Free Republic
Browse · Search
General/Chat
Topics · Post Article

Skip to comments.

Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease
NIH NCBI ^ | Oct 28 2020 | Timothy Cardozo and Ronald Veazey

Posted on 02/10/2021 9:21:27 AM PST by dhuls

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.

(Excerpt) Read more at pubmed.ncbi.nlm.nih.gov ...


TOPICS: Health/Medicine
KEYWORDS: ade; chinavirusvaccine; covid19; disclosure; informedconsent; obscured; risk; sideeffects
Main takeaway: 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.

Full Text: https://onlinelibrary.wiley.com/doi/10.1111/ijcp.13795

1 posted on 02/10/2021 9:21:27 AM PST by dhuls
[ Post Reply | Private Reply | View Replies]

To: dhuls

“COVID-19 vaccines designed to elicit neutralising antibodies may sensitise vaccine recipients to more severe disease than if they were not vaccinated.”

~~~

Is this even real?

Who wrote this?

Aside from the fact that neutralizing and sensitize were spelled wrong, this doesn’t appear to be medically cogent!
So I’m no doctor and therefor my opinion is basically worthless, but the idea of the antibody RNA IS to sensitize the immune system to recognizing it faster so that it can begin to fight the virus sooner. “Sensitizing” would only be a problem in an allergic or inflammatory reaction. It’s not a more “severe disease” if your immune system responds faster.


2 posted on 02/10/2021 9:29:22 AM PST by z3n
[ Post Reply | Private Reply | To 1 | View Replies]

To: z3n

Yes, this is real.

Spelling just happens to be a lost art in today’s “diverse” medical field.

This is from an October 2020 official National Institute of Health (NIH) National Center for Biotechnology Information (NCBI) study.

ADE is a real risk and our government does NOT want us guinea pigs to know it.


3 posted on 02/10/2021 9:37:27 AM PST by dhuls (better late than never)
[ Post Reply | Private Reply | To 2 | View Replies]

To: dhuls

Got my second dose of Pfizer this morning


4 posted on 02/10/2021 10:16:35 AM PST by Nifster (I see puppy dogs in the clouds)
[ Post Reply | Private Reply | To 1 | View Replies]

To: Nifster

Curious... were you given a consent form or anything in writing noting the potential risks associated with the “vaccine?”


5 posted on 02/10/2021 10:29:40 AM PST by dhuls (better late than never)
[ Post Reply | Private Reply | To 4 | View Replies]

To: dhuls

Yes both times.


6 posted on 02/10/2021 10:36:06 AM PST by Nifster (I see puppy dogs in the clouds)
[ Post Reply | Private Reply | To 5 | View Replies]

To: Nifster

Mind posting what the form stated?


7 posted on 02/10/2021 10:49:11 AM PST by dhuls (better late than never)
[ Post Reply | Private Reply | To 6 | View Replies]

To: dhuls

First one had a multi page small type side effects list that were reported during clinical. I’d already read it. Then a consent form saying I read and understood. Second one was a consent page with the proviso that if you didn’t understand the first one you should talk with someone they would provide to get clarification. Then the standard consent form


8 posted on 02/10/2021 11:14:17 AM PST by Nifster (I see puppy dogs in the clouds)
[ Post Reply | Private Reply | To 7 | View Replies]

To: z3n

The spelling made me think the authors might be British. A brief look at their backgrounds makes me think they probably aren’t.


9 posted on 02/10/2021 2:37:12 PM PST by FreedomForce
[ Post Reply | Private Reply | To 2 | View Replies]

To: z3n

Cytokine storm.

Vaccine for feline coronavirus testing found that those inoculated with a vaccine (which successfully produced antibodies), that those test animals died more quickly than the control animals, when exposed to the targeted virus.


10 posted on 02/10/2021 5:31:46 PM PST by Ozark Tom
[ Post Reply | Private Reply | To 2 | View Replies]

To: Ozark Tom

Bad stuff.

Your body attacks itself.

Years ago, this was known as Stage 2 of Anticardiolipin Antibody Syndrome.

The medical community really didn’t know much about it.

The medical community just recently took a serious interest in autoimmune diseases.


11 posted on 02/10/2021 5:43:15 PM PST by blueunicorn6 ("A crack shot and a good dancer”)
[ Post Reply | Private Reply | To 10 | View Replies]

Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.

Free Republic
Browse · Search
General/Chat
Topics · Post Article

FreeRepublic, LLC, PO BOX 9771, FRESNO, CA 93794
FreeRepublic.com is powered by software copyright 2000-2008 John Robinson