Authored by Zachary Stieber via The Epoch Times (emphasis ours),
The U.S. Centers for Disease Control and Prevention (CDC) didn’t include serious adverse events like heart inflammation on post-vaccination surveys even though the agency knew the issues could be linked to COVID-19 vaccines, documents show.
Even before the surveys were rolled out in December 2020 after the first vaccines were authorized, the CDC knew that myocarditis—a form of heart inflammation since confirmed as being caused by the Pfizer and Moderna shots—and other serious adverse events were of “special interest” when it came to the vaccines, according to a newly disclosed version of the protocol for the survey system.
The Nov. 19, 2020, protocol (pdf) for V-safe, the survey system, lists myocarditis, stroke, death, and a dozen “prespecified medical conditions.” The protocol was obtained by the Informed Consent Action Network (ICAN), a nonprofit that seeks transparency around health information. All of the conditions can cause severe symptoms.
V-safe is a system of surveys that was introduced during the COVID-19 pandemic to monitor vaccine safety. It was developed and is managed by the CDC.
Updated versions of the protocol list the same 15 adverse events.
None of the conditions were included in the actual surveys.
Respondents could check boxes if they experienced certain symptoms, but only 10 lower-level problems such as fever and nausea were listed as options.
“It’s deeply troubling that the CDC would construct V-safe in a manner that does not permit it to be able to easily assess the rate of harm from adverse events the CDC had already identified as potentially being caused by these products,” Aaron Siri, a lawyer representing ICAN, told The Epoch Times. “This calls into question what the CDC was really trying to accomplish with V-safe. Was it trying to assess the actual safety of these products? Or was it trying to design a system that would be more likely to affirm its previous public pronouncements regarding the safety of these products?”
The CDC did not respond to a request for comment for this article.
V-Safe Data Finally Made Public
The CDC rolled V-safe out in December 2020. Americans were told to use the surveys, which are only available through smartphones, to report how they felt after vaccination.
“Through V-safe, you can quickly tell CDC if you have any side effects after getting the COVID-19 vaccine,” one poster promoting the tool stated.
Users were asked how they felt, whether they had a fever, their temperature, and common symptoms. They were also asked whether they were unable to work or go about their daily activities, and whether they needed medical care.
About 10 million people signed up through July 31, 2022.
The CDC has described the results of V-safe in multiple studies, but refused to release the raw data until ICAN brought litigation against it. Data released to ICAN in October 2022 showed that more than 3.2 million people sought medical attention or missed school, work, or other normal activities following vaccination.
The CDC posted some of the v-safe data on Dec. 1, 2022, several months after a self-imposed deadline passed.
Hiding Free-Text Entries
V-safe users could report the serious adverse events, but only if they wrote them out in a free-text field.
The prompt was, “Any other symptoms or health conditions you want to report.”
The CDC has resisted releasing the results from the field, insisting that it would be too onerous to review the 6.8 million entries for personally identifiable information (PII), according to a joint status report made to the court in November 2022.
The agency declined a request from ICAN to provide a random sample of a few hundred entries, which plaintiffs say would back their argument that the entries likely hold little or no PII such as names and addresses.
The entries are important because they would show how many respondents reported experiencing the prespecified adverse events like heart inflammation.
The CDC instead offered to review all the entries and convert them into medical codes, according to the filing.
“It was apparently willing to do this because, even though it would have been more time consuming and complex then simply reviewing for PII, this approach would permit the CDC to hide from the public most of what is actually written in the free-text fields,” ICAN said in the document.
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As I/we learned yesterday it’s all a sham. They are doing any safety testing etc as part of theater to pacify the proles and to covertly continue the program.
The “vaccines” are bioweapon prototype countermeasures…PERIOD. That was what their intention, design and manufacture was about.
COVID-19 injectable bioweapons as case study in legalized, government-operated domestic bioterrorism. Or: why there won’t be any civil suits, or compensatory damages for injured victims or survivors of dead victims.
Since first realizing the implications of the many Congressional statutes and Health and Human Services regulations adopted to create and operate the bioterrorism program, mostly between 1997 and the present, I’ve been intermittently finding the specific citations for each statement while researching related issues.
Some statements are simply logical deductions from the first premise, corroborated by the observable actions and inactions of Food and Drug Administration officials as the observable injuries and deaths mount up in the American people.
Others are specifically written into the laws, but I don’t yet have the citations because I’ve prioritized my research time investigating other issues related to the bioterrorism program.
