Informed Consent for COVID Vaccine

A new article from Mercola.com today. I thought it was quite interesting, though others might think so as well. Constructive feedback welcome.

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STORY AT-A-GLANCE

• Significant concerns have been raised surrounding antibody‐dependent enhancement (ADE), and the possibility that COVID-19 vaccines could worsen COVID-19 disease via ADE
• International Journal of Clinical Practice researchers called the risk of ADE in COVID-19 vaccines not only nontheoretical but also compelling
• They noted that vaccine-elicited enhancement of disease has been previously found with SARS and Middle East respiratory syndrome-related (MERs) coronaviruses, as well as feline coronavirus, all of which are closely related to SARS-CoV-2, which causes COVID-19
• Given the strong evidence of ADE risk from COVID-19 vaccines, the researchers believe that a separate informed consent form should be given out to those receiving the vaccine, warning them of the specific risk of worsened COVID-19 disease from vaccination
• Despite researchers recommending back in October 2020 that ADE risk be “prominently and independently disclosed” to patients, no such warning exists

Informed consent to medical treatment is a right that ensures patients receive information about the recommended treatment so they can make a well-informed decision about their medical care.1 Medical practitioners are both ethically and legally obligated to ensure their patients have an opportunity for informed consent, which means disclosing both the risks and benefits of potential medical treatments.

In the case of the COVID-19 vaccine, it’s not possible to provide a full list of potential risks, considering the unprecedented speed with which they were developed and released to the public — the long-term effects are completely unknown.

Significant concerns have been raised, however, surrounding antibody-dependent enhancement (ADE), and the possibility that COVID-19 vaccines could worsen COVID-19 disease via ADE.2

Anyone receiving this experimental medical procedure would certainly want to be informed of its potential to worsen the very disease they’re trying to avoid, but it’s not included as part of the informed consent disclosure — despite researchers recommending back in October 2020 that it be “prominently and independently disclosed.”3

COVID-19 Vaccine Recipients Should Be Warned About ADE Risk
Writing in the International Journal of Clinical Practice, Timothy Cardozo of NYU Langone Health and Ronald Veazey with the Tulane University School of Medicine, noted, “Patient comprehension is a critical part of meeting medical ethics standards of informed consent in study designs.”4

As such, they set out to determine if enough research existed to require clinicians to disclose the specific risk that COVID-19 vaccines could worsen disease if the recipient is exposed to circulating virus. First, they reviewed preclinical and clinical evidence, which revealed that ADE is a significant concern. They noted:5

“COVID-19 vaccines designed to elicit neutralizing antibodies may sensitize 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 neutralizing 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).”

Their next step involved reviewing clinical trial protocols for COVID-19 vaccines to determine if this risk was properly disclosed to research subjects (at the time, the vaccines had not yet been released to the public). It was not, leaving people largely in the dark instead:6

“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.”

The conclusion reached by the study was that, in order to meet medical ethics standards of informed consent, people taking part in COVID-19 vaccine trials, as well as those who have received it after approval, should be clearly warned of the “specific and significant COVID-19 risk of ADE.”7

This, however, has not occurred, and most receiving it have likely not even heard of ADE, much less its association with the experimental COVID-19 vaccine.
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Full article can be read here:
https://articles.mercola.com/sites/...01/19/informed-consent-for-covid-vaccine.aspx

 

Informed consent is supposed to be the law, figuratively enforced by CDC and other agencies.

This fiasco today is solid evidence that informed consent is anathema to the medical industrial complex.

 

Mercola per Mediabiasfactcheck




CONSPIRACY-PSEUDOSCIENCE


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• Overall, we rate Mercola.com a Quackery level pseudoscience website that advocates for sometimes dangerous, inaction or action, to serious health issues.
  
• https://mediabiasfactcheck.com/mercola/

please stay away fro quack conspiracy sits - they are bad for your health

 

Not this canard again -.-. For those who don't know, mediabiasfactcheck has been seriously questioned by what appears to be a truly independent fact checking site, namely justfactsdaily.com:
https://www.justfactsdaily.com/media-bias-fact-check-incompetent-or-dishonest

The sad thing is that I'm actually left wing myself, but mediabias fact check does the left a disservice.

 

I think they are affiliated with splc.

 

I think this claim, like the other thread today, could use a bit more research to be sure.

 

splc?

 

Oh my!
Scientists are not stupid [well, some scientists are stupid ...]; they studied the problem and they developed countermeasures [the smart scientists, I mean].

An article on nature: and it mentions also risk of ERD, not only of ADE ...

https://www.nature.com/articles/s41564-020-00789-5

 

This one was a lot more in depth then the last one. The last one just had the little blurb on mercola.com, followed by the link to that questionable website and did not have his trademark "fact checked" sticker next to it. This one has the fact checked sticker and is longer than I quoted. If there's any part of it that you find questionable, though, feel free to bring it up.

 

It’s a lot to unpack. Given it comes from the same source as the other debunked claim, I’ll have to call it’s legitimacy into question. I’ll look into it.

 

How many Covid 19 vaccine guinea pigs, sorry, "participants" do you think have read that nature article? Let's take a look at the last paragraph in its conclusion:
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Going forwards, it will be crucial to evaluate animal and clinical datasets for signs of ADE, and to balance ADE-related safety risks against intervention efficacy if clinical ADE is observed. Ongoing animal and human clinical studies will provide important insights into the mechanisms of ADE in COVID-19. Such evidence is sorely needed to ensure product safety in the large-scale medical interventions that are likely required to reduce the global burden of COVID-19.
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Well, I suppose humans are animals...

