Children’s Health Defense Files CITIZEN PETITION Urging FDA to Revoke COVID Vaccine Licenses After Evidence Agency Violated Its Own Approval Rules — Here’s How Americans Can Submit Comments

Children’s Health Defense (CHD) has filed a sweeping Citizen Petition demanding that the U.S. Food and Drug Administration (FDA) immediately revoke the biologics licenses for all Pfizer-BioNTech and Moderna COVID-19 vaccines — Comirnaty, Spikevax, and their licensed analogues.

CHD alleges that the Biden-era FDA broke its own laws, bypassed mandatory safeguards, ignored manufacturing violations, and labeled experimental EUA products as “fully licensed vaccines” without the clinical, manufacturing, and regulatory compliance required under federal law.

According to CHD, the public, including doctors, nurses, parents, service members, and anyone affected by the mandates, may now submit comments directly to the FDA docket and demand the agency follow the law.

This petition could become the most consequential public challenge to COVID-19 vaccine licensure since 2020.

CHD CEO Mary Holland, a co-author of the petition, stated bluntly:

“The FDA granted full licensure to these vaccines without requiring the manufacturers to meet the legal standards that typically govern licensed vaccines.”

Holland said CHD initiated the petition after investigators discovered that under the Biden administration, the FDA “violated its own rules egregiously” by greenlighting Pfizer’s and Moderna’s BLA applications despite known deficiencies.

She added:

“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.”

The petition seeks a sweeping remedy: revoke the BLA licenses for all Pfizer-BioNTech and Moderna mRNA injections and re-designate them as Emergency Use Authorization (EUA) products as long as the federal PREP Act emergency declaration remains in effect.

According to the petition:

The most egregious of the FDA’s violations is that the only human clinical studies for COVID-19 vaccines were conducted under an EUA pathway that lacked IRB oversight and were not legally compliant clinical investigations.

In addition, ample evidence points to the FDA’s continual waiver of most (if not all) normally applicable BLA standards, such as cGMP/cGLP compliance in R&D and manufacture of these products.

COVID-19 vaccines that the FDA authorized for market under an EUA pathway in December 2020 jumped tracks without satisfying requisite standards to become BLA-labeled (Pfizer, August 23, 2021, and Moderna, January 31, 2022).

By law, manufacturing practices and the data collected while under an EUA status can never satisfy regulatory and statutory BLA standards, as legal investigational pathway standards are explicitly made inapplicable to the non-investigational uses of products (under EUA).

In a court declaration, Peter Marks, then head of the FDA’s Center for Biologics Evaluation and Research (CBER), correctly stated that, “products approved under BLAs are required to have the labeling that was approved as part of BLA.”

These COVID-19 vaccines were manufactured under EUA standards, without clinical trials, and without continuous compliance with BLA labeling standards. They cannot remain in interstate commerce because they are, in fact, misbranded products. By law, their licenses must be revoked.

In 2025, both Comirnaty and SPIKEVAX labels have been substantially revised with indication and usage restrictions, and additional warnings for myocarditis/pericarditis.

These actions were warranted; however, they do not rectify the underlying mislabeling violations described herein. This Petition is not arguing about the safety or efficacy of marketed COVID-19 mRNA vaccines, but rather violations of BLA labeling standards under the law.

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.

A Citizen Petition legally obligates the FDA to respond, something it cannot simply ignore.

CHD’s legal counsel Ray Flores described the petition as:

“The focal point for exposing COVID-19 vaccines… The burden is now on the FDA to justify its actions or correct them.”

If you believe the FDA must follow the law, submit your comment TODAY. You can leave your comment here: https://www.regulations.gov/commenton/FDA-2025-P-6831-0001

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