Vaccine Safety Records Case

Vaccine Safety Records Case

Vaccine Safety Records Case

Re: the Legality of not providing Covid Vaccine Safety Records in response to a FOIA

 

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Facts of the Case

  • Dates: Nov 1, 2022 (filed)
  • Location: Washington DC, USA
  • Court: US District Court for DC
  • Case #: 1:22-cv-03153
  • Plaintiff: Judicial Watch
  • Plaintiff’s Lawyer: Tom Fitton
  • Defendant: U.S. Dept of Health & Human Services (HHS)
  • Trial Type: FOIA
  • Judge:
  • Status: Ongoing
  • Verdict: TBD


*updated Nov 11, 2022

 

Background

Judicial Watch  filed a Freedom of Information Act (FOIA) lawsuit against the U.S. Department of Health and Human Services (HHS) for records on COVID-19 vaccine safety studies (Judicial Watch, Inc. v. U.S. Department of Health and Human Services ) [1]

Plaintiff Judicial Watch, Inc. is a not-for-profit, educational organization that seeks to promote transparency, integrity, and
accountability in government and fidelity to the rule of law. As part of its mission, Plaintiff regularly requests records from federal agencies, analyzes the responses it receives, and disseminates its findings and the records to the American public to inform them about ”what their government is up to. [1]

The lawsuit was filed in the U.S. District Court for the District of Columbia after National Institutes of Allergies and Infectious Diseases (a component of HHS) inadequately responded to a June 1, 2022, Judicial Watch FOIA request for: [1]

  1. All safety studies, data, reports, and analyses produced by the Division of Microbiology and Infectious Diseases (DMID) relating to the safety of ‘vaccines’ and/or gene therapies to treat and/or prevent SARS-CoV-2 and/or COVID-19 made by Pfizer, BioNTech, Moderna, Johnson & Johnson, and Janssen. [1]
  1. All emails sent to and from the following DMID officials relating to the safety of ‘vaccines’ and/or gene therapies to treat and/or prevent SARSCoV-2 and/or COVID-19 made by Pfizer, BioNTech, Moderna, Johnson & Johnson, and Janssen: [1]
    • The Director of DMID
    • The head of the Office of Genomics & Advanced Technologies
    • The head of the Office of International Research in Infectious Diseases
    • The head of the Office of Regulatory Affairs
    • The head of the Office of Clinical Research Affairs
    • The head of the Clinical Trials Management Section
    • The head of the Virology Branch
    • The head of the Respiratory Diseases Branch
    • The head of the Influenza, SARS, and Other Viral Respiratory Diseases Section

On May 3, 2022, the National Institutes of Health (NIH) released a paper titled “Safety and Immunogenicity of a Third Dose of SARS-CoV-2 mRNA Vaccine – An Interim Analysis” that “evaluated early safety and immunogenicity after a third mRNA vaccination in adults who received the mRNA-1273 primary series in the Phase 1 trial approximately 9 to 10 months earlier.” Contributors to that study include three affiliates of the DMID: Mamodikoe Makhene (DMID medical officer), Wendy Buchanan (DMID Clinical Project Manager) and Paul Roberts (DMID Chief Respiratory Pathogens Clinical Research). [1]

“The Biden administration is playing shell games with documents on the Covid vaccine,” stated Judicial Watch President Tom Fitton. “The arrogant cover-up of COVID vaccine safety information further undermines public confidence in these already controversial drugs.” [1]

on June 1, 2022 NIAID acknowledged receipt of the FDA request and assigned
the request No. 58421. [2]

Between June 21, 2022 and June 27, 2022, Plaintiff and a policy analyst from Defendant’s FOIA department agreed to narrow the scope of the request. Defendant never responded to Plaintiff’s June 27,2022 email. [2]

As of the date of this Complaint, Defendant has failed to: [2]

(i) determine whether to comply with the request;

(ii) notify Plaintiff of any such determination or the reasons therefor;

(iii) advise Plaintiff of the right to appeal any adverse determination; or

(iv) produce the requested records or otherwise demonstrate that the requested records are exempt from
production.

