by Sasha Latypova
This contract is now a famous document that was used by Pfizer in their Motion to Dismiss Brook Jackson’s case under False Claims Act. It is publicly available in a partially redacted form.
Important: understanding redactions!
Two types of redactions are used in this document, (b)(4) and (b)(6). Here is what they mean:
- (b) (4) Reveal information that would impair the application of state-of-the-art technology within a U.S. weapon system
- (b) (6) Reveal information, including foreign government information, that would cause serious harm to relations between the United States and a foreign government, or to ongoing diplomatic activities of the United States
In the Motion to Dismiss, Pfizer lawyers stated that the purpose of what the Government hired them to do was a “large scale manufacturing demo”. In my opinion, that’s the correct interpretation of the SOW for covid countermeasures – a demo – a fakery by definition. It is stated right here on the front page, complete with the misspelling of Pfizer’s name. Ok, I know, the Army was in a hurry…to make many shots for all of us…
…by foreign agents? This letter is addressed to ATI, DOD’s mega-manager, a non-profit company managing untold billions in OTA contracts for the DOD. According to the type of redaction used, the personnel of ATI mentioned in this letter: Sr. Contracts Manager, Agreements Specialist and Agreements Officer – all appear to be foreign agents: their names are redacted with (b) (6).
This document is also referred to as a “Statement of Work”, i.e. a description of a specific project that will be implemented under a previously established “umbrella” contract (Base Agreement discussed in the Part 1 of this series).
I have written about the role of DOD in “covid countermeasures” contracts previously here
I will discuss in more detail several sections from Pfizer’s Technical Direction Letter as they reveal the true purpose of this project, and how it fits into the US government-military-pharma-academia deadly “biosecurity” scam. Emphasis mine.
SECTION 1.0 INTRODUCTION, SCOPE, AND OBJECTIVES
Therefore, in response to a request by the Government, Pfizer is proposing to manufacture at-scale and fill-finish, for provision to the Government, a state-of-the-art candidate vaccine, developed in collaboration with BioNTech and capable of providing protection against the SARS-CoV-2 threat and related coronaviruses, subject to technical, clinical and regulatory success.
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 [REDACTED] , using the Pfizer/BioNTech unique mRNA delivery system and its associated cold chain requirements, under pandemic conditions.
This section is full of both, fuzzy hopey-dopey and ominous language:
“State-of-the-art” – are we talking about medicines? The definition of this word is something technologically cutting edge, advanced and up to the minute. It’s appropriate in describing new cool tech, latest gadgets and, yes, the latest weapons, too. In medicine, however, the latest and up to the minute product is THE RISKIEST, and thus least desired as a first line of therapy. Every non-brainwashed, experienced doctor knows that in medicine the preference is always for things that have been in use for decades vs. those newly introduced. The new tech is only really desired if everything else had been tried, has failed, and the situation is desperate or terminal. That’s because safety profiles of drugs cannot be fully evaluated even by well-conducted large clinical trials, and it often takes decades to characterize the product’s long-term safety. Certainly, this was not the case with covid illness. Safe, effective, well characterized, used for decades medicines have demonstrated efficacy and were immediately suppressed, censored, banned and otherwise excluded from use by the public health authorities.
“Capable of providing protection” – based on what? How would anyone know what is medically protective without careful, evidence based long term testing? No terms are defined (no definition section in this SOW, and these terms are also not defined in any other related documents).
The contract writers state over and over that this is a “prototype project”. In fact the word “prototype” is mentioned in this contract 22 times. Here is a quote from Section 1.3 Objective:
This effort constitutes a prototype project because it will be used to evaluate the technical feasibility of completion of the prototype project during the ongoing COVID-19 pandemic and unprecedented threats to several components of the prototype project. In addition, this is a prototype project because Pfizer will demonstrate and prove-out the at-scale, multi-lot proprietary manufacturing activities in order to assess the feasibility to support the necessary quantity of safe and effective doses required for vaccination of the U.S. population and deliver those doses within challenging cold chain requirements
Prototypes, prototype projects, and demonstrations of prototype large scale manufacturing. Got it. Very clear.
There is an interesting sub-section in Section 1 – Section 1.1.2. It describes what happens “without Government funding”:
A. Regulatory Planning
B. Clinical And Regulatory Approach
C. Chemistry Manufacturing Controls (CMC).
It is a peculiar sub-section. Contracts and statements of work are typically written to describe what deliverables are expected when and in exchange for how much money/value. They do not typically include what happens outside of the contract, as it is not relevant to the contracted trade. The “without Government funding” section, however, takes 5 out of 35 pages of this contract (p. 3-8) I will explain why below.
