Children’s Health Defense (CHD) has made a significant move by filing a Citizen Petition to the U.S. Food and Drug Administration (FDA), calling for the revocation of the biologics licenses for Pfizer-BioNTech and Moderna’s COVID-19 vaccines, which are marketed as Comirnaty and Spikevax. This petition raises serious allegations against the FDA, asserting that the agency has broken its own laws by sidestepping critical safeguards, neglecting manufacturing violations, and misleadingly labeling Emergency Use Authorization (EUA) products as fully licensed vaccines without fulfilling necessary regulatory requirements.
CHD’s approach indicates a crucial shift in how the public engages with vaccine oversight. The organization argues that the FDA acted improperly, stating that the vaccines were granted full licensure without the manufacturers meeting the legal benchmarks typically expected of licensed vaccines. Mary Holland, the CEO of CHD and a co-author of the petition, said plainly, “The FDA granted full licensure to these vaccines without requiring the manufacturers to meet the legal standards that typically govern licensed vaccines.” This statement underscores the perceived shortcomings of the FDA under the Biden administration, with CHD emphasizing the need for transparency and integrity in federal health regulations.
The petition addresses the underlying legal framework surrounding the vaccines. It argues that the FDA should revoke the licenses and revert the vaccines back to EUA status for as long as the federal emergency declaration is in effect. Such a move would not only impact the vaccines themselves but could also represent the most significant public challenge to COVID-19 vaccine licensure since the onset of the pandemic.
The substantial allegations laid out in the petition highlight key violations by the FDA. The document notes that the clinical studies for the vaccines were conducted under an EUA pathway, which did not comply with the necessary institutional review board (IRB) oversight. It also points out that the standards required for biologics licensing applications (BLAs) were not satisfied, raising questions about the legality of the FDA’s approvals. Peter Marks, a former head of the FDA’s Center for Biologics Evaluation and Research, acknowledged that products must have the labeling that was approved as part of their BLA, yet the vaccines were cleared under EUA standards before meeting these protocols.
Additionally, CHD emphasizes concerns regarding the manufacturing processes used for the clinical trial batches compared to the current commercial versions. The petition states that the trial data should not be the basis for BLA labeling due to significant gaps in the data, lack of defined efficacy endpoints, and unblinded participants. Such claims present a serious critique of the processes that led to the COVID-19 vaccines being authorized.
Another point raised is that the biodistribution studies for both Pfizer and Moderna’s vaccines did not align with established Good Laboratory Practices. Concerns about safety are amplified by findings that indicated significant skeletal abnormalities in the offspring of animals exposed to Moderna’s vaccine, which raises alarms about the vaccine’s effects on humans. These elements suggest that the trials did not follow the rigor typically mandated for clinical investigations in the United States.
CHD’s Citizen Petition sets a legal precedent that requires a formal response from the FDA, compelling the agency to justify its licensure decisions. Ray Flores, CHD’s legal counsel, framed the petition as “the focal point for exposing COVID-19 vaccines.” This declaration indicates that the organization believes in holding the FDA accountable for its actions and decisions, emphasizing a legal avenue for public concern and scrutiny.
In considering this petition, it is vital for individuals touched by the vaccine debate—doctors, parents, service members, and others—to understand their right to comment and engage with the FDA. The avenue for public commentary not only empowers individuals but serves as a means to foster accountability in health governance. By submitting comments, citizens can express their expectations for regulatory compliance and transparency around these critical health interventions.
The CHD Citizen Petition undeniably marks a pivotal moment in the ongoing discussion surrounding COVID-19 vaccines, bringing to the forefront legal, ethical, and safety concerns that demand careful consideration and response from the FDA. It represents a call for clarification amid a complex landscape where rapid vaccination efforts have significantly shaped public health policy and individual lives.
"*" indicates required fields
