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Informed consent disclosure to vaccine trial subjects of risk of COVID‐19 vaccines worsening clinical disease
onlinelibrary.wiley.com ^ | October 20, 2020 | Ronald Veazy, Timothy Cardozo

Posted on 03/29/2021 12:01:38 PM PDT by ransomnote

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This explanation of "Free to read & Use" was posted on another website hosting this document, however that website's link was not working so I pulled the text from Wiley.

This  image was taken from the website linked below:

europepmc.org/article/MED/33113270#free-full-text

1 posted on 03/29/2021 12:01:38 PM PDT by ransomnote
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Excerpt of article below:

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.

2 posted on 03/29/2021 12:10:02 PM PDT by ransomnote (IN GOD WE TRUST)
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To: ransomnote

FROM YOUR POSTED “STUDY”:

“...Current data on COVID‐19 vaccines is limited, but does not so far reveal evidence of ADE of disease. Non‐human primate studies of Moderna’s mRNA‐1273 vaccine showed excellent protection, with no detectable immunopathology. Phase 1 trials of several vaccines have not reported any immunopathology in subjects administered the candidate vaccines....”


3 posted on 03/29/2021 12:10:10 PM PDT by House Atreides
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To: House Atreides

https://freerepublic.com/focus/chat/3943889/posts?page=52#52 on 3/25/2021


4 posted on 03/29/2021 12:12:35 PM PDT by ransomnote (IN GOD WE TRUST)
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To: ransomnote
The government vaxxer cult won't like this one even a little bit.


5 posted on 03/29/2021 12:13:49 PM PDT by bagster ("Even bad men love their mamas".)
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To: House Atreides
well ok then...where t begin? How about the start: "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.

Soooo how is it that there is somehow this threshold of data by which a clinician is required/obligated to do anything???

And who, exactly, establishes that threshold? Amazing.

6 posted on 03/29/2021 12:16:57 PM PDT by corkoman
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To: House Atreides
FROM YOUR POSTED “STUDY”:

Haha. You put 'study' in quotation marks, then cite a quote from it.

Make up your mind, Harkonnen.

This is also from the paper.

COVID‐19 vaccines designed to elicit neutralising antibodies may sensitize vaccine recipients to more severe disease than if they were not vaccinated.

Ransomnote has been telling you vaxxers this for days, now. Try to let it seep into your brain some kinda way.

Vaxxer cult gonna vaxxer cult.


7 posted on 03/29/2021 12:19:48 PM PDT by bagster ("Even bad men love their mamas".)
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To: ransomnote
I got it.


8 posted on 03/29/2021 12:20:27 PM PDT by bagster ("Even bad men love their mamas".)
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To: ransomnote

To all you effin libtards seeking certainty with goo in your bodies:
“I will not take any vaccine made possible President Donald J. Trump under his “Operation Warp Speed” or any “Emergency Use Authorization” etc.

Oh, and stop with your tired trope “Pfizer didn’t take any money. They developed it themselves”

Sure they did, idiots.

What they really did was start investigations, begin processes for production, etc to put themselves in a position to be a part of government procurement.

Yeah, that’s right. They contracted for 195,000,000 doses with the government.

They made it easy for the US Government to say yes and Pfizer did this for a profit.

They ain’t no charity as their stockholders would say...


9 posted on 03/29/2021 12:21:36 PM PDT by Vendome (I've Gotta Be Me https://youtu.be/wH-pk2vZG2M)
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To: Vendome
Government-Funded Scientists Laid the Groundwork for Billion-Dollar Vaccines | Kaiser Health News (khn.org)

By Arthur Allen
NOVEMBER 18, 2020

Excerpted:

"Basic research conducted by Graham and others at the National Institutes of Health, Defense Department and federally funded academic laboratories has been the essential ingredient in the rapid development of vaccines in response to COVID-19. The government has poured an additional $10.5 billion into vaccine companies since the pandemic began to accelerate the delivery of their products."

10 posted on 03/29/2021 12:28:47 PM PDT by ransomnote (IN GOD WE TRUST)
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To: corkoman

“Soooo how is it that there is somehow this threshold of data by which a clinician is required/obligated to do anything???

