BREAKING: CHD Accuses FDA of “Unlawful Licensing,” Demands Revocation of All Pfizer and Moderna COVID Vaccines

A new CHD petition accuses the FDA of sweeping regulatory violations and urges the public to help pressure the agency through mass comment submission.

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Children’s Health Defense has filed a detailed Citizen Petition stating that the U.S. Food and Drug Administration departed from its own biologics licensing standards when granting full approval to Pfizer and Moderna’s COVID-19 vaccines.

The filing argues that the mRNA products should not have received full licensure and calls for them to be reclassified under emergency-use authority.

CHD leaders, including CEO Mary Holland, are urging Americans, from healthcare professionals to parents and military personnel, to submit comments to the FDA in what they hope will be a large-scale public response.

Children’s Health Defense (CHD) is asking the U.S. Food and Drug Administration (FDA) to revoke the licenses for all Pfizer-BioNTech and Moderna COVID-19 vaccines.

On Monday, CHD filed a Citizen Petition with the FDA and is urging the public, including healthcare workers, parents and military members, to submit comments on the petition.

“The FDA granted full licensure to these vaccines without requiring the manufacturers to meet the legal standards that typically govern licensed vaccines,” said CHD CEO Mary Holland, a co-author of the petition. “It’s critical that the FDA follow its own rules.”

Holland said CHD launched the petition after an investigation determined that under the Biden administration, the FDA “violated its own rules egregiously” by granting biologics licenses to the Pfizer and Moderna vaccines.

“CHD is supporting the transparency and integrity at the FDA that the American people deserve, and that U.S. Health Secretary Robert F. Kennedy Jr. has promised,” she added.

The petition, based on research by pharmaceutical and medical device industry veteran Sasha Latypova, asks FDA Commissioner Martin A. Makary to determine that the two mRNA vaccines — Comirnaty and Spikevax — are misbranded and adulterated.

A Citizen Petition is a formal request to the agency to take regulatory action. Citizen Petitions, typically submitted by an organization, require extensive documentation of the issue and the legal basis for the claim.

In its petition, CHD outlines how the experimental vaccines passed through the regulatory process and were granted full Biologics License Application (BLA) approval without meeting the required standards for that approval.

Latypova was the first to break the story that the vaccines won BLA approval without meeting the proper licensing standards. She told The Defender:

“It is important to point out that this petition is not about science, safety or efficacy of these products. We focus on the law and pharmaceutical regulations, and we outline many severe violations of the BLA standards that require immediate action by the FDA.”

The petition calls on the FDA to properly designate the shots as emergency use authorization (EUA) shots for as long as the U.S. Department of Health and Human Services (HHS) Declaration of Emergency, issued and repeatedly renewed under the Public Readiness and Emergency Preparedness Act, or PREP Act, remains in effect.

Currently, the emergency declaration is set to last until the end of 2029.

Read the full petition and cover letter here.

‘EUA vaccines cannot be merely marketed under a BLA label’

Both Pfizer’s Comirnaty and Moderna’s Spikevax were initially developed and deployed under EUA early in the COVID-19 emergency period.

Drugs made available under EUA don’t have to meet the same rigorous manufacturing, testing and clinical trial requirements mandatory for drugs that receive full BLA approval — the process the agency uses to license “biologics,” defined as medications created from living organisms. Vaccines fall under the FDA’s definition of a biologic.

The petition alleges the FDA allowed the vaccines to “jump tracks,” by transitioning them from EUA status to full licensure without requiring Pfizer or Moderna to perform the types of clinical investigation normally required for new, BLA-approved drugs.

“EUA vaccines cannot be merely marketed under a BLA label, however,” the petition states.”There are licensing standards that need to be met but are not.”

In the race to roll out the vaccines to the public during Operation Warp Speed, the FDA waived critical, legally required components of BLA compliance, the petition states. These critical components include Institutional Review Board (IRB) oversight, documented informed consent, validated manufacturing processes, good laboratory practice in preclinical testing and representative clinical trial data.

“The U.S. law permits EUA products to be adulterated and misbranded under the PREP Act declaration of public health emergency,” Latypova said. However, she added:

“Misbranding BLA products is a severe violation of the federal law. By claiming that these substandard, demonstrably misbranded and adulterated products are ‘BLA licensed vaccines,’ the FDA is abrogating its duty and continues to deteriorate what is left of the public trust in health regulations in the U.S.”

The petition notes that since the drugs first won BLA licensure, both Pfizer’s Comirnaty and Moderna’s Spikevax labels have had to be “substantially revised” with indication and usage restrictions, and the companies had to add warnings for myocarditis and pericarditis.

