Posted on 11/14/2022 6:22:14 PM PST by DoodleBob
ClinicalTrials.gov Identifier: NCT05295290
Recruitment Status : Not yet recruiting
First Posted : March 25, 2022
Last Update Posted : October 19, 2022
Sponsor: Pfizer
Collaborator: HealthCore-NERI
Information provided by (Responsible Party): Pfizer
Study Description
Brief Summary:
The primary aim of this low interventional cohort study is to characterize the potential long-term sequelae associated with myocarditis/pericarditis following vaccination with COMIRNATY, compared with associated myocarditis/pericarditis following COVID-19 in persons <21 years old, with up to 5 years of follow-up.
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: This is a low-interventional cohort study to determine cardiac and non-cardiac long-term outcomes of persons less than 21 years of age with myocarditis/pericarditis after the administration of COMIRNATY, compared with similarly aged persons with myocarditis/pericarditis associated with COVID-19, including MIS-C, without exposure to COMIRNATY.
Primary Purpose: Other
Official Title: Low Interventional Cohort Study of Myocarditis/Pericarditis Associated With COMIRNATY in Persons Less Than 21 Years of Age
Estimated Study Start Date : October 2022
Estimated Primary Completion Date : October 15, 2028
Estimated Study Completion Date : October 15, 2028
(Excerpt) Read more at clinicaltrials.gov ...
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Is this just another way of saying thank you for everyone who ‘volunteered’ to be a guinea pig; that there has been no real testing. What little testing was done was so short term, and they tried to hid that for 75 years. The was no testing whatsoever on children. They changed the definition of vaccine; they lied, and lied, and lied.
Unless some real scientists from, say, Hillsdale College, perform any examination of this, who knows what they will find, what they will hide, and just how much more will they lie, lie, lie
The question remains of whether they are going to hold off on giving people these vaxxes until the trial is over, or whether they will do it concurrently.
My understanding is that COMIRNATY was fully approved/it is not under EUA. It's a "vaccine." Yet, it's not being injected in the US.
I believe only the shots with an EUA are being injected.
Thus, technically, this trial is being conducted on a vaccine that got approved, but it hasn't been injected into the US public. In some way, that's what SHOULD happen, i.e. You run a trial BEFORE it's release to the public.
By not subjecting the shots under EUA to a trial like this, they can dodge that question.
I also believe Pfizer has liability for this vaccine, since it is approved.
Probably why nobody is getting it.
Mind you. Expecting 300 total patients....from vaccine and non vaccine groups, ALL who experienced myo/peri- carditis...long term...up to 5 years....That means at least 150 who got the cardiac inflammation from the vaccine....probably more actually did. Vaccine should have been stopped.
Wonder Why they don’t follow up on elderly folk who didn’t report signs of the side effect...my guess is that there are many SUBclinical episodes of the disorder in adults. They will never find them. They will never do a study. There could be cardiac scarring but it will never be looked for or at. If they do find evidence after autopsy, other reasons will be given. Other viral infection, autoimmune disease, etc..IMHO...
It’s not an actual study. It is a PR effort for companies that have legal immunity, and it’s whole purpose is to alter a growing awakening. There will be a conclusion that it is safe and they will push this in the face of the “died suddenly” crowd.
Or, the study will show that myocarditis IS highly correlated with COMIRNATY. But, that’s because Trump pushed Warp Speed. It’s his fault, ya know...
Who TH even had access to “ Comirnaty”.
Most people were forced to take the EUA product
let me guess
they will find no connection
why does the vaxx maker get to do the trial?
I think the pharma/CDC 'news' that they are going to trial the Covid Comirnaty 'vaccine' for myocarditis is a classic bait-and-switch.
Because people were expressing "vaccine hesitancy" and saying they didn't want to take an experimental 'vaccine', the FDA licensed Pfizer's Covid Comirnaty 'vaccine' - a legally separate version of the vaccine than the one being distributed since the original release under the EUA. Employers and officials who should/did know better told those refusing the 'vaccine', "Okay, the Covid vaccine isn't experimental anymore; it's licensed so NOW you have no excuse not to have it!"
