“It’s just…” – Why I Won’t Submit
By Addison Reeves | OffGuardian | August 7, 2021
It’s just two weeks. It’s just staying three feet apart. It’s just staying six feet apart. It’s just not going outside. It’s just not giving handshakes. It’s just working from home. It is just non-essential businesses that are closed.
It’s just bars. It’s just restaurants. It’s just theaters. It’s just concerts. It’s just dancing. It’s just intramural sports. It’s just choir.
It’s just non-essential medical services that you have to give up. It is just non-essential items that you are not allowed to buy. It’s just not being able to exercise. It’s just gyms. It is just the closure of your business for a while. It is just not making money for a while. It is just not being able to pay your bills for a little while.
It’s just a minor inconvenience. It’s just not being allowed to carpool. It’s just not socializing for a while. It’s just a mask. It’s just not traveling for a while. It’s just not hugging people for a while. It’s just missionary sex that is risky.
It is just not seeing your family and friends for a while. It’s just not visiting your grandparents temporarily. It’s just your grandparents not having visitors for their safety. It’s just one birthday you have to sacrifice. It’s just one Thanksgiving alone. It’s just one Christmas without your family. It’s just two birthdays you had to sacrifice. It is just not celebrating any milestones for a year and a half.
It’s just temporary. It’s just a safety measure. It is just your ability to pay cash. It is just contact tracing. It is just a health screening. It is just a temperature check. It is just a scan of your face. It’s just a minor loss of privacy.
It is just one semester. It is just two semesters. It is just one year out of your child’s life. It is just one more semester. It is just a high school graduation.
It’s just the birth of your grandchild that you missed. It is just not being able to be there for your relatives when they are ill or dying. It is just not having a funeral. It is just in person that you cannot grieve with your loved ones. It is just not getting to attend religious service. It is just not getting to practice some parts of your religion.
It is just misinformation that is being censored. It is just conservatives that are being censored. It is just some of the science that is being censored. It is just the people who have the opposing opinions that are banned online. It is just the opposition that the White House is targeting for censorship. It is just bad opinions that are being censored.
It’s just the economy. It is just small business owners who are suffering financially. It is just poor people who are suffering financially. It is just people of color who are suffering financially. It is just financial suffering. It is just a few small businesses that had to close permanently. It is just a few big businesses that closed.
It is just not going farther than a few kilometers from your house. It is just a curfew. It is just a permission slip. It is just being alone for two weeks. It is just being socially isolated for one year.
It is just one vaccine. It is just one set of booster shots. It is just regular booster shots every six months. It is just another two weeks. It is just one more lock-down. It is just once a week—twice tops—that you will have to prove that you are fit to participate in society. It is just the unvaccinated that will be segregated from society. It is just a medical test.
Pretty simple, no?
Just fucking do it.
But when you add up all the “justs,” it amounts to our entire lives.
For over a year and a half and counting, we have been robbed of the ability to live our lives fully, to make meaningful choices for ourselves, and to express our values the way we see fit.
It is “just” the inability to express our humanity and the total negation of our very selves. All of these measures have served as a prohibition of expressing outwardly one’s valid and complex internal reality. This kind of suppression of self does violence to one’s very soul.
All of these supposedly little and supposedly short-lived “justs” have transformed us into totalitarian states from which there appears to be no endpoint.
In New York City, California, Australia, etc., the people have permitted government such control over our daily lives that we have to ask it for permission to control our bodies, to move freely, to practice religion, to educate our children ourselves, to protest, etc.
Soon Biden, Trudeau, and other world leaders are going to clamp down on our ability to express ourselves and to associate with each other online so that we can no longer question, object to, or organize against government action. It is the destruction of democracy.
It astounds me that my Progressive friends — the same ones who claim to support “social justice” — are welcoming a fascist society in which government crushes any opposition and individuals cannot make choices about their own lives.
I will not comply because I do not want to live in the society that is being created by extraordinary submissiveness to government. I do not want to be complicit in this era’s atrocities.
What is the point of living if one merely exists to obey the elite to one’s own detriment? Is it even living if one lacks the agency to direct one’s life? I’ve already submitted in contradiction of my values to a shameful extent. One might say, “Well, what’s one more compromise,” but it won’t be just one more compromise. It will be just the next cut in a slow death by a thousand cuts.
