Biopharmaceutical company CureVac NV of Tübingen, Germany has released the interim results of its Phase 1 clinical trial on its experimental CVnCoV vaccine COVID-19. The vaccine, which was given to more than 250 healthy adults 18 to 60 years of age, is based on messenger ribonucleic acid (mRNA) technology.12
Unlike traditional vaccines, mRNA vaccines “introduce an mRNA sequence (the molecule which tells cells what to build), which is coded for a disease specific antigen,” wrote Rishma Parpia in an article in The Vaccine Reaction earlier this year.3 She added:
Once produced within the body, vaccine developers say the antigen is recognized by the immune system and stimulates a strong inflammatory response to produce antigens to fight the pathogen. Messenger RNA vaccines are faster and cheaper to produce than traditional vaccines and do not utilize any parts of the pathogenic virus or bacteria.3
According to a press release by CureVac, the CNnCoV vaccine was “generally well tolerated across all tested doses (2-12µg) and induced strong binding and neutralizing antibody responses in addition to first indication of T cell activation.” Trial participants were vaccinated intramuscularly with two doses 29 days apart. These included doses of two, four, six, eight and 12 milligrams (µg). Each dose level was given to groups consisting of up to 10 participants who had previously tested positive for the SARS-CoV-2 virus that can cause COVID-19.1
“We are very encouraged by the interim Phase 1 data. It represents a critical milestone in our COVID-19 vaccine program and strongly supports the advancement of our vaccine candidate,” said Dr. Franz-Werner Haas, CEO of CureVac. “Following further data readouts and discussion with regulatory authorities, we remain fully committed and on track to initiate a pivotal Phase 2b/3 trial before the end of 2020.”1
While CureVac reported that it observed no “serious adverse events” related to the CVnCoV vaccine, the company noted that some of the trial participants who received doses of 12 µg experienced Grade 3 adverse events mostly after being injected with the second dose. These reactions included fatigue, headache, chills, muscle pain and fever. CureVac reported that the reactions were “transient” and usually resolved within 24 to 48 hours.1
A Grade 3 adverse event is defined by the U.S. Department of Health and Human Services (HHS) as,
“severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care” such as “bathing, dressing and undressing, feeding self, using the toilet, taking medications.” In other words, a Grade 3 adverse event is serious. It is only one grade removed from “life-threatening” (Grade 4) and just two grades from “death” (Grade 5).45
CureVac is currently negotiating a deal to provide the European Union (EU) with 225 million doses of CNnCoV, with an option to supply EU countries with an additional 180 million doses, for a total of 405 million doses once the vaccine is approved by European regulatory authorities.26
preventing infection is not a criterion for success in any of these trials
the only criterion for a successful COVID-19 vaccine is a reduction of COVID-19 symptoms, and even then, the reduction required is minimal
many vaccine trials are NOT using inert placebos – making it easier to hide vaccine side-effects
AstraZeneca is masking potential side effects by administering the vaccine along with acetaminophen every six hours for the first 24 hours after inoculation. The pain and fever reducer could potentially mask and downplay side effects such as pain, fever, headache or general malaise
two trails were paused due to safety concerns
80% of Moderna’s Phase 1 participants receiving the 100 microgram (mcg) dose developed systemic side effects. 100% developed side effects after the second dose
CNBC also noted that as companies progressed through clinical trials, several vaccine makers abandoned their highest doses following reports of more severe reactions
Analysis evaluated 94 confirmed cases of COVID-19 out of 43,538 participants. This means only .2% are reporting. Repeat – only .2%!
In approximately 2 months they have not noted any serious safety concerns. This is NOT a long enough time to determine safety.
While the study states it will evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as prevention against severe COVID-19 disease, IT HASN’T YET DONE SO. Therefore, they have not yet obtained whether this vaccine does these things at all.
Social media fact-checking organizations are not the independent public health watchdogs they’re made out to be. Fact checkers for Facebook are funded by the Bill and Melinda Gates Foundation, which has given more than $250 million in grants to steer media outlets
In what it describes as a commitment to “fighting the spread of misinformation,”[i] Facebook claims to work with “independent, third-party fact-checking organizations” to review content and take action against that deemed to be “viral misinformation” or fake news.
