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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: ThunderSleeps

My younger daughter just got the vaccine last week. Not sure which one. She had a sore arm and actually called out from work for 2 days because it hurt so much. She doesn’t listen to me so it’s a lost cause trying to reason with her. I hope that’s the worst of her problems with Covid.


21 posted on 04/17/2021 8:21:17 PM PDT by Prince of Space (Irish lives matter!)
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To: Rebelbase

Tear in the perineum? A woman gave birth?


22 posted on 04/17/2021 8:27:55 PM PDT by heartwood (Someone has to play devil's advocate other.)
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To: Triple; All
4/15/21

“BC doc issues warning after vaccination side-effects & one patient dies”

“Dr. Charles Hoffe said his community has seen “numerous allergic reactions” with two cases of anaphylaxis, the death of a 72-year-old COPD patient after being vaccinated, and three people with on-going “neurological deficits.”

A BC doctor is sounding the alarm after after a disturbing number of patients in his small community developed side-effects from their COVID-19 vaccination.

In an April 5 letter to BC Chief Medical Officer of Health Dr. Bonnie Henry, Dr. Charles Hoffe said 900 First Nations members have received their first dose of the Moderna vaccine near Lytton, in the BC interior.

“I have been quite alarmed at the high rate of serious side-effects from this novel treatment,” Hoffe wrote.

Hoffe said his community has seen “numerous allergic reactions” with two cases of anaphylaxis, the death of a 72-year-old COPD patient who complained they were constantly short of breath after being vaccinated, and three people with on-going “neurological deficits.”

“So, in short, in our small community of Lytton, BC, we have one person dead, and three people who look as though they will be permanently disabled after their first dose of the Moderna vaccine,” Hoffe wrote.

He said the ages of the patients ranged from 38 to 82.

Hoffe told Henry he hasn't had to treat any patients who actually had COVID-19.

“So in our limited experience, the vaccine is clearly more dangerous than COVID-19,” he said.

“Furthermore, it is well known that the side-effects of the second shot are significantly worse than the first. So the worst is still to come.

“These were previously healthy people, who were offered an experimental therapy with unknown, long-term side effects to protect them against an illness that has the same mortality rate as the flu. Sadly, their lives have now been ruined.”

Hoffe asked Henry if it was “medically ethical” to continue the vaccine program in light of the severity of the side effects.

https://westernstandardonline.com/2021/04/bc-doc-issues-warning-after-vaccination-side-effects-one-patient-dies/

23 posted on 04/17/2021 8:36:23 PM PDT by 444Flyer (John 3, Revelation 20, Joshua 24:15, 1 Kings 18:16-39, Pick a side...)
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To: All

Interview with Dr. Hoff here:

“MODERNA Vaccine Wreaks Havoc on Lytton BC and Local Doctor Blows Whistle! (BANNED ON YOUTUBE!)”

https://odysee.com/@DRutter:9/moderna-vaccine-wreaks-havoc-on-lytton:7


24 posted on 04/17/2021 8:36:52 PM PDT by 444Flyer (John 3, Revelation 20, Joshua 24:15, 1 Kings 18:16-39, Pick a side...)
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To: 444Flyer

This is a joke publication from a junk journal — almost certainly not peer-reviewed, and very likely the author paid to have it published.


25 posted on 04/17/2021 8:44:02 PM PDT by Qilin
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To: Rebelbase

Yep. Side effects like blood clots, paralysis and death are best kept secret.

