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#1 Aug 25, 2020 7:43 pm

Expat
Active

Vaccine manufacturers rigging the trials

Who would have guess... right....

>>
The NIH and Moderna have rigged the clinical trial of their COVID-19 vaccine, mRNA-1273, to avoid capturing adverse reactions that occur more than 28 days after injecting this experimental vaccine. ICAN’s legal team has filed an emergency petition to stop this unethical conduct.

ICAN previously filed a petition to the FDA demanding that this clinical trial include a placebo. The clinical trial for this vaccine was then delayed and when its design was finally issued, it included a placebo. But it appears that NIH and Moderna have decided to play a different game to avoid capturing safety issues that could prevent licensure of their mRNA-1273 vaccine.

Their trick is to only capture adverse reactions that occur more than 28 days after injection if the participant withdraws from the clinical trial. This is nonsensical, since there is little for a participant to withdraw from after getting two doses during the first 28 days of the clinical trial. Once a participant has received both doses, if anything, a participant would have an incentive to remain part of the follow-up check-ups to address any adverse effects.

There could be many autoimmune, neurological and chronic health disorders which have a major impact on the quality of life that this experimental vaccine could cause. All of which may only arise more than 28 days after the injection. But yet, as long as the participant does not withdraw from the clinical trial, these will nonsensically be ignored as if they did not occur. This is unethical and renders vacuous any claim of safety for this product based on this trial.

Given that efficiency in this trial will be tracked for two years , the only reason to not track safety for this same duration is to avoid detecting safety issues that would prevent licensure. 

ICAN’s legal team, headed by Aaron Siri, has therefore filed a citizen petition and an emergency stay petition demanding that the clinical trial design for this vaccine be updated to require that all adverse reactions for the entire period of the clinical trial be tracked. These petitions also demand that the number of participants in this trial be increased and that they be tested before and after injection for any T-cells to SARS-CoV-2. ICAN intends to take further legal action if its rational and sensible requests are not met.
Pfizer and BioNTech have also rigged the clinical trial of their COVID-19 vaccine, BNT162b, to avoid capturing many potential life-altering adverse reactions that may occur from this experimental vaccine. ICAN’s legal team again filed an emergency petition to stop this unethical conduct.

While Pfizer and BioNTech have now included a placebo control group in their clinical trial, these companies have decided to play a different game to avoid capturing safety issues that could prevent licensure of their COVID-19 vaccine, BNT162b.

The study design for the clinical trial for BNT162b provides that -- despite reviewing efficacy for at least 2 years -- it will only capture “adverse events” for 1 month and “serious adverse events” for only 6 months after each dose.

The adverse events captured beyond a month after injection should not be limited to “serious adverse events,” since there are many autoimmune, neurological, and chronic health disorders which have a major impact on the quality of life, yet are categorized by the FDA as “adverse reactions” and not categorized as “serious adverse reactions.” To wit, there are a myriad of post-licensure adverse reactions reported by consumers and physicians and are also listed in the package inserts for one or more vaccines that any individual living with would categorize as “serious”; yet the FDA, under its current guidelines, may not. These include, but are not limited to: alopecia, autoimmune disease, lupus erythematosus, vasculitis, Bell’s Palsy, hypotonia, migraine, myelitis, neuropathy, seizures, mental disorders, rhinitis, and vertigo.

The study design for BNT162b nonetheless provides that these adverse events should be captured for only 1 month after vaccination while “serious adverse events” are captured for 6 months. These artificial limitations are unethical and make any claim of safety for this product based on this trial specious at best. 

Incredibly, the efficiency of Pfizer and BioNTech’s vaccine in this trial will be tracked for two years . As such, the only reason to not track safety for this same duration is to avoid detecting any safety issues that would prevent licensure. If BNT162b causes a systemic autoimmune issue to arise two months after vaccination, it would be irresponsible and unethical not to capture that reaction just because an autoimmune issue falls into the artificially defined zone of being an “adverse event” or “non-serious adverse event,” rather than what the FDA has decided to label a “serious adverse event.”

ICAN’s legal team filed a citizen petition and an emergency stay petition demanding that the clinical trial design for this vaccine be updated to require that all adverse reactions for the entire period of the clinical trial be tracked. These petitions also demand that the number of participants in this trial be increased and that they be tested before and after injection for any T-cells to SARS-CoV-2. ICAN intends to take further legal action if its rational and sensible requests are not met.
AstraZeneca and the University of Oxford have also rigged the clinical trial of their COVID-19 vaccine, ChAdox1 nCoV-19, to avoid capturing many potential life-altering adverse reactions that may occur from this experimental vaccine. ICAN’s legal team once again filed an emergency petition to stop this unethical conduct.

Unlike the clinical trials for Moderna and Pfizer’s vaccines for COVID-19, which are occurring in the United States, the current clinical trial for AstraZeneca’s COVID-19 vaccine is not under the direct authority of the FDA, since this clinical trial is not occurring in the United States. 

News reports have indicated that AstraZeneca will be starting a new clinical trial in the United States for its COVID-19 vaccine that presumably will include a placebo control group. In the meantime, its current clinical trial occurring outside the United States persists in using a MenACWY vaccine as a control. As if that were not enough to rig this trial’s safety results, the study design for their vaccine, ChAdox1 nCoV-19, like the design of Pfizer’s vaccine, provides that, despite reviewing efficacy for at least 2 years, it will only capture “adverse events” for 1 month and “serious adverse events” for only 6 months after each dose.