Facebook CEO Mark Zuckerberg has stated that when a post is identified as misinformation, meaning it’s given a warning label as such by Facebook, it results in users not clicking through 95% of the time.[ii]
While presented as a tool to protect the public, what it amounts to is blatant censorship, which can easily push certain agendas into public view while silencing others. Facebook, again, claims to be unbiased, but several of its fact-checking partners receive funding from the Bill and Melinda Gates Foundation, raising serious questions about conflicts of interest.
Gates Foundation Funds Prominent ‘Fact Checkers’
Who’s behind Facebook’s fact-checking? Africa Check is one fact-checking organization, which launched in 2018 across five sub-Saharan Africa countries. In 2019, they announced they were expanding coverage to prevent fake news from spreading across 10 more languages, including Swahili in Kenya, Wolof in Senegal and Afrikaans in South Africa.[iii]
In August 2019, the Gates Foundation paid $1,478,700 to Africa Check, for the reported purposes of advocacy to increase the accuracy of health claims made by public figures and promote the use of evidence-backed information by the media and others in terms of public health and development issues.[iv]An additional $445,760 grant was also paid to Africa Check by the Gates Foundation in 2017.[v]
Yet, in the Columbia Journalism Review, journalist Tim Schwab said he found 16 examples of Africa Check fact-checking media claims about Gates, and all of them — save one correction about an incorrect malaria statistic — were supportive or defensive of Bill and Melinda Gates and/or their foundation.[vi]
The Poynter Institute is another of the Gates’ Foundations beneficiaries, receiving a $382,997 grant from Gates in November 2015 “to improve the accuracy in worldwide media of claims related to global health and development.”[vii]
The Poynter Institute’s International Fact-Checking Network (IFCN) certifies Facebook’s fact-checking organizations, which must adhere to their code of principles.[viii] And, adding in one more layer of conflict, Facebook is also a major donor to Poynter and its subsidiary PolitiFact.[ix]
Is Bill Gates Media’s Puppet Master?
Bill Gates has emerged as a powerful figure in public health, despite holding no medical degree. Aside from being a top funder of the World Health Organization (WHO),[x] the Gates Foundation funds a number of mainstream media outlets, yielding a potentially disturbing level of control over the free press.
According to Schwab, “I recently examined nearly twenty thousand charitable grants the Gates Foundation had made through the end of June and found more than $250 million going toward journalism.“[xi] Recipients of Gates Foundation grants include:[xii]
BBC
NBC
Al Jazeera
ProPublica
National Journal
The Guardian
Univision
Medium
The Financial Times
The Atlantic
The Texas Tribune
Gannett
Washington Monthly
Le Monde
The Center for Investigative Reporting
Throwing money at the media means favorable press is a given, and the internet is awash in pieces praising the Gates Foundation’s charitable endeavors. Gannett’s USA Today is one example that has been quick to defend Gates from criticism, including claims that he would profit from the drug remdesivir.[xiii]
The Poynter Institute’s PolitiFact, another one of Facebook’s fact-checking partners,[xiv]also pushed back against claims that the Gates foundation would profit from a COVID-19vaccine, stating, “False claims about the Gates Foundation’s connection to the novel coronavirus know no borders” and adding that such “fake news” posts on social media would be “flagged as part of Facebook’s efforts to combat false news and misinformation on its News Feed.”[xv]
Just how far Gates’ puppet strings over the media extend remain unknown, Schwab reported, because the foundation only discloses charitable grants, not contracts, except for one with media outlet Vox.
“In the same way that the news media has given Gates an outsize voice in the pandemic, the foundation has long used its charitable giving to shape the public discourse on everything from global health to education to agriculture — a level of influence that has landed Bill Gates on Forbes’s list of the most powerful people in the world,” Schwab wrote.[xvi]
Facebook Sued for Censorship
In a lawsuit filed against Facebook, Zuckerberg and the fact-checking organizations Science Feedback, Poynter Institute and its subsidiary Politifact, nonprofit group Children’s Health Defense (CHD) alleges that Facebook censored information it shared regarding vaccine safety and 5G health concerns.[xvii]
In their lawsuit, they compared Facebook to the printing presses of 17th century England, through which the government controlled free speech. They allege that government actors, namely the U.S. Centers for Disease Control and Prevention and WHO, actively partnered with Facebook to censor CHD’s speech critical of government policy.
In regard to Facebook and Zuckerberg, the suit alleges, “At a time when the social media platform and its creator claim to be exponents of free expression and the scientific method for discovering truth, this case reveals the opposite: that they are indeed censors, and opponents of real science and open debate.”[xviii]
As the line between what constitutes real and fake news becomes increasingly, and perhaps intentionally, blurred, be sure to look beyond mainstream and social media’s seal of approval in your own search for truth.
