What Happened to Informed Consent for the Vaccine?

by Avi Abelow

The following is from a medical study dealing with the necessary consent required when offering the corona/covid-19 vaccine. I was quite surprised to have never heard this information from the medical community or the media until I found this in my own research (which includes being in direct contact with many medical professionals). I suggest everyone read it carefully (and read all the way to the end, where it references that this information also applies after the vaccine is approved):

“Phase 1 and 2 clinical trials of vaccine candidates have only been designed around immunogenicity as an efficacy endpoint 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”.

The conclusion:
“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.”

This was the first time I even heard about the potential risks of the vaccine and the need to inform people about the risks before agreeing to take it.

Has anyone who has taken the vaccine been told this information about the risks before giving consent to receive it? Has anyone heard anything about this in the media? Or only at the last moment from the doctors/nurses who gave you the vaccine?

Here is more detailed information from the study:

“Results of the study: 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 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.”

Here is an abstract of this study on the National Library of Medicine Website (https://pubmed.ncbi.nlm.nih.gov/33113270/).

Anyone know anything about this information? Again, this is the first I have heard about the potential risks that we are supposed to be told about before consenting to take the vaccine. Honestly, it is beyond surprising that many of us have not heard about this.

While the media hype about “the” solution to ending our crazy reality is exciting, it is very alarming that the information about the potential risks has not been shared with the public before agreeing on mass to take the vaccine. And as these medical documents claim themselves, the current situation of withholding this information from people before agreeing to take the vaccine is against medical ethics.

I have no problem with people agreeing to take the vaccine after they hear about the risks, but are they telling people about the risks?

One of the main points of concern that I have been hearing from many people wary to take the vaccine is the lack of data proving the risks wrong. They are not referring to data 7-14 days after the second shot, but months and years after the second shot. Hence the risk involved in making the decision to take it.

My only point in this and all posts about the virus is that everyone should be informed and do their own research before making a decision on what to do. Considering there is data that the Zelenko protocol works for cases diagnosed early, the question of whether one has to take the vaccine is a real question that one should consider in the risk/benefit analysis of whether to take the vaccine or not. Obviously, every choice has risks.

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