Vaccine Mandate Case: Supreme Court

Vaccine Mandate Case: Supreme Court

Vaccine Mandate Case: Supreme Court

Re: the Legality of Vaccine Mandates

 

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Facts of the Case

  • Dates: May 2, 2022 (decided)
  • Location: India
  • Court: Supreme Court
  • Case #:
  • Petitioner: Dr.Jacaob Puliyel
  • Petitioner’s Lawyer: Prashant Bhushan
  • Respondent: Union & State Governments of Delhi, Madhya Pradesh, Maharashtra & Tamil Nadu
  • Trial Type: Supreme Court
  • Justices: L Nageswara Rao & BR Gavai
  • Status: Decided
  • Verdict: for the Petitioner


*updated May 8, 2022

 

Background

a PIL filed by Dr.Jacaob Puliyel, challenging the vaccine mandates and seeking publication of the clinical trial and adverse events of vaccination. [1]

Dr. Jacob Puliyel, a former member of the National Technical Advisory Group of Immunization had approached the Apex Court assailing the constitutional validity of the vaccine mandates imposed by States, in particular, Delhi, Madhya Pradesh, Maharashtra and Tamil Nadu. He had sought the indulgence of the Court to issue directions to the concerned authorities to disclose the data pertaining to clinical trials of the COVID-19 vaccines administered to adults as well as children in India, as per the requirement of International Medical norms. The petitioner also impelled the Court to revamp the Adverse Events Following Immunization Reporting System which he alleged was opaque, flawed and unknown to the public at large. [1]

Petitioner Jacob Puliyal has said that even though the central government is saying that vaccination is optional, it is not mandatory, but in states like Delhi, Tamil Nadu, Maharashtra and Madhya Pradesh, it has become mandatory.  [2]

lawyer Prashant Bhushan had said that when the central government has said on many occasions, in response to statements and RTI that vaccination is not compulsory but optional, then in many states to open a shop, enter a shop or establishment. Vaccination certificates are sought on occasions such as entry of employees and people working there, walking on the streets, entering an educational institution? The petitioner, in his petition, has also referred to the circulars issued by the Government of National Capital Territory of Delhi on October 8 last year, November 8 in Madhya Pradesh, November 27 in Maharashtra and November 18 in Tamil Nadu and clearly written guidelines in which vaccination should be done. Essential restrictions have been imposed. [2]

At the same time, the Central Government opposed the petition to give the data of the clinical trial of Corona vaccine and not to force the vaccine. In the Supreme Court, the central government had said that such petitions filed for the vested interest of some people can affect the vaccination process. Even an oral comment of the court can be harmful. [2]

The Center told the Supreme Court that till November 24, 2021, one billion 19 crore 38 lakh 44 thousand 741 doses of corona vaccine have been given. Out of these, 2116 cases of adverse event following immunization i.e. AEFI have been registered so far. A report of rapid review and analysis has been completed for 495 (463 Coveshield and 32 Covaxin). Another report of 1356 cases (1236 Covishield, 118 Covaxin and 2 Sputnik) of severe AEFI cases (including 495 cases already analyzed) has been submitted to NEGVAC. [2]

The remaining cases are under rapid review and analysis and will be completed soon. On behalf of the Central Government, Solicitor General Tushar Mehta had said that this petition should not be heard. This may increase hesitation for the vaccine. The country has come out of it with great difficulty. [2]

Justice Nageswara Rao had said that that is why we said that if you have some specific facts, then they should be heard. We also do not want that there should be any problem regarding vaccination. [2]

In fact, on 9 August 2021, the Supreme Court had issued a notice to the Central Government on the petition not to compel people to apply the vaccine and make the trial data public. However, the Supreme Court refused to impose an interim stay on forcing the vaccine to be administered. Justice L Nageswara Rao said that 50 crore people in the country have been vaccinated. The WHO has also said that vaccine hesitancy has done a lot of damage. [2]