WHEREFORE, Plaintiff respectfully requests that the Court: [2]

(1) order Defendant to conduct a search for any and all records responsive to Plaintiff’s FOIA requests and demonstrate that it employed search methods reasonably likely to lead to the discovery of records responsive to Plaintiff’s FOIA requests;

(2) order Defendant to produce, by a date certain, any and all non-exempt records responsive to Plaintiff’s FOIA requests and Vaughn indices of any responsive records withheld under claim of exemption;

(3) enjoin Defendant from continuing to withhold any and all non-exempt records responsive to Plaintiff’s FOIA requests;

(4) grant Plaintiff an award of attorneys’ fees and other litigation costs reasonably incurred in this action pursuant to 5 U.S.C. § 552(a)(4)(E); and (5) grant Plaintiff such other relief as the Court deems just and proper.

 

Significance

The release of the Covid Vaccine Safety data may – like other granted FOIA requests – may show that the vaccines are not as advertised and may halt the distribution of these injections to an unknowing public. Furthermore if there was criminal fraud there may be convictions.

 

Plaintiff’s Argument

…More information is needed…

 

Defendant’s Argument

…More information is needed…

 

Relevant Prior Judgements/ Cases

Prior FOIA requests have led to data that clearly show that the covid injection trials were fraught with irregularities and improper methods that are likely fraudulent. This is likely why Pfizer attempted to block the release of these documents for 75 years. Thankfully a judge ordered Pfizer to release the docs.

Other FOIAs have shown similar evidence

Through previous FOIA activity, Judicial Watch has uncovered a substantial amount of information about COVID-19 issues: [1]

  • In October, Judicial Watch uncovered FDA records regarding the COVID booster vaccines through a FOIA lawsuit for records of communication from the former director and deputy director of the FDA’s Office of Vaccines Research and Review, Dr. Marion Gruber and Dr. Philip Krause. On September 13, 2021, Gruber and Krause were among a group of resigning doctors who agreed that,

“Available evidence doesn’t yet indicate a need for COVID-19 vaccine booster shots among the general population …”

  • In July 2022, NIH records revealed an FBI “inquiry” into the NIH’s controversial bat coronavirus grant tied to the Wuhan Institute of Virology. The records also show National Institute of Allergy and Infectious Diseases (NIAID) officials were concerned about “gain-of-function” research in China’s Wuhan Institute of Virology in 2016. The Fauci agency was also concerned about EcoHealth Alliance’s lack of compliance with reporting rules and use of gain-of-function research in the NIH-funded research involving bat coronaviruses in Wuhan, China.
  • FDA records showed top officials being pressured by companies and the Biden administration to impose timelines on approval for the booster shots “that make no sense”
  • HHS records revealed that from 2014 to 2019, $826,277 was given to the Wuhan Institute of Virology for bat coronavirus research by the NIAID.
  • NIAID records showed that it gave nine China-related grants to EcoHealth Alliance to research coronavirus emergence in bats and was the NIH’s top issuer of grants to the Wuhan lab itself. The records also included an email from the vice director of the Wuhan Lab asking an NIH official for help finding disinfectants for decontamination of airtight suits and indoor surfaces.
  • HHS records included an “urgent for Dr. Fauci ” email chain, citing ties between the Wuhan lab and the taxpayer-funded EcoHealth Alliance. The government emails also reported that the foundation of U.S. billionaire Bill Gates worked closely with the Chinese government to pave the way for Chinese-produced medications to be sold outside China and help “raise China’s voice of governance by placing representatives from China on important international counsels as high level commitment from China.”
  • HHS records included a grant application for research involving the coronavirus that appears to describe “gain-of-function” research involving RNA extractions from bats, experiments on viruses, attempts to develop a chimeric virus and efforts to genetically manipulate the full-length bat SARSr-CoV WIV1 strain molecular clone.
  • HHS records showed the State Department and NIAID knew immediately in January 2020 that China was withholding COVID data, which was hindering risk assessment and response by public health officials.
  • University of Texas Medical Branch (UTMB) records show the former director of the Galveston National Laboratory at the University of Texas Medical Branch (UTMB), Dr. James W. Le Duc warned Chinese researchers at the Wuhan Institute of Virology of potential investigations into the COVID issue by Congress.
  • HHS records regarding biodistribution studies and related data for the COVID-19 vaccines show a key component of the vaccines developed by Pfizer/BioNTech, lipid nanoparticles (LNPs), were found outside the injection site, mainly the liver, adrenal glands, spleen and ovaries of test animals, eight to 48 hours after injection.
  • Records from the Federal Select Agent Program (FSAP) reveal safety lapses and violations at U.S. biosafety laboratories that conduct research on dangerous agents and toxins.
  • HHS records include emails between National Institutes of Health (NIH) then-Director Francis Collins and Anthony Fauci, the director of National Institute of Allergy and Infectious Diseases (NIAID), about hydroxychloroquine and COVID-19.
  • HHS records show that NIH officials tailored confidentiality forms to China’s terms and that the World Health Organization (WHO) conducted an unreleased, “strictly confidential” COVID-19 epidemiological analysis in January 2020.
  • Fauci emails include his approval of a press release supportive of China’s response to the 2019 novel coronavirus.