And who, exactly, establishes that threshold? Amazing.”
***********************************************************
I don’t know the answer to that but AFTER 93 MILLION AMERICANS RECEIVED COVID-19 VACCINES.... there have been NO REPORTED CASE OF ADE.

https://www.medpagetoday.com/special-reports/exclusives/91648

The specter of ADE is simply another scary boogeyman that the anti-vaxxers hysterically throw against the wall to frighten the gullible.


11 posted on 03/29/2021 12:29:16 PM PDT by House Atreides
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To: ransomnote
"Current data on COVID‐19 vaccines is limited, but does not so far reveal evidence of ADE of disease. Non‐human primate studies of Moderna's mRNA‐1273 vaccine showed excellent protection, with no detectable immunopathology.13 Phase 1 trials of several vaccines have not reported any immunopathology in subjects administered the candidate vaccines. However, these subjects were unlikely to have yet encountered circulating virus."

Doesn't sound so "Scary! Scary!".
Sounds like an accurate description of the risk.
I assume this possible ADE risk of being made more sick by a variant is the reason there are calls to continue ineffective masking and other, possibly very slightly helpful, protocols after vaccination.

12 posted on 03/29/2021 12:34:21 PM PDT by mrsmith (US MEDIA: " Every 'White' cop is a criminal! And all the 'non-white' criminals saints!")
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To: Vendome

I consider it damning of our health establishment that vaccines for this disease were approved before any treatments were.
That’s backwards!


13 posted on 03/29/2021 12:37:38 PM PDT by mrsmith (US MEDIA: " Every 'White' cop is a criminal! And all the 'non-white' criminals saints!")
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To: Jane Long

THere is a Mt Everest sized pile of evidence, here’s more, let me know if you want me to stop pinging you!


14 posted on 03/29/2021 12:58:00 PM PDT by little jeremiah (Thirst for truth is the most valuable possession and no one can take it away from you.)
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To: ransomnote; Jane Long; SecAmndmt; Secret Agent Man; Jan_Sobieski; Roman_War_Criminal; ...

Thanks for posting


15 posted on 03/29/2021 1:00:43 PM PDT by metmom (...fixing our eyes on Jesus, the Author and Perfecter of our faith..)
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To: bagster

You’re too late.


16 posted on 03/29/2021 1:01:16 PM PDT by metmom (...fixing our eyes on Jesus, the Author and Perfecter of our faith..)
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To: ransomnote

mRNA is not new. Animals held up well to the vaccination, until they were challenged with the natural virus. The outcome? Organ failure.

We are setting up many, many possible ticking time bombs.

With a survival rate of 99%+ survival rate, I suggest getting your immunity the old fashion way.

Lastly, every single one of us should be asking “why the crazy push for the use of this vaccine?”


17 posted on 03/29/2021 2:09:27 PM PDT by walkingdead (We are sacrificing American youth's future on the altar of our own fear. And it is a travesty.)
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To: mrsmith

But the lemmings insist that it’s safe, and they did their ‘research’, and they also trust the ‘authoritative sources’ who say it’s fine to take and it’s about protecting the community.


18 posted on 03/29/2021 2:20:18 PM PDT by Roman_War_Criminal (Jesus + Something = Nothing ; Jesus + Nothing = Everything )
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To: Roman_War_Criminal

The evidence is that the vaccines are safe and very effective.
But that’s beside my point.

Treatments should have been explored and tested from the earliest cases.
Instead patients who tested positive were just sent home and told to come back if it got bad. There was no attempt to try any treatments- no matter how speculative- on them.
That’s not good healthcare.


19 posted on 03/29/2021 2:46:05 PM PDT by mrsmith (US MEDIA: " Every 'White' cop is a criminal! And all the 'non-white' criminals saints!")
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I have repeatedly said that mRna Vaccines may be one of the greatest breakthroughs in the recent history of Medical Science.

The problem is that we don’t know yet.

I am selflessly volunteering to be in the ‘control group’

a random article about covid

https://yurideigin.medium.com/lab-made-cov2-genealogy-through-the-lens-of-gain-of-function-research-f96dd7413748?


20 posted on 03/29/2021 6:17:30 PM PDT by algore
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