The GMI Research Group (GMIRG) is dedicated to investigating the most important health and environmental issues of the day. Special emphasis will be placed on environmental health. Our focused and deep research will explore the many ways in which the present condition of the human body directly reflects the true state of the ambient environment.
Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of GreenMedInfo or its staff.
Moderna’s listing the Bill & Melinda Gates Foundation as a “strategic collaborator”, to advance mRNA-based development projects.
A 2019 Shareholder Letter under “Partnerships”, shows $187 million in grants from the Biomedical Advanced Research and Development Authority (BARDA, which operates under DHS), Defense Advanced Research Projects Agency (DARPA, an agency of the DOD),and the Bill and Melinda Gates Foundation.
Fauci, head of NIAID, which operates under the NIH and has announced the beginning of a phase one clinical trial for Moderna’s COVID-19 vaccine, is also funding the trial. NIAID scientists and collaborators at Moderna also developed it.
Please read Hammond’s article in full as he presents so many different cases of media bias. He contacted the author of the USA Today article and exposed the inaccuracies. In the end, they finally changed the title to better reflect the content. He goes into the whole weaponization of “fake news” and the fact the supposed “fact checkers” are continually caught in falsehoods.
ICAN’s legal team led by Aaron Siri, sued the National Institutes of Health (NIH) and Moderna to receive a copy of their Covid Vaccine Phase 1 Trial Safety Summary Report and what we found will create an avalanche of opposition to any forced vaccine.
From ICAN:
You and I both know forced vaccines are a bad idea.
You and I both support common-sense exemptions to any vaccine–like exempting those who may have adverse reactions–or those who have pre-existing health conditions where a vaccine may make their health situation worse.
There are many thousands more who have religious reasons for avoiding a mandated vaccine.
There are those who are conscientious objectors–and they lean on the right to say no or opt out.
These are all legitimate reasons — and reasons that have always been supported by our U.S. Constitution and understood to protect all citizens from tyranny. But what if the vaccine itself is unproven.
What if the vaccine itself is hurting people–making them sick, and risking the very lives of those it claims it will save?
This is what ICAN is discovering right now.
In fact, our legal team led by Aaron Siri, sued the National Institutes of Health (NIH) and Moderna to receive a copy of their Covid Vaccine Phase 1 Trial Safety Summary Report and what we found will create an avalanche of opposition to any forced vaccine.
In our initial reporting, we discovered that 70% of trial participants reported adverse events–some of which are extremely concerning.
As promised, I wanted to make sure that you have a copy of this report yourself–so you can be armed with the truth about the Covid 19 vaccine–the truth that the NIH and Moderna DO NOT WANT YOU TO SEE.
This is why I do what I do every day. You see, you and I deserve to know what we are putting into our bodies; I want answers, not stonewalling.
And sadly, the FDA, the NIH, Big Pharma, Big Government, the MainStream Media, Silicon Valley, all of them are COVERING UP and CENSORING THE TRUTH!
The only way ICAN and our weekly television program, The HighWire, can survive is with your support. If you believe in seeking the truth, if you believe in maintaining your liberty and your rights as an American citizen, if you believe in a free and independent press that is unwilling to compromise or cover-up the truth, then I hope you will consider joining our cause today.
Pfizer broke big news this week, that their #Covid19 Vaccine has proven 90% effective in trials. While all major news outlets are in a frenzy, Del has found some shocking information in the fine print.
Analysis evaluated 94 confirmed cases of COVID-19 out of 43,538 participants. This is .2%. Repeat, only .2% reporting.
They have not noted any serious safety concerns for only 2 months.
While the study states it willevaluate the potentialfor the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as prevention against severe COVID-19 disease, IT HASN’T YET DONE SO. Therefore, they have not yet obtained whether this vaccine does these things at all.
Re: Covid-19 vaccines: Many ADRs are already expected
Dear Editor
The Ted-tenders electronic daily: Supplement to the Official Journal of the EU, details a contract negotiated by the Medicines and Healthcare Products Agency (MHRA), dated 14.9.20 (1).
It states:
“The MHRA urgently seeks an Artificial Intelligence (AI) software tool to process the expected high volume of Covid-19 vaccine Adverse Drug Reaction (ADRs) and ensure that no details from the ADRs’ reaction text are missed”.