I’m posting the information as I understand it today [June 9, 2022], despite those limitations, in case it’s useful for readers who also follow FDA Vaccine and Related Biological Products Advisory Committee (VRBPAC) reporting by Toby Rogers, Igor Chudov, Steve Kirsch, Jessica Rose, and others.
They continue to rightly raise public awareness and alarm about FDA’s ongoing failure to protect the public from the Emergency Use Authorized (EUA) products.
But they don’t address the main reason why FDA is acting as it is.
FDA is not pulling the EUA products from the market or stopping the ‘vaccination’ campaign because Health and Human Services Secretary Xavier Becerra and FDA Commissioner Robert Califf are running the US government’s bioterrorism program jointly with Defense Secretary Lloyd Austin, Department of Justice Attorney General Merrick Garland, Department of Homeland Security Secretary Alejandro Majorkas, Pfizer CEO Albert Bourla, Moderna CEO Stephane Bancel, and World Health Organization Director-General Tedros Adhanom Ghebreyesus.
Main Premise
Use of EUA-covered medical countermeasure (MCM) products including masks, PCR tests, mRNA and DNA injections, and other drugs, devices and biologics, once designated as such by the Secretary of Health and Human Services (March 10, 2020, retroactive to February 4, 2020) “shall not be considered to constitute a clinical investigation.” 21 USC 360bbb-3(k). FDA EUA law, adopted 1997 and amended 2003, 2004, 2005, 2013, 2017.
This is true no matter how untested, unmonitored, unsafe, or ineffective they are, no matter whether their harmfulness to human health and uselessness for infection-control are known before use, or discovered afterward.
Legal implications derived from the main premise:
There is no stopping condition.
EUA products are exempt from laws regulating researcher use of investigational, experimental drugs, devices and biologics on human beings.
EUA products are exempt from laws regulating physician use of approved drugs, devices and biologics as medical treatments for patients.
There are no manufacturers of experimental products (EUA products are not part of any clinical investigation, and therefore not experimental.)
There are no government or private contracts for purchase of experimental products; there are only contracts for ‘large scale vaccine manufacturing demonstrations.’
There is no act of administration of any experimental products.
There are no nurses or pharmacists administering experimental products.
There are no human subjects (of experiments) or patients (of physicians providing treatment) receiving experimental products: no victims.
There is no party responsible for the wellbeing of recipients after administration of EUA products.
There is no treatment group and no control group.
Human beings administering EUA products have no informed consent obligations to provide information about ingredients, risks, benefits, alternatives, or the option to accept or refuse the products. See 21 USC 360bbb-3(e)(1)(A)(ii)) waiving informed consent for unapproved products (2004); 21 USC 360bbb-3(e)(2)(A) waiving informed consent for unapproved use of an approved product (2004); 21 USC 355(i)(4) waiving informed consent for experimental products classified by HHS as ‘minimal risk’ drugs (2016); 21 USC 360j(g)(3)(D)(i) waiving informed consent for experimental ‘minimal risk’ devices (2016).
Human beings receiving EUA products have no informed consent rights to receive information about ingredients, risks, benefits, alternatives, or the option to accept or refuse the products. See citations, bullet point above.
There are no Institutional Review Boards supervising administration of the experimental products.
There are no safety standards for EUA products.
There are no efficacy standard for EUA products. See 21 USC 360bbb-3(c)(2)(A), 1997, 2003, 2004, re: ‘may be effective.’
There are no clinical investigators studying the effects of EUA products on human subjects.
There are no doctors, nurses, or other treatment providers providing experimental treatment to their patients subject to the Hippocratic Oath (“first do no harm”) using EUA products.
There is no coordinated, public, federal government monitoring of recipients after receiving the products for adverse effects and deaths.
There is no coordinated, public, federal government data collection or analysis.
There is no legal requirement for medical supervision during product administration.
There is no legal requirement for recipient monitoring after product administration.
‘Real world evidence’ — mass administration of products to general public, followed by collection of private/proprietary information about the effects, from health insurance systems, government databases (Medicare, Medicaid, Defense Medical Epidemiology Database, Veterans Health Administration) and other private databases — is authorized for the purposes of FDA regulatory decisions. See 21 USC 355g. 2016.
There is no requirement for individual prescriptions to be written prior to dispensing EUA products, and products dispensed without prescriptions “shall not be deemed adulterated or misbranded.” See 21 USC 360bbb-3a(d). 2013.
Manufacturers, as contractors, are considered HHS employees for purposes of legal immunity under Federal Tort Claims Act. See 42 USC 247d-6a(d)(2)(A).