But Comirnaty was never produced by the pharmas. The EUA product is still the only one being given because under the EUA the pharmas are excused from liability. Because Comirnaty is FDA licensed, they would be liable for false claims etc.
SO the Media/CDC/Fauci all worked to confuse or flat out lie the public into believing what they get vaxxed with is the licensed Comirnaty produce when in fact the pharmas just aren't going to manufacture that one due to liability concerns.
So now the pharma/Fauci/CDC say they are going to trial Comirnaty - the separate product they do not manufacture or administer to patients- and that trial will no doubt take forever, with so many more coerced into the toxic Covid 'shots' in the meantime.
Who is going to volunteer?
To see if you get heart disease?
Fetterman voters may sign up
Thanks for posting DBob!
They the barn door after the horse left are closing!!
I suspect Fauci will be dead and gone before the testing results are reported and the product is (my guess) deemed defective and withdrawn from use! To confirm what Ransomnote indicated:
Mon Dec 13, 2021 - 10:22 am EST
“(Children’s Health Defense) – A federal district court judge has rejected a claim by the U.S. Department of Defense (DOD) that the Pfizer-BioNTech COVID-19 vaccine being administered under Emergency Use Authorization is interchangeable with Pfizer’s Comirnaty vaccine, which in August was fully licensed by the U.S. Food and Drug Administration (FDA).
In an order issued Nov. 12 in Doe et al. v. Austin, U.S. Federal District Judge Allen Winsor of the U.S. District Court for the Northern District of Florida denied a preliminary injunction requested by 16 service members against the U.S. Military’s COVID vaccine mandate. A hearing is scheduled for Sept. 14, 2022.
However, the judge’s acknowledgment that “the DOD cannot mandate vaccines that only have an EUA” is significant for two reasons.
One reason pertains to the difference in ingredients and manufacturing process between Pfizer’s EUA vaccine and the approved Comirnaty vaccine, and the other pertains to the legal difference between a fully licensed vaccine and an EUA vaccine.
The latter reason would apply not just to the Pfizer-BioNTech vaccine, but also to the vaccines produced by Moderna and Johnson & Johnson (Janssen), both of which are authorized only as EUA products.” (More at link)
Also:
“Despite repeated attempts by the Biden regime and others to blur the lines between the two injections, COMIRNATY is, indeed, different from the EUA injection from Pfizer that was administered starting in late 2020 under Donald Trump’s Operation Warp Speed agenda.
It turns out that a lawsuit, Church v. Biden, clearly established a legal distinction between the EUA-administered Pfizer-BioNTech covid injection and the FDA-approved COMIRNATY injection – and that distinction is said to be “significant.”
With that said, the U.S. military’s intentional obfuscation between the two is a major breach of the public trust, not to mention a betrayal of the servicemen and servicewomen who are putting their lives on the line, only to be illegally forced to take an experimental “vaccine.”
Neither the Food and Drug Administration (FDA) nor the Centers for Disease Control and Prevention (CDC) are of any help on this front as both agencies are part of the racket that is intentionally confusing the public about the difference between the two shots.
“Meanwhile, even though Pfizer’s own prescribing information for the two distinct ‘vaccines’ clarifies which product is which, it is critical to note the FDA-approved COMIRNATY jab mandated by the U.S. military is the only Pfizer product that has been given state and federal authority by Congress to be mandated – the EUA product has not,” reports Undercover DC. “ (More at link)
Not holding my breath for the study conclusions. We have a sad epidemic of “Suddenly and unexpectedly” and I do not need a Study to confirm my suspicions.
p
Real question- stop injections until trial results?
That is hilarious. You can’t kill people in large enough numbers to meet the DimWIT/WEF death goals without yearly injections
Some of the doomed will get in line no matter what the testing shows. But some vaxxxxine deniers will need coercion like free fries or maybe even reeducation camps to get them in line.
The injections will keep being pushed no matter what any testing shows. Excess deaths are up to 36% and are rising. The vaxxxxine genocide will continue until the population is reduced by 90%.
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