By Debbie Lerman at Brownstone dot org.

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/avail...