saved or helped many of the experiment participants, PHS officials say.”AP WAS THERE: Black men untreated in Tuskegee Syphilis Study

This study seems to echo the sentiments we see going on with the coronavirus situation, in which only one type of drug is being promoted (the COVID vaccines) while suppression of other treatments that have been proven to work (such as Ivermectin) has been denounced by the very same government/health/medical fields that have conducted these experimental studies.

A study that involved the CDC/FDA’s approval, this time on Black and Latino babies, was conducted in the early 1990’s and involved the measles vaccine:

“1990: CDC Inoculated Black and Latino Babies with an Unlicensed Measles Vaccine
A covert clinical trial by the Center for Disease Control (CDC) and Kaiser Permanente inoculated Black and Latino babies with an experimental measles vaccine without informing parents the vaccine was experimental. More than 1500 six-month old black and Hispanic babies in Los Angeles are given the deadly “experimental” measles vaccine that had never been licensed for use in the United States; a vaccine that had been tested in African and Mexican babies resulting in high death rates. The parents were never informed and they never gave their consent. The CDC harmed babies, violated federal law, and trampled on parental rights with impunity.”
1990 FDA Issued a Waiver From Consent; Covert CDC Experimental Vaccine Test on Black / Latino Babies

It’s interesting that the measles vaccine experiment identifies Kaiser Permanente specifically, because as we see in another section of the FDA BLA Approval for Comirnaty, it seems as if Kaiser Permanente makes another appearance in the role of human experimentation:

Text in the gray box below is from page 10 of the FDA BLA Approval documents
[ https://www.fda.gov/media/151710/download ]

13. Study C4591014, entitled “Pfizer-BioNTech COVID-19 BNT162b2 Vaccine
Effectiveness Study – Kaiser Permanente Southern California.”

Final Protocol Submission: March 22, 2021

Study Completion: December 31, 2022

Final Report Submission: June 30, 2023

It would seem that the approval by the FDA of these IND drugs (Pfizer-BioNTech/Comirnaty vaccine) is a way for the government/health agencies to skirt away from liability by stating that since the vaccines are no longer “experimental” by their definition, and that they are FDA “approved”, it is no longer required to gain informed consent of these drugs. In addition, as to the technicality of their terms and protocols, there are a multitude of ways to interpret their “informed consent” rules, which officials can then bend or define in any way that best reflects the use of their study/drug.

[ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/informed-consent#exceptions ]

Also keeping in mind how long it was determined before the “health agencies” granted approval of the Pfizer-BioNTech/Comirnaty vaccine – (4-6 months) – it would be conclusive to state that the vaccines have NOT sufficiently been studied in young children or pregnant women (or even the rest of the age groups because of the short amount of time the clinical trial study was conducted in), and the subsequent approval of this vaccine is to continue this research on the population who is exceedingly being pressured into taking this investigational new drug.

There is also the matter of the many adverse events that have been reported since the inoculation of these injections, that have largely gone unheeded within the health/medical institutions that are endorsing this drug. Other than the widely acknowledged myocarditis and pericarditis, most common in young males, which is still being studied and allowed to persist onto the public.

So again, taking into account the collusion of the government/health/medical/research fields to conduct experiments on the public, it would be necessary to reflect upon these agencies for additional breaches upon human rights, consent, and ethical behavior.

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Featured image by Ahmad Ardity from Pixabay