 

I agree, it's a lot to read and understand. But I think that Alpin's nature article actually adds to the point. We're dealing with vaccines that are essentially still in the experimental phase and people are frequently learning of the nasty side effects, apparently including death itself, the hard way.

 

Urgency has imposed the choice to jump the final phase of the test of a vaccine.
We are doing this on humans, on the general population.

It's not only about ADE or ERD risk. You haven't noted something ...
Do you know for how long does the immunization generated by these vaccines last?
No you don't, I don't, they don't ... We will discover this.

Usually this is part of the last phase of the test of a vaccine: you wait until the immunization decreases to find out for how long it lasts.
This is an other "irrelevant detail" which we are going to discover. And it's not a so irrelevant detail: if the immunization lasts 6 moths [that is to say it's seasonal, like for the anti-flu vaccine] in August they will have to vaccinate again all the persons vaccinated now in January ... and so on.

Let's say that we are running calculated risks, hoping that they are not miscalculated risks ...

 

This said ... which is the point:

vaccines generate immunization. More persons we vaccinate and more we will be able to contain the diffusion of the virus up to stop it.
This is the real point. I'm not impressed by the incredibly high percentage of efficiency of some anti-Covid-19 vaccines. It's all to be proved on the real population. But even if instead of 90-95% they will have an efficiency comparable with the one of the anti-flu vaccines, we will have "tools" to generate a decent herd immunity.

The real question is: in which measure will this herd immunity be "decent"?
We cannot predict this ... we will discover this.

Collateral effects? Sure ... but now we have vaccinated millions of persons and severe negative reactions are really rare.
This promises something.

 

I actually don’t have to go to MBF at all because it is BLATANTLY obvious

 

Some people need others to tell them how to analyze data and how to think. They need authority figures to guide them through life. I suppose they have been conditioned that way, and that's why the charlatan Anthony Fauci has such a large following in the US. And in Australia too it seems.

They accept the charlatan's statements without question, but are quick to disregard the dissenters. Groupthink on full display.

 

All I have to say to that: "Trust those who seek the truth, doubt those who find it."

 

It's worse than you think:
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COVID Vaccine May Not Prevent Infection, Disease Transmission

January 14, 2021

STORY AT-A-GLANCE

• The World Health Organization warned there is no guarantee that COVID-19 vaccines will prevent people from being infected with the SARS-CoV-2 virus and transmitting it to other people
• Vaccinated persons still need to mask and social distance because they could be able to spread the new coronavirus to others without knowing it, according to WHO and U.S. health officials
• As with measles and polio, there is no guarantee of eliminating the SARS-CoV-2 virus through mass vaccination programs
• There is a possibility the U.S. government will introduce “COVID-19 vaccine passports” and that some local governments and businesses will make COVID-19 vaccines mandatory, including in schools
• Technology companies have been working on creating a digital certificate, which contains personal medical information giving evidence that an individual has been vaccinated and which can be used as a screening tool by employers and businesses

At a virtual press conference held by the World Health Organization December 28, 2020, WHO officials warned there is no guarantee that COVID-19 vaccines will prevent people from being infected with the SARS-CoV-2 virus and transmitting it to other people.1

In a New Year's Day interview with Newsweek, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), reinforced the WHO's admission that health officials do not know if COVID-19 vaccines prevent infection or if people can spread the virus to others after getting vaccinated.2

According to U.S. and WHO health officials, vaccinated persons still need to mask and social distance because they could be able to spread the new coronavirus to others without knowing it.3,4

Although the U.S. Food and Drug Administration granted Emergency Use Authorization (EUA) in December 2020 for Pfizer/BioNTech5 and Moderna6 to release their experimental mRNA vaccines for use in the U.S., the companies only provided evidence from clinical trials to demonstrate that, compared to unvaccinated trial participants, their vaccines prevented more mild to severe COVID-19 disease symptoms in vaccinated participants.

The companies did not investigate whether the vaccines prevent people from becoming asymptomatically infected with the SARS-CoV-2 virus and/or transmitting it to other people.7,8
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Full article: https://articles.mercola.com/sites/...t-prevent-infection-disease-transmission.aspx

Also, based on other articles I've read, I don't even trust the notion that the vaccines would make the symptoms more mild- there is evidence that in some cases, it would actually make the symptoms worse.

 

We will know this soon. In Italy we are giving the second shots, but in UK there are subjects who are already [theoretically] immune.
Great Britain is going to play the role of the guinea pig for the other countries. We thank London and we wait to see what's going to happen there ...

 

I personally think we'd be better off if no one had been given a vaccine, but I do agree with you that we will be looking things from London soon enough.

 

So rare, in fact, that anti-vaxx people can not even find reliable data for a dozen or two 90 yo old

Sigh.

So the 10s of thousands (at least) have been spared a serious illness or death, it would be better to had gotten the this very serious disease to have avoided the mere handful of serious reactions that comes from the vaccine!

The minds of anti-vaxxers are a odd place to prefere the 400,000 deaths and a million or 2 severe illnesses instead to the handful of vaccine reactions.

 

Handful? No, thousands have had adverse reactions. It's deaths that aren't so common.