The U.S. Food and Drug Administration is facing its most significant COVID-era legal challenge to date after Children’s Health Defense (CHD) filed a sweeping Citizen Petition demanding that the agency immediately revoke the biologics licenses for Pfizer and Moderna’s mRNA COVID-19 vaccines. CHD alleges the Biden-era FDA violated its own approval rules, bypassed mandatory safeguards, and allowed experimental EUA-standard products to be labeled as fully licensed vaccines—despite failing to meet the legal requirements for licensure.
Background: A Direct Challenge to FDA Authority
CHD’s petition argues that the FDA granted full licensure to Pfizer’s Comirnaty and Moderna’s Spikevax without meeting the statutory standards required for licensed biologics, including:
- Non-compliant clinical trials lacking IRB oversight
- Incomplete or deficient nonclinical assessments
- Manufacturing batches that differed from clinical batches
- Absence of continuous cGMP and GLP compliance required for BLAs
CHD CEO Mary Holland stated that FDA approvals “violated the agency’s own rules egregiously,” greenlighting applications that would have failed under ordinary standards.
The petition further argues that human trials conducted under EUA rules cannot legally be used to support BLA (Biologics License Application) approvals because investigational and emergency pathways are not interchangeable under federal law.
The Evidence: Misbranding and Regulatory Violations
According to the petition, the core violation is simple but consequential:
EUA-produced and EUA-studied products cannot legally be sold as fully licensed vaccines.
CHD asserts:
- The FDA allowed EUA-manufactured batches to be marketed as BLA-approved products.
- Pfizer and Moderna’s clinical trials lacked traditional informed consent protocols because they were treated as EUA countermeasures rather than investigational products.
- Key toxicology and biodistribution studies were incomplete, non-compliant, or performed on substitute constructs that differed from final vaccine formulations.
- Moderna’s studies in male rats revealed skeletal abnormalities in offspring—yet the product was licensed for universal use.
A crucial detail: In 2025, both Comirnaty and Spikevax labels were updated with restricted indications and myocarditis warnings—yet these revisions did not resolve the underlying legal misbranding problem.
Attorney Ray Flores, representing CHD, described the petition as “the focal point for exposing COVID-19 vaccine licensure” and emphasized that the FDA is now legally required to respond.
A Unique Complication: RFK Jr.’s Connection
The situation is politically sensitive.
Children’s Health Defense—formerly led by current U.S. Health Secretary Robert F. Kennedy Jr.—is now challenging an FDA that falls under his own agency.
Kennedy, who endorsed Donald Trump in 2024 and now serves in his administration, has long criticized the FDA’s handling of the COVID vaccines. The petition now forces his department to evaluate and formally respond to an organization he once led.
This is the first direct legal confrontation of its kind during the Trump-Kennedy administration.
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Prophetic Context: Discerning the Times
The COVID era revealed a deep battle over truth, transparency, and medical authority—one Scripture warned would characterize the last days.
Isaiah 59:14 (NASB 1977) declares:
“Justice is turned back, and righteousness stands far away; for truth has stumbled in the street and uprightness cannot enter.”
Many Christians have sensed that government agencies—especially those entrusted with health—have drifted from truth toward political expediency.
The CHD petition exposes what many believe is the fulfillment of Paul’s warning:
Ephesians 5:11 (NASB 1977):
“Do not participate in the unfruitful deeds of darkness, but instead even expose them.”
Whether intentional or not, the FDA’s alleged violations represent a breakdown of institutional integrity at a time when global trust is rapidly eroding—precisely what Jesus described when He warned of deception spreading across the nations (Matthew 24).
Strategic Implications for the American Public
If CHD succeeds:
- The Pfizer and Moderna vaccines could be reclassified as EUA-only products.
- Previous mandates may face new legal scrutiny.
- Ongoing lawsuits may be reopened or strengthened.
- Public trust in federal health agencies—already diminished—may fall even further.
- Congress could intervene, especially given rising bipartisan criticism of the FDA’s pandemic-era decisions.
Perhaps most importantly, this petition may represent the first serious attempt to hold federal regulators accountable for decisions made under emergency pressure—decisions that impacted nearly every American.
Conclusion
Children’s Health Defense has delivered a direct legal and moral challenge to the FDA, asserting that the agency violated its own rules in approving mRNA vaccines under BLA standards. With the petition now officially received, the burden shifts to the FDA—and by extension, the Biden-era regulatory legacy—to justify its actions or correct them.
Regardless of the ultimate outcome, this petition marks a pivotal moment in the post-COVID reckoning now unfolding across science, law, public trust, and prophecy.
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Dr. Ardis Store – Trusted by Thousands, Feared by Big Pharma. Start Your Health Revolution Here
After much research, the following supplements can prevent Covid and other viruses. My family and I mainly follow the protocol of Dr Bryan Ardis. This is only my opinion based on my own family’s success. Please make sure you do your own research and speak with your medical professional before making any changes to your health routine.
EDTA
Glutathion
NAC
Zinc
Vitamin C (Ascorbic Acid)
Vitamin D3
Quercetin
Cats Claw
Nicotine
Bromelain
Curcumin
Dr. McCullough recommends taking this treatment triad for at least three months for anyone suffering from or worried about post-COVID or post-vaccine syndromes.
Nattokinase, Bromelain, and Curcumin are available over the counter at just about any health food store or pharmacy.
Selenium
Dandelion Root
Black Sativa Extract (may facilitate cellular repair)
Green Tea Extract (provides added defenses at the cellular level through scavenging for free radicals)
Irish Sea Moss (could help rebuild damaged tissue and muscle)
In an acute emergency, if you get Covid, Dr Ardis suggests taking low doses of Nicotine in the form of Lozenges, Gum, or Patches for a few days until symptoms subside.
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