Tag Archives: ICAN-VS-CDC-LAWSUIT

ICAN Obtains Crucial Pfizer Vaccine Lot, Dose, and Distribution Information

As the result of FOIA requests, ICAN is the first to exclusively receive lot, dose, and distribution information on Pfizer’s Covid-19 vaccine, which may finally make it possible to perform certain crucial scientific analysis on the safety profile of this product.

 

A disproportionate number of the injuries and deaths reported to VAERS appear related to certain lots of Pfizer’s Covid-19 vaccine.  But without knowing the number of doses shipped per lot, it was not possible to determine if this disparity in adverse event reports for certain lots is meaningful (or, rather, is simply a result of more doses having been administered from those lots when compared to other lots).

So, in March, amid numerous Freedom of Information Act requests sent by ICAN’s attorneys to federal health authorities, there were two requests sent to the CDC for records concerning Pfizer’s Covid-19 vaccines.  First, ICAN sought information on the lot numbers and total number of doses within those lots for all of the Pfizer Covid-19 vaccines manufactured, distributed, and administered in the U.S.  ICAN also sought information on where the lots were shipped and distributed, both inside and outside of the U.S.  This month, the CDC finally released some of this information, which can be found here. As far as ICAN knows, this is the first time any data like this has been made available to the public.

Although many individuals and organizations have sought to do analyses on reported adverse events from Covid-19 vaccines, up until now, their attempts were always hampered by the fact that no one had any denominator to work with – that is, the total number of lots or doses of Covid-19 vaccines vis-à-vis the total number of adverse events reported for each lot number. But with this new groundbreaking data to work with, that crucial type of analysis into things like adverse events may finally be possible!

In the meantime, ICAN intends to go back to the agency and obtain more complete data. Additionally, ICAN has numerous similar requests pending with the CDC and other agencies for related data and you can rest assured that ICAN will make public any data that is released so that Americans can finally get the full and unvarnished truth about these products.

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Source: https://www.icandecide.org

PFIZER EXACT LOT SIZES HAVE BEEN RELEASED BY FOIA

Source: world orders review

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ICAN Files Challenge to Authorization of Covid Injections in 5 to 11 Year Old Children

In a recent update, ICAN announced that its attorneys had filed a formal petition with the FDA demanding it revoke the emergency use authorization (EUA) it granted for the use of Covid-19 vaccines in 12- to 15-year-olds. As promised, ICAN has now filed another petition, this time demanding that the FDA revoke the EUA it granted for Pfizer’s and Moderna’s Covid-19 vaccines in children ages 5 to 11.
This 23-page petition, which contains 120 footnotes and over 1,600 pages of source materials, points out that the FDA’s grant of the EUA was illegal from the start since an emergency use authorization requires, first and foremost, the existence of an emergency, which there is definitively not when it comes to Covid-19 and children.
Moreover, the petition outlines in great detail all of grave flaws in the FDA’s benefit-risk assessment of these vaccines, which used flawed science and inaccurate numbers that, in each and every instance, functioned to overstate the benefit of these vaccines in children and heavily understated the risk of serious side effects.

The FDA is legally required to formally respond to ICAN’s petition. Forcing a formal response means the FDA, when its day of reckoning arrives, can never claim ignorance for its unethical and illegal conduct. When the FDA responds, we will keep you posted. In the meantime, you can read the petition for yourself here, and you are welcome to leave a comment in support by clicking the blue comment button on the website:

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Source: https://www.icandecide.org/

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FDA’s Advisory Committee Ignores Member’s Conflict of Interest and Allows Him to Attend Meetings and Vote

On June 14-15, 2022, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) convened and voted to recommend an emergency use authorization for both Moderna’s COVID-19 vaccine for children ages 6 months to 17 years and Pfizer’s COVID-19 vaccine for children 6 months to 4 years.
After the members introduce themselves, one of the first things done at these VRBPAC meetings is the reading of VRBPAC’s Conflict of Interest Statement which includes a statement that the “FDA has determined that all members of this advisory committee, both regular and temporary members, are in compliance with federal ethics and conflicts of interest law.”
During the reading of the Conflict of Interest Statement on June 14, it was noted that one temporary voting member, Dr. James Hildreth, had received a waiver allowing him to participate in the VRBPAC meeting. In his Acknowledgement of Financial Interests form, Dr. Hildreth disclosed that both he and his employer had financial interests that could be affected by the matter he was planning to voting on at VRBPAC.
Namely, Dr. Hildreth’s employer, Meharry Medical College, is a COVID-19 vaccine trial site and expected to receive between $1.5 million to $2 million for conducting that trial. Additionally, Meharry Medical College enrolled participants in the trials for the very product that was being considered by him at VRBPAC – Moderna’s pediatric COVID-19 trials – for which it was to receive $400,000 – $600,000. Finally, Dr. Hildreth disclosed that he would personally make up to $5,000 for enrolling participants in one of those trials.
ICAN, through its attorneys, demanded that VRBPAC immediately remove Dr. Hildreth as a temporary voting member, bar him from participating the following day, and discard his vote from that day’s meeting. Regardless of Dr. Hildreth’s experience or expertise, it was completely inappropriate for VRBPAC to proceed with Dr. Hildreth’s participation given the nature of these conflicts of interest.
VRBPAC instead, unbelievably, recited the very same Conflict of Interest Statement the next day, assuring the public that “all members” of VRBPAC “are in compliance with federal ethics and conflicts of interest laws.” Not surprisingly, Dr. Hildreth voted “yes” to all three products being considered, two of which were Moderna pediatric vaccines.
ICAN will continue to build the record and case against the improper actions by our federal “health” agencies so that they cannot claim ignorance when judgment day arrives.