Therefore, ICAN’s legal team has also filed a citizen petition and an emergency stay petition demanding that the clinical trial design for this vaccine be updated to require that all adverse reactions for the entire period of the clinical trial be tracked against a placebo control group. These petitions also demand that the number of participants in this trial be increased and that they be tested before and after injection for any T-cells to SARS-CoV-2. ICAN intends to take further legal action if its rational and sensible requests are not met.

Just as the pharmaceutical companies will never rest when it comes to promoting and selling their vaccine products, we will never rest in exposing the truth regarding these products. 
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#2 Aug 25, 2020 7:51 pm

Real Distwalker
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Re: Vaccine manufacturers rigging the trials

Expat wrote:

Who would have guess... right....<<

Who would guess what?  That ICAN - the largest and most radical anti-vaccine organization in America - would be anti-vaccine? 

Next you will be telling me that the Pope lives in the Vatican.

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#3 Aug 25, 2020 10:29 pm

Expat
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Re: Vaccine manufacturers rigging the trials

If they are the largest, Ill take your word for that, it is because they via the Highwire present facts as supplied not only by umpteen "experts" and professionals within the health services, they also do solid research across USA, British, Australian, etc etc health services, and government sources. Citing recognised, if sometimes "lost" information from all kinds of places like the rather fkd up CDC and WTO. Reports you can no longer find which were backed up before they were deleted conveniently for example.

They are the largest because public subscription has made them so. They are not supported by big pharma like CNN, ABC, Fox News etc, they are supported by a LARGE section of the health aware public. So much so that after being censored off facebook, and YouTube, they will very soon have their own live streaming service built from the ground up.

They have been stating things back in March, maybe even February that are just being woken up to by learned Government experts only recently.

If you listened to the presentations, which admittedly can go on a bit, the statements are solid. "I", as in the presenter, "am not against vaccines, I am against unsafe poorly tested, and damaging vaccines where the potential harms outweigh the benefits". Slight paraphrasing, but essentially that is what is said.

Also vis a vis Covid, while railing against the stupidity that has been the management of this pandemic, which by the way if better records and protocols would at best be listed as a grade 2 out of 5, they say definitively while they consider much of the isolation of younger and fit and healthy people a farce, where like probably you and other members of your family have caught it, and hardly been affected. They state categorically the older, and more infirm, including obese, and diabetic, not to mention cancer patients, and immune damaged, should all be ring fenced and protected. So you healthy lot can get the herd immunity which in lots of places has almost been achieved. Even with the mass sloughter of Black in New York, and the elderly in care homes by shipping out covid patients to old peoples homes, the death rate is only 0.26%, while yes there are still some survivors who are seriously affected, something the media seems to ignore, probably 80% of the population will hardly know if they have had it. Yet the economies of the World are in free fall.

They have been trying to make vaccines for Saars type infections back into the 60's, and they were dismally unsuccessful, and trials were halted because when the animal subjects were infected after being immunised they all died. Pro vaccine experts have said as much. Never mind the anti-vaxers.

If you watched and listened, it is almost certain you would find yourself in a lot of agreement with what they have been saying. You already said a lot of it off your own bat already.

When I first clicked onto them I thought airheads, total bollocks. But instead of showering disdain from a great uninformed height, I watched and listened, and understood.

If you only suck up data from the rather corrupt mouths of those "experts" that have their hand in the till of Big Pharma you are much more stupid than I take you to be.

Oh and last but not least they supply all the data sources so you can go and check for yourself.

Last edited by Expat (Aug 25, 2020 10:40 pm)

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#4 Aug 25, 2020 10:39 pm

Expat
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Re: Vaccine manufacturers rigging the trials

Real Distwalker wrote:
Expat wrote:

Who would have guess... right....<<

Who would guess what?  That ICAN - the largest and most radical anti-vaccine organization in America - would be anti-vaccine? 

Next you will be telling me that the Pope lives in the Vatican.

Be glad at least someone is watching what is going on, as thanks to them you now have a real placebo in the trial instead of another vaccine, which is what they were doing originally. Also the result were spiked by additional use of pain killers as most of the volunteers had side effects that required pain relief.

In addition ALL the volunteers were pre checked for their T cell response, so Moderna had a pretty good idea what would happen before they jabbed the first volunteer... If you don't think this kind of trial is cavalier, I guess running a basically untested vaccine program is right up your street. I wonder why they have asked for specific immunity from prosecution just in case people have complications 4 years later.

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#5 Aug 26, 2020 9:46 am

Real Distwalker
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Re: Vaccine manufacturers rigging the trials

They are anti-vaccine.  That is their purpose.  They won't change that. 

The National Right to Life isn't going to talk about the benefits of abortion.   The NRA isn't going to talk about the parts of gun control that make sense.  PETA isn't going to going to give you a balanced look at the fur industry.  ICAN isn't going to be fair regarding vaccines.

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#6 Aug 26, 2020 7:12 pm

Expat
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Re: Vaccine manufacturers rigging the trials

And you have watched how many presentations?

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