Did the covid vaccines fail to account for proper informed consent during the clinical trial period? What did we know all the way back in MARCH 2021?

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7645850/#!po=68.1818

This is a very interesting article.  It was published over a year ago, and this is the first I have seen it.

“The specific and significant COVID‐19 risk of Antibody Dependent Enhancement (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.”

Lets unpack that.  Informed consent is you, the patient, giving consent for any treatment or medical procedure, based on a list of risks/benefits the medical intervention has.  A great example is when I prescribe Lamictal, I have to tell patients that it is highly effective at stabilizing mood, it is one of the safest mood stabilizers for bipolar disorder during pregnancy and lactation, but you must dose it exactly as prescribed and NEVER increase the dose faster due to risk of Steven Johnson Syndrome.  I inform patients that there is a black box warning for SJS with the drug, that it is very rare (I have had 1 patient out of thousands develop mild SJS), but the signs to look for are this and this, and if that happens, go straight to the ER for fluids and steroids.  If the patient agrees to taking the med, complete informed consent has been given.  I informed them it works really good, but I also told them the potential ugly dirty of the drug.  Some have decided to not take it due to that risk and then we discuss alternatives.  THIS IS HOW INFORMED CONSENT SHOULD GO.

So back to this paper and this experimental covid vaccine.  What did they FAIL to disclose to trial participants?

“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.”  “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.”

“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.”

The conclusion of this article:

“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.”

So here is the part that really grinds my gears.  This paper came out in the Journal of Clinical Practice IN MARCH 2021.  How many millions/billions of covid injections have been given SINCE this article?!?!?  Why did we not change our informed consent rules?  Why did each trial site not have the same rules to follow?  WHY did we NOT start to disclose this information to EVERY PERSON who got a covid injection after this paper was printed?!?!?  This is almost two years old!!!!!   No words.  Yet we clearly knew waaaaaaay back then that people who were vaccinated had a risk of getting sicker than they did from just catching covid without the vaccine.  I wish every covid vaccine trial site and manufacturer would just collapse into a huge hole in the earth.