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Update on COVID-19 Vaccine Manufacturers’ FOIA Requests

Recently, we told you that vaccine manufacturers have to submit FOIA requests to the FDA to obtain additional information regarding serious adverse events, including deaths, following the use of their products that are submitted to VAERS.
We know this because Janssen’s Chief Medical Officer (CMO) said so during his presentation at the CDC’s Advisory Committee on Immunization Practices (ACIP) meeting, convened to investigate the safety of the J&J/Janssen vaccine.
ICAN set out to determine whether the manufacturers were actually investigating injuries from their products through FOIA.  At the time of our legal update, ICAN’s attorneys had only received copies of the FOIA requests submitted by Pfizer, Moderna, and Johnson & Johnson and the results were concerning.  Since then, ICAN received a response to our FOIA request for copies of all requests submitted to the FDA by Janssen since December 1, 2020, as well as any responses to the same.
It turns out that, at the time Janssen’s CMO gave his presentation to ACIP on April 14, 2021, Janssen had already received copies of VAERS reports of death and life-threatening injuries suffered by 3 people following receipt of the J&J/Janssen vaccine and Janssen had other requests outstanding, including one for “copies of all VAERS reports for all cases of thrombosis” between February 28, 2021 and April 14, 2021 – a request which would ultimately result in the production of an incredible 492 pages of records. Despite having the concerning reports in its possession at the time, Janssen’s CMO made the comment that, “based on the current data, Janssen believes the overall benefit risk profile for our vaccine is positive across the population for which it’s authorized.”
What changed between April 14, 2021 and May 5, 2022 when the FDA strictly limited the use of the J&J/Janssen COVID-19 vaccine? Well, Janssen received another 870 pages documents in response to its other 103 FOIA requests, all of which describe in graphic detail the death and severe, life-threatening injury its product potentially unnecessarily caused in dozens, if not hundreds, of individuals. Meanwhile, Janssen continued to push out positive press on its vaccine, touting the “strong and stable” and “strong and long-lasting” immune responses it purportedly generated, as well as its “consistent” safety profile. This, of course, did not reflect the reality that by September 30, 2021, there were 14,682 serious adverse events and 2,498 deaths reported to VAERS following receipt of the J&J/Janssen COVID-19 vaccine.
This just goes to show that the FDA’s limiting of the use of this product on May 5, 2022 likely should have happened a full year earlier. And Janssen likely knew that as well.

But to Janssen’s credit, it did at least seek to identify actual harms from its COVID-19 vaccine. It’s reward from the FDA? Essentially killing its product. But when Pfizer and Moderna, each of which have far more injury reports to VAERS per dose given in the United States, fail to follow up on these reports with FOIA requests to the FDA, they are rewarded by the FDA with continued touting of their products.

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Source:  https://www.icandecide.org/
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CDC Director Violates FDA’s Emergency Use Authorizations and Posts Misinformation about COVID-19 Vaccines

While Twitter has suspended and permanently blocked numerous individuals for posting so-called “misinformation” concerning COVID-19 vaccines, it has not done so to “health” authorities – those who arguably should be held to an even higher standard – when they blatantly share inaccurate information.
On June 18, 2022, CDC Director Rochelle Walensky posted a tweet with a video of herself discussing the CDC’s recent recommendation of the COVID-19 shots for children under 5. In the video, Dr. Walensky made the following two claims:
  • “We now know based on rigorous scientific review that the vaccines available here in the United States can be used safely and effectively in children under 5.”
  • “We have taken another important step together on our fight against COVID-19 by making safe and effective vaccines available for our little ones.”
But as Dr. Walensky should certainly be aware, in issuing Emergency Use Authorizations (EUAs), the FDA has not (under its ridiculously low standards) made a finding that these vaccines are “safe and effective.” Instead, the grant of an EUA means only that the FDA has determined “it is reasonable to believe that [each vaccine] may be effective” and that “it is reasonable to conclude, based on the totality of scientific evidence available, that the known and potential benefits of [each vaccine] outweigh the known and potential risks of the vaccine.”

