Why has the PREP act been amended 11 times to accommodate COVID-19?
Why has the PREP act been amended 11 times to accommodate COVID-19?
And yes, Pfizer is a 'covered person' according to the PREP act, but can they lose this coverage if they fail to deliver on their end of the deal?
What is the PREP act?
The Public Readiness and Emergency Preparedness (PREP) Act (PREPA) was signed into law by George Double-ya in 2005 as a tort1 liability shield intended to protect vaccine manufacturers from financial risk in the event of a declared public health emergency.2
Now, I don’t even know where to start throwing rotten tomatoes at this piece of crap law but here are some valid questions I can think to ask:
Where is the shield of protection for the people who are injured at the hands of the manufacturers?
What is a public health emergency and who has the power to define/declare one?
Why should vaccine manufacturers get protected from financial liability if they produce a product that damages their consumers?
A1: Instead of having a shield of protection, consumers (individuals who trusted their ‘leaders’) got ramrodded by the shield of greed. We have all been witnesses to this during the COVID debacle. The injured are to this day gaslit, insulted, mocked, censored, and personally taking on all costs of recovery from injury that arose from having taken the COVID-19 injectable products. That is, if they are still alive and able to do so.
There is no protection of, or for, the consumer. And certainly no shield of glory.
A2: A public health emergency should never have been declared in the context of this coronavirus - there was no emergency in this case. Off-label drug use would have made this coronavirus issue vanish in a week. The WHO declared this COVID-19 thing a pandemic and governments unanimously followed in their declarations of a state of emergency that continues to this day.
A3: They shouldn’t. They should pay out for every single person’s claim of injury. Of course, these claims should be backed by causality assessments done by non-conflicted parties.
By invoking provisions of PREPA, the HHS secretary can wield (Wield? Like a sword? Going through your stomach, type thing?) broad authority to declare an emergency, which in turn would trigger drug company immunity from liability at any time, thereby conferring upon drug companies legal immunity for harm caused by their misconduct. (What??) The immunity that could be conferred on drug and vaccine manufacturers can be applied regardless of wrong-doing by affected drug companies.3
So that’s the PREP Act. They can kill us, rob us, disable us, make us lose our homes, whatever, and they will be held responsible for none of it, even if it is provable that they caused the damage. As long as this shitty law is in place. Thanks Double-ya.
Now I have another question, why has it been amended 11 times since the COVID-19 debacle began?
I can answer why it’s been amended for the 11th time. This one is simple: they needed to buy more time because of potential litigations. If say, one of the manufacturers of the COVID-19 products was found to been responsible for killing, let’s say, a dozen individuals, and they didn’t have their mighty shield of PREP H - I mean A -protection, then they would be sued out of existence. This is what Brook Jackson is trying to do and I really, really hope she succeeds.
You can read all the details of the 11th amendment here.
Now I would like to call your attention to two expressions:
‘Medical’ or ‘Covered Countermeasure’ and
‘Covered Person’, as seen in this HHS Advisory Opinion on the PREP Act document.
What is a medical or covered countermeasure and was this always the preferred term in used in the PREP act?
The first thing I wanted to know in the face of finding all these bloody amendments was whether or not the use of the word countermeasure was new to the COVID-19 debacle era. It is not. This term has been part-and-parcel of the PREP Act from its inception, and I believe that this is for the sole purpose of broad and nondescript coverage. For example, according to HHS and the PREP Act (Countermeasures injury compensation program), a countermeasure includes:
…drugs, biological products, and devices: manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic or to limit the harm such pandemic or epidemic might otherwise cause. The category also extends to products used to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by a “qualified pandemic or epidemic product”.4
When the above definition was in place in 2010, vaccines were covered by the term ‘biological products’.
Furthermore:
The PREP Act states that a “Covered Countermeasure” must be a “qualified pandemic or epidemic product,” or a “security countermeasure,” as described immediately below; or a drug, biological product or device authorized for emergency use in accordance with Sections 564, 564A, or 564B of the FD&C Act.
They have to cover their asses properly, right? And they certainly have. I mean, it’s all there - even the kitchen sink! If you consider it a device.
The word ‘countermeasures’ certainly covers more than just ‘vaccines’. By the way, it would likely cover gene-based products and perhaps even what would be considered genetically-modified (GMO) products. I don’t know about that for sure, yet. They are biological products, after all.
The following definitions come directly from the Federal Register of the United States Countermeasures Injury Compensation Program (CICP): Administrative Implementation, Interim Final Rule dated December 15, 2010.