Lawyer Prashant Bhushan had said that according to the sero report, 2/3 people have been infected with Covid. In such a situation, the anti body is more effective than the corona vaccine. Now a policy has been made that if the vaccine is not applied then one cannot travel. Many restrictions have been imposed. The government is not making clinical data public. Since the vaccine is voluntary, then if someone does not get the vaccine, then he should not be denied any facility. The petitioner’s lawyer Prashant Bhushan has filed an application asking that the clinical trial of the vaccine as well as the data regarding the adverse effect of the vaccine be made public. [2]

 

India made headlines last year when it refused to offer a liability shield to Pfizer or Moderna, unlike countries such as Canada — which still has a federal vaccine mandate and a ban on the unvaccinated for travel. As such, no contract was signed between India’s authorities and these vaccine manufacturers. Instead, India relied on their own domestically produced vaccines. [3]

Pfizer infamously wanted to hide their COVID trial-related data for seventy-five years but was forced by a court order to release it. As their data dumps are being made publicly available bit by bit, public outrage continues to grow. [3]

 

 

Significance

This case is the first in the Supreme Court to decide on the legality of Vaccine Mandates

 

Plaintiff’s Argument

Vaccine Mandates

The sheet anchor of Advocate, Mr. Prashant Bhushan’s argument against the vaccine mandates was that in the absence of clinical trial data people were restrained from providing informed consent and the same impinged on the right to self-determination protected under Article 21 of the Constitution of India, 1950. Relying on K Puttaswamy v. UOI (2017) 10 SCC 1 and Common Cause v. UOI (2018) 5 SCC1, he emphasised that informed consent is necessary for medical procedures and bodily integrity is an integral part of the right to privacy. The Court was apprised that though the Government of India had indicated that vaccines are to be administered voluntarily, the States have imposed mandated restricting movement, denying essential services and curbing the right to livelihood in derogation of Articles 19 and 21. Mr. Bhushan argued that when there exists scientific evidence to substantiate the claims that nature immunity is better than vaccine-immunity; vaccination does not prevent from getting infected or transmitting; vaccines are ineffective in preventing new variants; vaccines have serious adverse effects; long-effects of the vaccine are unknown, mandating vaccination is unconstitutional. [1]

“For any vaccine to be mandated, the public health rationale underlying such a policy must be based essentially on efficacy and safety of vaccination and prevention of transmission of the disease“, Mr. Bhushan submitted. [1]

He referred to the decision of the UK Parliamentary Committee; judgement of the High Court of New Zealand in Yardley v. Minister for Workplace Relations and Safety [2022] NZHC 291 and orders of Gujarat High Court and Meghalaya High Court sticking down vaccine mandates. [1]

 
Non-Disclosure of data

Mr. Bhushan submitted that the segregated data of clinical trials of vaccines must be disclosed through peer reviewed scientific journals. The disclosure would have a significant impact on determining the adverse effects of the vaccines. The significance of disclosure was asserted by placing reliance on the Nuremberg Code and Report Nos. 59 (2012) and 66 (2013) of the Parliamentary Standing Committee on Health and Family Welfare. [1]

He informed the Court that an RTI Application was filed enquiring whether the Subject Expert Committee had looked at the raw days and/or discussed it. Responding to the same, the Central Drugs Control Standard Organisation stated that the brief of interim clinical trial results along with Subject Expert Committee’s recommendations was publicly available on CDSCO website. Dissatisfied with the response, an appeal was filed and the First Appellate Authority refused to reveal any data stating that the manufacturers had refused to disclose data publicly. [1]

 
Adverse Effect Following Immunization Reporting System

Mr. Bhushan submitted that besides it being an opaque and flawed system, there was a lack of public awareness about the same. [1]

 
Children’s Vaccine Mandate

Citing articles published in scientific journals, Mr. Bhushan argued that the overall risk from COVID-19 for children being remarkably low, it is not reasonable to vaccinate them, that too, without providing an opportunity to the parents to provide informed consent [1]

 
Rebuttal Arguments of the petitioner

Mr. Bhushan contended that the non-disclosure of trial data is preventing independent experts from making their own determinations. He stressed upon the petitioner’s plea that disclosure would permit the independent experts to look into the veracity of the claims of the manufacturers. In this regard, he referred to a United States District Court judgment, wherein the regulatory body was directed to disclose all the information pertaining to the Pfizer vaccine. [1]

