Tag Archives: FDA approvals

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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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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DOD and Pfizer Sending Fake Comirnaty Vials to Coast Guard

Dr. Jane Blows open the DOD’s dirty tricks being played on our military as they shuffle and race to ship out Pfizer Biontech EUA vials of God knows what, and slapping on labels with conflicting temperature instructions, untraceable manufacturing origination sites, and made up LOT numbers, many of these vials are showing up at military bases with their internal temperature alarms having gone off, and they’re being told by Ft. Detrick personnel to “just change the expiration dates” randomly.
And in the Natural Health Series, Bee Pollen – what is it and how can it help you remain medically independent and healthy without traditional medicine; and the show concludes with a recap of 3 embalmers – out of many that are pulling never before seen clots out of the jabbed – first seen on the Dr. Jane Ruby show in February.

Pfizer Fraud Exposed: Vaccine Advisory Committee Lied To Get FDA Approval For Babies

REP. JIM JORDAN EXPOSES THE BIDEN ADMIN’S LIES ON VACCINE EFFICACY

23/6/2022 – Watch as Rep. Jim Jordan exposes the Biden Admin’s lies on vaccine efficacy, as Deborah Birx testimony throws a monkey wrench into the narrative.

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YOU DID NOTHING: TRUTH BOMB ON FDA

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Remdesivir: A Child Sacrifice

Child Sacrifice: The FDA Approved Remdesivir Based on a Trial in Which 3 out of 53 Children Died

The trial was conducted by Gilead, the developer of remdesivir, and there was no control group.

The mortality rate of children with no treatment against COVID is 0.005% (1 in 20,000 die).

Based on this trial, the mortality rate of children with remdesivir treatment is 5.66% (1 in 17.7 die).

Dr. Meryl Nass: “Over 70% had an adverse reaction, 21% had a serious adverse event, and three of the children died. Because there was no control group, it’s unclear how either Gilead or the FDA determined that the drug benefited children, because there’s nothing to compare it to.”

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What are the dangers of the Vaccine?

FDA Report – Slide 16

https://thedrardisshow.com/fda-cber-10-2020

Remdesivir and Covid fact checking dhhs

https://thedrardisshow.com/remdesivir-and-covid-fact-checking-dhhs

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The next batch of Pfizer vaccine documents from the FDA has been produced [April 2022]

The next batch of Pfizer vaccine documents from the FDA has been produced (11,043 pages), as well as an unredacted version of the post-marketing experience report

(See page 7): http://phmpt.org/pfizers-documents/

Source: phmpt.org/pfizers-documents/

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FDA Does Not Follow Its Own Advice Regarding Testing

The FDA repeatedly asserts the importance of tracking Covid infections in the workplace, schools, etc., authorizing hundreds of tests and even claiming that “testing remains a cornerstone of the national response to the pandemic and plays a central role in helping Americans get back to work, school and other important activities …”
But it does not appear the FDA follows its own advice in getting its employees back to work.  In February 2022, ICAN, through its attorneys, demanded that the FDA produce documents showing how many FDA employees had COVID-19 in JuneJuly, and August 2021.  The FDA’s response?  Here it is in the FDA’s exact words: “FDA does not collect this information and therefore we have no responsive records.”
So, while companies are often required to track positive Covid-19 cases, the FDA itself is apparently not doing so?!
A marker of an authoritarian government is when its officials enforce requirements on everyday citizens that they themselves do not follow.  As another example, consider that the federal government mandates millions of 2- to 5-year-old children in Head Start programs to wear masks but, yet, look at this image from just a couple of weeks ago:
Shame on all of the politicians who would force a two-year-old to wear a mask all day long while they hobnob, gather and socialize in Congress mask-free.

