COVID-19 Vaccines, Antibody-Dependent Enhancement and Informed Consent

Let's open this posting with a definition:

"Antibody-Dependent Enhancement or ADE occurs when the antibodies generated during an immune response recognize and bind to a pathogen, but they are unable to prevent infection. Instead, these antibodies act as a “Trojan horse,” allowing the pathogen to get into cells and exacerbate the immune response.

On a few occasions ADE has resulted from vaccination:

Respiratory syncytial virus (RSV) — RSV is a virus that commonly causes pneumonia in children. A vaccine was made by growing RSV, purifying it, and inactivating it with the chemical formaldehyde. In clinical trials, children who were given the vaccine were more likely to develop or die from pneumonia after infection with RSV. As a result of this finding, the vaccine trials stopped, and the vaccine was never submitted for approval or released to the public.

Measles — An early version of measles vaccine was made by inactivating measles virus using formaldehyde. Children who were vaccinated and later became infected with measles in the community developed high fevers, unusual rash, and an atypical form of pneumonia. Upon seeing these results, the vaccine was withdrawn from use, and those who received this version of the vaccine were recommended to be vaccinated again using the live, weakened measles vaccine, which does not cause ADE and is still in use today.

A more recent example of ADE following vaccination comes from dengue virus:

Dengue virus — In 2016, a dengue virus vaccine was designed to protect against all four serotypes of the virus. The hope was that by inducing immune responses to all four serotypes at once, the vaccine could circumvent the issues related to ADE following disease with dengue virus. The vaccine was given to 800,000 children in the Philippines. Fourteen vaccinated children died after encountering dengue virus in the community. It is hypothesized that the children developed antibody responses that were not capable of neutralizing the natural virus circulating in the community. As such, the vaccine was recommended only for children greater than 9 years of age who had already been exposed to the virus."

Here is another quote about ADE and SARS-CoV-2 vaccines from a paper entitled "Antibody-dependent enhancement and SARS-CoV-2 vaccines and therapies" by Wen She Lee et al as found in Nature Microbiology with my bolds throughout:

"Antibody-based drugs and vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are being expedited through preclinical and clinical development. Data from the study of SARS-CoV and other respiratory viruses suggest that anti-SARS-CoV-2 antibodies could exacerbate COVID-19 through antibody-dependent enhancement (ADE). Previous respiratory syncytial virus and dengue virus vaccine studies revealed human clinical safety risks related to ADE, resulting in failed vaccine trials."

Here is the conclusion from the paper:

"ADE has been observed in SARS, MERS and other human respiratory virus infections including RSV and measles, which suggests a real risk of ADE for SARS-CoV-2 vaccines and antibody-based interventions. However, clinical data has not yet fully established a role for ADE in human COVID-19 pathology. Steps to reduce the risks of ADE from immunotherapies include the induction or delivery of high doses of potent neutralizing antibodies, rather than lower concentrations of non-neutralizing antibodies that would be more likely to cause ADE.

Going forwards, it will be crucial to evaluate animal and clinical datasets for signs of ADE, and to balance ADE-related safety risks against intervention efficacy if clinical ADE is observed. Ongoing animal and human clinical studies will provide important insights into the mechanisms of ADE in COVID-19. Such evidence is sorely needed to ensure product safety in the large-scale medical interventions that are likely required to reduce the global burden of COVID-19."

To put it very simply, ADE can occur in vaccinated humans and animals when they are exposed to the wild virus (the challenge).

With that background, let's look at a very little-reported article that appeared on the National Institutes of Health National Liberary of Medicine website entitled "Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease" by Timothy Cardozo and Ronald Veazey as shown here:

The authors open by noting the following:

"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."

Here is another definition, also from the NIH website:

"Informed consent is the process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. The patient must be competent to make a voluntary decision about whether to undergo the procedure or intervention.  Informed consent is both an ethical and legal obligation of medical practitioners in the US and originates from the patient's right to direct what happens to their body. Implicit in providing informed consent is an assessment of the patient's understanding, rendering an actual recommendation, and documentation of the process. The Joint Commission requires documentation of all the elements of informed consent "in a form, progress notes or elsewhere in the record." The following are the required elements for documentation of the informed consent discussion: (1) the nature of the procedure, (2) the risks and benefits and the procedure, (3) reasonable alternatives, (4) risks and benefits of alternatives, and (5) assessment of the patient's understanding of elements 1 through 4.

It is the obligation of the provider to make it clear that the patient is participating in the decision-making process and avoid making the patient feel forced to agree to with the provider. The provider must make a recommendation and provide their reasoning for said recommendation."

In other words, medical practitioners have the legal and moral obligation to ensure that the people that they are treating understand the risks and benefits of the medical procedure (including vaccinations) and that they do not feel coerced into receiving the medical procedure. 

Let's go back to the article by Cardozo and Veazey.  The authors reviewed published literature and clinical trial protocols to identify evidence that COVID-19 vaccines could worse disease if the vaccine recipients are exposed to the wild virus.  Here are the 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."

The authors concluded that the specific risk of ADE linked to the COVID-19 vaccines should have been prominently and independently disclosed to research subjects in trials and for future patients after the vaccines are approved for use.  Given that the current crop of COVID-19 vaccines are not scheduled for completion for at least another year and that they are currently being used under an Emergency Use Authorization, one would think that providing informed consent to all vaccine recipients would be critical.

In closing, as one example, let's look at the COVID-19 vaccine consent form for the State of New York:

This is the only warning given to vaccine recipients about the nature of the COVID-19 vaccine that they are about to receive:

I wonder how many recipients actually read all of the fine print which, as you will notice, says nothing about ADE?  Note that recipients are stating that they were given the "chance to ask questions which were answered to my satisfaction" and that they "understand the benefits and risks of the vaccination as described".  How many laypeople actually understand the risks and benefits of the mRNA vaccine technology let alone know what questions to ask?  How many laypeople understand that the "jab" could well lead to a greater susceptibility to ADE, making future exposures to the new variants of the SARS-CoV-2 virus even riskier?

This study is the smoking gun in the COVID-19 narrative and is should be of particular interest to all of us given that it appears on the website of Anthony Fauci's employer.  Recipients of COVID-19 vaccines are not properly being informed of the risks of antibody-dependent enhancement by governments, vaccine manufacturers, the mainstream media and public health officials.  Most people have absolutely no concept of ADE and its potential impact on their future health and are being coerced into accepting an unproven vaccine with the promise of a return to societal normalcy by their governments (the carrot) and the threat of having their freedom restricted for the indefinite future (the stick), contradicting the very concept of informed consent.

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