When everyone from the President to your primary care doctor declared loudly and wholeheartedly in December 2020 that the newly FDA-authorised Covid mRNA vaccines were ‘safe and effective’ – what were those claims based on?
In this article, I will review the contractual and regulatory framework applied by the U.S. Government to the initial development, manufacture and acquisition of the Covid mRNA shots. I will use the BioNTech/Pfizer agreements to illustrate the process.
The analysis will show that:
- The Covid mRNA vaccines were acquired and authorised through mechanisms designed to rush medical countermeasures to the military during emergencies involving weapons of mass destruction.
- These mechanisms did not require the application of, or adherence to, any laws or regulations related to vaccine development or manufacturing.
- The FDA’s Emergency Use Authorisation for the vaccines was 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. (This last point is being challenged in multiple court cases, so far to no avail.)
What all of this means is that none of the laws or regulations that we count on to protect us from potentially harmful, or deadly, medical products was applied to the Covid mRNA vaccines. The assertion of ‘safe and effective’ was based entirely on aspirations, opinions, beliefs and presumptions of Government employees.
In Part 1 of this article I will provide a summary of the main contractual and legal points and explain how they excluded any requirements for regulatory oversight. In Part 2, I will go through a detailed analysis of the underlying documentation.
Contractual Framework for Covid mRNA Vaccines
When the U.S. Government entered into its Covid vaccine agreement with Pfizer, which was acting on behalf of the BioNTech/Pfizer partnership, in July 2020, the agreement encompassed a minimum of 100 million doses of a “vaccine to prevent COVID-19” and a payment of at least $1.95 billion. The agreement also allowed for future procurement of hundreds of millions of additional doses.
That’s a lot of money for a lot of items, especially since the vaccines had not yet been tested, approved or manufactured to scale and, as the agreement stated, were purely “aspirational”.
Obviously, this is not normal procedure. But, then, those were not normal times. The Government declared that we were “at war” with a catastrophically dangerous virus that would kill millions and millions of people of all ages unless we could develop “medical countermeasures” (a military term) and get everyone to take them as quickly as possible.
In keeping with the declaration of war, it was a military framework that was used for acquiring the aspirational products that became known as Covid mRNA vaccines.
Military Acquisition
The Government side to the agreement with Pfizer was the Department of Defence (DoD), represented by a convoluted chain of parties, each operating as a subcontractor, or co-contractor, for the next.
You’ll find details about the role of each of these military procurement groups in Part 2 of this article. The important point to recognise is that all of these bodies are charged exclusively with military objectives: “ensuring military readiness”, “enhancing the mission effectiveness of military personnel” and “supporting the Army and Unified Land Operations, anytime, anywhere”.
This is crucial, because the laws and procedures governing military procurement have a very different set of assumptions and cost-benefit considerations than those used in civil society.
In fact, agencies governing civilian and public health, like the NIH, NIAID and HHS, do not have the authority to grant certain types of special acquisition contracts, which is why the Covid vaccine contracts had to be overseen by the Department of Defence.
Thus, HHS “partnered” with DoD to “leverage DoD’s OTA authorities… which HHS lacked”.
What are “OTA authorities”?
Other Transaction Authority/Agreement (OTA)
(Note: OTA is used interchangeably to refer to Other Transaction Agreement and Other Transaction Authority.)
The OTA is a procurement method that, according to Department of Defence guidelines, has been used since 1958 to “permit a federal agency to enter into transactions other than contracts, grants or cooperative agreements”.
What types of transactions are we talking about?
First and foremost, the OTA acquisition structure “operates outside the Federal Acquisition Regulations”. This means no federal laws related to Government purchases apply to OTAs. Such laws generally involve things like ensuring competition, accounting standards, cost management, record-keeping and labour practices. For purchases of medical products, they also include things like oversight of research on human subjects and privacy laws.