Submitting only validates tyrannical displays of power and ensures that there will be more such displays in the future.
And what does one get for compromising? Merely your continued membership in a society that will only have you if you immolate yourself and become nothing more than a reflection of the desires of the ruling class.
If you cannot be truly yourself in a society, is that society worth clinging to? I think not. As much as leaving the stability of my comfort zone terrifies me, staying in it means continuing to silence and shrink myself for a disingenuous feeling of acceptance. In that way, it is more of a discomfort zone.
Each time I expressed my fears about the future direction of society, my friends said “it won’t happen.” Each time it did happen, they shrugged their shoulders and reminded me that compliance was an option.
At this point, if the government were to cart me away to an internment camp (which is not a completely far-fetched notion and which has happened in the past) for being a dangerous dissident I am certain that my friends and family would watch it happen and say it was my fault for not complying.
They are no longer capable of recognizing the humanity of the opposition or of questioning government.
I will not submit because I don’t want to live in a world in which my supposed allies would happily see me persecuted by the government.
I will not comply because the political climate has become so censorial, authoritarian, and generally toxic that my viewpoints will never be represented in the political process here. Without representation, my values and beliefs will be violated again and again by a polity that sees any deviation from itself as invalid. Thus, my compliance will provide zero assurance of any better treatment in the future.
I will not bend because I am not a conformist.
I will not give in because I do not want to reward government manipulation and coercion.
I will not surrender because I could die at any moment, and I do not want my final memories to be ones of craven submission to tyranny and the resultant misery and self-loathing.
I will not comply because it is not the government’s first intrusion on my body, mind, and spirit; and if we comply, it will definitely not be the last. All I will accomplish by my compliance is validating the government’s claim on my body and life.
I am not submitting because this is war, and I am not handing the enemy its victories.
I will not comply because the reward for compliance will still be being treated as a second class-citizen by society.
I won’t acquiesce because I am a conscientious objector.
I will not cede because the measures are unnecessary and the only practical effect will be to increase government power.
I don’t comply because I do not want to be a mere slave in the future version of the world they are creating, doing only what I am told to do and having to beg for access to the necessities of life that I am entitled to as a living being on this earth.
I will not yield because their religion is not my religion, and I refuse to worship a false idol.
I will not capitulate because I do not want to betray my ancestors and predecessors who fought for me to be free.
I will not surrender because freedom is more important than convenience and ease.
I will not comply because if I did I would be filled with rage against society, resentment towards my friends and family, and self-loathing that would eat me alive. I would become bitter and closed-hearted, and I don’t want that for myself.
All of this is why I won’t “just fucking do it.”.
Addison Reeves is a lawyer, political scientist, philosopher, and civil rights and civil liberties advocate based in New York. Addison critiques modern culture from a radical, leftist perspective at ModernHeretic.com or you can follow him on Telegram
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The FBI’s Forgotten Criminal Record
By James Bovard | Future of Freedom | August 2017 edition
President Trump’s firing of FBI chief James Comey on May 9 spurred much of the media and many Democrats to rally around America’s most powerful domestic federal agency. But the FBI has a long record of both deceit and incompetence. Five years ago, Americans learned that the FBI was teaching its agents that “the FBI has the ability to bend or suspend the law to impinge on the freedom of others.” This has practically been the Bureau’s motif since its creation in 1908.
The bureau was small potatoes until Woodrow Wilson dragged the United States into World War I. In one fell swoop, the number of dangerous Americans increased by perhaps twentyfold. The Espionage Act of 1917 made it easy to jail anyone who criticized the war or the government. In September 1918, the bureau, working with local police and private vigilantes, seized more than 50,000 suspected draft dodgers off the streets and out of the restaurants of New York, Newark, and Jersey City. The Justice Department was disgraced when the vast majority of young men who had been arrested turned out to be innocent. … continue
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Bravo! Although I try not to use profanity in expressing my outrage at what is being done to Us, I would have to agree with its proper use in this article. After all, what is being done to Us is fu#k*ng PROFANE!
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It’s just total BS
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YOU CANNOT “CATCH” COVID 19 FROM A COUGH, YOU CAN ONLY GET IT BY VACCINE INJECTION!