He submitted that even considering the Government’s submission on privacy of the patients who participated in the trials, it ought to have made available segregated data. He emphasised that the assertion, vaccines significantly reduce the risk of transmitting the disease, had to be established by the Government by adducing evidence. Mr. Bhushan argued that by merely stating there exists a robust system for granting approval, it cannot be taken outside the ambit of judicial scrutiny. Mr. Bhushan asserted that the information available on the website pertains only to recommendations made by the expert bodies, but does not indicate the material on the basis of which such recommendations were made. [1]

With respect to the adverse reporting system, he pointed out that only the vaccinator can report such effects; the public at large have no knowledge about the reporting system and only known adverse effects can be reported. [1]

 

Defendant’s Argument

Argument from State Government of the Union Government

Solicitor General, Mr. Tushar Mehta at the outset, had questioned the bona fides of the petitioner. He contended that by way of a Public Interest Litigation, the petitioner cannot seek raw data of the clinical trial of the COVID-19 vaccines, merely to satisfy his curiosity, nor can he sit in judgment of the wisdom of domain experts. He refuted the claim of serious adverse effects. According to the official record till 13.03.2022, 1,80,13,23,547 doses had been administered and 77314 people or 0.004% of the vaccinated population had been adversely affected. Refuting the submissions made by Mr. Bhushan, alleging irregularities in the vaccine approval process, he took the Court through the statutory framework and submitted that the same had been adhered to while granting approval. Referring to the Epidemic Diseases Act, 1897 and Disaster Management Act, 2005, he demonstrated the wide ambit of power entrusted upon the Central Government to take measures during a pandemic. [1]

Mr. Mehta vehemently opposed the claim of the petitioner that there was a lack of mechanism for addressing adverse effects from immunization. On the issue of disclosure of clinical trial data, it was asserted that the same was in the teeth of confidentiality provisions. It was highlighted that the Helsinki Declaration and the WHO statement relied upon by the petitioner to seek raw clinical trial data only refers to the obligation to disclose final results, findings and outcomes which have already been disclosed.

Addressing the issue of children’s vaccine mandate, it was argued that evidence provided by the petitioner is based on mRNA vaccine, whereas the vaccine being administered in India was inactivated virus vaccines. It was further pointed out that for pediatric vaccines there is a statutory regime in place, which is being strictly followed. [1]

Mr. Mehta referred to a catena of foreign judgments with respect to vaccination in general, and the vaccination during the COVID-19 pandemic in particular to indicate that individual liberty is not absolute and is subject to other factors, like legitimate aim; and the necessity to achieve that aim.

Moreover he argued that the vaccine mandate is a matter of policy; a matter of scientific adjudication and the scope of judicial review in policy matters, especially when the executive decision is based on expert opinion, is limited. [1]

 

Argument from State Government of Tamil Nadu

Appearing for the State of Tamil Nadu, its Additional Advocate General, Mr. Amit Anand Tiwari submitted that the State Government has exercised power under Tamil Nadu Public Health Act, 1939 and the Disaster Management Act, 2005 to mandate vaccination for accessing public spaces. The mandate was justified, broadly on three grounds : [1]

  1. It prevents mutation

  2. Unvaccinated people causes health risk and

  3. Economic impact.

 

Argument from State Government of Maharashtra

Advocate, Mr. Rahul Chitnis, appearing for the State of Maharashtra, submitted that the Government has mandated vaccination to enter shops, malls etc., and also to avail public transportation, but the same would pass the test of proportionality as expounded by the Apex Court in Modern Dental College And Research Centre And Ors. v. State of Madhya Pradesh. [1]

 
Argument from State Government of Madhya Pradesh

The Counsel adopted the submissions made by the Solicitor General about the need to balance rights. It was also clarified that the Government did not intend to make vaccines mandatory to avail ration. On the contrary, the purpose of the notification was to encourage individuals to get vaccinated. [1]