Why is it a good idea to bypass all these acquisition regulations? For the military, OTAs can provide “access to state-of-the-art technology solutions from traditional and non-traditional defence contractors”. More specifically, according to DARPA (Defence Advanced Research Projects Agency), OTAs are designed to “avoid many of the hurdles that scare away private industry”, including “burdensome regulations”.
The second defining aspect of OTAs is that they apply to projects that are
directly relevant to enhancing the mission effectiveness of personnel of the Department of Defence or improving platforms, systems, components or materials proposed to be acquired or developed by the Department of Defence, or to improvement of platforms, systems, components or materials in use by the armed forces.
In other words, OTA is not a pathway for Government acquisitions primarily intended for civilian populations.
In fact, from the time of OTA inception in 1958 until Covid, the vast majority of OTAs were awarded for weapons, military supplies and information technologies. For example, in an overview from 2013-2018, the top OTAs dealt with underwater weapons, ground vehicles, rocket propulsion systems and “technologies related to the use of the electromagnetic spectrum or the information that rides on it”.
What About OTAs for Medical Products?
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”.
Broadly speaking, this included “prototype technologies for therapeutic medical countermeasures targeting viral, bacterial and biological toxin targets of interest to the DoD”. Furthermore, such technologies could include “animal models of viral, bacterial or biological toxin disease and pathogenesis, assays, diagnostic technologies or other platform technologies”.
Note that there is a mention of FDA licensing, which means a medical product cannot be purchased through OTA without any FDA involvement. The extent of that involvement will be discussed in the section on regulations below.
But before we get to the FDA, just looking at what an OTA can be applied to, it does not look like manufacturing 100 million doses of anything is even in the ballpark.
Pfizer’s Other Transaction Agreement (OTA)
DoD can make three types of agreements under OTA: research, prototypes and manufacturing. Importantly, according to National Defence Magazine, the agreements (which are “other than contracts”) are supposed to start with prototypes and then move “from prototypes to production contracts”. In other words, you start with an OTA for a prototype and then get an actual production contract.
In contrast, the agreement between Pfizer and the U.S. Government, routed through the Department of Defence and the CBRN Medical Countermeasure Consortium, classified what Pfizer agreed to deliver as a “prototype project” and “manufacturing demonstration”. As stated in the agreement:
The intent of this prototype project is to demonstrate that Pfizer has the business and logistics capability to manufacture 100 million doses of its currently unapproved mRNA-based COVID-19 vaccine for the Government [(b)(4) redaction]
So the military acquisition branch of the Government is paying Pfizer to show that it can manufacture 100 million doses of a never-before produced or tested product, while also acquiring those 100 million doses, and potentially hundreds of millions more. The “prototype” somehow includes not just the manufacturing process but also the 100 million doses created through that process.
Nowhere in the history of Other Transaction Agreements is there anything remotely resembling this conflation of a prototype (“a preliminary model of something”, according to the Oxford English Dictionary) and the manufacturing of millions of exemplars of that prototype. Actually, it is unclear from the wording of the OTA whether the “prototype” applies to the mRNA Covid vaccine, the mRNA platform for manufacturing the vaccine, the actual manufacturing of 100 million vaccines or all of the above.
Regulatory Framework for Covid mRNA Vaccines
What about regulatory oversight of the development and manufacturing processes?
For pharmaceutical products, like vaccines, this would include: 1) clinical trials to demonstrate the safety and efficacy of the products, and 2) compliance with ‘Good Manufacturing Practices’ to ensure what is in each dose is actually what is supposed to be in each dose.
Who is responsible for this type of oversight in the context of Pfizer’s OTA?
Pfizer will meet the necessary FDA requirements for conducting ongoing and planned clinical trials, and with its collaboration partner, BioNTech, will seek FDA approval or authorisation for the vaccine, assuming the clinical data support such application for approval or authorisation.
What are the FDA requirements “for approval or authorisation”?
According to the Pfizer OTA, those requirements are whatever it takes to “grant an Emergency Use Authorisation (‘EUA’) under Section 564 of the Federal Food, Drug, and Cosmetic Act”.