The VACCINE is the DISEASE!
Dr. Judy Mikovit says the FLU shots from the mid-90s have been poisoning people
Dr Judy Mikovits joins Mike Adams and she’s dismayed, that despite all of her best efforts to warn people for the past year and the best efforts of people like Dr Luc Montagnier, Dr Dolores Cahill, Dr Sherri Tenpenny and many others who predicted this mass murder, and yet it happened, anyway.
“100 million Americans have been injected with a synthetic virus with…the most dangerous spike protein, consisting of HIV, XMRV and SARS.”
FAUCI IS BEHIND EVERY PANDEMIC SINCE 1984
She reminds us that the lab origins of the current pandemic are hardly novel; that every “pandemic” has had lab origins since 1984, when Anthony Fauci started working at the NIAID, starting with AIDS.
“HIV/AIDS; you’ll remember the story of how we were lied to by Tony Fauci, Bob Gallo, the people at the top of NIH, CDC, FDA, even then. So the scenario, the game plan is exactly the same…
“We knew the spike protein, alone, the envelope protein, alone is the disease, so they can all backtrack, because they just injected everyone in the world with a synthetic deadly virus. They injected the poison. The word ‘virus’ means ‘poison’ and they injected it into everybody in the world, so they can back off now, because they’ve accomplished their end game. You will have customers for life and you will succeed at mass-murder.
“You’re going to kill everyone with HIV, you’re going to kill the 6% of America that had XMRV, when we were supposedly debunked. Xenotropic Murine Leukemia Virus is the mouse’s syncytin gene. So we knew the mouse virus was in everybody from the vaccines. We knew the flu vaccine put people at risk of dying of COVID…what I think what everybody has to wake up to is NEVER, EVER, EVER get another shot and we will never, ever, ever see another pandemic.
COVID MOTIVE IS TO KILL SICK PEOPLE TO AVOID TRILLIONS IN INSURANCE
“We’ve been creating these in our labs my entire career. This was my job.” She says their motivation is “To kill people and cover up these crimes. Remember, they’re cremating people, so you can’t realize it was the vaccine strain, so you can’t realize that we were right in 2011, in 1984…
“When our paper, that was ultimately published in Science, in October of 2009…and the entire upper echelons of the government realized that these things were coming out of our laboratories and they re-wrote history then. They called it…an ‘unintended spread of a Biosafety Level 2 contaminant.’
“It’s not ‘Biosafety Level 2’, when it’s contagious cancer, contagious prostate cancer, contagious ovarian cancer, lung cancer! And who are the people now, who they’re inoculating? We never inoculated an AIDS patient! They have an acquired immune dysfunction or deficiency! They can’t make an appropriate antibody or immune response of any kind, that’s why they’re sick. So why, now would you inject them, if the intention is now to kill them and call it ‘COVID’ – it’s not COVID! You created the cancer. You created the disease and now you’re murdering the victims to cover up your crimes…
“We’ve been lied to for 40 years…[HIV] was spread by a Hepatitis vaccination program with a contaminated vaccine. Who dies in the first wave of HIV? All the people that had HIV and XMRV; mouse viruses from a contaminated blood supply. This is what our book showed…
“You mean you can’t mix animal tissue, aborted fetal tissue; that you’re actually injecting into the most vulnerable people another animal’s virome? And other viruses? Mycoplasma, mold, Borrelia, think of the explosion of so-called ‘tick-borne diseases’, chronic Lyme disease. No, they’re not tick-borne, when you have no possibility for exposure. They’re injected! Animal cell lines all have ticks! Mycoplasma, mold, Borrelia, animals get bit in farms. Our animals are vaccinated heavily with these toxic things, activating their viromes to be expressed and when you inject it, you don’t need a transmissable virus.
“So this is a big cover-up, because you’re going to have to pay tens of millions of dollars…In HIV/AIDS, at the height of the epidemic, it was one million Americans. Now it’s 25 to 50 million Americans. Kill them, call it ‘COVID’ and you don’t have to pay life insurance, you don’t have to pay off the penalties to take care of these people for the rest of their lives. It’s trillions of dollars.”