 

Decision

…More information is needed…

 

Aftermath

…More information is needed…

 


Further Research

Court Documents:
In the news:
  • …More information is needed…

 

Media


Pfizer Vaccine Data Analyzed

source: Canadian Covid Care Alliance


12 yr old Vaccine Trial Victim, Maddie

source: Odysee/ shortXXvids


EU MEP Terhes Questions the Pfizer Redacted Contract -Nov 4, 2021

source: Odysee/ Cielos Tóxicos

 

References

  1. Judicial Watch Sues for Records on COVID Vaccine Safety Studies

  2. Official Complaint

 

Keyword

Biden, Division of Microbiology and Infectious Diseases, DMID, Fauci, Fitton, FOIA, Freedom of Information Act, Freedom of Information Act request, National Institute of Allergy and Infectious Diseases, National Institutes of Health, NIAID, NIH, Records, Safety, USA. Judicial Watch, Vaccine, Wuhan Institute of Virology 


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Virus Science Case

Virus Science Case

Virus Science Case

Re: the Legality of Health Acts supported by Science that does not follow the Scientific Method

 

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Facts of the Case

  • Dates: Oct 2022
  • Location: Hamburg, Germany
  • Court: Hamburg District Court
  • Case #:
  • Plaintiff: Marvin Haberland
  • Plaintiff’s Lawyer:
  • Defendant: City of Hamburg
  • Trial Type:
  • Judge:
  • Status: Ongoing
  • Verdict: TBD


*updated Oct 16, 2022

 

Background

A German engineer and researcher Marvin Haberland has challenged the court for a fine he received for not wearing a mask. As he describes in an online interview with New Zealand Dr Sam Bailey, he is taking this as an opportunity to challenge the legality of the German covid measures. These measures he says are based on invalid scientific methodologies which the German law says should be illegal. [1]

He states that if he were to directly challenge the law, the German courts would not allow his case to be heard. However a case challenging a fine would be heard and offers an opportunity to challenge the health law and the science of virology. [1]

A court date was set for October 19 at the Hamburg District Court. It was awaited with great excitement – and many people had also already announced their intention to attend the public hearing. So this trial is not only unique, but also explosive. [2]

But now the district court has canceled the date. The reason given is that the judge has fallen ill. The court has not yet announced when the trial, scheduled for October 19, will be rescheduled. [2]

Regarding the merits of his case, Haberland said

“If the judge should actually rule against me, then that would be okay for me personally in a way. Because then we would have a verdict that says: In virology, you don’t have to do any control experiments, so to speak. But that would, to a certain extent, make the whole thing ridiculous. [3]

In any case, the judge has everything before him – and he is actually completely free in his decision. Either he examines all my evidence requests and then makes his judgment or he does not look at all this and rejects the evidence requests. Then, however, he would have to justify why he does that. After that, I would go to the next court instance. And there is no “alternative” anymore, i.e. everything has to be examined. In this respect, nothing bad can actually happen now. One way or another, it will lead to success in terms of educational work.” [3]

 

Significance

If this case is upheld it would show that the science of virology has not followed the scientific measures and all measures and restrictive acts would have to end.