In fact, the two regulations applied to the authorisation of the Pfizer mRNA Covid vaccines were EUA and its partner, the PREP Act, which grants legal immunity from prosecution to anyone who has anything to do with the vaccines, unless they commit outright fraud.
Emergency Use Authorisation (EUA)
EUA is a very special way to authorise a medical countermeasure in very specific types of emergencies. It was designed, according to the Department of Justice, to quickly make available effective vaccines and treatments against – among other CBRN agents – potential biowarfare and bioterror agents like anthrax, botulinum toxin, Ebola and plague.
As explained in Harvard Law’s Bill of Health, “Ultimately, it was the War on Terror that would give rise to emergency use authorisation.” The article continues,
The record indicates that Congress was focused on the threat of bioterror specifically, not on preparing for a naturally-occurring pandemic.
You can read about the details of EUA regulations in part two of this article. In summary, an Emergency Use Authorisation can be granted by the Food and Drug Administration once the HHS or DoD have declared that there is an attack, threat of an attack or national security threat created by a CBRN agent (a weapon of mass destruction).
Significantly, as the Harvard Law article explains, EUA was not intended to cover brand-new vaccines:
The only vaccine ever to have received an EUA prior to the current pandemic was AVA, an anthrax vaccine that had already been formally approved for other purposes.
This is extremely important: EUA was meant for dire situations of warfare or terrorism, not to protect the entire population from naturally occurring pathogens. For this reason, EUA products do not require the type of legal safety oversight that is applied in civilian contexts by the FDA.
And without adherence to legal safety standards in clinical trials and manufacturing, there is no way of knowing whether the products, in this case the Covid mRNA vaccines, are actually safe.
No Legal or Regulatory Standards Apply to the FDA’s Decision to Grant EUA
Here’s the kicker about EUA: because it was intended to be issued only in war and WMD-related emergencies, there are no legal requirements for how it is issued, beyond the determination of the FDA that such authorisation is appropriate. No legal standards for how clinical trials are conducted. No laws regulating the manufacturing processes. Only “reasonable beliefs” based on whatever evidence is available to the FDA at the time that it makes its determination.
This is how it is described in U.S. Code 360bbb-3, which covers EUA:
Criteria for issuance of authorisation
- An agent referred to in a declaration [by the HHS Secretary] can cause a serious or life-threatening disease or condition
- Based on the totality of scientific evidence available to the Secretary, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that
- The product may be effective in diagnosing, treating or preventing such disease or condition
- The known and potential benefits of the product outweigh the known and potential risks, taking into consideration the material threat posed by the CBRN agent(s)
- There is no adequate, approved and available alternative to the product
In its EUA Guidance for Industry and Other Stakeholders, the FDA recommends that EUA applications contain information about clinical trials, manufacturing processes, potential risks etc. Crucially, as stated at the top of every page, these are merely “nonbinding recommendations”.
It’s up to the EUA applicant to decide what information to submit, and it’s up to the FDA to decide whether that information meets the “statutory requirements” (as stated above).
PREP Act
If you agree to develop, manufacture and sell hundreds of millions of aspirational products to the Government under the contract-like Other Transaction Agreement and bioterror-contingent Emergency Use Authorisation, you need very good liability protection.
This is provided by the PREP (Public Readiness and Emergency Preparedness) Act that was designed to go hand-in-hand with EUA. Again, it is possible to envision a bioterrorism scenario, like an anthrax attack, in which the Government needs to get lots of countermeasures very quickly. Many people will inevitably die in the attack, but if there’s a chance that the countermeasure will work, it needs to get made and distributed as quickly as possible. If it has some bad side effects, or even if it kills some people, one could argue that the manufacturer should not be held liable.
Clearly, this was never intended to apply to a new, untested vaccine used to counter a naturally occurring virus in hundreds of millions of people.
What, then, are the standards for determining the necessity of a PREP Act declaration?