THERE IS LOTS OF HOPE
But she says there is good news in all of this and she does have a message of hope. “We know that everything that would have prevented the infection naturally will prevent the disease causation. So you want ozone therapy, you want hyperbaric oxygen therapy. You never want to take another drug…you want quercetin, you can take nice, ozonated cream, like I just put on my skin.
“Remember, I got infected with deadly XMRV from the lab…and I’m just fine…Magic Johnson’s just fine. What do you do? You stop the expression, you never inject yourself, you don’t do immune activation. No GMOs, no fake food. Take their entire industry down. As Zach Bush says, ‘Know your farmer, not your doctor.’ Eat clean, get out of their system. End it. End it all today and you’ll realize health.”
GERMAN CHIEF PATHOLOGIST SOUNDS ALARM ON FATAL VACCINE INJURIES
by rightsfreedoms
The director of the Pathological Institute of the University of Heidelberg, Peter Schirmacher, has carried out over forty autopsies on people who had died within two weeks of their vaccination. Schirmacher expressed alarm over his findings.
Published: August 3, 2021
The regional daily Augsburger Allgemeine reported: “Schirmacher assumes that 30 to 40 percent of them died from the vaccination. In his opinion, the frequency of fatal consequences of vaccinations is underestimated – a politically explosive statement in times when the vaccination campaign is losing momentum, the Delta variant is spreading rapidly and restrictions on non-vaccinated people are being discussed.”
The Merkel administration quickly moved to respond to this “politically explosive” statement from Heidelberg. According to the German Press Agency (dpa), the Paul Ehrlich Institute announced that Schirmacher’s statements were “incomprehensible”. The Chancellor’s lackey, senior German immunologist Thomas Mertens dismissed the findings right away: “I don’t know of any data that would allow a justifiable statement to be made here and I am not assuming an unreported number.”
The immunologist Christian Bogdan from the Erlangen University Hospital, member of the Standing Vaccination Commission (STIKO), also contradicted Schirmacher’s assumption of a “high number of unreported vaccination complications or even deaths”.
The pathologist however received support from his own ranks, and the Federal Association of German Pathologists stated that more autopsies of vaccinated people who died within a certain time frame after vaccination should be performed.
The head of the “Autopsy Working Group” in this association wanted to make general practitioners and health authorities aware of this. In other words, doctors of the patients who die within a few days or weeks after vaccination should apply for an autopsy in case of doubt or the health authorities should take action.
The Federal Association of Pathologists had already requested this in March in a letter to Health Minister Jens Spahn (CDU), but it went unanswered.
Schirmacher’s warning could of course ruin a multi-digit long-term billion-dollar business for various pharmaceutical companies, while the already low willingness to get the jab in the remaining unvaccinated group could further decrease dramatically and ultimately the entire pandemic strategy of the federal government could unravel.
But the seriousness and reputation of the director of the Pathological Institute at the University of Heidelberg are unassailable.
Schirmacher himself is already leading an autopsy project on people who have died from Covid-19, which is subsidized by the state. He himself then expanded the focus and also autopsied more than 40 deceased vaccinated people. Even if his results are only a snapshot, it is a dramatic one: 30 to 40 percent died from the vaccination itself. The pathologist cited “rare, severe side effects of the vaccination – such as cerebral vein thrombosis or autoimmune diseases”.
Schirmacher responded to the criticism from some colleagues. He denied a lack of competence: “The colleagues are definitely wrong because they cannot assess this specific question competently.” Moreover, he has not tried to spread panic, and he is not an opponent of vaccinations – Schirmacher himself has been vaccinated.
The Robert Koch Institute meanwhile refers to the regular safety reports of the Paul Ehrlich Institute on its website. However, should it become apparent in the coming weeks that politics, science and the media are campaigning against Schirmacher and his alarming results are being completely ignored, it would be another red flag regarding the safety of the products.
Twitter meanwhile suspended the account of former New York Times science correspondent Alex Berenson for sharing details of a Pfizer clinical trial with similar findings which completely obliterates the narrative of the political establishment.
According to Pfizer: “During the blinded, controlled period, 15 BNT162b2 and 14 placebo recipients died; during the open-label period, 3 BNT162b2 and 2 original placebo recipients who received BNT162b2 after unblinding died. None of these deaths were considered related to BNT162b2 by investigators.” It stated that the causes of death were balanced between BNT162b2 and placebo groups: 15 people who took the vaccine died and 14 people who took the placebo died.