It further explains: “For reasons of extreme urgency under Regulation 32(2)(c) related to the release of a Covid-19 vaccine MHRA have accelerated the sourcing and implementation of a vaccine specific AI tool…… it is not possible to retrofit the MHRA’s legacy systems to handle the volume of ADRs that will be generated by a Covid-19 vaccine. Therefore, if the MHRA does not implement the AI tool, it will be unable to process these ADRs effectively. This will hinder its ability to rapidly identify any potential safety issues with the Covid-19 vaccine and represents a direct threat to patient life and public health”.
Why do they expect that a high volume of ADRs will be generated?
And would it not be more sensible to determine the safety profile of a Covid-19 vaccine while the stable door is shut, rather than monitor the galloping horse once it has bolted?
In 2009 they reached a fraud settlement with the U.S. Department of Justice for $2.3 BILLION, the largest ever fraud settlement in the history of the DOJ at that time. (Source.)
It is very unlikely that Merck, AZ, J&J and Moderna are just going to sit back and let Pfizer dominate this new, lucrative COVID vaccine market. Look for similar press releases from those companies very soon, touting how effective their vaccines are as well, as they look to get their piece of the pie.
Pfizer’s stock has already soared, and market analysis is now predicting that due to this announcement their sales will now reach $258 million in the fourth quarter of 2020, with sales in 2021 expected to reach $4.6 BILLION. (Source.)
All of these companies have already received BILLIONS through Operation Warp Speed, so they will ALL come out ahead financially no matter what happens.
The real losers will be the citizens of the U.S. and other countries who receive these vaccines.
According to a study that examined how informed consent is given to COVID-19 vaccine trial participants, disclosure forms fail to inform volunteers that the vaccine might make them susceptible to more severe disease if they’re exposed to the virus
Previous coronavirus vaccine efforts — including those for SARS, MERS and RSV — have revealed a serious concern: The vaccines have a tendency to trigger antibody-dependent enhancement (ADE)
ADE means that rather than enhance your immunity against the infection, the vaccine actually enhances the virus’ ability to enter and infect your cells, resulting in more severe disease than had you not been vaccinated
Lethal Th2 immunopathology is another potential risk. A faulty T cell response can trigger allergic inflammation, and poorly functional antibodies that form immune complexes can activate the complement system, resulting in airway damage
There’s evidence showing the elderly — who are most vulnerable to severe COVID-19 and would need the vaccine the most — are also the most vulnerable to ADE and Th2 immunopathology
According to a study that examined how informed consent is given to COVID-19 vaccine trial participants, disclosure forms fail to inform volunteers that the vaccine might make them susceptible to more severe disease if they’re exposed to the virus.
The study,1 “Informed Consent Disclosure to Vaccine Trial Subjects of Risk of COVID-19 Vaccine Worsening Clinical Disease,” published in the International Journal of Clinical Practice, October 28, 2020, points out that “COVID-19 vaccines designed to elicit neutralizing antibodies may sensitize 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 neutralizing 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),” the paper states.
“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.
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.”
What Is Antibody-Dependent Enhancement?
As noted by the authors of that International Journal of Clinical Practice paper, previous coronavirus vaccine efforts — for severe acute respiratory syndrome coronavirus (SARS-CoV), Middle East respiratory syndrome coronavirus (MERS-CoV) and respiratory syncytial virus (RSV) — have revealed a serious concern: The vaccines have a tendency to trigger antibody-dependent enhancement.
What exactly does that mean? In a nutshell, it means that rather than enhance your immunity against the infection, the vaccine actually enhances the virus’ ability to enter and infect your cells, resulting in more severe disease than had you not been vaccinated.2
This is the exact opposite of what a vaccine is supposed to do, and a significant problem that has been pointed out from the very beginning of this push for a COVID-19 vaccine. The 2003 review paper “Antibody-Dependent Enhancement of Virus Infection and Disease” explains it this way:3
“In general, virus-specific antibodies are considered antiviral and play an important role in the control of virus infections in a number of ways. However, in some instances, the presence of specific antibodies can be beneficial to the virus. This activity is known as antibody-dependent enhancement (ADE) of virus infection.
The ADE of virus infection is a phenomenon in which virus-specific antibodies enhance the entry of virus, and in some cases the replication of virus, into monocytes/macrophages and granulocytic cells through interaction with Fc and/or complement receptors.