But I did hear one today for something where a mentioned side effect was “tear in the perineum”. That is attention getting.
~~~~~~~~~~~
Hadn’t heard that one!

They should add ‘skull fracture’ as I have read many accounts of persons collapsing on pavement or in the bathroom the night or two after injection.


26 posted on 04/17/2021 8:48:26 PM PDT by ransomnote (IN GOD WE TRUST)
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To: Triple

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.


27 posted on 04/17/2021 8:59:56 PM PDT by Valpal1
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To: Qilin
This is a joke publication from a junk journal — almost certainly not peer-reviewed, and very likely the author paid to have it published.

Who exactly could fairly review it in the medical manipulation and censoring of all opposing views medical climate? CDC? Gates Foundation paid-off medical loyalists? Fake "Dr." and criminal Tedros?

28 posted on 04/17/2021 9:01:24 PM PDT by 444Flyer (John 3, Revelation 20, Joshua 24:15, 1 Kings 18:16-39, Pick a side...)
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To: ding_dong_daddy_from_dumas

I have that! The good ol’ days.


29 posted on 04/17/2021 9:13:10 PM PDT by Gene Eric (Don't be a statist!)
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To: Qilin

>> almost certainly not

completely possibly


30 posted on 04/17/2021 9:17:02 PM PDT by Gene Eric (Don't be a statist!)
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To: Jane Long

“who had even breezed through a bout of China flu, last year...and, was on NO meds.....died after his 1st vax.“

Inam so very sorry for your loss. One of the most crazy things I have heard is the recommendation to be vaccinated even if you already had covid. This is madness, absolute madness.


31 posted on 04/17/2021 9:17:31 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: walkingdead

Thank you.

His family doc had recommended the vax.

I agree...why recommend for those who have the antibodies?


32 posted on 04/17/2021 9:23:47 PM PDT by Jane Long (America, Bless God....blessed be the Nation 🙏🏻🇺🇸)
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To: Qilin
"This is a joke publication from a junk journal — almost certainly not peer-reviewed, and very likely the author paid to have it published."

"Microbiology & Infectious Diseases (ISSN 2639-9458) is the premier global open access, peer-reviewed journal that considers articles on all aspects of the prevention, diagnosis and management of infectious diseases and covers the topics dealing with the epidemiology, clinical diagnosis, treatment, and control of infectious diseases with particular emphasis placed on those diseases that are most common in under-resourced countries. Archives of Infectious Diseases encourages research, education, and dissemination of knowledge in the field of Infectious Diseases across the world thus promoting translational research by striking a synergy between basic science, clinical medicine, and public health.

The Journal invites Original Articles, Clinical Investigations, Epidemiological Analysis, Data Protocols, Case Reports, Clinical Photographs, Editorials, Review Articles and special commentaries.

Our journal strongly supports the Open Access initiative. All published articles will be assigned DOI provided by Cross Ref. Microbiology & Infectious Diseases will keep up-to-date with the latest advancements in the feilds of microbiology and infectious diseases. Abstracts and Pdfs of all articles published are freely available to everyone immediately after publication.

Authors are requested to submit manuscripts as an e-mail attachment to the Editorial Office at microbiology@scivisionjournals.com.

https://www.scivisionpub.com/journals/microbiology-infectious-diseases-home

33 posted on 04/17/2021 9:33:51 PM PDT by 444Flyer (John 3, Revelation 20, Joshua 24:15, 1 Kings 18:16-39, Pick a side...)
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https://www.scivisionpub.com/journals/microbiology-infectious-diseases-home


34 posted on 04/17/2021 9:34:42 PM PDT by 444Flyer (John 3, Revelation 20, Joshua 24:15, 1 Kings 18:16-39, Pick a side...)
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To: Triple

After reading it 3 times I think I got the main points. But why do they write such long, complicated sentences using the passive voice? Some things are a pleasure to read. This seemed to want to inflict pain.


35 posted on 04/17/2021 9:49:10 PM PDT by ding_dong_daddy_from_dumas (Re-imagine the media!)
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To: ding_dong_daddy_from_dumas

Because - lawyers.


36 posted on 04/17/2021 10:19:33 PM PDT by mad_as_he$$
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To: Jane Long

She’s 17. My wife’s Aunt’s son’s daughter. Not sure, is that 2nd or 3rd cousin? I’ve never been able to keep track of that kind of thing. But yeah, 17, no previously known health issues...


37 posted on 04/17/2021 11:03:42 PM PDT by ThunderSleeps (Biden/Harris - illegitimate and everyone knows it.)
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To: Ken H

Most any problems with the vaccine are likely attributed to already, unknowingly having covid. It’s why they say it take quite a while for the vaccine to work. All covid like immediate problems are attributed to covid already in the system.
Notice the supposed spike in covid cases? I notice the hospital chopper over my house increase.


38 posted on 04/17/2021 11:08:07 PM PDT by Bellflower (Who dares believe Jesus? He says absolutely amazing things, which few dare consider.)
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To: Oscar in Batangas

They are without liability, so why worry!


39 posted on 04/17/2021 11:09:35 PM PDT by Bellflower (Who dares believe Jesus? He says absolutely amazing things, which few dare consider.)
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To: 444Flyer

“...Authors are requested to submit manuscripts as an e-mail attachment to the Editorial Office at microbiology@scivisionjournals.com..,.”
*************************************************************************
I’m thinking about submitting the results of a “study” I’ve been conducting. Like the “study” this thread concerns, my “study” is not an actual double blinded clinical trial with real patients. My study involves the DESCRIPTIONS of incidents of either adverse COVID vaccine reactions or lack of adverse vaccine reactions. The study looks at how DESCRIPTIONS of incidents of adverse reactions vary with whether the DESCRIBER is a “vaxxer” or “anti-vaxxer”. Anti-vaxxers report their friends, acquaintances and family members who receive the vaccination have grave, life-threatening side affects and complications. Vaxxers, on the other hand, seldom report such grave incidences.

The conclusion of my “study” must be that either:

1). Vaxxers sometimes suppress reporting the bad reactions among their personal acquaintances and/or Anti-vaxxers sometimes lie about and make up stories about bad reactions among their acquaintances.

or

2). Being a personal acquaintance of an Anti-vaxxer will cause you to have a bad/grave reaction to vaccination.

My “study” will conclude, with an 89% degree of certainty, that the 2nd possibility is true. It will recommend that prior to vaccination people should break off being friends or acquaintances of Anti-vaxxers and, if an Anti-vaxxer is a member of the family... immediately disown that person. Lives depend upon that.

Now... I just have to come up with the funds needed to pay that “journal” to publish my “study”.


40 posted on 04/17/2021 11:49:36 PM PDT by House Atreides
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