 
Argument from the Vaccine Manufacturers

Senior Advocate, Mr. Guru Krishnakumar, appearing for Bharat Biotech, controverted Mr. Bhushan’s argument that Phase III Trial of the vaccine has not been published. Moreover, it was emphasised that WHO guidelines referred to by the petitioner do not mandate the disclosure of the primary data and only the analysis of the data. Reliance was placed on Section 8(1)(d) of the Right to Information Act which exempts the disclosure of information including commercial confidence, trade secrets or intellectual property, the disclosure of which would harm the competitive position of a third party. The Counsel appearing for SII also opposed the petitioner’s plea for disclosure. [1]

 

Relevant Prior Judgements/ Cases

decision of the UK Parliamentary Committee; judgement of the High Court of New Zealand in Yardley v. Minister for Workplace Relations and Safety [2022] NZHC 291 and orders of Gujarat High Court and Meghalaya High Court sticking down vaccine mandates. [1]

 

Decision

The Supreme Court on Monday held that no individual can be forced to get vaccinated and the right to bodily integrity of a person under Article 21 of the Constitution include the right to refuse vaccinate. [1]

The Court also held that the vaccine mandates imposed by various state governments and other authorities in the context of COVID-19 pandemic are “not proportionate. The Court held so as no substantial data has been produced on record to show that the risk of transmission of COVID-19 virus from the unvaccinated persons are higher than from vaccinated persons. [1]

The Government is entitled to impose restrictions on individual rights in public health interests, but the restrictions should meet the 3-fold requirement legality, need and proportionality laid down by the Supreme Court in the Puttaswamy judgment. [1]

“No data has been provided by the Union of India or States before us controverting the material placed by petitioner which indicates that the risk of tranmission by unvaccinated is at par with vaccinated.In light of this the vaccine mandates cannot be said to be proportionate till the infection rate remains low and new development of research emergence which justifies the mandate”, the Court stated. [1]

Therefore, the Court suggested that all authorities, including private institutions and educational institutions, should review the restrictions on the unvaccinated. The Court however clarified that this direction is confined to the present context of the COVID pandemic situation. It further clarified that it does not extend to any other directions on COVID-19 appropriate behaviour issued by the authorities. [1]

 
Union’s vaccine policy not unreasonable or arbitrary.

The Court also held that the policy of the Union Governemnt on COVID-19 vaccination policy is reasonable. It also held that the clinical trial data of the vaccines have been published in accordance with the relevant norms. The material provided by the Union of India does not support the conclusion that emergency use approval has been granted in haste. [1]

 
Publish reports on Adverse Events

The Court also directed the Union of India to publish reports on Adverse Events Following Immunisation (AEFI) from public and doctors on a publicly accessible system without compromising data of the individuals who are reporting the same. [1]

 
Vaccination for children approved

Regarding vaccine for children, the Court said that it is not possible for us to second guess the opinion of experts and the vaccination indeed follows the global standards and practices. [1]

“On pediatric vaccine, it is in tune with international standards. We direct the Union of India to make sure the key findings of the stages of trial already approved for children be made public at the earliest”, the Court said. [1]

The Court rejected the arguments against the maintainability of the writ petition. Though executive has wide latitude in policy matters, it does not bar the Courts from scrutinizing if the policy is beyond the pale of arbitrariness.

 

Aftermath

…More information is needed…

 


Further Research

Court Documents:
  • Read the Court Ruling
In the news:

On Corona Cases

 

Media


Supreme Court of India rules against vaccine mandates

source: RebelNews


Yohan Tengra: India Supreme Court Stops C19 Vaccine Mandates

source: WorldCouncilForHealth


Supreme Court Upholds Individual’s Right Against Forcible Vaccination

source: NDTV


Pfizer Vaccine Data Analyzed

source: canadiancovidcarealliance.org


12 yr old Vaccine Trial Victim, Maddie

source: shortXXvids


source: …

 

References


 

Keyword

Adverse, Adverse Events Following Immunisation, AEFI, Bharat Biotech, Bhushan, constitution, Delhi, Disaster Management Act, Effects, Epidemic Diseases Act, India, informed consent, Madhya Pradesh, Maharashtra, Mehta, Nuremberg Code, Puliyel, Reporting, Reporting System, Side, Supreme Court, System, Tamil Nadu, Unconstitutional, Vaccine Mandate 


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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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