Informed consent disclosure to vaccine trial subjects
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.
References
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- Huisman W, Martina BE, Rimmelzwaan GF, Gruters RA, Osterhaus AD. Vaccine‐induced enhancement of viral infections. Vaccine. 2009;27:505‐512. – PMC – PubMed
- Boyoglu‐Barnum S, Chirkova T, Anderson LJ. Biology of infection and disease pathogenesis to guide RSV vaccine development. Front Immunol. 2019;10:1675. – PMC – PubMed
- Chen WH, Hotez PJ, Bottazzi ME. Potential for developing a SARS‐CoV receptor‐binding domain (RBD) recombinant protein as a heterologous human vaccine against coronavirus infectious disease (COVID)‐19. Human Vacc Immunother. 2020;16:1239‐1242. – PMC – PubMed
- Jiang S, He Y, Liu S. SARS vaccine development. Emerg Infect Dis. 2005;11:1016‐1020. – PMC – PubMed
- Tseng CT, Sbrana E, Iwata‐Yoshikawa N, et al. Immunization with SARS coronavirus vaccines leads to pulmonary immunopathology on challenge with the SARS virus. PLoS One. 2012;7:e35421. – PMC – PubMed
See more here: pubmed.ncbi.nlm.nih.gov
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Tom O
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The date on pubmed says March, 2021. I wonder how many of the millions of vaxxed suckers since March 2021 were informed of this? If they weren’t, why not? The damn thing even talks about “medical ethics” while by their actions, they threw them out the window. Things like this make it very difficult to want to obey the 10 Commandments in action and spirit.
I have never believed in the death penalty, mainly because it is too quick, but for these people that have willingly done what they have done to millions of people world wide, stripped naked, smeared with honey and staked out on an ant hill for a hour a day for the rest of their lives might come close to an appropriate sentence.
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Tom O
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Actually looking at this line at the top of the abstract –
2021 Mar;75(3):e13795.doi: 10.1111/ijcp.13795. Epub 2020 Dec 4.
I don’t think the published date was March 2021 but Dec. 4, 2020, considering the last line of the document is a copyright statement – © 2020 John Wiley & Sons Ltd.
If that’s the case, they even knew before the roll out.
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JaKo
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Hi Tom 0,
I don’t think people realized the gravity of the whole covidian enterprise some good time ago, when I suggested resurrection of the good old guillotine!
Yes it is too quick for these monsters, but it has something very special — the recognizable head separated from the body => good proof of “job-well-done.”
Cheers, JaKo
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Linden
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Exactly how I feel. I’ve always tried to be moderate and kind, but the people behind this evoke feelings of loathing and wish for cruel revenge. I make no apology though, because I’ve never before been faced with such evil behaviour towards so many innocent people.
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Herb Rose
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Hi Tom,
You’re too kind. Those responsible should be given the vaccines they’ve produced, including all the toxic contaminates, and the viruses they are supposed to treat. Let them live out their lives experiencing the pain of shingles combined with measles while disabled from the side effects. of their toxins. They probably won’t live long but it will seem like an eternity to them. Let them see what it’s like to look forward to dying.
Herb
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Howdy
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“Things like this make it very difficult to want to obey the 10 Commandments in action and spirit.”
An eye for an eye, a tooth for a tooth. It is God’s place to judge the offenders. Not that It will make any difference, but that is what the Bible states.
Or karma. Whichever one believes in.
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JaKo
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Overall, I don’t think Tom 0 came far enough evaluating the info from this article — I found it hard to believe, not in the semantic sense, but it reads, to me at least, more like a nightmare than just a bad dream.
How could persons implicated in this scheme still walk free among us. How could all the big pharma corporate honchos not share the solitary confinement of Mr. Assange…
Well, perhaps it is not “advisable” to preach along these lines, it may bring the wrath of the puppet-masters upon one’s being…
Cheers, JaKo
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Mervyn
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Caution was thrown to the wind when the experimental covid vaccine manufacturers received total legal immunity.
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Linden
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All vaccine manufacturers have had immunity for many years now. Governments (therefore taxpayers) foot the bill when compensation is fought and won. Wrong, wrong, wrong.
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Tom O
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There really isn’t immunity if they KNEW the vaccines would do significant harm. There is nothing in this roll out that suggests that what is happening is an unforeseen issue, thus there is no immunity for these companies. It just takes the will and, of course, the finances to push it through to completion. And I think there are enough lawyers that want to be billionaires that will pounce on this case and pick Pharma’s carcass. Will the victims get compensated? Not so much.
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