But tons of people who were in the placebo group have now taken the jab, thus “the trial blind is broken now” and “this is all the data we will ever have,” Berenson pointed out.
German chief pathologist sounds alarm on fatal vaccine injuries
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Patient comprehension is a critical part of meeting medical ethics standards of informed consent in study designs.
The aim of the study was to determine if sufficient literature exists to require clinicians to disclose the specific risk that COVID‐19 vaccines could worsen disease upon exposure to challenge or circulating virus.
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Journal ListWiley-Blackwell Online OpenPMC7645850
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International Journal of Clinical Practice
Int J Clin Pract. 2021 Mar; 75(3): e13795.
Published online 2020 Dec 4. doi: 10.1111/ijcp.13795
PMCID: PMC7645850
PMID: 33113270
Informed consent disclosure to vaccine trial subjects of risk of COVID‐19 vaccines worsening clinical disease
Timothy Cardozocorresponding author 1 and Ronald Veazey 2
Author information Copyright and License information Disclaimer
This article has been cited by other articles in PMC.
Associated Data
Data Availability Statement
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Abstract
Aims of the study
Patient comprehension is a critical part of meeting medical ethics standards of informed consent in study designs. The aim of the study was to determine if sufficient literature exists to require clinicians to disclose the specific risk that COVID‐19 vaccines could worsen disease upon exposure to challenge or circulating virus.
Methods used to conduct the study
Published literature was reviewed to identify preclinical and clinical evidence that COVID‐19 vaccines could worsen disease upon exposure to challenge or circulating virus. Clinical trial protocols for COVID‐19 vaccines were reviewed to determine if risks were properly disclosed.
Results of the study
COVID‐19 vaccines designed to elicit neutralising antibodies may sensitise vaccine recipients to more severe disease than if they were not vaccinated. Vaccines for SARS, MERS and RSV have never been approved, and the data generated in the development and testing of these vaccines suggest a serious mechanistic concern: that vaccines designed empirically using the traditional approach (consisting of the unmodified or minimally modified coronavirus viral spike to elicit neutralising antibodies), be they composed of protein, viral vector, DNA or RNA and irrespective of delivery method, may worsen COVID‐19 disease via antibody‐dependent enhancement (ADE). This risk is sufficiently obscured in clinical trial protocols and consent forms for ongoing COVID‐19 vaccine trials that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials.
Conclusions drawn from the study and clinical implications
The specific and significant COVID‐19 risk of ADE should have been and should be prominently and independently disclosed to research subjects currently in vaccine trials, as well as those being recruited for the trials and future patients after vaccine approval, in order to meet the medical ethics standard of patient comprehension for informed consent.
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1. THE RISK OF ADE IN COVID‐19 VACCINES IS NON‐THEORETICAL AND COMPELLING
Vaccine‐elicited enhancement of disease was previously observed in human subjects with vaccines for respiratory syncytial virus (RSV), dengue virus and measles. 1 Vaccine‐elicited enhancement of disease was also observed with the SARS and MERS viruses and with feline coronavirus, which are closely related to SARS‐CoV‐2, the causative pathogen of COVID‐19 disease. The immune mechanisms of this enhancement have invariably involved antibodies, from direct antibody‐dependent enhancement, to immune complex formation by antibodies, albeit accompanied by various coordinated cellular responses, such as Th2 T‐cell skewing. 2 , 3 , 4 , 5 , 6 , 7 Notably, both neutralising and non‐neutralising antibodies have been implicated. A recent study revealed IgG‐mediated acute lung injury in vivo in macaques infected with SARS that correlated with a vaccine‐elicited, neutralising antibody response. 