 

Plaintiff’s Argument

Essentially the plaintiff argues that the German Law  and the Infection Protection Act, requires all science to follow the “Scientific Method”. This would entail controlled studies and detailed recording of methodologies to show that whatever is claimed could not be falsified. Mr Haberland argues that this required process was never completed and that consequently none of the covid measures are legal. [1]

In a German interview with Transition News:

“I have been working intensively on the subject of health, nutrition and medicine for five years now and have come across the fact that there is quite a controversial discussion in science as to whether things are done scientifically in virology and whether the scientific method is applied correctly. After all, even in the German Infection Protection Act, which is quite unique in the world, it is explicitly stated right at the beginning in paragraph 1 that everyone involved, every researcher, every institution, every authority, every university and ultimately also every doctor is obliged to work according to the state of the art in science. [3]

In particular, this also includes conducting control experiments. That is quite clear. Therefore, I have meticulously reviewed all relevant publications and asked the Robert Koch Institute and all authorities for publications in which the pathogen has been detected. You, Torsten, had also written to five authors who have carried out authoritative studies in the matter of SARS-CoV-2 detection – and I have also read all these studies. I noticed the same thing that Stefan Lanka and other scientists have found out, namely that in none of these studies corresponding control experiments were made.” [3]

A control experiment he explains is:

“For example, I want to prove that I can break a window pane with a feather. To do this, I have to do an experiment that can prove or verify this hypothesis – and then I also have to offer an experiment that can be used to falsify the hypothesis. [3]

For this I tie the feather to a stone so that it can fly better. Afterwards I throw the stone and the feather in connected form through the window and see what happens. Of course, the window also breaks. [3]

If I did not do a control experiment, I could theoretically conclude that it was the spring that caused the pane to break. The control experiment would now consist of taking away the independent variable to be investigated, i.e. the spring, and throwing the stone alone through the window – and then seeing whether the glass then remains intact or not. Only then will I know for sure whether the spring can be held causally responsible for the glass breakage. By the way, the spring stands here for the particles, which are claimed to be viruses. But the spring cannot be held accountable for the shattering of the window, because of course this also happens when the stone hits the glass alone. [3]

Such an experiment has really never been done. And there are even institutions that openly admit that.” [3]

“As part of my court case, I sent a request based on the Freedom of Information Act to the Doherty Intsitute at the University of Melbourne. This institute had published a study in 2020 that was the first outside of China that virologists claimed to have isolated “SARS-CoV-2.” I wanted to know from the authors of this paper whether they had carried out corresponding control experiments. And they actually wrote me back that they had not done such control experiments. [3]

Thereupon I asked: Why don’t you do any controls? And the answer was that they didn’t have enough capacity left for that. Their study was published as having no control experiment. But also in the guidelines of the German Research Foundation, for example, it is clearly stated with regard to what scientific work means that one should not publish early before one has finished all documentation and thus also all control experiments. [3]

I also received an answer from France, namely from the scientific director of the world-famous Institut Pasteur in Paris, which corresponds to the Robert Koch Institute here. According to this, no control tests were carried out there either. This, too, is now before the judge. He must now decide whether, according to Section 1 of the Infection Protection Act, the scientific character is still given.” [3]

“It is completely undisputed in science that you have to control your results. That is also recognized worldwide. The Charité itself also writes that in its guidelines. Just like the Robert Koch Institute, they are committed to the methods of good scientific practice published by the German Research Foundation. And every researcher has these guidelines in his or her employment contract. Among other things, it says that you should always and consistently challenge yourself, that you should document everything you do. And everyone who receives research funding in Germany is obliged to comply with these scientific rules. In this respect, this also applies to the Charité. [3]

I have submitted numerous motions for evidence. These include a request to the judge that he ask a biologist of his choice whether he can present a study in which a virus has been detected, including a control experiment. Another request to the court is to ask a laboratory or virologist to perform an appropriate experiment.” [3]

“In the soldiers’ trial before the Federal Administrative Court, for example, extensive motions for evidence were filed and experts were even heard – and yet in the end, this highest German court did not appreciate all this and ruled against the plaintiff soldiers. Does something like that affect your confidence? [3]

Of course, you can never say that there are no viruses. Because you can’t prove the non-existence of something. You can only prove the existence of something. And, it should be emphasized again, at least according to the current state of science and according to the scientific methods, no one has ever proven a virus.” [3]

 

Defendant’s Argument

…More information is needed…

 

Relevant Prior Judgements/ Cases

…More information is needed…

 

Decision

…More information is needed…

 

