Sasha Latypova responds to Robert Barnes.
Responding to Criticism Regarding My Statements on Pfizer's DOD Contract
This applies to a large number of other similar DOD contracts (there are hundreds of pharma/device suppliers who have been contracted in similar manner to deliver "countermeasures").
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Available DOD contracts for covid countermeasures. Sorted alphabetically by manufacturer name.
Pfizer’s Technical Direction Letter (used by Pfizer in motion to dismiss Brook Jackson’s lawsuit).
Pfizer DOD purchasing contract.
Recently, there have been public comments made in response to mine and Katherine Watt’s position on DOD contracting with private pharma manufacturers for “covid countermeasures”. The criticism is coming from attorney Robert Barnes who is the chief counsel in Brook Jackson’s case under False Claims Act against Pfizer. Brook witnessed numerous instances of fraud and violations of clinical trial regulations and safety standards, reported them up the chain, including to the FDA, and was promptly fired from her job. Katherine reported on the status of this case:
I am not going to write a detailed review in response to Robert Barnes statements. I will address some key issues that relate to what I have investigated and reported on in the past 2 years, because I think these are very important to future successful prosecution of this massive crime. I wish Robert success in his case and I hope he wins (or at least gets to the discovery phase), as any progress on this matter is extremely important. I am also happy to make any of my materials on numerous categories of fraud committed by Pfizer available in support of his legal strategy.
The quotes here are from a post by Robert titled “A Reasoned Rant”:
An argument (I suspect originated from allies of Pfizer) recently emerged in the public discourse that the Covid vaccines are really “bioweapons” which required no clinical testing for safety or efficacy, because Pfizer was merely an agent and instrumentality of the Defense Department.
I have been speaking out against Pfizer, Moderna, J&J, AstraZeneca, FDA, CDC, and any emergency authorized “vaccine” or “therapeutic” for covid for 2.5 years and published extensive evidence of manufacturing and regulatory fraud committed by these companies.
This basically blames Trump for starting a bioweapon program “intended to kill and disable” people under the guise of a vaccine, while also immunizing Pfizer from any suit (including Brook Jackson’s whistleblower claim) as a mere “agent” of the government. To get to this conclusion, various authors misconstrued the procedural manner Operation Warp Speed functioned.
While I believe Trump is responsible for what occurred on his watch, I don’t think he is to blame for the design and development of these biowarfare agents, despite his bombastic claims to the contrary. They had been designed and developed by many parties including DARPA, NIH, other gov agencies, academia and private companies long before he was elected, as pre-planning and practice runs for “the pandemic” had gone on for years. In the years immediately preceding 2020, the program was lead by DOD Emerging Technologies, DARPA and BARDA and was called “pan-influenza vaccine manufacturing base”. It was super important to the US Government to “keep it warm” and cozy and flush with money so they could protect us from the future “pandemic” they themselves created. Characters including Col Matt Hepburn were in charge.
Trump can’t be even credited with the “warp speed” name - that verbiage was invented under Obama administration in conjunction with the zika vaccine scam. He is responsible, in the best case, for being duped and not having enough leadership in him to admit he was duped. We won’t know the truth until a full honest investigation is conducted on this matter.
I see some substack authors pushing a theory that would immunize Pfizer and shift blame to the DOD. These authors often mis-cite the pleadings in the Brook Jackson case I am co-counsel on. They are mistaken. The DOD is definitely in bed with Big Pharma, but legally speaking, Pfizer was not a mere agent of the DOD in this context, and their lies to the government material to Pfizer's funding. Indeed, the contract required the vaccines not be administered if the FDA ever withheld authorization or withdrew authorization.
I would like to clarify that I do not “shift the blame to DOD”. The blame is on both DOD and Pfizer as collaborators in the global mass murder campaign. My question - under what scenario do you believe the FDA would NOT authorize these injections? I have documented their (and EMA, MHRA and Health Canada) clear decision to authorize the shots before reviewing any data from clinical trials:
Preclinical studies were likewise irrelevant to the decision to “approve” these injections, and were composed of fraud, manipulation of data, use of irrelevant test articles and non-compliance with enforceable parts of regulatory guidance. This included an outright false claim made by the FDA on behalf of Moderna regarding vaccine-related skeletal malformations in babies of vaccinated rats.