To share this legal update, please use this link: https://www.icandecide.org/ican_press/fda-does-not-follow-its-own-advice-regarding-testing/

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REGIONAL DIRECTOR FOR PFIZER COVID-19 VACCINE TRIALS BLOWS WHISTLE ON FRAUD BUT FDA SILENCES HER

Mirrored from the BMJ Youtube channel: https://www.youtube.com/watch?v=RaLxhFiOBYk

Brook Jackson blew the whistle on fraud over Pfizer’s COVID-19 vaccine trials, and expected the FDA to respond and correct everything.

The FDA did not even inspect the site, and when she went to the British Medical Journal (BMJ) to publish her report, Facebook marked the BMJ article as fake news through their fact checkers.

This is a typical tactic the FDA has been using for years.

Full article: https://healthimpactnews.com/2022/how-the-criminal-fda-protects-big-pharma-by-controlling-the-media/

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Shocking report released by FDA . . .

Repost by permission from Liberty Counsel Action.

In spite of the shocking report released by the FDA on March 1, MANY are still under pressure, or being forced, to inject the COVID shots. States have a growing number of ways people can provide “proof of their vaccine status” when it is demanded. These “vaccine credentials” are a direct attack on our freedom to travel, work or live independently.

Urge our state and federal leaders with your faxes to protect our freedom and ban Vaccine Passports. — Mat

Now we know why the FDA argued to a federal court that it could only release 500 pages per month, and it would take more than 75 years to release the Pfizer documents it reviewed in a matter of months. The FDA did not want the public to know what’s in these documents.

Thankfully, a federal judge ordered the FDA to release 55,000 pages per month and complete the release in less than eight months.

On March 1, 2022, one document of the 55,000 pages lists 1,291 adverse injuries that Pfizer reported to the FDA.

By Feb. 28, 2021, Pfizer had recorded 158,893 “events,” which are adverse reactions to these shots. This 38-page report included a nine-page, single-spaced appendix that details a “LIST OF ADVERSE EVENTS OF SPECIAL INTEREST.” That list includes “1,291 different adverse events following vaccination.”

This mind-blowing list includes: acute kidney injury, brain stem embolism, brain stem thrombosis, cardiac arrest, cardiac failure, cardiac ventricular thrombosis, cardiogenic shock, central nervous system vasculitis, death neonatal, deep vein thrombosis, frontal lobe epilepsy, foaming at mouth, epileptic psychosis, facial paralysis, fetal distress syndrome, gastrointestinal amyloidosis, generalized tonic-clonic seizure, Hashimoto’s encephalopathy,  interstitial lung disease, jugular vein embolism, juvenile myoclonic epilepsy, liver injury, multisystem inflammatory syndrome in children (MIS-C), myocarditis, neonatal seizure, pancreatitis, pneumonia, stillbirth, tachycardia, Type 1 diabetes mellitus and many other serious conditions.

This is a heartbreaking bombshell for those who believed the narrative of “safe and effective.” And we may only be starting to see the impact this will have on people’s lives.

Even knowing all of this, many states are rolling out electronic credentials or Vaccine Passports to push these shots! It is critical to stop the mandates and Vaccine Passports. Urge state and federal lawmakers: STOP THE VACCINE PASSPORTS AND MANDATES!

But even in the minority of states that don’t already have Vaccine Passports or are actively considering it, Apple has turned all updated iPhones into potential Vaccine Passports. These iPhones (with iOS 15.1 or later) can decipher between “verifiable” proof of COVID injection documentation or not and display this on their screen for every phone user. They used an individualized QR code to verify this for each person just a few months ago.

Android is no better. Google users can store digital versions of their vaccine card through its Chrome or Google Pay apps.

This means that 96% of the world’s phone users already have the technology literally in their hands for a digital Vaccine Passport. At the same time, advocates of Vaccine Passports (who want to control you) have a template to foment mass hysteria. All they need is another excuse to flip the technology switch and lock everyone in their homes who hasn’t taken the “government-approved” action.

MIT’s Technology Review has advocated Vaccine Passports since March 2020.