By claiming – two separate times – that these vaccines are “safe and effective,” Dr. Walensky is misleading the public by suggesting these vaccines have met the legal standard required for licensure.

Worse yet, because her tweet is “descriptive printed matter” that is both advertising and promoting Pfizer’s and Moderna’s vaccines, the tweet itself is in violation of both EUAs issued to these companies because it does not “clearly and conspicuously” contain the required disclaimer that these products have not yet been licensed as safe and effective by the FDA.

ICAN, through its attorneys, has sent Dr. Walensky a formal letter demanding that she immediately remove the misleading tweet and we will keep you posted on the CDC’s response.

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The ‘Best Team in America’ Joins the Legal Effort Against Pfizer for Fraud, Racketeering, Battery, and More

The ‘Best Team in America’ Joins the Legal Effort Against Pfizer for Fraud, Racketeering, Battery, and More.

Dr. Naomi Wolf: “We’re going after Pfizer, first as a private corporation, and also, thank God, our lawyers are aligning with 20 attorneys general … This is important because the attorneys general can bring criminal charges, and what the lawyers have found abundantly is that there’s civil and criminal causes of action.”

“There are a number of various causes of action, civilly, that I can disclose to all of you that all of the lawyers have found. They found fraud for sure.”

ABSOLUTELY DISGUSTING!
BECAUSE THERE IS A DEPOPULATION AGENDA PEOPLE!
THIS IS A FACT THAT IS SHOWING ITSELF MORE AND MORE WITH EVERY PASSING DAY!

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COVID-19 Vaccine Manufacturers Fail to Properly Investigate Adverse Events Reports

Vaccine manufacturers, like the rest of the public, must submit a FOIA to the FDA to obtain additional information regarding serious adverse events, including deaths, submitted to VAERS. The problem: they are not doing it.
 
At the CDC’s Advisory Committee on Immunization Practices (ACIP) meeting in April 2021, Janssen’s Chief Medical Officer gave a presentation regarding the safety of its J&J COVID-19 vaccine. During his presentation, he indicated that pharma companies, like the public, only gain access to VAERS reports each Friday when they are released, and that, because “there is significant redaction of some of the data fields,” “it is not possible for [vaccine manufacturers] to follow-up for further information,” except that they “can attempt to do so through Freedom of Information [Act] applications.” Implying this was a common practice, Dr. Maree stated that the “FDA has been very supportive in helping [them] try to expedite these requests.”

ICAN set out to determine if vaccine manufacturers were, in fact, investigating VAERS reports of serious injuries by making FOIA requests to the FDA. Through its attorneys, ICAN requested that  the FDA provide copies of all FOIA requests submitted by ModernaJohnson & Johnson, and Pfizer since the inception of the companies’ COVID-19 vaccines.

For those familiar with these companies’ history, the results will not be all that surprising. Based on the FDA’s response so far, two of the three vaccine manufacturers did not submit a single FOIA request to the FDA regarding reports of adverse events to their COVID-19 vaccines.

  • Moderna filed one single FOIA request in April 2021 for a copy of the FDA’s site visit report of its facility in Massachusetts – but not a single FOIA about an adverse event following vaccination.
  • Johnson & Johnson submitted one single FOIA request in July 2021 for the FDA’s risk assessment regarding benzene levels in aerosol sunscreen – but again, not a single FOIA about an adverse event following vaccination.
  • Pfizer submitted only four FOIA requests for VAERS reports related to its COVID-19 vaccine between December 18, 2020 and February 7, 2021, at least three of which were apparently at the FDA’s prompting. Two of Pfizer’s requests related to anaphylaxis and syncope indicated they were in response to an FDA “query,” that specifically told Pfizer it “may request a copy of redacted VAERS report[s] via FOIA.”  Pfizer has not filed a single FOIA request since February 2021, nor has it filed any requests related to any other adverse event following vaccination, including myocarditis.
Unfortunately, as the experiences of many vaccine-injured individuals have proven, these companies do not appear to be adhering to their claims of taking adverse events to their products seriously. ICAN, however, does and we will continue to hold these companies accountable.

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Source: https://www.icandecide.org

CDC Spends Your Money Culturing, Producing and Selling Cell Lines from Human Fetus Body Parts

ICAN has discovered that the CDC has cultured at least 22 different human cell lines, including cells derived from various body parts of aborted fetuses and neonates.

