FDA Director Violated the Agency’s COVID-19 Vaccine EUA Conditions

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  • Source: UncoverDC
  • 09/19/2023

The U.S. Food and Drug Administration (FDA) has repeatedly violated the conditions it established when issuing and reissuing the ongoing Emergency Use Authorizations (EUA) for the experimental COVID-19 mRNA injections. Specifically, the agency has, on numerous occasions, failed to follow its "Conditions Related to Printed Matter, Advertising, and Promotion" by claiming the jabs are "safe and effective" and by neglecting to include a disclaimer that "clearly and conspicuously" states that these gene-therapy products have not been licensed as safe and effective.

On August 31, 2022, the FDA amended the EUAs of the Moderna and Pfizer-BioNTech COVID-19 jabs to authorize bivalent formulations of the shots for use as a single booster dose at least two months following primary or booster vaccination. Those amended EUAs were reissued on October 12, 2022, and state the following regarding printed matter, advertising, and promotion: 

All descriptive printed matter, advertising, and promotional material relating to the use of the Pfizer-BioNTech COVID‑19 Vaccine or Pfizer-BioNTech COVID‑19 Vaccine, Bivalent, clearly and conspicuously shall state, as applicable, that:

  • The Pfizer-BioNTech COVID‑19 Vaccine has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older, in individuals 5 through 11 years of age, or in individuals 6 months through 4 years of age as appropriate; or
  • The Pfizer-BioNTech COVID‑19 Vaccine, Bivalent has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 5 years of age and older; and
  • The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

For many months Twitter, the mainstream media, and other social media platforms have narrow-mindedly pushed the dictatorial vaccine narrative supplied by the Biden administration as, like the EUAs, the COVID-19 "public health emergency" continues to be renewed. These big-pharma-funded censorship outlets have embarked on an all-out war against those who bravely dare to speak up and discuss the significant health dangers resulting from the unprecedented COVID-19 jab campaign. Indeed, these courageous beacons of truth have been permanently canceled and blocked for posting so-called COVID-19 "vaccine misinformation." And this is occurring even though they have concrete evidence to support their claims.


Remarkably, the FDA is not the only taxpayer-funded government agency to violate the COVID-19 vaccine EUA. The enormous depth of the tyranny at play in this great nation—as pointed out by Del Bigtree's Informed Consent Network (ICAN)—was also illustrated by CDC Director Rochelle Walensky. On June 18, 2022, Walensky ignored the rules when she posted the above tweet of herself discussing the CDC's (heartwrenching) recommendation of the COVID-19 shots for children under five. Walensky falsely stated in the tweet:

"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."

She added:

"We have taken another important step together on our fight against COVID-19 by making safe and effective vaccines available for our little ones."

On June 23, 2022, calling out the fact that the COVID-19 jabs have not been found to be safe and effective, ICAN reported:

"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."

Following CDC Director Walensky's blatant public deception and EUA regulation violation when speaking about the COVID shots, ICAN emphasized on November 10, 2022, that Dr. Peter Marks, the Director of the FDA's vaccine division—and the leader at FDA who signed and approved the EUAs for the COVID-19 jabs—also violated the terms of the EUAs. 

In early November, Dr. Marks released two videos (above) titled "Why should I get my COVID-19 vaccine now?" and "Why should I get my child an updated COVID-19 vaccine?" Both FDA-sponsored videos promote EUA COVID-19 jabs. Yet again astonished by the hypocrisy, a stunned ICAN exclaimed:  

"Amazingly, in violation of the FDA's EUAs signed by Dr. Marks himself, neither promotional video includes the language legally required as a condition of the EUA — that these products have not yet been approved or licensed as safe and effective. 

Meaning, the FDA itself is violating its own core condition for its EUAs of COVID-19 vaccines." 

On November 9, 2022, Aaron Siri, ICAN's attorney, wrote a letter to Dr. Marks "demanding he "immediately remove" the videos and requesting that he "explain why a Director within the FDA would violate its own EUA conditions." Siri added, "ICAN looks forward to your prompt response."

Unlike Dr. Anthony Fauci, Dr. Peter Marks has remained meticulously out of the spotlight. Nonetheless, he played a pivotal role in the early pandemic effort to mass produce COVID-19 "vaccines." According to an October 26, 2020, Fierce Pharma article titled "The 22 most influential people in the fight against COVID-19," Marks—who was "tasked with making sure any shot that reaches the arms of Americans is safe and effective"—may very well be "the most important person in the closely watched COVID-19 vaccine review process." Indeed, his ideas became the "multibillion-dollar federal program Operation Warp Speed (OWS)" that supported many vaccine candidates, including the Pfizer and Moderna mRNA jabs.

After OWS got underway, Fierce Pharma stated Marks stepped away from the vaccine development process to focus on his regulatory role. However, with the incredible lack of transparency behind Pfizer's jab, and the growing list of injuries and even death from the COVID-19 injections, it seems critical that Marks immediately respond to Aaron Siri's letter surrounding the FDA's EUA regulatory violations.

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