Debbie Lerman is a retired science writer and author of The Deep State Goes Viral: Pandemic Planning and the Covid Coup.
"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...
No Regulatory Oversight = No Scientifically Valid Claims
... [A]ny 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:
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."
Published under a Creative Commons Attribution 4.0 International License.