Covid mRNA Vaccines Required No Safety Oversight

"In this article, I will review the contractual and regulatory framework applied by the US 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...

What all of this means is ... [t]he 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...

Military Acquisition

[A]gencies 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... 

Emergency Use Authorization (EUA)

EUA is a very special way to authorize 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 [Chemical, Biological, Radiological, and Nuclear] agents – potential biowarfare/bioterror agents like anthrax, botulinum toxin, Ebola, and plague...

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...

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 [weapon of mass destruction]-related emergencies, there are no legal requirements for how it is issued, beyond the determination of the FDA that such authorization 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...

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 [OTA} and bioterror-contingent Emergency Use Authorization, 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...

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...

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 + 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?

Since the OTA, EUA, and PREP regulations are intended for use during a catastrophic CBRN emergency, we might ask ourselves: did the US 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 authorization process based on the assumption that the entire population was threatened by the equivalent of a bioterrorism or biowarfare attack? It sure seems like they did. And if so, did they have a legal obligation to inform the public of this situation in order to resort to the OTA and EUA procurement and authorization 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 Authorization 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."