A year ago, ICAN, through its attorneys, sent a request to the CDC seeking documents regarding an aborted fetal cell line being used in vaccine production known as HEK. In response, the CDC recently produced 281 pages of documents. One of the emails from 2015 shockingly reveals a list of 22 human cell lines that the CDC “has cultured.” Another email lists 47 cell lines that the CDC had “produced in the last two years” and at least 18 of them are human cell lines, including lines derived from the kidney and intestine of different fetuses.

ICAN will continue to seek and uncover the full extent of the CDC’s involvement in culturing and producing cell lines from fetus body parts.

To share this legal update, please use this link: https://www.icandecide.org/ican_press/cdc-spends-your-money-culturing-producing-and-selling-cell-lines-from-human-fetus-body-parts/

Source: http://www.icandecide.org

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The FDA and CDC Are Preparing a “Framework” to Exempt Future COVID-19 Shots from Clinical Trials

The FDA and CDC Are Preparing a “Framework” to Exempt Future COVID-19 Shots from Clinical Trials. ICAN is Fighting Back.

ICAN attorneys and research staff watch every meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) and the CDC’s Advisory Committee on Immunization Practices (ACIP). What is seen over the course of many meetings are the patterns and methods by which these agencies rig the approval process to achieve pre-determined outcomes.  Now VRBPAC and ACIP are gearing up to pre-approve all future COVID-19 shots, regardless of formulation, with no additional clinical trials!
After VRBPAC’s April 6, 2022 meeting, ICAN, through its attorneys, wrote a letter to FDA Commissioner Robert Califf, the members of VRBPAC, and the Senators and Representatives responsible for the FDA’s budget, explaining our concerns in detail.
To summarize, VRBPAC appears to be following the same plan it follows for the flu vaccine every year and we know how well that works. Each year, they engage in “the flu strain selection process” and agree on the strains that will be included in the flu vaccine that year. Vaccine manufacturers love this because they can create a single flu vaccine and sell it worldwide.  Most importantly, however, they can then skip the regulatory review process because these new formulations are automatically deemed safe and effective since they are “biologically similar” to previous versions of the flu vaccine.
The problem from a public health perspective is that this process does not work.  As ICAN has noted previously, at best, FDA’s own data show flu vaccine effectiveness in the previous season was between 8% and 14%.  Evidence from an influenza outbreak at a large university campus showed flu vaccine effectiveness was zero.
What does all of this have to do with COVID-19 shots?  The White House, FDA, and CDC have come up with a disturbing plan: they are proposing to take the flu strain selection process (that does not work) and apply it to future COVID-19 shots!
What this means is that each year, FDA/VRBPAC and CDC/ACIP (under the direction of the WHO) will engage in an elaborate performance of “COVID-19 variant selection.” They will potentially choose between 1 and 4 strains to put into the COVID-19 shots (for example, combining spike proteins from Wuhan, Beta, Delta, and Omicron variants in a single shot).  The worst part?  They will argue that this new formulation is biologically similar to previous COVID-19 shots, and therefore they will not require pharmaceutical companies to conduct any new clinical trials.
ICAN is already fighting back, and you can also take action. You can join us in pushing back before VRBPAC and ACIP meet again in June regarding this proposal by contacting your elected officials today to tell them to reject this dangerous proposal and hold the FDA and CDC accountable if they do succeed. ICAN also intends to legally challenge this proposal if it is adopted but let’s hope that won’t be necessary.

Source: icandecide.org

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Aborted fetal cells: It is now clear who is actually spreading “myths.”

FDA Incompetence and Ammunition Against Senator Richard Pan in One Fell Swoop

Because politicians and other high profile individuals were claiming that vaccines do not contain aborted fetal material, ICAN made a simple request to the FDA for “[d]ocuments sufficient to show that the MMR, Varicella and Hepatitis A vaccines contain material from the cell line of aborted fetal tissue.”

After 238 days, the FDA finally confirmed that there is material from aborted fetal tissue in these vaccines by referring ICAN to the package inserts for these products.

With that admission, someone should inform Dr. Richard Pan (California State Senator) and Stephen Sweeney (former New Jersey State Senator and Senate President), because both of them asserted that vaccines do not contain such aborted fetal material, including during their quest to eliminate religious exemptions to vaccination!

Dr. Pan even stated on the floor of the California Senate that “vaccines are not made from aborted fetal cells, that unfortunately is a myth” and that “the continuing production of those vaccines do not involve aborted fetal cells.” Dr. Pan’s website similarly states that it is a “MYTH” to claim that aborted fetal tissue or cells are present in the vaccines.

It is now clear who is actually spreading “myths.”

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Source: https://www.icandecide.org

Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for “fair use” for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational or personal use tips the balance in favor of fair use.