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Informed Consent for COVID Vaccine

Informed consent to medical treatment is a right that ensures patients receive information about the recommended treatment so they can make a well-informed decision about their medical care.1 Medical practitioners are both ethically and legally obligated to ensure their patients have an opportunity for informed consent, which means disclosing both the risks and benefits of potential medical treatments.

In the case of the COVID-19 vaccine, it’s not possible to provide a full list of potential risks, considering the unprecedented speed with which they were developed and released to the public — the long-term effects are completely unknown.

Significant concerns have been raised, however, surrounding antibody-dependent enhancement (ADE), and the possibility that COVID-19 vaccines could worsen COVID-19 disease via ADE.2

Anyone receiving this experimental medical procedure would certainly want to be informed of its potential to worsen the very disease they’re trying to avoid, but it’s not included as part of the informed consent disclosure — despite researchers recommending back in October 2020 that it be “prominently and independently disclosed.”3

COVID-19 Vaccine Recipients Should Be Warned About ADE Risk

Writing in the International Journal of Clinical Practice, Timothy Cardozo of NYU Langone Health and Ronald Veazey with the Tulane University School of Medicine, noted, “Patient comprehension is a critical part of meeting medical ethics standards of informed consent in study designs.”4

As such, they set out to determine if enough research existed to require clinicians to disclose the specific risk that COVID-19 vaccines could worsen disease if the recipient is exposed to circulating virus. First, they reviewed preclinical and clinical evidence, which revealed that ADE is a significant concern. They noted:5

“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).”

Their next step involved reviewing clinical trial protocols for COVID-19 vaccines to determine if this risk was properly disclosed to research subjects (at the time, the vaccines had not yet been released to the public). It was not, leaving people largely in the dark instead:6

“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 conclusion reached by the study was that, in order to meet medical ethics standards of informed consent, people taking part in COVID-19 vaccine trials, as well as those who have received it after approval, should be clearly warned of the “specific and significant COVID-19 risk of ADE.”7

This, however, has not occurred, and most receiving it have likely not even heard of ADE, much less its association with the experimental COVID-19 vaccine.

What Is Antibody-Dependent Enhancement (ADE)?

When your body is exposed to a pathogen, it first ramps up a nonspecific response as part of your innate immune system. Next, your adaptive immune response takes over, generating neutralizing antibodies against the pathogen, which work to bind to the offender so it can’t enter your cells.

While vaccines may generate neutralizing antibodies, they can also induce binding antibodies, sometimes referred to as non-neutralizing antibodies, which increase the ability of a virus to enter your cells and worsen the disease.

Children’s Hospital of Philadelphia explained, “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.”8

It’s possible for pathogens to cause ADE, the most well-known being dengue virus, which has four different serotypes. If a person is infected with one serotype, neutralizing antibodies may effectively fight back against the disease.

However, if they’re exposed to a different serotype later, the neutralizing antibodies already circulating in their system can bind to the virus and enhance its entrance into cells, causing a severe form of the disease known as dengue hemorrhagic fever.9

Vaccinations are also known to cause ADE. In 1969, attempts to create a vaccination against respiratory syncytial virus (RSV) catastrophically failed after it led to increased rates of severe illness in infants. Eighty percent of vaccinated infants ended up hospitalized compared to only 5% of the nonvaccinated infants, and two vaccinated infants died due to enhanced RSV infections caused by the vaccine.10

RSV is an upper respiratory illness that is very similar to that caused by coronaviruses. In my May 2020 interview with Robert Kennedy Jr., he talked about the failed RSV vaccine:

“At the time, they did not test it on animals. They went right to human testing. They tested it on I think about 35 children, and the same thing happened. The children developed a champion antibody response, robust, durable. It looked perfect, and then the children were exposed to the wild virus and they all became sick. Two of them died. They abandoned the vaccine. It was a big embarrassment to FDA and NIH …”

An early version of the measles vaccine also resulted in ADE (measles belongs to the same family as RSV). Children who were vaccinated with the formalin inactivated measles vaccine were more likely to develop a severe, atypical measles infection, including high fever, unusual rash and pneumonia, leading the vaccine to be withdrawn from the market.11

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