The mRNA-based Covid-19 vaccines were not developed, manufactured, or distributed under traditional regulatory frameworks that govern drug approval in the United States. Instead, they were made available under Emergency Use Authorization (EUA) and the Public Readiness and Emergency Preparedness (PREP) Act, legal tools originally created for Chemical, Biological, Radiological, and Nuclear (CBRN) emergencies. These frameworks were designed for situations resembling war or terrorist attacks involving weapons of mass destruction—not for routine public health drug development. So then, should we classify the PLANDEMIC as a terrorist attack?
- EUA and PREP Act framework – COVID-19 mRNA vaccines were developed, manufactured, and distributed under Emergency Use Authorization (EUA) and the PREP Act, legal structures designed for wartime or terror-related emergencies, not for standard civilian drug approval or regulated clinical trials.
- Absence of regulatory oversight – Unlike conventional medical products, EUA/PREP Act countermeasures face no enforceable requirements for regulatory oversight, safety testing, clinical trials, or systematic data collection. Any trials or reporting by manufacturers are voluntary.
- No liability or accountability – Manufacturers, distributors, and administrators are granted broad legal immunity under the PREP Act, meaning even if safety signals emerge or harm occurs, no legal liability applies as long as the emergency declaration remains active (currently extended to 2029).
- Invalidity of “safe and effective” claims – Since EUA does not generate scientifically valid data on safety or efficacy, and products were never subject to non-emergency approval pathways, claims about COVID-19 mRNA vaccine effectiveness and safety cannot be based on regulated scientific standards.
mRNA Vaccines DID NOT UNDERGO a Legally Regulated Drug Approval or Manufacturing Process
The EUA pathway is not part of the drug approval process, as clearly stated in a 2009 Institute of Medicine publication. It was never designed to demonstrate product safety or effectiveness, but rather to expedite access to medical countermeasures during emergencies. The PREP Act further shields all parties involved—manufacturers, distributors, and healthcare providers—from legal liability tied to these products. Combined, these mechanisms allow products to reach the public without meeting the standards normally required for drug development, approval, or oversight.
Manufacturing contracts for the Covid vaccines were handled through Pentagon Other Transaction Agreements (OTAs), which are military-style procurement contracts used to bypass conventional oversight and speed deployment of technology. These contracts, by design, are exempt from civilian regulatory frameworks.
Lack of Regulatory Oversight
Under this system, there was no legally binding requirement for:
- Clinical trials conducted under FDA or international standards
- Institutional Review Board (IRB) oversight to protect human subjects
- Systematic collection and publication of safety or efficacy data
- Regulatory inspections or compliance with manufacturing standards
Any studies, trials, or data collection were voluntary and under the full control of manufacturers. Therefore, claims regarding safety and effectiveness were based on promotional assertions rather than legally validated scientific evidence.
Implications for Safety and Accountability
Because EUA and PREP Act provisions insulate all parties from liability, there is no enforceable obligation to investigate safety signals, follow up on adverse events, or adjust product deployment based on new findings. Even if evidence of harm emerges, no manufacturer or distributor can be held legally accountable while the PREP Act declaration remains in effect.
This raises profound questions about how regulators, health officials, and journalists discuss the Covid vaccines. Descriptions of these products as “safe and effective” ignore the reality that they have never been subjected to the legally regulated drug development process. Furthermore, the PREP Act declaration currently extends until December 2029, meaning this framework will remain in place unless the HHS Secretary revokes it.
Key Questions Moving Forward
To engage honestly with the issue, regulators and public health authorities should be asked:
- Why were products designed for battlefield emergencies deployed to billions of civilians under EUA?
- How can claims of safety and effectiveness be substantiated without regulated trials?
- Should mRNA products now undergo traditional approval pathways outside of EUA/PREP Act coverage?
- Why are recipients not explicitly informed that these remain unapproved emergency-use countermeasures?
In sum, the Covid mRNA vaccines bypassed the standard legal and regulatory process for drug approval. They remain shielded under emergency wartime provisions, leaving unresolved questions about safety, effectiveness, accountability, and informed consent. Bookmark Infections.news to get the latest updates about the engineered plandemics that the military use against civilians to control the populace illegally and immorally.
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