Covid mRNA Vaccines Are Unregulated Military Countermeasures

Brownstone Institute ^ | August 28, 2025 | Debbie Lerman

[Heartlander]

Covid mRNA Vaccines Are Unregulated Military Countermeasures

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

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 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 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. 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/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 publication, p. 28)

Here’s how the FDA and 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 that, once a product is granted EUA and administered to some patients, 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/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 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 validatable 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 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/PREP Act to be mentioned.

It never is.

Here are some questions to ask a CDC or FDA regulator, or a 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 Authorization (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?

• Do you know that PREP Act and EUA-covered countermeasures do not require any follow-up if/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/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 mean time, 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?

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

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?

Republished from the author’s Substack

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TOPICS: Crime/Corruption; Government
KEYWORDS: chinavirusvaccine; conspiratards; crimesvshumanity; iflunkedscience; mrna; qanonsense; substackloser

[DCBryan1]

What is E-1101?

[one guy in new jersey]

The determination early on with respect to the COVID-19 DemPanic was: We are on a “war footing”.

Everything that followed was therefore initiated, directed and choreographed by the U.S. Department of Defense.

[Pollard]

Well Mr MAHA just issued marketing authorization status which is the equivalent of having gone through all clinical trials and are safe for public use and can be advertised.

Happy myocarditis young men. A bright side, albeit morbid, would be that only the wackos still wearing masks are getting covid jabs. The bad side is that some of them are mothers and will get it for their kids.

[cuz1961]

The lethal poison fruit of the FAUCI tree.

/

[delta7]

mRNA jabs kill and disable. The only question: was it by design or ignorance?

The fact RFK stopped all funding for mRNA says much, he is obviously holding back some very damning information about mRNA jabs.

[Jan_Sobieski]

The world is run by perverse incentives. Social security, Medicare, Medicaid, and pensions give the powers that be a perverse incentive to ensure that no one lives to collect. Hence, gain of function, jabs, and bioengineered foods.

[delta7]

The world is run by perverse incentives. Social security, Medicare, Medicaid, and pensions give the powers that be a perverse incentive to ensure that no one lives to collect. Hence, gain of function, jabs, and bioengineered foods.
———————
Satan is the master of deception. The fact most people no longer practice Christianity or believe in God and his word, makes his infiltration and destruction much easier.

The good news? Us believers can see clearly what is happening. Pray for Discernment.

[jacknhoo]

Matthew 24:13 But he that shall persevere to the end, he shall be saved.

[TexasGator]

“to ensure that no one lives to collect.”

Thank you for noting Putin’s perverse plan.

The average Russian male has a life expectancy of 64 years so he set the retirement age at 65.

He had to since he depleted the pension fund paying for his two week war.

[bgill]

Why is he still walking the streets?

[13Sisters76]

We know all this. ANY medication or vaccine usually undergoes YEARS of testing before it is available- just not this time.
The instances, all over the globe, of dying infants and elderly and collapsing of young people have told us that this JUST ISN’T SAFE.
Now that Fauci has retired and made all his money, can we please go back to common sense?

[TexasGator]

"Satan is the master of deception."

But I am a close second. :)

signed, Martin Armstrong

[TexasGator]

Jeffrey Albert Tucker is an idiot anarchist capitalist.

[Carry_Okie]

The EUA was itself illegal because effective multidrug therapies did exist. The FDA instead chose to evaluate them as single-drug therapies and declared them ineffective. It was a screw job in favor of big Pharma, population reduction, and saving the government from Social Security payment volume.

[NonValueAdded]

While the article clearly states that there is no liability for failure to perform adequate trials, there is NO reason why the “vaccines” cannot be studied and tested after the fact. Big Pharma might be off the hook but there is an absolute need to know exactly what is in them and what harm can they cause.

[delta7]

Matthew 24:13 But he that shall persevere to the end, he shall be saved.
—————————
Amen brother, but what about all the unbelievers? Family, friends, co-workers?

For them I say: “ Try Jesus, if you don’t like him, Satan will always take you back”……I do get some bizarre replies.

[delta7]

Big Pharma might be off the hook
———————-
No, not necessarily. Those waivers the sheep had to sign ( the first warning) would mean nothing if their was criminal intent or negligence by Pfizer and Moderna…..which is coming to light.

I suspect as more and more people are suffering from the mRNA jabs, more will pursue that legal route.

[delta7]

I will add, I didn’t buy into the forced jabs…..long story but I did get five months off after telling my HR I wasn’t getting jabbed….I did in the end get a waiver AND five months of full pay and vacation time.

Those Covid days were very, very good to me, I stood my ground. Now, I don’t have to worry about those nasty spike proteins effecting my immune system or my health.

[delta7]

mRNA IS PERFECTLY SAFE FOR YOUR KIDS”

That was CDC Director Susan Monarez, who was fired today after just 4 weeks on the job.

And less than 24 hours after Bill Gates met with President Trump:

❌ CDC Director Susan Monarez: FIRED
❌ CDC vaccine chief: RESIGNED
❌ CDC chief