Here are some excerpts with my notes:
1.1.2 ACTIVITIES UNDERTAKEN WITHOUT GOVERNMENT FUNDING
A. Regulatory Planning. 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. Given that these clinical trials are regulated by the FDA and HHS, there is no need for separate regulation by the U.S. Army Medical Research and Materiel Command. BioNTech is the Investigational New Drug (“IND”) holder, while Pfizer is the designated agent for all interactions with the FDA and is taking the lead on all communications with and submissions to FDA.
Note: This simply says “FDA regulations exist”, and Pfizer/BioNTech will plan to comply with them. This is in a section titled “the Government has nothing to do with this”, and for avoidance of doubt they are stating that the Army Medical Research regulations DO NOT APPLY either.
B. Clinical and Regulatory Approach
Note: In this part they talk about various meetings with pharma regulators that BioNTech and Pfizer attended, including meetings with the FDA, German and Chinese regulators. That’s nice. Business people went to many meetings…
C. Chemistry Manufacturing Controls (CMC). Pfizer will complete the necessary CMC and scale-up activities to demonstrate the ability to manufacture 100M doses [REDACTED (b) (4)] . Pfizer will use diligent efforts to manufacture and quality release (using Pfizer’s quality system) 100M doses within the US in a non-preservative multi-dose vial [REDACTED (b) (4)]
Note: (b)(4) redactions in very interesting locations. 100M doses of [redacted words] that would, if unredacted, impair the application of the “state-of-the-art tech” in weapon systems. Why redact with (b) (4) if it were really a pharmaceutical vaccine? So, is this a “vaccine” or a state-of-the art weapons system?
This section continues on and on, multiple pages describing formulation activities, sourcing, stability testing, manufacturing quality controls, yada-yada-yada. Many (b) (4) redactions throughout.
The CMC program may include, but not be limited to: (a) [REDACTED (b)(4)] ; (b) drug substance development; (c) drug product development (LNP formulation, d) analytical development in GLP and GMP setting; (e) GLP and GMP manufacturing; and (f) and shipping of -80 °C frozen product.
Note: Again a very interesting redaction with (b) (4) – something that precedes drug substance development, if unredacted, this will impair the application of state-of-the art tech in weapons systems.
By now it should be abundantly clear that the US DOD is ordering weapons systems from Pfizer. Take a minute to think about what this means…
Let me explain the purpose of the “stuff that happens without Government funding” section of the contract:
The contract is under Other Transaction Authority contracting method. Under OTA, the DOD can only order prototypes (not complete functional products, especially not properly developed and tested pharmaceuticals). For properly developed, tested and approved medicines they would have to use normal regulated contracting, which would be a bummer as they obviously need the the secrecy of the OTA for this project. To use OTA, the DOD has to engage “non-traditional defense contractors”, meaning companies that have not sold anything to the DOD during prior 12 months. That’s the authorized scope of OTA – its stated purpose is for one-off, relatively small (less than 1 year) projects around things like novel prototypes that may not be available from established contractors. That’s a problem for the DOD. They want to keep buying secret stuff in large steady volumes from the same crony companies, instead of looking for newbie vendors every 12 months. So, the DOD uses an OTA loophole which allows them to “cost-share” if the company is an established defense contractor (like Pfizer). Also, a long term lucrative relationship with the DOD is much more likely to keep vendors highly cooperative and never questioning the scope of work, or walking away from the deal.
Then on p. 8, the DOD states that the items in the previous 5 pages of yada-yada-blah-blah about FDA clinical, regulatory and manufacturing compliance you just read are OUT OF SCOPE of this contract.
To be sure, cost-sharing is a common practice in contracting for R&D collaborations, and I have negotiated several agreements that included elements of cost-sharing. Here is why the DOD “cost-share” is a smokescreen – in legitimate contract practice, when the contract includes cost sharing between the parties, all cost elements that are being shared are IN THE SCOPE of the contract. If those elements are excluded from scope – it is not cost sharing. Those are activities irrelevant to the contract. Which, in fact, is the truth: the FDA regulations were at the time and continue to remain irrelevant to the mRNA/DNA injections. Because they are not pharmaceuticals, but weapons.
The DOD contract writers cleverly dumped all the activities related to the FDA regulatory and cGMP, i.e. anything that a proper pharmaceutical product would have to comply with, into a fake “cost-sharing” category, and then excluded them from the scope of the contract!
Finally, I am including comments from a reader, because they describe well what this statement of work for $2B really is – a fraud on all of us. A document written (intentionally in my opinion) in a confusing, contradictory and non-enforceable way to defraud not the government (the government wrote it), but all of us, the people:
Pfizer has killed many people the NRA hasn’t Up your Shaft David Hogg and the same for your stupid March for Our Lives