Understanding the Legal Framework of Emergency Use Authorization (EUA)

In a previous discussion, we explored the legal structure that allows for the issuance of Emergency Use Authorization (EUA) for medical products. This type of authorization was granted to Covid mRNA vaccines, along with hundreds of other medical products used during the Covid pandemic. This article aims to delve deeper into the context of EUA law, an aspect that is often overlooked in discussions about EUA.

Legal Prerequisites for EUA

To issue an EUA for a product intended for civilian use, several steps must be taken, involving multiple government agencies. The first and most crucial step is the declaration of an emergency by the Secretary of Health and Human Services (HHS) that warrants an EUA. This emergency must always involve CBRN (chemical, biological, radiological, nuclear) agents, also known as weapons of mass destruction (WMD).

The specific EUA law applied to the Covid countermeasures is Section 564(b)(1)C of the Federal Food, Drug, and Cosmetic Act. This law states that an EUA for products intended for civilian use requires a determination by the Secretary of HHS that there is a public health emergency, or a significant potential for one, that affects or has a significant potential to affect national security or the health and security of United States citizens living abroad. This emergency must involve a CBRN agent or agents, or a disease or condition that may be attributable to such agents.

Implications of the EUA for Covid Countermeasures

Based on the wording of this law, the EUA issued for the Covid countermeasures states that 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).

This leads to 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." This raises the question: Is the EUA for the Covid countermeasures admitting that SARS-CoV-2 is an engineered potential bioweapon rather than a zoonotic pathogen?

Defining "CBRN Agent"

The US legal code defines "biological agents" (the "B" in CBRN) as biological weapons, and the use of such agents/weapons is regarded as a crime. This definition suggests that the term "biological agents" in the context of EUA law refers to a weapon, not a zoonotic virus.

CBRN Agents as a Prerequisite for EUA

Further confirmation that CBRN agents are necessary for invoking Section 564 comes from Section 716 of P.L. 115-91, a law regarding wartime authorization of medical products. 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, this section was used to authorize the Covid mRNA vaccines and other Covid-related countermeasures.

Conclusion

Based on the laws governing EUA for Covid mRNA vaccines and other countermeasures, there are two mutually exclusive possibilities: either SARS-CoV-2 was considered a CBRN agent that created a public health emergency with a significant potential to affect national security, or the EUA granted to the vaccines violated the law governing EUAs.

There is evidence to support the first possibility, including the federal government's pandemic response plan and the evidence that SARS-CoV-2 was an engineered virus that leaked into the civilian population in Wuhan, China, from a US-supported bioweapons lab. However, if the US government insists that 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.

What are your thoughts on this matter? Do you think the EUA for Covid countermeasures suggests that SARS-CoV-2 is an engineered bioweapon? Or do you believe the EUA was granted illegally? Share your thoughts with your friends and sign up for the Daily Briefing at 6pm every day to stay informed.