Follow up question - under what scenario would the manufacturer recall these products? Under what scenario would the FDA force a recall?
My and Katherine’s position, which is supported by 2.5 years of the observable reality of the regulators “not noticing” a pile of dead bodies, horrific injuries, and plummeting birth rates in perfect correlation with vaccination rates, and just “not finding” the safety signals tells us that there are no such conditions. The HHS is lying to the public and is enabling the mass murder, and this is fully intentional. That is also supported by the legal structure identified and documented by Katherine which the criminal government-pharma cartel is utilizing that makes the pharmaceutical regulations not applicable to these “EUA prototype countermeasures under public health emergency” and with PREP Act as a shield.
In this case, the prototype was not the vaccine, but the method used to create it – a wide scale, sped-up process of producing medical countermeasures in a pandemic for national security and future military use. The prototype was the process, not the product.
This has been misconstrued to make the vaccine a “prototype weapon” because the prototype legislation primarily presumed purchases for weapons, but this confuses the most common use of the law with the purpose of the project here.
The main problem with the above statement - it assumes that a safe pharmaceutical can be made by a “prototype” manufacturing process. That is a naive assumption. A well intentioned FDA performing as an honest regulator would have never made this “mistake”. A guard dog would bark at a stranger sneaking into the house at night.
In pharmaceutical manufacture there is no possibility of having a “prototype process” delivering a “safe product”, especially in quantities of billions of doses. Everyone involved in setting up the global “vaccine” disaster were fully aware of this.
Pharmaceutical products can only be trusted and used properly when the process of their manufacture can be trusted - it must be fully characterized and tightly controlled at all times. Noncompliance with cGMP means that no statements about safety or efficacy of anything can be made at all, because IT IS NOT KNOWN WHAT IS BEING MADE.
A consumer or a healthcare provider usually cannot detect (through smell, touch, or sight) that a drug product is safe or if it will work, and therefore safety testing and assurance processes are both needed.
Adherence to the current Good Manufacturing Practices (cGMP) regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.
While cGMPs require testing, testing alone is not adequate to ensure quality. In most instances testing is done on a small sample of a batch (for example, a drug manufacturer may test 100 tablets from a batch that contains 2 million tablets), so that most of the batch can be used for patients rather than destroyed by testing. Therefore, it is important that drugs are manufactured under conditions and practices required by the cGMP regulations to assure that quality is built into the design and manufacturing process at every step.
The FDA knows all this and always have known this - the text above is copied from the FDA website explaining their history and why they exist in the first place.
Under what scenario do you think the FDA “FORGETS” THIS? Under what scenario do you think the government gives a private company $10 billion and a PREP Act and orders a “prototype process” to deliver “safe and effective” potion, when the government knows full well this cannot be done?
Pfizer’s DOD contract focused on logistics solely because FDA compliance was a precondition of payment for the contract all the way through. Pfizer tried to play off of this by claiming the absence of all the FDA rules from their DOD contract meant the FDA rules were not preconditions of payment. We rightly satirized Pfizer’s claim as absurd. The reason is the plain language of the contracts Pfizer themselves admitted into the record, contracts these same authors oddly fail to discuss in detail while spinning their seductive Dominion-like conspiracy tale that the Covid vaccines were bioweapons (which, if true, did something they managed to forget to talk about – completely immunize and inoculate Pfizer under sovereign immunity and eviscerate Brook Jackson’s case.)
I agree with the satirizing, and I agree that Pfizer’s claim is absurd, but it is also the Government’s claim - they countersigned the absurd contract, and they also sided with Pfizer in their expression of interest in this case.
About the term “weapons”:
“Gene therapy as a weapon” has been a known category of biological weapons according to the US Government/DOD reports since at least 1997. Renaming a technology into “vaccines” did not change the technology, it just renamed it. (Kind of like “directed evolution” vs “gain of function”, same difference). The mRNA tech is just as weaponizable as before renaming. The use of these injections is currently indistinguishable from their use as weapons because there is no reliable and controlled manufacturing process, nor a transparent and traceable pharmaceutical distribution chain. They are ordered by the DOD under Other Transaction Authority, made by defense suppliers, distributed by the DOD in a completely opaque chain, and owned by the DOD until injected. More about mRNA as a weapon here:
Pfizer had to comply "with current Good Manufacturing Processes as defined by FDA guidance", including "clinical trials", and any "failure to comply" that had any "material adverse effect on the safety" of the product would be a "material failure."