This phenomenon has been reported in vitro and in vivo for viruses representing numerous families and genera of public health and veterinary importance. These viruses share some common features such as preferential replication in macrophages, ability to establish persistence, and antigenic diversity. For some viruses, ADE of infection has become a great concern to disease control by vaccination.”
Previous Coronavirus Vaccine Efforts Have All Failed
In my May 2020 interview above with Robert Kennedy Jr., he summarized the history of coronavirus vaccine development, which began in 2002, following three consecutive SARS outbreaks. By 2012, Chinese, American and European scientists were working on SARS vaccine development, and had about 30 promising candidates.
Of those, the four best vaccine candidates were then given to ferrets, which are the closest analogue to human lung infections. In the video below, which is a select outtake from my full interview, Kennedy explains what happened next. While the ferrets displayed robust antibody response, which is the metric used for vaccine licensing, once they were challenged with the wild virus, they all became severely ill and died.
The same thing happened when they tried to develop an RSV vaccine in the 1960s. RSV is an upper respiratory illness that is very similar to that caused by coronaviruses. At that time, they had decided to skip animal trials and go directly to human trials.
“They tested it on I think about 35 children, and the same thing happened,” Kennedy said.“The children developed a champion antibody response — robust, durable. It looked perfect [but when] the children were exposed to the wild virus, they all became sick. Two of them died.They abandoned the vaccine. It was a big embarrassment to FDA and NIH.”
Neutralizing Versus Binding Antibodies
Coronaviruses produce not just one but two different types of antibodies:
Neutralizing antibodies,4 also referred to as immoglobulin G (IgG) antibodies, that fight the infection
Binding antibodies5 (also known as nonneutralizing antibodies) that cannot prevent viral infection
Instead of preventing viral infection, binding antibodies trigger an abnormal immune response known as “paradoxical immune enhancement.” Another way to look at this is your immune system is actually backfiring and not functioning to protect you but actually making you worse.
Many of the COVID-19 vaccines currently in the running are using mRNA to instruct your cells to make the SARS-CoV-2 spike protein (S protein). The spike protein, which is what attaches to the ACE2 receptor of the cell, is the first stage of the two-stage process viruses use to gain entry into cells.
The idea is that by creating the SARS-CoV-2 spike protein, your immune system will commence production of antibodies, without making you sick in the process. The key question is, which of the two types of antibodies are being produced through this process?
Without Neutralizing Antibodies, Expect More Severe Illness
In an April 2020 Twitter thread,6 The Immunologist noted: “While developing vaccines … and considering immunity passports, we must first understand the complex role of antibodies in SARS, MERS and COVID-19.” He goes on to list several coronavirus vaccine studies that have raised concerns about ADE.
The first is a 2017 study7 in PLOS Pathogens, ”Enhanced Inflammation in New Zealand White Rabbits When MERS-CoV Reinfection Occurs in the Absence of Neutralizing Antibody,” which investigated whether getting infected with MERS would protect the subject against reinfection, as is typically the case with many viral illnesses. (Meaning, once you recover from a viral infection, say measles, you’re immune and won’t contract the illness again.)
To determine how MERS affects the immune system, the researchers infected white rabbits with the virus. The rabbits got sick and developed antibodies, but those antibodies were not the neutralizing kind, meaning the kind of antibodies that block infection. As a result, they were not protected from reinfection, and when exposed to MERS for a second time, they became ill again, and more severely so.
“In fact, reinfection resulted in enhanced pulmonary inflammation, without an associated increase in viral RNA titers,” the authors noted. Interestingly, neutralizing antibodies were elicited during this second infection, preventing the animals from being infected a third time. According to the authors:
“Our data from the rabbit model suggests that people exposed to MERS-CoV who fail to develop a neutralizing antibody response, or persons whose neutralizing antibody titers have waned, may be at risk for severe lung disease on re-exposure to MERS-CoV.”
In other words, if the vaccine does not result in a robust response in neutralizing antibodies, you might be at risk for more severe lung disease if you’re infected with the virus.
And here’s an important point: COVID-19 vaccines are NOT designed to prevent infection. As detailed in “How COVID-19 Vaccine Trials Are Rigged,” a “successful” vaccine merely needs to reduce the severity of the symptoms.They’re not even looking at reducing infection, hospitalization or death rates.
