Covid mRNA Vaccines Are Unregulated Military Countermeasures

Covid mRNA Vaccines Are Unregulated Military Countermeasures
by Debbie Lerman at Brownstone Institute

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

Covid mRNA Vaccines Are Unregulated Military Countermeasures
by Debbie Lerman at Brownstone Institute – Daily Economics, Policy, Public Health, Society