AUSTIN, Texas (PNN) - September 7, 2025 - mRNA vaccines did not undergo a legally regulated drug approval or manufacturing process.
All mRNA products on the market and in development today became available as a result of the declared COVID-19 pandemic - which was nonexistent - through legal pathways intended for CBRN (chemical, biological, radiological, nuclear) emergencies - in other words, war or terror incidents involving weapons of mass destruction (WMD).
These WMD-related laws include EUA and blanket legal indemnity granted through the PREP Act.
The manufacturing agreements for the COVID-19 mRNA “vaccines” were military Other Transaction Agreements (OTA) signed by The Pentagon. This type of “other than contract” agreement is intended to supply the military with cutting-edge technology while bypassing pesky regulations and red tape. It is not intended for civilian use.
These laws and contractual instruments do not require any regulatory oversight for the development, manufacture, distribution or administration of countermeasures covered under the EUA and PREP Act. Any oversight activities, clinical investigations or reporting of trial methods/practices/results are entirely voluntary on the part of the developers/manufacturers.
In other words, any trials, inspections, experiments or other activities carried out on these products do not have to comply with any safety standards, laws or regulations that apply to the development of non-emergency medical products.
This is not speculation or interpretation. It is the letter of the law.
According to these laws and the OTA contracts, the developers/manufacturers of the countermeasures are solely responsible for conducting whatever trials or experiments they choose, under whatever conditions they want, with whatever reporting standards they decide to follow. There is no enforceable legal or regulatory oversight on any of these activities.
Therefore, any claims about the products made by the manufacturers are not based on clinical trials conducted according to regulatory guidelines or scientific standards and cannot be the basis for regulatory approval under non-EUA drug development frameworks.
This is stated very clearly in the quote at the beginning of this article, which I will repeat here. (It was brought to light by Katherine Watt, who has done the most thorough and extensive research on these and related laws).
It is important to recognize that an EUA is not part of the development pathway; it is an entirely separate entity that is used only during emergency situations and is not part of the drug approval process. (2009 Institute of Medicine of the National Academies, p. 28)
Here is how the FDA and CDC explain what EUA means, compared to other “Access Mechanisms” for medical products.
The process of granting EUA is not likely to generate any information about a product’s effectiveness.
The process of granting EUA is not designed to provide evidence of safety or effectiveness, but safety signals might be identified.
It is unlikely that, once a product is granted EUA and administered to some patients, any useful information will be obtained to benefit any future patients.
There is no systematic data collection on effectiveness or safety with EUA, and no data are published in medical journals as part of the regulatory approval process.
No informed consent is required, but patients who “volunteer” to take the product must be told they can refuse and that the product is unapproved/available under EUA.
No institutional review board (IRB) is required. [IRB is a board that is supposed to protect the well-being of human subjects in clinical trials.]
One important note: The last line in this table references “access to investigational product” which legally applies only to the “Clinical Trial” and “Expanded Access” categories. The term “investigational” is misapplied in the case of EUA, because EUA precludes legally binding investigation, and only covers countermeasures which, by definition, are non-investigational. I know this sounds extremely convoluted to the point of absurdity, but that is how these laws are (I would contend intentionally) written, to confuse and obfuscate.
Here is what this means in terms of potential harm caused by these products, and the ability to hold anyone legally accountable for them.
The process through which the products were developed and manufactured was not expected by regulators, lawmakers or anyone else to produce any useful information regarding safety or efficacy. Therefore, any claims related to safety or efficacy were purely promotional and not based on any scientifically valid table data.
There is not, nor has there ever been, any requirement to follow up on any safety signals that may or may not be detected in the process of the unregulated experiments conducted on these products.
Even if safety signals are detected and people are harmed or killed, no one who tests, develops, manufactures, distributes, administers or does anything else related to these products is legally liable.
As long as these products are covered by an emergency PREP Act declaration, this legal framework remains intact.
Given this information about how COVID-19 mRNA “vaccines” were developed and manufactured, any investigation of their potential harms or benefits must necessarily begin with an acknowledgement that they were never subjected to any non-EUA drug development regulations or legal oversight.
In addition, it must be acknowledged that they are still covered by the PREP Act, which is based on a declaration by the HHS Secretary that we are in an emergency, or potential emergency, related to COVID-19. The current PREP Act declaration is in effect until December 2029. The HHS Secretary has the sole discretion and power to end that declaration.
Therefore, when someone sits down to interview a regulator who claims to be undertaking an investigation of COVID-19 mRNA “vaccines” or writes an article about “giving the COVID-19 vaccines a good hard look,” at the very least you should expect the topic of EUA/PREP Act to be mentioned.
