If Covid EUAs Are Legal, the Virus Must Be a Potential Bioweapon

The legal context of Emergency Use Authorization is critical, yet completely ignored.

Illustration by Anthony Freda

In a previous article I laid out the legal framework for issuing Emergency Use Authorization (EUA) for medical products. EUA was the type of authorization granted to Covid mRNA vaccines, along with hundreds of other medical products used during the declared Covid pandemic.

Once we understand the basic legal framework, we can investigate the most important aspect of EUA that nobody ever discusses: the context in which EUA law operates.

Legal Requirements for Emergency Use Authorization (EUA)

In order to issue EUA for a product intended for use in a civilian population, several steps have to happen, involving multiple government agencies. You’ll find all the details here. The key step is the first one: 

The Secretary of Health and Human Services (HHS) has to declare that there is an emergency specifically warranting EUA. And that situation always has to involve CBRN (chemical, biological, radiological, nuclear) agents, also known as WMD (weapons of mass destruction).

The specific EUA law applied to the Covid countermeasures is Section 564(b)(1)C of the Federal Food, Drug and Cosmetic Act. The law states that emergency use authorization for products intended for civilian use require:

A determination by the Secretary of HHS that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad, and that involves a CBRN agent or agents, or a disease or condition that may be attributable to such agent(s)

[BOLDFACE ADDED]

Based on the wording of this law, the EUA issued for the Covid countermeasures states: 

the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes Coronavirus Disease 2019 (COVID-19)

[BOLDFACE ADDED]

Thus, combining the general EUA law with the specific case used for Covid, we arrive at the legal claim that “the virus that causes COVID-19” is “a CBRN agent or agents” that “affects, or has a significant potential to affect, national security.”

So is the EUA for the Covid countermeasures admitting that SARS-CoV-2 is an engineered potential bioweapon rather than a zoonotic pathogen? It sure looks like it. Unless you include zoonotic viruses in the definition of CBRN agents, which are considered weapons of mass destruction. Or unless there is another virus that causes COVID-19. 

(Interestingly, the EUA declaration for Covid does not name the virus that is “a CBRN agent or agents.” The legal reason for this might be that the HHS Secretary was leaving room for variants and did not want to have to declare another EUA emergency every time a new variant was announced. Or maybe there’s another reason. I doubt it’s random.)

What about the definition of “CBRN agent”? Can that term in the context of the EUA law refer to a zoonotic virus? 

If you look for the definition of “biological agent” (the “B” in CBRN) in the US Legal Code, you will go down the following pathway (the pathway indicates how laws are categorized within the code):

Crimes and Criminal Procedure -> Crimes -> Biological Weapons -> Definitions

So in the context of United States law, the term “biological agents” means biological weapons, and the use of such agents/weapons is regarded as a crime.

Wikipedia provides this definition:

A biological agent (also called bio-agent, biological threat agent, biological warfare agent, biological weapon, or bioweapon) is a bacterium, virus, protozoan, parasite, fungus, or toxin that can be used purposefully as a weapon in bioterrorism or biological warfare (BW).

To reiterate: The U.S. legal code regards “biological agents” as bioweapons. EUA can only be issued if there is an attack, or threat of an attack, with such agents. 

No EUA without CBRN agent(s)

If we need further confirmation that CBRN agents are a prerequisite for invoking Section 564, here is another clarification. This comes from a different section of the legal code that was not used for Covid, but that clarifies the context in which EUA can be used.

Section 716 of P.L. 115-91 (a law regarding wartime authorization of medical products) gives the Secretary of Defense the power to issue EUA outside of the legal framework of Section 564 in a very specific situation. Here’s how this is described:

In a case in which an emergency use of an unapproved product or an emergency unapproved use of an approved product cannot be authorized under section 564 of the Federal Food, Drug, and Cosmetic Act because the emergency does not involve an actual or threatened attack with a biological, chemical, radiological, or nuclear agent or agents, the Secretary of Defense may authorize an emergency use outside the United States...

[BOLDFACE ADDED]

Again, I’m not focusing here on what the Secretary of Defense can do with EUA when there is an emergency outside the U.S. What’s important is that this law clearly states that: if there is no actual or threatened attack with a CBRN agent, then EUA cannot be authorized under section 564 of the Federal Food Drug and Cosmetic Act. 

Yet it was Section 564 that was used to authorize the Covid mRNA vaccines, among many other Covid-related countermeasures.

So how could EUA be applied to Covid countermeasures? 

They told us SARS-CoV-2 was a naturally occurring virus that jumped from bats to pangolins, or maybe raccoon dogs, and then into humans, causing a disease called COVID-19. How does that have anything to do with CBRN agents which are, by definition, weapons of mass destruction?

It doesn’t. 

CONCLUSION

Based on the analysis of the laws governing Emergency Use Authorization for Covid mRNA vaccines and other countermeasures, there are two mutually exclusive possibilities:

1. SARS-CoV-2 was considered a CBRN agent (in other words, a WMD) that created a public health emergency with a significant potential to affect national security, or

2. The EUA granted to the vaccines (and all other Covid countermeasures) – that was supposed to be reserved for national security threats caused by CBRN agent/s – violated the law governing EUAs

My vote is for #1, with evidence from the Pan-CAP-A, dated March 13, 2020, which details the federal government’s pandemic response plan. In the org chart for the response, in the box for “POLICY” the National Security Council (NSC) is in charge, and Weapons of Mass Destruction (WMD) are the first sub-category. “Resilience” refers to a sub-group under the NSC called the “Resilience Directorate” which, during the Obama administration, incorporated the previously named “Biodefense Directorate,” which was in charge of biowarfare/bioterrorism.

Another compelling reasons to vote for #1 is the overwhelming evidence that SARS-CoV-2 was an engineered virus that leaked into the civilian population in Wuhan, China, from a US-supported bioweapons lab.

If, however, the U.S. government insists that the answer is #2, and the virus should be regarded as a zoonotic spillover event, then it appears all EUA determinations for medical countermeasures related to SARS-CoV-2 were issued illegally.