“Covered countermeasure” is a term of art defined in the PREP Act and includes three categories (section 319F-3(i)(1) of the PHS Act (42 U.S.C. 247d-6d(i)(1)). The first category, consisting of “qualified pandemic or epidemic product[s],” is defined in section 319F-3(i)(7) of the PHS Act (42 U.S.C. 247d-6d(i)(7)). This category includes products (drugs, biological products, and devices) manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic or to limit the harm such pandemic or epidemic might otherwise cause. The category also extends to products used to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by a “qualified pandemic or epidemic product.” In order to qualify, a drug, biological product, or device must be: (1) Approved or cleared under the Federal Food, Drug, and Cosmetic Act (FFDCA) or licensed under the PHS Act; (2) the subject of research for possible use and subject to an exemption under sections 505(i) or 520(g) of the FFDCA; or (3) covered under an emergency use authorization (in accordance with section 564 of the FFDCA).
The second category includes “security countermeasure[s].” A security countermeasure, defined in section 319F-2(c)(1)(B) of the PHS Act (42 U.S.C. 247d-6b(c)(1)(B), is a drug, biological product, or device that the Secretary determines: (1) Is a priority to diagnose, mitigate, prevent, or treat harm either from an agent identified as a material threat or from a condition that may result in injuries or deaths and may be caused by administering a drug, biological product, or device against such an agent; (2) is a necessary countermeasure; and (3) is approved or cleared under the FFDCA or licensed under the PHS Act or will likely be approved, cleared or licensed within eight years or is authorized for emergency use under section 564 of the FFDCA.
The final category consists of products subject to emergency use authorizations. This category extends to drugs (as defined in section 201(g)(1) of the FFDCA, 21 U.S.C. 321(g)(1)), biological products (as defined in section 351(i) of the PHS Act (42 U.S.C. 262), or devices (as defined in section 201(h) of the FFDCA, 21 U.S.C. 321(h)) that are authorized for emergency use in accordance with section 564 of the FFDCA.
It is highly unfortunate that when you click on the link suggested in this document as a source of information: http://www.hrsa.gov/countermeasurescomp/, you get the following:
So, the use word of the word ‘countermeasures’ did not begin when the COVID-19 debacle began and includes all sorts of things like drugs, injections and devices. I would guess that the devices refer to security devices. I don’t know.
What is a covered person?
So this is where the water gets a bit muddy for me. Enter the U.S. Army with their infamous Contract. From what I understand, and I might be wrong, Pfizer and other manufacturers had been running their so-called Phase I/II trials as part of the race to the product that was going to save the world. As somewhat part of this race, the Army determined a finish line whereby whomever was selected as the winner by them, would become an Army bedfellow - complete with $1,950,097,500.00. No, I am not joking. where did this money come from?
So the manufacturers had done their Phase I/II work ‘independently’ of the military up to the point where the bidding war was won. Pfizer prevailed. So one has to ask, were the military involved prior to announcing the winner of their contest which, only thereafter, legally bound these entities?
On page 20 of a document entitled Department of the Army U.S. Army Contracting Command - New Jersey Picatinny Arsenal, New Jersey 07806-5000, there is a paragraph in the Statement of Work For COVID-19 Pandemic - Large Scale Vaccine Manufacturing Demonstration about Covered Countermeasures and Covered Persons. By the way, good luck to anyone trying to reach this website: JPM Medical Countermeasure Systems.
According to this document, ‘Pfizer is a “Covered Person” as per Section V of the PREP Act Declaration’. Let’s go to the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 (March 17, 2020) - Section V, shall we?
So there is no doubt here, whether you want to go with manufacturer or distributor, Pfizer (and BioNTech) are Covered Persons according to the PREP Act. As per Pfizer’s own delightful website: “Here you'll find all the latest progress related to the creation, manufacturing and distribution of our vaccine to help protect against the novel coronavirus.” They are so proud.
There is a question of whether or not Pfizer played their part in completing their task, however. Could they be disqualified as Covered Persons if they did not? What was their task? Pfizer might be able to argue that they did play their part since it is written in the Army contract (section 1.2 Scope) that “The scope of this prototype project is the demonstration by Pfizer of the supply and logistics capability to manufacture and distribute to the Government of 100M doses of a novel mRNA-based vaccine that has received FDA-approval or authorization based on demonstration of efficacy (hereafter FDA-approved or authorized).” A demonstration of efficacy? What about safety. Isn’t the mantra ‘safe and effective’? I guess ‘Effective’, is not as catchy.
It has been argued that Pfizer did not deliver on “developing a medical countermeasure that is a safe and effective vaccine to prevent SARS-CoV-2 infection”. In this case, do they lose their status as Covered Persons? Is it written in the contract that Pfizer was meant to deliver a safe and effective vaccine to prevent SARS-CoV-2 infection? I mean, from a creepy legal document contract point of view?
I did look, and I found evidence that this is indeed what was intended with a focus on prevention:
Emergency Use Authorization of Medical Products and Related Authorities: Guidance for Industry and Other Stakeholders, January 2017; and Development and Licensure of Vaccine to Prevent COVID-19: Guidance for Industry June 2020.