The reason this concerns me so greatly is that even before COVID, Bill Gates and others bemoaned that they did not have the technology in place to roll out electronic Vaccine Passports. If they had the technology in place, I have no doubt that they would have rammed Vaccine Passports down our throats along with stay-at-home orders, lockdowns, masks, injection mandates and requirements and many other restrictions.

Now they have that technology in place.

Vaccine Passports pose a serious threat to freedom. We have already seen how proof of vaccination has been used in America and around the world to determine if you can work, shop, dine, attend public events or places, and travel.

WE MUST END THE MANDATES AND STOP VACCINE PASSPORTS. Demand that our state and federal lawmakers protect our freedom. STOP VACCINE PASSPORTS AND MANDATES. Send your faxes today.

Last week in the military case in which Liberty Counsel Action is providing research, Lt. Col. Peter Chambers testified. A recipient of the Purple Heart, Chambers wanted to retire in 2023 with 40 years of service. Instead, he will be medically retired this May.

Although a medical doctor, he relied on the “safe and effective” narrative. He trusted his government. After taking the Moderna shot, he developed demyelination, which is a serious neurological disease. In a dramatic moment on the stand, he pointed to the document released by the FDA on March 1, and there it is—one of the 1,291 adverse injuries from the shots is demyelination.

While an AK-47 fired by a terrorist could not stop this Green Beret in Afghanistan, Moderna did.

We must stop this insanity. Stop the mandates. Stop the Vaccine Passports!

Help defend freedom and DOUBLE YOUR DONATION with our 2022 Challenge Grant for your recurring or one-time gift today.

Please pray for our military as we continue to assist in their defense for religious freedom.

Sincerely,

Mat Staver, Chairman
Liberty Counsel Action

Sources:

“COVID-19 Vaccine Surveillance Report Week 36.” England Public Health. September 9, 2021. Assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1016465/
Vaccine_surveillance_report_-_week_36.pdf.

“CUMULATIVE ANALYSIS of POST-AUTHORIZATION ADVERSE EVENT REPORTS of PF-07302048 (BNT162B2) RECEIVED through 28-FEB-2021.” 2021. Pfizer: Worldwide Safety. Approved April 30, 2021. Phmpt.org/wp-content/uploads/2021/11/5.3.6-postmarketing-experience.pdf.

Greaney, Alec. “COVID Vaccine Proof Can Now Be Added to IPhone’s Apple Wallet. Here’s How.” NBC New York. Accessed March 17, 2022. Nbcnewyork.com/news/coronavirus/covid-vaccine-proof-can-now-be-added-to-iphones-apple-wallet-heres-how/3358178/.

Melville, Shawn Paul. 2022. “BREAKING: Stunning ‘Adverse Events Data’ Released from Pfizer’s COVID-19 Vaccine Trials Today!” Civilian Intelligence Network 3.0. March 1, 2022. Civilianintelligencenetwork.ca/2022/03/01/breaking-stunning-adverse-events-data-released-from-pfizers-covid-19-vaccine-trials-today/.

“Resources & Research: COVID Vaccine.” Liberty Counsel Action, 2021. Lcaction.org/vaccine.

Sterling, Greg. 2015. “Report: Apple, Android Now 96 Percent of Smartphones Globally.” 2015. MarTech. February 24, 2015. Martech.org/report-apple-android-now-96-percent-smartphones-globally/.

‌Toledo, Arsenio. “Fully Vaccinated and Boosted Make up Vast Majority of COVID-19 Cases, Hospitalizations and Deaths in the UK.” Natural News. March 11, 2022. Naturalnews.com/2022-03-11-fully-vaccinated-majority-covid-cases-hospitalizations-deaths.html.

P.S. Send faxes to STOP VACCINE PASSPORTS AND MANDATES and sign our petition.

Then, effectively DOUBLE your gift with our Challenge Grant.

Liberty Counsel Action is a 501(c)(4) tax-exempt non-profit organization. Donations are not tax deductible.

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