Debbie Lerman asks a pertinent question: What do you believe the claims of “safe and effective” for mRNA products are based on?

Outside of a war or terror incidents involving weapons of mass destruction, covid injections were the first mRNA products to be “approved” using a legal mechanism intended for countermeasures to chemical, biological, radiological and nuclear emergencies.

Called the Emergency Use Authorisation (“EUA”), this authorisation process is separate from and not part of the drug approval process.  Yet the covid “vaccines” were widely touted as “safe and effective” as if they had undergone the rigorous testing and safety monitoring that is required under laws regulating drugs.

The “safe and effective” mantra was a marketing slogan, not based on evidence.  All mRNA products must be viewed in this context.

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Covid mRNA Vaccines Are Unregulated Military Countermeasures

Note from the Author: Please try to post the title of this article and perhaps the first paragraph or two on various social media platforms. It has come to my attention that “countermeasures” is a highly censored term, and I would love your help in testing this. Please share your experiences in the comments section [of my article on Substack].

By Debbie Lerman, 21 August 2025

mRNA Vaccines DID NOT UNDERGO a legally regulated drug approval or manufacturing process

“It is important to recognise 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 publication, p. 28

All mRNA products on the market and in development today became available as a result of the declared covid pandemic, 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 Emergency Use Authorization (“EUA”) and blanket legal indemnity granted through the PREP Act.

The manufacturing agreements for the covid 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.

No Regulatory Oversight = No Scientifically Valid Claims

These laws and contractual instruments do not require any regulatory oversight for the development, manufacture, distribution or administration of countermeasures covered under EUA and PREP Act. Any oversight activities, clinical investigations or reporting of trial methods, practices or results are entirely voluntary on the part of the developers or 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. These articles will walk you through the convoluted legalese:

• What is EUA?
• What is the PREP Act?

According to these laws, and the OTA contracts, the developers or 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 recognise 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 publication, p. 28

Here’s how the Food and Drug Administration (“FDA”) and the Centres for Disease Control and Prevention (“CDC”) explain what EUA means, compared to other “Access Mechanisms” for medical products:

Here’s what this table tells us about EUA:

1. The process of granting EUA is not likely to generate any information about a product’s effectiveness.
2. The process of granting EUA is not designed to provide evidence of safety or effectiveness, but safety signals might be identified.
3. It is unlikely, once a product is granted EUA and administered to some patients, that any useful information will be obtained to benefit any future patients.
4. There is no systematic data collection on effectiveness or safety with EUA, and no data is published in medical journals as part of the regulatory approval process.
5. 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 or is available under EUA.
6. 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 a 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’s how these laws are (I would contend intentionally) written, to confuse and obfuscate. Sasha Latypova provides a detailed explication of this legal morass.

Here’s what this means in terms of potential harms 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 validate-able 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.

Questions To Ask Anyone Addressing Covid mRNA Vaccines

Given this information about how covid mRNA vaccines were developed and manufactured, I would argue that 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 Health and Human Services (“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.

So when someone sits down to interview a regulator who claims to be undertaking an investigation of covid mRNA vaccines, or writes an article about “giving the covid vaccines a good hard look,” I would at the very least expect the topic of EUA and PREP Act to be mentioned.  It never is.

Here are some questions to ask a CDC or FDA regulator, or an MAHA enthusiast, if you find yourself talking to one at a cocktail party, or if you are a journalist interviewing them or writing about their activities:

• Do you know that the mRNA vaccines on the market and in trials now were all developed under Emergency Use Authorisation (EUA)?

• Do you know that EUA was intended to rush countermeasures to the battlefield or the site of a CBRN attack and is not part of the drug approval process?

• Do you know that covid mRNA vaccines are covered by the PREP Act, which means no one can be held legally liable for any activity related to their development, manufacture, distribution, administration or anything else?

• Do you know the PREP Act was intended to cover medical countermeasures rushed to the scene of a CBRN emergency – not to a disease outbreak involving billions of civilians? Do you know that it was considered unconstitutional by many lawmakers at the time of its covert and rushed passing? [Also see HERE.]

• Do you know that PREP Act and EUA-covered countermeasures do not require any follow-up if or when safety signals are detected?

• Given this information, what do you believe the claims of “safe and effective” for these products are based on?

• Given this information, would you agree that the only way to put mRNA products on a legal regulatory pathway is to subject them to the same laws and regulations that govern the development and manufacturing of non-emergency medical products? And that this means they must undergo legally binding, regulated clinical trials outside the EUA-PREP Act-CBRN emergency framework?

• In the meantime, while we’re waiting for the years that it will take such legally regulated trials to take place, do you agree that anyone who wants to get, or is recommended by a healthcare professional or regulatory agency to receive, an mRNA product – including in the context of clinical trials – should be notified of its status as an EUA/PREP Act-covered countermeasure?

• Do you believe we are still in a covid-19 emergency warranting blanket legal protection for all countermeasures until the end of 2029? If not, why do you think the HHS Secretary has failed to end the PREP Act emergency declaration for covid?

• Will you join the efforts to ask the Secretary to end the emergency and to repeal the PREP Act entirely

About the Author

Debbie Lerman is a retired science writer and a practising artist in Philadelphia, Pennsylvania, United States.  Since 2022, she has become a prominent investigative researcher and writer focusing on covid-related topics.  Lerman is a Brownstone Fellow and author of the book ‘The Deep State Goes Viral: Pandemic Planning and the Covid Coup’.

Featured image: Adapted from ‘Duke-NUS CoRE Regulatory Perspective – Making Sense of Emergency Use Authorisations’, Duke-NUS Medical School, a partnership between Duke University (Durham, North Carolina, USA) and the National University of Singapore (“NUS”), 9 December 2020

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Rhoda Wilson

While previously it was a hobby culminating in writing articles for Wikipedia (until things made a drastic and undeniable turn in 2020) and a few books for private consumption, since March 2020 I have become a full-time researcher and writer in reaction to the global takeover that came into full view with the introduction of covid-19. For most of my life, I have tried to raise awareness that a small group of people planned to take over the world for their own benefit. There was no way I was going to sit back quietly and simply let them do it once they made their final move.

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