Here’s how the Health and Human Services (HHS) website describes the factors considered by the HHS Secretary:
In deciding whether to issue a PREP Act Declaration, HHS must consider the desirability of encouraging the design, development, clinical testing or investigation, manufacture, labelling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administering, licensing and use of the countermeasure recommended in the Declaration. HHS may also consider other relevant factors.
As with the EUA determination, there are no legally binding standards or directives for issuing a PREP Act. If the products made under EUA cause harm or death, no one involved in making or administering those products can be held accountable, as long as there is accompanying PREP Act protection.
Conclusion
The BioNTech/Pfizer Covid mRNA vaccines were authorised for use in the entire population of the United States based on the application of the following sequence of agreements and determinations:
- Department of Defence uses ‘contract-like’ Other Transaction Authority (OTA) to buy aspirational products. DoD is not responsible for overseeing clinical trials or manufacturing. Pfizer is responsible for getting authorisation from the FDA.
- The FDA is permitted to issue Emergency Use Authorisation (EUA) to Pfizer for mRNA vaccines because the HHS Secretary declares that there is an emergency that warrants EUA.
- FDA makes its EUA determination based on whatever evidence and considerations it feels are appropriate, given the emergency situation. There are no legal standards that apply to the FDA’s considerations, except that it believes the product may be effective, the benefits outweigh the risks based on available information and there is no alternative product.
- The Health and Human Services Secretary grants total legal immunity through the PREP Act to anyone involved in developing, making, shipping or administering the vaccines, based on his determination that there is an emergency that justifies this action.
That’s what the ‘safe and effective’ claim for the BioNTech/Pfizer Covid mRNA vaccines was based on in December 2020, ahead of millions of people – including children and pregnant women – being mandated to take the injections. Objectors were ridiculed, silenced, ostracised and fired. Harms and deaths were, and continue to be, covered up, uninvestigated and uncounted.
Questions About the Legality of the EUA for Covid mRNA Vaccines
It sounds like something in this whole process must be illegal, right?
So far, trying to charge pharmaceutical companies with wrongdoing related to Covid vaccines has failed, because the EUA plus PREP combo means they were not required to apply any legal or regulatory standards to their clinical studies or manufacturing processes.
But what about the Government?
Since the OTA, EUA and PREP regulations are intended for use during a catastrophic CBRN emergency, we might ask ourselves: did the U.S. Government believe SARS-CoV-2 was an engineered potential bioweapon? Did the Government use what we might consider an extra-legal (in civilian terms) acquisition and authorisation process based on the assumption that the entire population was threatened by the equivalent of a bioterrorism or biowarfare attack? It sure seems like it did. And if so, did it have a legal obligation to inform the public of this situation in order to resort to the OTA and EUA procurement and authorisation pathway?
Moreover, even if the Government considered COVID-19 to be a disease caused by a potential bioterror agent, how could the HHS Secretary justify an Emergency Use Authorisation that required him to determine that “there is a public health emergency that has a significant potential to affect national security” when it was known that COVID-19 was deadly almost exclusively in old and infirm populations?
In December 2020 the following facts were known about COVID-19 without a reasonable doubt:
- The infection fatality rate (IFR) for the entire population was less than 1%.
- The IFR for anyone under 55 was 0.01% or lower.
- The IFR for children was near zero.
A disease that has significant potential to affect national security has to be very severe, especially in its effect on the military. Yet in December 2020, military-aged people were known to be at nearly no risk from COVID-19. And still the HHS Secretary determined that there was an emergency that warranted EUA for the mRNA vaccines. And all military personnel were mandated to get the injections.
I hope that by publishing this information as widely as possible we can eventually find a way to demand some measure of accountability.
Acknowledgements
Sasha Latypova and Katherine Watt have been trying to draw attention to this shocking legal and regulatory framework for a long time. I am deeply grateful for, and indebted to, their in-depth research and tireless work to disseminate this information.
Debbie Lerman is a Brownstone Fellow who has a degree in English from Harvard. She is a retired science writer and a practising artist in Philadelphia, PA. This article was first published by the Brownstone Institute.
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