8 Inflammation and tissue damage in the lung in this animal model recapitulated the inflammation and tissue damage in the lungs of SARS‐infected patients who succumbed to the disease. The time course was also similar, with the worst damage occurring in delayed fashion in synchrony with ramping up of the immune response. Remarkably, neutralising antibodies controlled the virus in the animal, but then would precipitate a severe, tissue‐damaging, inflammatory response in the lung. This is a similar profile to immune complex‐mediated disease seen with RSV vaccines in the past, wherein vaccinees succumbed to fatal enhanced RSV disease because of the formation of antibody‐virus immune complexes that precipitated harmful, inflammatory immune responses. It is also similar to the clinical course of COVID‐19 patients, in whom severe COVID‐19 disease is associated with the development of anti‐SARS‐CoV‐2 serum antibodies, 9 with titres correlating directly with the severity of disease. 10 Conversely, subjects who recover quickly may have low or no anti‐SARS‐CoV‐2 serum antibodies. 11
The elicitation of antibodies, specifically neutralising antibodies, is the goal of nearly every current SARS‐CoV‐2 vaccine candidate. The prior evidence that vaccine‐elicited, antibody‐dependent enhancement (ADE) of disease is likely to occur to some degree with COVID‐19 vaccines is vertically consistent from controlled SARS studies in primates to clinical observations in SARS and COVID‐19. Thus, a finite, non‐theoretical risk is evident in the medical literature that vaccine candidates composed of the SARS‐CoV‐2 viral spike and eliciting anti‐SARS‐CoV‐2 antibodies, be they neutralising or not, place vaccinees at higher risk for more severe COVID‐19 disease when they encounter circulating viruses. Indeed, studies in mice of prior SARS vaccines revealed this exact phenotype, with four human vaccine candidates eliciting neutralising antibodies and protecting against SARS challenge, but viral re‐challenge of thus vaccinated animals resulting in immunopathologic lung disease. 5 Independently, SARS/MERS vaccine candidates, commonly exhibited ADE associated with high inflammatory morbidity in preclinical models, obstructing their advancement to the clinic. 4 , 12 SARS ADE of both disease in non‐human primates and viral infection of cells in vitro was clearly mapped to specific antibody‐targeted SARS viral spike epitopes. 6 This phenomenon was consistent across a variety of vaccine platforms, including DNA, vector primes and virus‐like particles (VLP), irrespective of inoculation method (oral, intramuscular, subcutaneous, etc). An unknown variable is how long this tissue damage lasts, possibly resulting in permanent morbidity (eg, diabetes from pancreatic damage 7 ).
Current data on COVID‐19 vaccines is limited, but does not so far reveal evidence of ADE of disease. Non‐human primate studies of Moderna’s mRNA‐1273 vaccine showed excellent protection, with no detectable immunopathology. 13 Phase 1 trials of several vaccines have not reported any immunopathology in subjects administered the candidate vaccines. However, these subjects were unlikely to have yet encountered circulating virus. 14 Nevertheless, all preclinical studies to date have been performed with the Wuhan or closely related strains of the virus, while a mutant D614G virus is now the most prevalent circulating form. Several observations suggest that this alternative form may be antigenically distinct from the Wuhan derived strain, not so much in composition, but in conformation of the viral spike and exposure of neutralisation epitopes. 15 , 16 , 17 , 18 Similarly, Phase 1 and 2 clinical trials of vaccine candidates have only been designed around immunogenicity as an efficacy end point and have not been designed to capture exposure of subjects to circulating virus after vaccination, which is when ADE/immunopathology is designed to occur. Thus, the absence of ADE evidence in COVID‐19 vaccine data so far does not absolve investigators from disclosing the risk of enhanced disease to vaccine trial participants, and it remains a realistic, non‐theoretical risk to the subjects.
