Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease

National institute of health ^ | October 2020 | Timothy Cardozo

[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.

[Triple]

The government knows that the people taking these experimental vaccines do not have enough information to give informed consent.

And yet they pay to promote the vaccines.

[beethovenfan]

Wonderful.

[Rurudyne]

We now exist for government, to serve its purposes, which is why we need its permission to do pretty much anything and it simply does as the ruling elites please.

That is reversed from the genius of our founding where the citizens didn’t need government’s leave, rather the federal government needed explicit authorization to do anything.

[Triple]

Exactly...

[Rebelbase]

Saw a commercial today hyping the vaccine like it was the latest fad and if you haven’t had it yet you aren’t cool.

[Ken H]

It’s been 6 months since the article was published. Lots of vaccinated people have surely had exposure to the virus. Have there been any cases of what the article describes?

[Triple]

Did you notice that none of those commercials include the usual monologue at the end that says all the risks. All other pharma adds have that...why not the vaccines?

The dog that isn’t barking!

[Oscar in Batangas]

WHAT informed consent???
I’ve sat on DOZENS of new drug safety review committees.
THIS “Stuff” was foisted off on the people with barely a safety net at all.
Even new drugs for asthma, COPD and other maladies nearly UNIVERSALLY exclude pregnant women and children under the age of 12 from participating in the study. Some even require pregnancy avoidance for half a year or more AFTER the study is finished.
OF COURSE the drug companies would leap at a turn on the roulette wheel when the winning number is announced even before the ball is dropped.
PS: Where are the animal safety studies for such committees to review? Or are humans the ‘lab rats’ for this one?

[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.

[Triple]

Torn perineum...ouch!

I don’t want to know how that happens.

[ransomnote]

It’s been 6 months since the article was published. Lots of vaccinated people have surely had exposure to the virus. Have there been any cases of what the article describes?

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

Once ADE sets in, you build up antibodies just as you would if you were naturally infected, so the first 'break through' Covid-19 cases for those vaccinated, which manage to make it past the MSM/CDC suppression of information censors likely include ADE cases.

The links below are from the article: 18 Reasons I Won't Be Getting a Covid Vaccine (deconstructingconventional.com)

• It's happening in Washington State

• It's happening in New York

• It's happening in Michigan

• It's happening in Hawaii

• It's happening in several other states too.

• It happened to 80% of 35 nuns who got the vaccine in Kentucky. Two of them died by the way.

But as these illnesses occur, they are dismissed as 'welp, no vaccine provides 100% coverage' and any resulting deaths are counted as "Covid-19" deaths, and used as proof more should be vaccinated and more vaccine 'booster' doses are needed.

 Administration of the vaccine began in December of 2020 so we're just at the point where ADE should be noticably rising. Oh but PFizer/Moderna aren't going to tell us what happened to their lab victims (trial participants) after the conclusion of the trials.

 

[ding_dong_daddy_from_dumas]

Maybe the problem is that "health experts" don't know how to write. This article need to be translated into English.

[Triple]

Which parts did you have trouble understanding?

[Jane Long]

Saw a commercial today hyping the vaccine like it was the latest fad and if you haven’t had it yet you aren’t cool.

---

Have you seen the one playing “I’ll be Seeing You” while showing Granny finally getting to hug those grands?

Such drama.

We were at a party, today, and EVERYONE there has been gathering w/family, hugging, traveling....since this scanDemic started....and, ALL are fine.

[Flaming Conservative]

You’re wasting your time if you think you’ll convince any of the pro-Covid19 vaccine FReepers, here. No matter what awful things happen to some recipients, they pooh pooh it all. I sincerely hope no FReeper has a fatal or catastrophic response to the vaccine. Some FReeper yesterday, actually accused the anti-Covid19 vaxxers among us of hoping they get sick from the vaccine! Absolutely not! But, it would be unusual if none of them got sick, because it is happening out there. Pray without ceasing.

[ThunderSleeps]

My wife just got the call tonight we’ve been dreading. A cousin got the second vaccine shot last week. She’s in the hospital now, grand Mal seizures. No history of anything like that. Great, just great...

[Jane Long]

Prayers for your cousin.

How old is she, if you don’t mind saying?

And, warning!!

I posted, earlier this week about how a dear friend of ours....a VERY healthy 70 yr old, who had even breezed through a bout of China flu, last year...and, was on NO meds.....died after his 1st vax.

His family has asked for an autopsy.

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.

[444Flyer]

My wife just got the call tonight we've been dreading. A cousin got the second vaccine shot last week. She's in the hospital now, grand Mal seizures. No history of anything like that. Great, just great...

I just prayed for her! The sick tyrants could care less about common people and are are fully taking advantage of them with trickery, lies and psychological manipulation. I pray your cousin is O.K..

[444Flyer]

From ‘Microbiology & Infectious Diseases” (2021)

“COVID-19 RNA Based Vaccines and the Risk of Prion Disease”

https://scivisionpub.com/pdfs/covid19-rna-based-vaccines-and-the-risk-of-prion-disease-1503.pdf

[crosdaddy]

Just saw one of those myself.