DOD is authorized to contract with pharmaceutical corporations to conduct ‘prototype’ experiments on the general public, and under such contracts, is exempt from legal obligation to comply with Good Clinical Practices or other FDA regulations. See 10 USC 2371b (2015), renumbered 10 USC 4022 (Jan. 1, 2021, effective Jan. 1, 2022)
One of the factors to be considered by HHS secretary in making determinations about EUA products (qualified security countermeasures) and use of Special Reserve Fund/Strategic National Stockpile appropriations to procure them is “whether there is a lack of a significant commercial market for the product at the time of procurement, other than as a security countermeasure.” See 42 USC 247d-6b (c)(5)(B)(iii)
There are no required standards for quality-control in manufacturing; no inspections of manufacturing procedures; no prohibition on wide variability among lots; no prohibition on adulteration; and no required compliance with Current Good Manufacturing Practices. EUA products, even though unregulated and non-standardized, “shall not be deemed adulterated or misbranded.” See 21 USC 360bbb-3a(c). 2013.
There are no labeling requirements regarding the contents or ingredients in EUA products. 21 USC 360bbb-3(e)(2)(B)(ii). 2004.
There is no limitation of administration of EUA products past their expiration dates.
There cannot be clinical trial fraud, because there are no clinical investigations, no investigational drugs, no investigators and no human subjects.
There are no marketing standards.
There cannot be consumer fraud, because the only legal parties to the financial transactions are the US government (DOD) as buyer; the US government (HHS) as regulator authorizing exemptions from consumer protection laws that otherwise apply to medical products; and the pharmaceutical corporations as sellers, contracted to develop and manufacture the products. There are no commercial pharmaceutical products, no commercial marketplace, and no commercial market consumers.
There is no access to courts for judicial review of the facts or law relating to HHS Secretary declarations of EUA products, which are committed to agency discretion. See 42 USC 247d-6d(b)(7). 2005.
There is no access for plaintiffs, to civil courts for judicial review, and no entity to whom civil liability can attach, for injuries and deaths caused by declared covered countermeasures, unless and until FDA/HHS and/or Attorney General/DOJ file enforcement action against manufacturers and prove willful misconduct proximate to injury or death, but HHS and DOJ have operated the EUA product program together with the manufacturers since inception, and will not prosecute their co-conspirators. See 42 USC 247d-6d. 2005.
Even if there were access to courts for judicial review, and a fact-finder found evidence of harms caused by administration of products to recipients, and even evidence that those who caused the harms, by developing, manufacturing, distributing and/or administering the EUA products, knew the EUA products were toxic and knew their own actions were harmful, “just following orders” is an authorized, legal defense. See 42 USC 247d-6d(c)(4). 2005.
Summary:
There are no actions that can be legally classified as crimes or civil torts; there are no medical battery or homicide victims, or plaintiffs; and there are no medical batterers or murderers. Because legally, nothing has been done, and no one has done anything, to anyone else.
The recursive loop can be infinite, as covered countermeasures are developed, authorized and deployed, through HHS Secretary EUA declarations, as treatments for complications from prior countermeasures.
Katherine Watt
https://bailiwicknews.substack.com/p/covid-19-injectable-bioweapons-as
Steve, did you see the follow-up to that one dated Dec 19 where she went in depth to explain many of the patently illegal/immoral laws they passed? These laws go all the way back to the late 1960’s.
https://bailiwicknews.substack.com/p/biomedical-security-state-and-state?utm_source=share&%3Butm_medium=android
Karl Denniger wrote a Ticker about this.
People have short memories but the entire roll out was managed by Army Gen. Gustave F. Perna. He retired in late 2021 or sometime last year, I believe.
https://www.defense.gov/News/News-Stories/Article/Article/2188680/army-general-to-co-lead-operation-warp-speed-for-covid-19-vaccine/
This is why the so called emergency continues to get extended every 90 days.
I just want to emphasize this point
third party access to and testing of vial contents is prohibited under the terms of the DOD-mediated supply and distribution contracts between purchasing governments, manufacturing corporations and “vaccination” sites, on penalty of federal “criminal or civil prosecution.
Yup,
The chain of custody goes from the point of manufacture until it’s been injected into the arm.
Nobody knows what shite is in those ever changing components.
Yes I did. She has done some phenomenal work.
Thanks
Kathy Watt says it all in a short get to the point Video. The HHS and DOD are enemies of the people.
Is it on bitchute or odysee?
both
see it here
https://ratical.org/PandemicParallaxView/ALwKW-DomesticBioteroProg-110422.html
what did anyone expect from a jewcunt?