By Debbie Lerman at The Epoch Times
When everyone from the President to your primary care doctor declared loudly and wholeheartedly in December 2020 that the newly FDA-authorized 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 authorized 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 Authorization 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.
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.
You’ll find details about the role of each of these military procurement groups in Part 2 of this article. The important point to recognize 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 Defense.
What types of transactions are we talking about?
“... directly relevant to enhancing the mission effectiveness of personnel of the Department of Defense or improving platforms, systems, components, or materials proposed to be acquired or developed by the Department of Defense, 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.
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.
“The intent of this prototype project is to demonstrate that Pfizer has the business and logistics capability to manufacture 100M 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.
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.
“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 authorization for the vaccine, assuming the clinical data supports such application for approval or authorization.”
What are the FDA requirements “for approval or authorization?”
According to the Pfizer OTA, those requirements are whatever it takes to “grant an Emergency Use Authorization (“EUA”) under Section 564 of the Federal Food, Drug, and Cosmetic Act.”
You can read about the details of EUA regulations in part 2 of this article. In summary, an Emergency Use Authorization can be granted by the Food and Drug Administration once the HHS and/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.
“Criteria for issuance of authorization 1. An agent referred to in a declaration [by the HHS Secretary] can cause a serious or life-threatening disease or condition 2. 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 a. The product may be effective in diagnosing, treating or preventing such disease or condition b. 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) 3. There is no adequate, approved, and available alternative to the product”
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?
“In deciding whether to issue a PREP Act Declaration, HHS must consider the desirability of encouraging the design, development, clinical testing or investigation, manufacture, labeling, 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.”
1. Department of Defense 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 authorization from the FDA. 2. The FDA is permitted to issue Emergency Use Authorization (EUA) to Pfizer for mRNA vaccines because the HHS Secretary declares that there is an emergency that warrants EUA. 3. 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. 4. 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.
So far, trying to charge pharmaceutical companies with wrongdoing related to COVID vaccines has failed, because the EUA + PREP combo means they were not required to apply any legal/regulatory standards to their clinical studies or manufacturing processes.
But what about the government?
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 percent. • The IFR for anyone under 55 was 0.01 percent or lower. • The IFR for children was near zero.
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Big Bob said:
( December 15th, 2023 @ 6:30 pm )
I doubt it.
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A friend of mine had two family members killed by the mRNA Covid shot. YMMV
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Just watched a friend, living in ENC, get covid. OH my, almost killed her. Getting my vax this weekend. Antii vax is the single dumbest hill to die on.
In a nod to my conservative friends, Im going with Novovax. This is not an mRNA vaccine, but one made like a flu shot. |