Aftermath

…More information is needed…

 


Further Research

Court Documents:
  • …More information is needed…
  •  
Supporting Documents:
In the news:
  • …More information is needed…

 

Media


COVID Goes To Court

source: Odysee / DrSamBailey


Dr. Stefan Lanka: Biology as it is not

source: Odysee / Lanka


FOIAs Collected form around the World show no evidence of Covid Isolation

source: Odysee / shortXXvids

 

References

  1. Marvin Haberlands Gerichtstermin am 19. Oktober in Hamburg abgesagt

  2. Selbst das Institut Pasteur machte keine Kontrollversuche – und hat somit ‹SARS-CoV-2› nicht nachgewiesen


 

Keyword

Bailey, Charité, Control, Controlled Experiment, Doherty Intsitute, Engelbrecht, Existence, FOIA, German Infection Protection Act, Germany, Haberland, Hamburg, Isolation, Lanka, Mania, Marvin, Massey, RKI, Robert Koch Institute, Science, Scientific Method, University of Melbourne, Virology, Virus


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ICAN Placebo FOIA

ICAN Placebo FOIA

ICAN Placebo FOIA

Re: the data & proof of placebo control studies during vaccine clinical trials

 

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Facts of the Case

  • Dates: (filed) Oct 12, 2017
  • Location: New York, USA
  • Court: U.S. District Court for the Southern District of New York
  • Case #:
  • Plaintiff: ICAN
  • Plaintiff’s Lawyer: Robert F. Kennedy, Jr.
  • Defendant: HHS, FDA
  • Trial Type: FOIA
  • Judge:
  • Status: Decided
  • Verdict: for the Plaintiff


*updated: April 16, 2022

 

Background

The Department of Health and Human Services (HHS) was sent a 19-page legal notice on October 12, 2017 by the Informed Consent Action Network (ICAN) requesting confirmation that certain obligations regarding vaccine safety required under the 1986 Act had been fulfilled or will be fulfilled. [1]

Specifically at issue is the use of placebo’s (inert substances) during clinical safety trials

The notice asked (HHS) to “[p]lease explain how HHS justifies licensing any pediatric vaccine without first conducting a long-term clinical trial in which the rate of adverse reactions is compared between the subject group and a control group receiving an inert placebo?” [3]

ICAN sought copies of the reports HHS was required to submit to Congress every two years, starting in 1988, detailing improvements it made to vaccine safety. ICAN was represented by Robert F. Kennedy, Jr. [2]

ICAN was founded by Del Bigtree who hosts the weekly live online news program “The HighWire,” and is an Emmy-award winning producer of the CBS medical talk show “The Doctors.” He is producer of the groundbreaking documentary “Vaxxed: From Coverup to Catastrophe.” [2]

“The 1986 National Childhood Vaccination Injury Act granted economic immunity to pharmaceutical companies for vaccine injuries and hence eviscerated their economic incentive for them to take responsibility for vaccine safety,” says Bigtree. “Market forces driving vaccine safety were simply eliminated.” [2]

Congress therefore charged the Secretary of HHS with the explicit responsibility to assure vaccine safety. Biannual reports of HHS’s progress in improving vaccine safety were to be submitted to Congress. Yet, as ICAN has now proven, these reports were never created. [2]

The request included over 55 organizations whose members exceed five million Americans also voicing concern about vaccine safety. Freedom of Information Act (FOIA) documents show that the agency took the notice very seriously calling upon all internal departments and resources to craft their response. According to the FOIA documents, all HHS operating divisions, The National Vaccine Program Office, Assistant Secretary for Financial Resources, and The Office of the Assistant Secretary of Health all took part in the response. In Addition, FOIA email documents also state, “The National Vaccine Program Office staff has pulled together a draft response and is requesting that it be cleared with CDC, OGC, FDA, HRSA, NIH, and AHRQ for review prior to signature.”  [1]

Despite nine different government entities working on the response, their eventual January 18, 2018 reply was both lackluster and telling. Their brief 9-page response was unable to provide solid answers to the eleven questions asked of the agency concerning vaccine safety. The flimsily HHS reply triggered a deeply thorough 88-page response from ICAN laying out every detail concerning the problems and issues happening in regards to vaccine safety stemming from HHS. Its opening page writes: [1]