ADE in Dengue Infections
The Dengue virus is also known to cause ADE. As explained in a Swiss Medical Weekly paper published in April 2020:8
“The pathogenesis of COVID-19 is currently believed to proceed via both directly cytotoxic and immune-mediated mechanisms. An additional mechanism facilitating viral cell entry and subsequent damage may involve the so-called antibody-dependent enhancement (ADE).
ADE is a very well-known cascade of events whereby viruses may infect susceptible cells via interaction between virions complexed with antibodies or complement components and, respectively, Fc or complement receptors, leading to the amplification of their replication.
This phenomenon is of enormous relevance not only for the understanding of viral pathogenesis, but also for developing antiviral strategies, notably vaccines …
There are four serotypes of Dengue virus, all eliciting protective immunity. However, although homotypic protection is long-lasting, cross-neutralizing antibodies against different serotypes are short-lived and may last only up to 2 years.
In Dengue fever, reinfection with a different serotype runs a more severe course when the protective antibody titer wanes. Here, non-neutralizing antibodies take over neutralizing ones, bind to Dengue virions, and these complexes mediate the infection of phagocytic cells via interaction with the Fc receptor, in a typical ADE.
In other words, heterotypic antibodies at subneutralizing titres account for ADE in persons infected with a serotype of Dengue virus that is different from the first infection.
Cross-reactive neutralizing antibodies are associated with decreased odds of symptomatic secondary infection, and the higher the titer of such antibodies following the primary infection, the longer the delay to symptomatic secondary infection …”
The paper goes on to detail results from follow-up investigations into the Dengue vaccine, which revealed the hospitalization rate for Dengue among vaccinated children under the age of 9 was greater than the rate among controls. The explanation for this appears to be that the vaccine mimicked a primary infection, and as that immunity waned, the children became susceptible to ADE when they encountered the virus a second time. The author explains:
“A post hoc analysis of efficacy trials, using an anti-nonstructural protein 1 immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA) to distinguish antibodies elicited by wild-type infection from those following vaccination, showed that the vaccine was able to protect against severe Dengue [in] those who had been exposed to the natural infection before vaccination, and that the risk of severe clinical outcome was increased among seronegative persons.
Based on this, a Strategic Advisor Group of Experts convened by World Health Organization (WHO) concluded that only Dengue seropositive persons should be vaccinated whenever Dengue control programs are planned that include vaccination.”
ADE in Coronavirus Infections
This could end up being important for the COVID-19 vaccine. Hypothetically speaking, if SARS-CoV-2 works like Dengue, which is also caused by an RNA virus, then anyone who has not tested positive for SARS-CoV-2 might actually be at increased risk for severe COVID-19 after vaccination, and only those who have already recovered from a bout of COVID-19 would be protected against severe illness by the vaccine.
To be clear, we do not know whether that is the case or not, but these are important areas of inquiry and the current vaccine trials will simply not be able to answer this important question.
The Swiss Medical Weekly paper9 also reviews the evidence of ADE in coronavirus infections, citing research showing inoculating cats against the feline infectious peritonitis virus (FIPV) — a feline coronavirus — increases the severity of the disease when challenged with the same FIPV serotype as that in the vaccine.
The paper also cites research showing “Antibodies elicited by a SARS-CoV vaccine enhanced infection of B cell lines in spite of protective responses in the hamster model.” Another paper,10“Antibody-Dependent SARS Coronavirus Infection Is Mediated by Antibodies Against Spike Proteins,” published in 2014, found that:
“… higher concentrations of anti-sera against SARS-CoV neutralized SARS-CoV infection, while highly diluted anti-sera significantly increased SARS-CoV infection and induced higher levels of apoptosis.
Results from infectivity assays indicate that SARS-CoV ADE is primarily mediated by diluted antibodies against envelope spike proteins rather than nucleocapsid proteins. We also generated monoclonal antibodies against SARS-CoV spike proteins and observed that most of them promoted SARS-CoV infection.
Combined, our results suggest that antibodies against SARS-CoV spike proteins may trigger ADE effects. The data raise new questions regarding a potential SARS-CoV vaccine …”
A study11 that ties into this was published in the journal JCI Insight in 2019. Here, macaques vaccinated with a modified vaccinia Ankara (MVA) virus encoding full-length SARS-CoV spike protein ended up with more severe lung pathology when the animals were exposed to the SARS virus. And, when they transferred anti-spike IgG antibodies into unvaccinated macaques, they developed acute diffuse alveolar damage, likely by “skewing the inflammation-resolving response.”
