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.