Given the gravity of HHS’s responsibility, it is deeply troubling that the majority of HHS’s letter contains little more than broad unsupported conclusory assertions. Most of these conclusory assertions do not withstand basic scrutiny. HHS’s responses even often contradict its own source materials.”  [1]

Among several concerning points, HHS choose to began their January reply by writing, “…many pediatric vaccines have been investigated in clinical trials that included a placebo.” [1]

As defined by the CDC, a “placebo” is: “A substance or treatment that has no effect on human beings.” [1]

HHS’s response also claimed that safety in these trials was reviewed for a significant duration, without specifying any duration. [3]

Recently on his show The HighWire, host Del Bigtree began publicly unpacking ICAN’s 88-page response by focusing on pre-licensure vaccine safety trials. The HHS reply contradicted itself by first admitting,

Inert placebo controls are not required to understand the safety profile of a new vaccine, and are thus not required. In some cases, inclusion of placebo control groups is considered unethical.

Later in their same letter, HHS states, “Vaccines are held to strict standards of safety.” [1]

Bigtree stated: “They’ve now printed it. So now you know for a fact that they just admitted those products you’re injecting into your kids have never been compared to a control. An inert saline injection.”​ [1]

Furthermore, according to HHS’s childhood vaccine schedule, babies receive 3 injections of each of the following vaccines between day one and 6 months of life all untested against a placebo control. [1]

 

 

Even pro-vaccine luminaries like Dr. Stanley Plotkin, vaccine authority and author of Plotkin’s Vaccines, appears to be in agreement with ICAN. Emails from a recent FOIA request show Plotkin wrote in June 2018 correspondence, “One point I do agree with [Robert F] Kennedy [Jr] about: there should be more safety studies…”​ [1]

 

 

Significance

Vaccine manufacturers insist that their products are safe and effective, despite many in the public reporting otherwise (injuries). Control experiments are essential to understanding how a medical product performs. Until this FOIA request, there has not been a public disclosure of this information casting doubt as to the “Science” underpinning the safe and effective claim. This information could harm the faith in one or all vaccines, and could be potentially destructive to this industry.

 

Plaintiff’s Argument

Given the conflicting information coming from HHS, ICAN’s 88-page response pressured their assertions writing: [1]

It is troubling that HHS chose to begin its response by misstating that prior to licensure for children “ many pediatric vaccines have been investigated in clinical trials that included a placebo.” At worst, HHS knowingly perpetuated this inaccurate claim but at best, HHS was unaware this claim was incorrect. This leaves the public to wonder what other critical assumptions underpinning HHS’s confidence in vaccine safety are incorrect.” [1]

ICAN’s original HHS notice directly pointed to concerns about the two Hepatitis B vaccines licensed for injection into one-day-old babies. Namely that the vaccines, according to the FDA’s own vaccine insert included in the original HHS notice, show that not only were the shots not tested against inert placebos, both vaccines were licensed after trials that solicited adverse reactions for only four days [Merck] and five days [GlaxoSmithKline] respectively after vaccination. To this point, HHS responded by referring back to the same inserts which contained the concerning data by simply writing, “Data relied upon in licensing infant use of hepatitis B vaccines is summarized in the respective package inserts.” [1]

ICAN’s response included a detailed chart containing every pediatric vaccine, citing to FDA documents, which indisputably proves that it was categorically false for HHS and the FDA to claim that “many pediatric vaccines have been investigated in clinical trials that included a placebo.” [3]

Perhaps one of the most damning findings referred to in ICAN’s 88-page HHS letter was titled HHS’s “Safety” Pyramid Scheme. Since inert placebo controls are not required and rarely used in vaccine safety testing, other vaccines take that role in what are referred to as “active controls.”  ICAN’s 88-page response to HHS points out to the agency the following: [1]

HHS’s own industry guidance for drug testing explains that an active control is only appropriate if it is a “drug whose effect is well-defined,” which means “historical placebo-controlled trials are available to define the active control effect.” Despite its own policy and guidance, HHS does not require this minimal assurance for vaccines.” [1]

 

 

 [SOURCE] Page 14 ICAN Response December 31, 2018

[SOURCE] Page 14 ICAN Response December 31, 2018

 

Defendant’s Argument

…More information is needed…

 