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2. CHALLENGES TO INFORMED CONSENT FOR COVID‐19 VACCINE STUDIES
Informed consent procedures for vaccine trials commonly include disclosure of very minor risks such as injection site reactions, rare risks from past, unrelated vaccines/viruses, such as Guillain‐Barre syndrome for swine flu (interest in which is likely behind the interest in Astra Zeneca’s recent vaccine transverse myelitis event) and generic statements about the risk of idiosyncratic systemic adverse events and death. Specific risks to research participants derived from biological mechanism are rarely included, often because of ambiguity about their applicability. 19
Signed consent forms from the COVID‐19 vaccine trials are not publicly available because of privacy concerns. They also vary from clinical site to clinical site, and sample consent forms on which they are based are not required to be disclosed until after the trial is over, if at all. However, these consent forms are usually very similar in content to the “Risks to participants” section of the trial protocols, which have been released publicly by Pfizer, Moderna and Johnson & Johnson for their COVID‐19 vaccine trials ( 20 & Supplement). As these three vaccines are representative of the diversity of vaccines being tested, it is very likely that the consent form inferred from these protocols is similar or identical to those from any and all of the vaccine trials currently underway. All three protocols mention the risk of disease enhancement by the vaccine, but all three list this risk last or next to last in the list of risks, after risks from the Ad26‐Cov2 vector, adenovirus vectors in general, risks of vaccination in general, risks for pregnancy and birth control (which are said to be “unknown”), risks of blood draws and risks from collection of nasal swab samples (for the Johnson and Johnson vaccine), after allergy, fainting, local site injection reaction, general systemic adverse reactions and laboratory abnormalities for the Moderna vaccine and after local site injection reactions and general systemic adverse events for the Pfizer vaccine. In addition, both Moderna and Johnson and Johnson term the risk of vaccine‐elicited disease enhancement as “theoretical.” Finally, in citing the risk, Pfizer and Moderna note prior evidence of vaccine‐elicited disease enhancement with RSV and dengue, as well as feline coronavirus (Pfizer) and measles (Moderna), however, SARS and MERS are not mentioned. Johnson and Johnson discusses SARS and MERS, but make an unusual scientific argument that vaccine‐elicited disease enhancement is because of non‐neutralising antibodies and Th2‐skewed cellular responses and that Ad26 vaccination does not exhibit this profile.Blank consent forms for AstraZeneca and Johnson and Johnson are also available online at https://restoringtrials.org/2020/09/18/covid19trialprotocolandstudydocs/, and while the AstraZeneca form clearly discloses the specific risk of ADE, the disclosure is listed last among risks only in an attached information sheet. In all, the evidence from the Pfizer, Moderna and Johnson & Johnson protocols for their COVID‐19 vaccine trials and the sample consent forms, when contrasted with the evidence for antibody‐dependent enhancement of disease presented by this report and widely available to any skilled practitioner in the field, establishes that patient comprehension of the specific risk that receiving the COVID‐19 vaccine could convert a subject from someone who experiences mild disease to someone who experiences severe disease, lasting morbidity or even death is unlikely to be achieved by the informed consent procedures planned for these clinical trials.
Medical ethics standards required that, given the extent of evidence in the medical literature reviewed above, the risk of ADE should be clearly and emphatically distinguished in the informed consent from risks observed rarely as well as the more obvious risk of lack of efficacy, which is unrelated to the specific risk of ADE. Based on the published literature, it should have been obvious to any skilled medical practitioner in 2019 that there is a significant risk to vaccine research subjects that they may experience severe disease once vaccinated, while they might only have experienced a mild, self‐limited disease if not vaccinated. The consent should also clearly distinguish the specific risk of worsened COVID‐19 disease from generic statements about risk of death and generic risk of lack of efficacy of the vaccine.
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3. CONCLUSION
Given the strong evidence that ADE is a non‐theoretical and compelling risk for COVID‐19 vaccines and the “laundry list” nature of informed consents, disclosure of the specific risk of worsened COVID‐19 disease from vaccination calls for a specific, separate, informed consent form and demonstration of patient comprehension in order to meet medical ethics standards. The informed consent process for ongoing COVID‐19 vaccine trials does not appear to meet this standard. While the COVID‐19 global health emergency justifies accelerated vaccine trials of candidates with known liabilities, such an acceleration is not inconsistent with additional attention paid to heightened informed consent procedures specific to COVID‐19 vaccine risks.
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DISCLOSURE
The authors have declared no conflicts of interest for this article.
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AUTHOR CONTRIBUTIONS
TC and RV conceived this commentary. TC wrote the manuscript. RV edited and approved the manuscript.
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ACKNOWLEDGEMENTS
Supported by NIH award R21AI157604 (to TC).
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DATA AVAILABILITY STATEMENT
All data referenced in this report have been published in peer‐reviewed literature or are available on the World Wide Web/Internet at the URL’s indicated in the References section. Therefore, all data referenced in this report are publicly available in widely available data repositories.
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So, it does not meet the standard. When will this be corrected???? Will it mention the clinical study autopsy results of the vaccine victims done in Texas and Germany?
Probably not
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