SARS Vaccine Worsens Infection After Challenge With SARS-CoV
An interesting 2012 paper12 with the telling title, “Immunization with SARS Coronavirus Vaccines Leads to Pulmonary Immunopathology on Challenge with the SARS Virus,” demonstrates what many researchers now fear, namely that COVID-19 vaccines may end up making people more prone to severe SARS-CoV-2 infection.
The paper reviews experiments showing immunization with a variety of SARS vaccines resulted in pulmonary immunophathology once challenged with the SARS virus. As noted by the authors:13
“Inactivated whole virus vaccines whether inactivated with formalin or beta propiolactone and whether given with our without alum adjuvant exhibited a Th2-type immunopathologic in lungs after challenge.
As indicated, two reports attributed the immunopathology to presence of the N protein in the vaccine; however, we found the same immunopathologic reaction in animals given S protein vaccine only, although it appeared to be of lesser intensity.
Thus, a Th2-type immunopathologic reaction on challenge of vaccinated animals has occurred in three of four animal models (not in hamsters) including two different inbred mouse strains with four different types of SARS-CoV vaccines with and without alum adjuvant. An inactivated vaccine preparation that does not induce this result in mice, ferrets and nonhuman primates has not been reported.
This combined experience provides concern for trials with SARS-CoV vaccines in humans. Clinical trials with SARS coronavirus vaccines have been conducted and reported to induce antibody responses and to be ‘safe.’ However, the evidence for safety is for a short period of observation.
The concern arising from the present report is for an immunopathologic reaction occurring among vaccinated individuals on exposure to infectious SARS-CoV, the basis for developing a vaccine for SARS. Additional safety concerns relate to effectiveness and safety against antigenic variants of SARS-CoV and for safety of vaccinated persons exposed to other coronaviruses, particularly those of the type 2 group.”
The Elderly Are Most Vulnerable to ADE
On top of all of these concerns, there’s evidence showing the elderly — who are most vulnerable to severe COVID-19 — are also the most vulnerable to ADE. Preliminary research findings14 posted on the preprint server medRxiv at the end of March 2020 reported that middle-aged and elderly COVID-19 patients have far higher levels of anti-spike antibodies — which, again, increase infectivity — than younger patients.
Immune Enhancement Is a Serious Concern
Another paper worth mentioning is the May 2020 mini review15 “Impact of Immune Enhancement on COVID-19 Polyclonal Hyperimmune Globulin Therapy and Vaccine Development.” As in many other papers, the authors point out that:16
“While development of both hyperimmune globulin therapy and vaccine against SARS-CoV-2 are promising, they both pose a common theoretical safety concern. Experimental studies have suggested the possibility of immune-enhanced disease of SARS-CoV and MERS-CoV infections, which may thus similarly occur with SARS-CoV-2 infection …
Immune enhancement of disease can theoretically occur in two ways. Firstly, non-neutralizing or sub-neutralizing levels of antibodies can enhance SARS-CoV-2 infection into target cells.
Secondly, antibodies could enhance inflammation and hence severity of pulmonary disease. An overview of these antibody dependent infection and immunopathology enhancement effects are summarized in Fig. 1 …
Currently, there are multiple SARS-CoV and MERS-CoV vaccine candidates in pre-clinical or early phase clinical trials. Animal studies on these CoVs have shown that the spike (S) protein-based vaccines (specifically the receptor binding domain, RBD) are highly immunogenic and protective against wild-type CoV challenge.
Vaccines that target other parts of the virus, such as the nucleocapsid, without the S protein, have shown no protection against CoV infection and increased lung pathology. However, immunization with some S protein based CoV vaccines have also displayed signs of enhanced lung pathology following challenge.
Hence, besides the choice of antigen target, vaccine efficacy and risk of immunopathology may be dependent on other ancillary factors, including adjuvant formulation, age at vaccination … and route of immunization.”
Figure 1: Mechanism of ADE and antibody mediated immunopathology. Left panel: For ADE, immune complex internalization is mediated by the engagement of activating Fc receptors on the cell surface. Co-ligation of inhibitory receptors then results in the inhibition of antiviral responses which leads to increased viral replication. Right panel: Antibodies can cause immunopathology by activating the complement pathway or antibody-dependent cellular cytotoxicity (ADCC). For both pathways, excessive immune activation results in the release of cytokines and chemokines, leading to enhanced disease pathology.