During the pandemic, the FDA authorized the vaccines for people ages 6 months and older. Today, they are licensed for more limited groups. Moderna’s Spikevax is licensed for adults age 65 and older, and for everyone 6 months to 64 years old who has at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

Pfizer’s shot is licensed for adults 65 and older, and people ages 5 through 64 with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

FDA ‘failed to follow its own regulatory guidelines’

CHD’s petition alleges the FDA “failed to follow its own regulatory guidelines when it illegally granted BLAs to COVID-19 mRNA vaccines.”

According to the petition, leaked European Medicines Agency (EMA) documents from late 2020 — documented by The BMJ — indicate that European regulators issued “three Quality Major Objections” to Pfizer’s manufacturing process, which made the vaccine maker out of compliance with existing regulations.

The leaked documents showed discrepancies between the material used to make the shots tested in the Phase 3 clinical trial and the final product intended for commercial distribution.

Email correspondence between EMA staff, senior agency executives and colleagues at the FDA revealed that U.K. regulators “were under massive political pressure to overlook all regulatory deficiencies,” and that concerns raised by staff reviewers were ignored or overlooked.

The CHD petition also alleges:

• Pfizer’s trial data cannot lawfully serve as the basis for BLA labeling because clinical-trial batches were produced through a different process than those later used for the commercial batches, and because the clinical trials had large data gaps — they lacked clear efficacy endpoints and participants were unblinded.

• Pfizer and Moderna initiated human testing before completing nonclinical assessments that, by law, must precede human dosing for novel biologics.

• The toxicology and biodistribution studies for the Pfizer and Moderna vaccines didn’t follow Good Laboratory Practices, and sometimes relied on surrogate mRNA constructs that were used as a stand-in for the final vaccine formulations.

• Moderna’s only biodistribution study was conducted exclusively on male rats, but the vaccine is approved for use in all sexes. Those studies also found statistically significant skeletal abnormalities in the offspring of animals exposed to Moderna’s vaccine — findings that merit further investigation before licensure.

• Because the vaccines were treated as EUA countermeasures rather than new products under investigation, the trials did not involve IRB oversight or the type of informed consent procedures required under U.S. law for a clinical investigation.

The petition cites public FDA advisory committee discussions and a declaration by former FDA official Dr. Peter Marks, in which officials explicitly stated that the vaccines would not use the typical investigational regulatory pathways, because they didn’t want Operation Warp Speed to be limited by the requirements of IRB and informed consent.

• The vaccines — labeled today as fully licensed — are in fact EUA products “in disguise,” bearing BLA labels without satisfying the statutory standards those labels require.

An EUA product cannot be retroactively deemed BLA-compliant, so the FDA must withdraw all current licenses and take corrective action to bring the vaccines into alignment with federal law. The petition cites a history of federal court cases that have distinguished EUA and BLA products.

According to the petition, the American public assumes that licensed vaccines satisfy strict manufacturing, testing and disclosure standards, and that the FDA’s actions during the pandemic compromised these expectations.

“Reversing these licensures or granting EUA status is imperative,” the petition states. “Acting on this Citizen Petition will enhance the FDA’s credibility with the public. Given the obvious safety, effectiveness, labeling, and branding concerns over mRNA COVID-19 vaccines detailed above along with anticipated comments on this docket, we respectfully appeal to the FDA to implement the actions requested in this Citizen Petition.”

CHD calls on the public to submit comments on FDA’s website

The FDA is now obligated to review the petition and respond within 180 days, although the agency may extend that timeline.

In the meantime, CHD said it hopes that hundreds of thousands of people will read the petition on the FDA’s website, and express their support — sharing their thoughts and experiences.

Attorney Ray Flores, outside counsel to CHD and one of the petition’s signatories, said the petition should “become the focal point for exposing COVID-19 vaccines.”

He said that, like a Substack post or other social media, people can upload comments with supporting documents or can voice their support with personal anecdotes.

“Since it is CHD’s desire to correct rather than sue, and not to depend on the courts at this time, the Citizen Petition places the burden on the FDA itself to justify and correct its actions,” Flores said.

Holland called on the public for support.

“I hope the public will join the call for the agency to fulfill its critical mission and that the FDA will remove the licenses, and restore the EUA for these products if it chooses to keep them on the market.”

Brenda Baletti, Ph.D.

Brenda Baletti, Ph.D., is a senior reporter for The Defender. She wrote and taught about capitalism and politics for 10 years in the writing program at Duke University. She holds a Ph.D. in human geography from the University of North Carolina at Chapel Hill and a master’s from the University of Texas at Austin.

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