Covid mRNA Vaccines Required No Safety Oversight: Part Two

Debbie Lerman explains how a war on terror emergency provision to protect us from weapons of mass destruction was used for the procurement and development of covid vaccines.

Originally published by the Brownstone Institute and reprinted here with permission…

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In Part 1 of this series, I reviewed the contractual and regulatory framework applied by the US government to the initial development, manufacture, and acquisition of the Covid mRNA shots, using the BioNTech/Pfizer agreements to illustrate the process. 

I showed that Emergency Use Authorization (EUA) was granted to these products based on clinical trials and manufacturing processes conducted with 

• no binding legal standards,

• no legally proscribed safety oversight or regulation, and 

• no legal redress from the manufacturer for potential harms.

In this follow-up article, I will provide a detailed analysis of the underlying documentation.

Other Transaction Authority/Agreement (OTA): A Military Acquisition Pathway

The agreement between the US government, represented by the Department of Defense (DoD), and Pfizer, representing the BioNTech/Pfizer partnership, in July 2020, for the purchase of a “vaccine to prevent COVID-19” was not an ordinary acquisition contract.

It was an agreement under Other Transaction Authority (OTA) – an acquisition pathway that, according to Department of Defense guidelines, has been used since 1958 to “permit a federal agency to enter into transactions other than contracts, grants, or cooperative agreements.”

A thorough review of the use of OTA by the DoD, including its statutory history, can be found in the February 22, 2019 Congressional Research Service report. This report, along with every other discussion of OTA, specifies that it is an alternative acquisition path for defense and military purposes. It is not intended, nor has it ever been used before Covid, for anything intended primarily for civilian use.

If you look for OTA laws in the US Code, this is the path you will go down:

Armed Forces -> General Military Law -> Acquisition -> Research and Engineering -> Agreements -> Authority of the DoD to carry out certain prototype projects

This legal pathway very clearly shows that OTA laws are intended for acquisition of research and engineering prototypes for the armed forces. 

According to the DARPA website, 

The Department of Defense has authority for three different types of OTs: (1) research OTs, (2) prototype OTs, and (3) production OTs. 

These three types of OTs represent three stages of initial research, development of a prototype, and eventual production.

Within those three types, there are specific categories of projects to which OTA can apply:

• Originally, according to the OTA Overview provided by the DoD, the Other Transaction Authority was “limited to apply to weapons or weapon systems proposed to be acquired or developed by the DoD.” 

• OTA was later expanded to include “any prototype project directly related to enhancing the mission effectiveness of military personnel and the supporting platforms, systems, components, or materials proposed to be acquired or developed by the DoD, or to improvement of platforms, systems, components, or materials in use by the Armed Forces.”

So far, none of that sounds like an acquisition pathway for millions of novel medical products intended primarily for civilian use.

Is There any Exception for Civilian Use of OTA That Might Apply to Covid mRNA Vaccines?

The FY2004 National Defense Authorization Act (P.L. 108-136) contained a section that gave Other Transaction Authority to “the head of an executive agency who engages in basic research, applied research, advanced research, and development projects” that “have the potential to facilitate defense against or recovery from terrorism or nuclear, biological, chemical or radiological attack.”

This provision was extended until 2018, but does not appear to have been extended beyond that year. Also, note that even in this exceptional case of non-DoD use of OTA, the situation must involve terrorism or an attack with weapons of mass destruction (CBRN).

What Other OTA Laws Might Apply?

The 2019 CRS report cited above provides this chart, showing that a few non-DoD agencies have some OTA or related authorities:

According to this table, The Department of Health and Human Services (HHS) has some research and development (R&D) Other Transaction Authorities. The law pertaining to the OT Authority of HHS is 42 U.S.C. §247d-7e. 

Where is this law housed and what does it say?

The Public Health and Welfare -> Public Health Service -> General Powers and Duties -> Federal-State Cooperation -> Biomedical Advanced Research and Development Authority (BARDA) -> Transaction Authorities

So there is a place in the law related to civilian health and welfare where OTA might be applicable, although it is valid only for research and development, not prototypes or manufacturing.

The law states that the BARDA secretary has OT Authority

with respect to a product that is or may become a qualified countermeasure or a qualified pandemic or epidemic product, activities that predominantly—

(i) are conducted after basic research and preclinical development of the product; and

(ii) are related to manufacturing the product on a commercial scale and in a form that satisfies the regulatory requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] or under section 262 of this title.

The “regulatory requirements” enumerated in the law mean that it would be impossible for BARDA/HHS to enter into agreements – even just R&D – for any medical products (like the mRNA vaccines) that did not undergo rigorous safety testing and strict manufacturing oversight. 