Do a Risk-Benefit Analysis Before Making Up Your Mind
In all likelihood, regardless of how effective (or ineffective) the COVID-19 vaccines end up being, they’ll be released to the public in relatively short order. Most predict one or more vaccines will be ready sometime in 2021.
Ironically, the data17,18,19 we now have no longer support a mass vaccination mandate, considering the lethality of COVID-19 is lower than the flu for those under the age of 60.20
If you’re under the age of 40, your risk of dying from COVID-19 is just 0.01%, meaning you have a 99.99% chance of surviving the infection. And you could improve that to 99.999% if you’re metabolically flexible and vitamin D replete.
So, really, what are we protecting against with a COVID-19 vaccine? As mentioned, the vaccines aren’t even designed to prevent infection, only reduce the severity of symptoms.Meanwhile, they could potentially make you sicker once you’re exposed to the virus. That seems like a lot of risk for a truly questionable benefit.
To circle back to where we started, participants in current COVID-19 vaccine trials are not being told of this risk — that by getting the vaccine they may end up with more severe COVID-19 once they’re infected with the virus.
Lethal Th2 Immunopathology Is Another Potential Risk
In closing, consider what this PNAS news feature states about the risk of vaccine-induced immune enhancement and dysfunction, particularly for the elderly, the very people who would need the protection a vaccine might offer the most:21
“Since the 1960s, tests of vaccine candidates for diseases such as dengue, respiratory syncytial virus (RSV), and severe acute respiratory syndrome (SARS) have shown a paradoxical phenomenon:
Some animals or people who received the vaccine and were later exposed to the virus developed more severe disease than those who had not been vaccinated. The vaccine-primed immune system, in certain cases, seemed to launch a shoddy response to the natural infection …
This immune backfiring, or so-called immune enhancement, may manifest in different ways such as antibody-dependent enhancement (ADE), a process in which a virus leverages antibodies to aid infection; or cell-based enhancement, a category that includes allergic inflammation caused by Th2 immunopathology. In some cases, the enhancement processes might overlap …
Some researchers argue that although ADE has received the most attention to date, it is less likely than the other immune enhancement pathways to cause a dysregulated response to COVID-19, given what is known about the epidemiology of the virus and its behavior in the human body.
‘There is the potential for ADE, but the bigger problem is probably Th2 immunopathology,’ says Ralph Baric, an epidemiologist and expert in coronaviruses … at the University of North Carolina at Chapel Hill.
In previous studies of SARS, aged mice were found to have particularly high risks of life-threatening Th2 immunopathology … in which a faulty T cell response triggers allergic inflammation, and poorly functional antibodies that form immune complexes, activating the complement system and potentially damaging the airways.”
Hopefully it is abundantly clear this vaccine could be the kiss of death for Lyme/MSIDS patients if ADE happens.
Not only is this vaccine NOT needed, it is experimental – which means there are many unanswered questions. The fact they are not being honest with vaccine volunteers does not bode well with transparency and honesty. If they will withhold information in early research, will they not also withhold other critical information?
Also, there are proven treatments that are working beautifully.
Madison Area Lyme Support Group 
Rapid Response:
Re: Covid-19 vaccines: Many ADRs are already expected
Dear Editor
The Ted-tenders electronic daily: Supplement to the Official Journal of the EU, details a contract negotiated by the Medicines and Healthcare Products Agency (MHRA), dated 14.9.20 (1).
It states:
It further explains: “For reasons of extreme urgency under Regulation 32(2)(c) related to the release of a Covid-19 vaccine MHRA have accelerated the sourcing and implementation of a vaccine specific AI tool…… it is not possible to retrofit the MHRA’s legacy systems to handle the volume of ADRs that will be generated by a Covid-19 vaccine. Therefore, if the MHRA does not implement the AI tool, it will be unable to process these ADRs effectively. This will hinder its ability to rapidly identify any potential safety issues with the Covid-19 vaccine and represents a direct threat to patient life and public health”.
Why do they expect that a high volume of ADRs will be generated?
And would it not be more sensible to determine the safety profile of a Covid-19 vaccine while the stable door is shut, rather than monitor the galloping horse once it has bolted?
(1) https://ted.europa.eu/udl?uri=TED:NOTICE:506291-2020:TEXT:EN:HTML&src=0
Competing interests: No competing interests