Tag Archives: FDA Safety Surveillance of COVID-19 Vaccines

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.

To share this legal update, please use this link: https://www.icandecide.org/ican_press/cdc-director-violates-fdas-emergency-use-authorizations-and-posts-misinformation-about-covid-19-vaccines/

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YOU DID NOTHING: TRUTH BOMB ON FDA

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Pfizer Documents reveal at least 800 people never finished the COVID Vaccine Trial due to Death, Injury or Withdrawn Consent ~

https://expose-news.com/2022/06/15/pfizer-documents-800-people-never-finished-trial/

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Jab Data is In: Children Are Going to Die, Pfizer, Moderna Release Study Results for kids 6mo-4 yrs

On Friday, June 3rd’s edition of The Stew Peters Show, Dr. Jane Ruby presents Pfizer documents that expose the under 50% efficiency of vaccines from ages 6 months to 2 years old.

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The Marburg pathogen: It will be the excuse used to force the unvaxxed into quarantine camps (FEMA) where kill-shots will be administered.

Todd Callender joined the The Prather Point to discuss the next Plandemic (the Marburg pathogen_. It will be the excuse used to force the unvaxxed into quarantine camps (FEMA) where kill-shots will be administered. — https://www.bitchute.com/video/4ajhXs6ykjhs/

Todd Callender joins the The Prather Point to discuss the next PLANdemic (the Marburg pathogen), which will be the excuse used to force the unvaxxed into quarantine camps (FEMA) where kill-shots will be administered.

He also says that those who received the Covid shots already have the dormant Marburg virus encapsulated in lipid nanoparticles, which can be activated via 5G frequencies. Those who have Marburg will then become zombie-like, because it affects frontal cortex brain function.

Coming Marburg, 5G & Mind Control – Maria Zeee w/ Todd Callendar and Dr. Peter Chambers (48:23)
https://www.bitchute.com/video/3GGXZS3uvz2t/

Nov. 28, 2021 Swiss Referendum – NO to Green Pass – Marburg Virus is the Next Planned Pandemic (52:18)
https://www.bitchute.com/video/Z8QN90S8DZa5/

Source: AgentOfChange

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MONKEYPOX – WE HAVE TWO DAYS TO PROVE TO EVERYBODY THAT THIS IS AN AGENDA AGAIN! – DR DAVE MARTIN

Fauci’s NIAID Received $10M MONKEYPOX Research Grant Last Year: Report https://www.youtube.com/watch?v=HEWSPTnNeb4

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This is a serial killer

This is a serial killer

She KNOWS what she’s doing, that’s the scary part of it

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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.”

To share this legal update, please use this link: https://www.icandecide.org/ican_press/fda-incompetence-and-ammunition-against-senator-richard-pan-in-one-fell-swoop/

Source: https://www.icandecide.org

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#SCIENTIFICFRAUD: PFIZER AND CDC COMMITTED FRAUD

PFIZER AND CDC COMMITTED FRAUD BY WITHHOLDING CRITICAL DATA RESULTING IN HARM AND DEATH TO MILLIONS!

There are people out in the world that legitimately believe that they need me to get a vaccine in order for their 4 vaccine shots to work.

I randomly think about that sometimes and laugh out loud – Candace Owens.

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.