HHS “Partnership” with DoD Circumvented Civilian Protection Laws

To summarize the predicament of Other Transaction Authority/Agreements with respect to civilian authorities, in general, and Covid mRNA vaccines, in particular:

• OTA was written and codified as a way for the military to acquire weapons and other necessary systems and equipment without a lot of bureaucratic red tape. It covers research and development, prototypes, and subsequent manufacturing.

• The only OTA for a public health agency is for the HHS and it only covers Research & Development, not prototypes or manufacturing.

• Even the R&D OTA given to the HHS still requires products to be manufactured “in a form that satisfies the regulatory requirements” for drug and vaccine safety.

In other words: There is no way HHS could have used its very limited OTA to sign contracts for hundreds of millions of novel medical products.

So what did HHS do?

As the Government Accountability Office (GAO) noted in its July 2021 report on “Covid-19 Contracting:” HHS “partnered” with DoD to “leverage DoD’s OTA authorities…which HHS lacked.” (p. 24)

What are DoD’s OT Authorities for Medical Products?

As discussed, OTA is intended to help the military get equipment and technology without lots of bureaucratic hassle. None of the original laws pertaining to OTA mentioned anything other than “platforms, systems, components, or materials” intended to “enhance the mission effectiveness of military personnel.”

But five years before Covid, an exceptional use of OTA was introduced: 

In 2015, DoD announced the establishment of the CBRN Medical Countermeasure Consortium, whose purpose was to use the OTA acquisition pathway to “work with DoD to develop FDA licensed chemical, biological, radiological, and nuclear medical countermeasures.” [FDA = Food & Drug Administration]

As described in the 2015 announcement, this included “prototype technologies for therapeutic medical countermeasures targeting viral, bacterial, and biological toxin targets of interest to the DoD.” The list of agents included the top biowarfare pathogens, such as anthrax, ebola, and marburg. 

The announcement went on to specify that “enabling technologies can include animal models of viral, bacterial or biological toxin disease and pathogenesis (multiple routes of exposure), assays, diagnostic technologies or other platform technologies that can be applied to development of approved or licensed MCMs [medical countermeasures].”

Although this still does not sound anything like the production of 100 million novel vaccines for civilian use, it does provide more leeway for OTA than the very limited Other Transaction Authority given to HHS.

While the HHS OTA requires adherence to extensive development and manufacturing regulations, the OTA pathway for the DoD to develop medical countermeasures requires only “FDA licensure.”

Thus, using DoD Other Transaction Authorities, it would theoretically be possible to bypass any safety regulations – depending on the requirements for FDA licensing of an OTA-generated product. As we will see, in the case of the Covid mRNA vaccines, Emergency Use Authorization was granted, requiring no legal safety oversight at all.

Emergency Use Authorization (EUA)

Here’s how the Food & Drug Administration (FDA) describes its EUA powers: 

Section 564 of the FD&C Act (21 U.S.C. 360bbb–3) allows FDA to strengthen public health protections against biological, chemical, nuclear, and radiological agents. 

With this EUA authority, FDA can help ensure that medical countermeasures may be used in emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by biological, chemical, nuclear, or radiological agents when there are no adequate, approved, and available alternatives (among other criteria).

It’s extremely important to understand that these EUA powers were granted in 2004 under very specific circumstances related to preparedness for attacks by weapons of mass destruction, otherwise known as CBRN (chemical, biological, radiological, nuclear) agents.

As explained in Harvard Law’s Bill of Health, 

Ultimately, it was the War on Terror that would give rise to emergency use authorization. After the events of September 11, 2001 and subsequent anthrax mail attacks, Congress enacted the Project Bioshield Act of 2004. The act called for billions of dollars in appropriations for purchasing vaccines in preparation for a bioterror attack, and for stockpiling of emergency countermeasures. To be able to act rapidly in an emergency, Congress allowed FDA to authorize formally unapproved products for emergency use against a threat to public health and safety (subject to a declaration of emergency by HHS). The record indicates that Congress was focused on the threat of bioterror specifically, not on preparing for a naturally-occurring pandemic.

The wording of the EUA law underscores the fact that it was intended for use in situations involving weapons of mass destruction. Here are the 4 situations in which EUA can be issued:

1. a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents;

2. a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces, including personnel operating under the authority of Title 10 or Title 50, of attack with—

   1. a biological, chemical, radiological, or nuclear agent or agents; or

   2. an agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to United States military forces;

3. a determination by the Secretary 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 biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents; or

4. the identification of a material threat pursuant to section 319F–2 of the Public Health Service Act [42 U.S.C. 247d–6b] sufficient to affect national security or the health and security of United States citizens living abroad.

Nowhere in these four situations is there any mention of a naturally occurring epidemic, pandemic, or any other kind of public health situation that is not caused by “biological, chemical, radiological or nuclear agent/s.”

Could SARS-CoV-2 qualify as such an agent?

If you look for the definition of “biological agents” in the US Legal Code, you will go down the following pathway:

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).

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The third and final part of this series will be published tomorrow…