The contract is very curiously written - the bullet point above is particularly sloppy for a contract language, because it should say “Good Manufacturing Practices” (not Processes). In another part of the contract (2.0 Applicable References) it said “ Current Good Manufacturing Procedures” - it’s like they can’t quite get this one right! cGMP is a very extensive set of laws. I have negotiated a number of contracts and this particular one seems very odd to me, as if it was written on purpose to confuse the reader. While it says that Pfizer will follow the “FDA guidance” (which ones? which FDA Guidances apply? The manufacturer must know this - you must know what you are supposed to be in compliance with in order to comply!), it also says this - pre-clinical studies, clinical trials and chemistry manufacturing controls (i.e. all the parts that constitute regulatory compliance) are OUT OF SCOPE of the contract. They are not ordered and not paid for by the DOD:
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Further, in the “Deliverables” section, the contract writers describe the cGMP correctly and even cite applicable law! Does this mean Pfizer is on the hook?
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Not really. It appears that this deliverable only requires Pfizer to WRITE A PLAN. This section is NOT about being in compliance with these laws, but about writing an essay on how you would potentially do it. The acceptance criteria stated in the section for this item is that the Government/DOD will “review” it. That’s it.
This is in part the confirmation of what I and Katherine have been describing as “playacting” on behalf of Pfizer and FDA, creating “props” for a propaganda/biowarfare to be waged on the public (such as this “Manufacturing Development Plan” or a “Quality Plan”. Not a real pharmaceutical compliance process. I also wonder why the sections are so heavily redacted - cGMP/quality are not “proprietary” items.
The SOW further stated the agreement is Pfizer’s "provision to the Government, a state of the art candidate vaccine...providing protection against the SARS-Cov-2 threat and related coronaviruses” but only after “subject to technical, clinical and regulatory success." Pfizer led the government to believe Pfizer could do "unprecedented phase" clinical trial design and its mRna technologies would "abolish the risk of anti-vector immunity." Indeed, Pfizer promised they could scale fast "while preserving high quality and safety standards." Pfizer promised its product would be "for the prevention of Covid-19."
I completely agree Pfizer promised all these things by signing the contract. And they of course lied because they could not deliver these things, and they knew that, and they also saw all the loopholes included in this contract by the DOD contract writers. However the DOD/HHS/FDA also lied by countersigning the contract - nobody involved in this are idiots or naive. Prior to that moment there had been about 20 years of regulatory knowledge of failures to make a safe and manufacturable mRNA product, and not a single success. An example of the regulatory knowledge can be found in the the 2015 FDA Guidance for gene therapy products, including vaccines:
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This Guidance at the time included gene therapy vaccines:
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It further stated that manufacture of these products was an extremely difficult problem. It stated in another section that it was generally not acceptable to even test these products on healthy volunteers, because the risks were too high. For reasons including lack of safety, absence of reliable “therapeutic window” (a dose that would be generally safe for a large and identifiable population), and lack of manufacturing success all previous attempts at putting mRNA products on the market failed. The FDA knew this history very well. The DOD/Operation Warp Speed knew or should have known this too, since the FDA was the Chief Science Advisor to them. So, in full knowledge that the clauses cited from the DOD-Pfizer contract could not be possibly implemented, the DOD and Pfizer both signed that contract.
If you see the US Government/DOD signing a contract with a private company which promises to deliver flying unicorns that fart rainbows in exchange for $10 billion - you should suspect that both parties signing this contract are in cahoots to defraud the taxpayer. In fact they do this routinely, printing and spending money on various scams so why is anyone surprised. Unfortunately, the False Claims Act does not contemplate a scenario where the government is committing fraud in cahoots with a private company, so I completely understand the frustration inherent in pursuing this under FCA.
Art for today: Chris and Rabbit, oil on panel, 12x16.
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