Decision

The US Department of Health and Human Services (HHS) settled a court-ordered stipulation  admitting that they could not produce 30 years of required evidence showing they have made improvements in the manufacturing, testing, warning, field surveillance, adverse reaction reporting and research on vaccines in order to reduce the risk of adverse reactions as mandated by the 1986 National Childhood Vaccine Injury Act (1986 Act). [1]

LOS ANGELES, Sept. 14, 2018 /PRNewswire/ — The U.S. Department of Health and Human Services (HHS) has admitted that, in direct violation of Federal law, it failed to provide a single vaccine safety report to Congress for thirty years, according to Informed Consent Action Network (ICAN).

HHS conceded that those reports do not exist and the Court entered an order confirming this concession. [2]

 

Aftermath

ICAN’s response:

“It is apparent that HHS doesn’t have a clue as to the actual safety profile of the now 39 doses, and growing, of vaccines given by one year of age, including in utero,” said Bigtree. “In 1986, a one-year old child received eleven doses. [2]

“HHS spends billions annually promoting vaccines and generates a steady stream of reports promoting vaccines,” Bigtree says. “Yet, when, despite Federal law, HHS cannot bother to complete the simple task of preparing a biennial report on vaccine safety, there is little hope HHS is tackling the much harder job of improving vaccine safety.” [2]

The 1986 Act shifted financial liability for vaccine injuries to the U.S. Government which has since 1986 paid over $3.9 billion for serious vaccine injuries. [2]

The reality is that none – save one – of the pediatric vaccines was licensed based on a placebo controlled clinical trial! … No proof has ever been provided. [3]

 
Further ICAN Lawsuits
  • ICAN also sued the FDA numerous times to force it to release clinical trial reports for other vaccines, including, for example, the chicken pox vaccine, which we explained in another recent legal update.
  • when the Phase III trial for AstraZeneca and the University of Oxford’s COVID-19 vaccine was underway in England using another vaccine (Menveo) as a control (instead of a placebo), ICAN filed a forceful petition demanding that the FDA mandate that all clinical trials of COVID-19 vaccines use a placebo control as well as track safety long-term in a properly sized trial.

Nine days after ICAN filed its petition, on June 30, 2020, the FDA changed course and issued emergency guidance to industry that all COVID-19 clinical trials must use a placebo control.

  • On July 17, 2020, ICAN sued the FDA in federal court demanding the entire clinical trial report for Menveo, just in case the agency was considering permitting this vaccine as a control in the AstraZeneca trial to be conducted in the United States.  On July 20, 2020, ICAN also filed a forceful amended petition with the FDA thanking it for requiring a placebo control group but demanding, among other things, that it also require that these clinical trials track all adverse events during the entire duration of the trial – not just for a limited time period.
  • Not long thereafter, in mid-September, in a highly unusual move, the full clinical trial protocols for the COVID-19 vaccines for which ICAN filed its petitions were released to the public.  See copies for each of the manufacturer’s vaccines: AstraZeneca, Pfizer, Moderna, and Johnson & Johnson.  Those protocols revealed that some of ICAN’s demands regarding the duration for tracking vaccine safety had been met.

 

Media


Tucker Carlson’s Explosive Interviview with RFK jr 26/11/2021

source: Odysee\AussieFighter


ICAN Lead Attorney, Aaron Siri on recent legal wins

source: theHighWire.com


Pandemic of the VACCINATED—75 Athletes Collapse from Heart Failure

source: Youtube\apidta

 

References

  1. The US Government Loses the Vaccine Debate
  2. ICAN vs. HHS: Key Legal Win Recasts Vaccine Debate
  3. ICAN v. FDA – ICAN Brings Lawsuit Related to “Placebo” in COVID-19 Clinical Trial

 

Keyword

1986, Adverse Reaction, Babies, Bigtree, Congress, Control, Del, Experiment, FDA, Field Surveillance, FOIA, Freedom of Information Act, GlaxoSmithKline, Health and Human Services, Hepatitis B, HHS, HighWire, ICAN, Informed Consent Action Network, Injection, Kennedy, Manufacturing, Merck, National Childhood Vaccine Injury Act, Nonprofit, Placebo, Plotkin, Reporting, RFK, Risk, Testing, US Department of, Warning 


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