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Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease
National institute of health ^ | October 2020 | Timothy Cardozo

Posted on 04/17/2021 6:12:38 PM PDT by Triple

Abstract

Aims of the study: 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.

Methods used to conduct the study: Published literature was reviewed to identify preclinical and clinical evidence that COVID-19 vaccines could worsen disease upon exposure to challenge or circulating virus. Clinical trial protocols for COVID-19 vaccines were reviewed to determine if risks were properly disclosed.

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.

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.


TOPICS:
KEYWORDS: covid; plandemic
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To: Bellflower

Your comment relates to my statement that the winning number on the roulette wheel is known even before the ball is dropped...
No risk, No liability
Such a deal!!


41 posted on 04/18/2021 12:26:52 AM PDT by Oscar in Batangas (An Honors Graduate from the Don Rickles School of Personal Verbal Intercourse)
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To: Triple

One has to be an IDIOT to get these shots!!!

113 PAGES of documented injuries, deaths from COVID SHOTS!!!

https://drive.google.com/file/d/1DczVUPjOli3J4rHHtvRzh94NVT74x0kM/view?fbclid=IwAR0JO9vi09xTidjgT0_P86QgKY6woI-aVaFZFybyzYBdxXD-H88UePx9K2k


42 posted on 04/18/2021 3:49:21 AM PDT by afchief
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To: Jane Long
“I caught heck from a couple of very rude vax promoters. One even suggested that this dear man (married to his HS sweetheart, for 50 yrs) probably had syphilis.”

Sorry to hear about your friend. What an absolutely awful thing to say. Someone say that to me gets their face rearranged and if they are in my house they go out the door face first without the door being opened first. At this point I don't GAF

43 posted on 04/18/2021 3:51:25 AM PDT by Polynikes ( Hakkaa paalle)
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To: Triple

44 posted on 04/18/2021 4:02:49 AM PDT by Travis McGee (EnemiesForeignAndDomestic.com)
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To: Triple
Torn perineum...ouch!

I don’t want to know how that happens.

Common among leftists. Think "pillow biting"...

45 posted on 04/18/2021 6:27:18 AM PDT by grey_whiskers (The opinions are solely those of the author and are subject to change with out notice.)
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To: House Atreides

Just ask George Sore-Ass to increase your pay this month; or Anthony Faux-Xi.


46 posted on 04/18/2021 6:31:33 AM PDT by grey_whiskers (The opinions are solely those of the author and are subject to change with out notice.)
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To: Travis McGee

+1


47 posted on 04/18/2021 6:32:00 AM PDT by grey_whiskers (The opinions are solely those of the author and are subject to change with out notice.)
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To: ThunderSleeps

So sad, and, again, prayers for your niece.

Any idea what made a person that young (17) even decide to get the vax?


48 posted on 04/18/2021 6:32:00 AM PDT by Jane Long (America, Bless God....blessed be the Nation 🙏🏻🇺🇸)
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To: Rebelbase

Trump says get your jab. Melania says get your Jab. Trust Trump’s plan.


49 posted on 04/18/2021 6:46:46 AM PDT by NELSON111 (Congress: The Ralph Wolf and Sam Sheepdog show. Theater for sheep. My politics determines my "hero")
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To: ransomnote
Oh but PFizer/Moderna aren't going to tell us what happened to their lab victims (trial participants) after the conclusion of the trials.

You don’t know that.

Besides, the trials go for two years so it isn’t something to worry about yet.

50 posted on 04/18/2021 7:01:17 AM PDT by semimojo
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To: Triple

ALL!!!


51 posted on 04/18/2021 7:25:46 AM PDT by nanook (Thomas Jefferson was right.)
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To: nanook

Let me summarize:

The disclosures on all the Covid 19 vaccines fail to disclose the risks of the vaccines. They leave out the side effects to the degree that informed consent is impossible.

The NIH published the study.

(Don’t be part of the experiment, they are lying by omission. Notice the vaccines promotion videos carry not risk message at the end, like every other pharma add.)


52 posted on 04/18/2021 8:15:47 AM PDT by Triple (Socialism denies people the right to the fruits of their labor, and is as abhorrent as slavery)
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To: Travis McGee

If people were informed...


53 posted on 04/18/2021 8:18:08 AM PDT by Triple (Socialism denies people the right to the fruits of their labor, and is as abhorrent as slavery)
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To: House Atreides
“Antivaxxer” attempted label doesn't apply as this isn't a ‘vaccine’. It is a artificial gene injection experimental technology.
54 posted on 04/18/2021 8:39:04 AM PDT by 444Flyer (John 3, Revelation 20, Joshua 24:15, 1 Kings 18:16-39, Pick a side...)
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To: Travis McGee

55 posted on 04/18/2021 8:51:04 AM PDT by 444Flyer (John 3, Revelation 20, Joshua 24:15, 1 Kings 18:16-39, Pick a side...)
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To: Jane Long
Any idea what made a person that young (17) even decide to get the vax?

No, that's the mind-boggling crazy thing about it. Her parents are nominally anti-vaxxers. As in, in previous years when their kids were younger they have loaded them in the car and gone to anti-vax rallies and stuff...proselytized other family members against vaccinations -- including us, but my wife and I have had our kids get the routine vaccinations.

I honestly don't know if this was some kind of rebellion move by their daughter or what. Not really a good time to ask them why or what was going on with her, why she went 180 deg from their family's usual thing.

56 posted on 04/18/2021 9:06:58 AM PDT by ThunderSleeps (Biden/Harris - illegitimate and everyone knows it.)
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To: ransomnote

My 13 year old grand-daughter got COVID 6 weeks ago. Just lost sense of smell and taste. Well she was exposed at school with a kid that sat behind her at school to COVID. She tested positive. Her Dr said what is happening is the PCR test is coming up positive for COVID because it is picking up anti-bodies. She had an antigen test and it was good.


57 posted on 04/18/2021 10:09:57 AM PDT by Engedi
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To: BigpapaBo

Ping to self.


58 posted on 04/18/2021 10:37:33 AM PDT by BigpapaBo (If it don't kill you it'll make you _________!)
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To: Valpal1

Old news and disproven theory as the covid vaccines have been shown to reduce symptom severity in breakthrough cases and ADE has not been a problem.

~~~~~~~~~~~~~~~

These experimental “vaccines” have not been sufficiently studied by honest people to show they are safe and effective - that’s why they are not FDA approved.

As people develop ADE, they will look like ‘breakthrough cases’ because both natural infection and ADE have the same antibodies.

We are their lab rats - Pfizer’s Phase III ends 2 years from now - WE are their drug trial.


59 posted on 04/18/2021 1:46:52 PM PDT by ransomnote (IN GOD WE TRUST)
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To: ransomnote

Except the breakthrough cases have lower hospitalization rates and much lower fatality rate. If it were actual ADE, then it should be the opposite. And there have been enough cases to know that.


60 posted on 04/18/2021 2:14:00 PM PDT by Valpal1
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