Now this isn’t precisely prevention of infection from SARS-CoV-2, but one could argue that it implies the same thing as prevention of COVID-19. So said arguer above, is right on her point, but it remains to be determined whether or not Pfizer loses their mighty PREP shield cuz they didn’t deliver. They didn’t. Even the Walensky, the former director of the CDC has come out publicly with the declaration that their product does not prevent infection. There’s been a whole internet whorl wind about this.
*I don’t mean to be an asshole here, but the following statement in section 1.2 Scope could literally mean killing people.
The successful provision of these doses shall establish the effectiveness of a technology capable of potentially providing immediate and long-term solutions to coronavirus infections.
A gun could be an effective technology that would provide an immediate and long-term solution to a coronavirus infection if it was used to shoot a person dead. I am sorry to be an ass. But the above statement can be read this way.
Now let’s jump to the 11th amendment version of Section V. It’s far too long to post screenshots here so I leave to my readers to go to the link to read it.
I would like to point out that the word ‘vaccine’ is used twice in the 1st version and… wait for it… 111 times in the 11th amendment. Seems like they had some hefty amendments, eh? Maybe they changed the definition of a vaccine 109 more times.
If you simply do a quick side-by-side of the first part of the 1st and 11th versions, you’ll notice some differences right away. Not too weird. It is an amendment, after all.
Note that these are the amendments made to each version, not to the original specifications pertaining to each of Section V (Covered Persons) and Section VI (Covered Countermeasures).
What hasn’t changed is that even the ‘officials’ of ‘program planners’ (whatever the hell that means) are free from liability as ‘covered persons’!
Since we’re doing a comparison here, let’s return to ‘countermeasures’ covered in Section VI of the respective 1st and 11th versions of the PREP Act docs.
The respective Section VI amendments are very visibly different from the get go.
I assume that ‘any antiviral’ was added to cover Remdesivir damages. Does ‘any biologic’ include transfecting platforms? They included ‘any respiratory protective device’ to get liability from mask damage in the 11th amendment version.
Take keen note of how they elongated and sectioned a whole whack of stuff in the list of things now considered to be a Covered Countermeasure. Take (c) for example. In version 11, instead of the amendment referring to a product intended to mitigate the evils of COVID-19, it refers to technology ‘intended to enhance the use or effect’ of say, the injections. What exactly are they referring to here? What technology? Are they referring to the LNPs? I imagine so, so why not just script that? They do refer to technology in the 1st version in Section VI. Covered Countermeasures original specifications in subsection iii, but not in the amendments section.
I just find it weird how they keep changing the way these things are written down. It almost seems like they are trying to keep up with the fall-out of the disaster they’re creating as time passes. The PREP Act was basically collecting dust for quite some time - that is, until this COVID debacle was unleashed on us. Maybe that’s why we needed 11 amendments. Lucky number 12?
Although PREPA was around for more than 15 years, prior to COVID-19, the act's defensive application in litigation was not widespread, but now the application of the act is being included more frequently in a variety of COVID-19 related lawsuits, including Shareholder Derivative Litigation.5
In (d), they reiterate what was written in the first version that refers to ‘any device’, ‘and all components and constituent materials of any such product’. Psst. Does this include dsDNA and lipopolysaccharide? Again, what are they referring to here? What devices? Security devices? When I think of a device, I think of a machine. This is in fact part of the definition of the word ‘device’.6 The GO crowd is gonna go wild!
This PREP Act thing is just rife with toxic waste people. Rife. In fact, I think it IS toxic waste. Did you know that the poor vaccine manufacturers had a temper tantrum until they got their liability shield into law? It’s true. We’ll give you vaccines if you let us kill people with them and walk away rich. Sounds fair, right? They are making these amendments with great intention and purpose in an attempt to cover as many guilty and faulty asses as they can, in my opinion.
This is with absolutely no regard for the consumers of their products.
You get NOTHING, by law, if any of their devices or technologies or biologics mess you up. If it’s covered under the PREP Act. Which it is.
Please tell a friend about this today. I bet if people knew, they would not be ok with this. It has always been controversial and it has now gone from controversial to a license to kill, in my opinion.
A tort is a civil wrong that causes a claimant to suffer loss or harm, resulting in legal liability for the person who commits the tortious act.
https://en.wikipedia.org/wiki/Public_Readiness_and_Emergency_Preparedness_Act
https://en.wikipedia.org/wiki/Public_Readiness_and_Emergency_Preparedness_Act#References
https://www.federalregister.gov/documents/2010/10/15/2010-25110/countermeasures-injury-compensation-program-cicp-administrative-implementation-interim-final-rule. Found under Supplementary Information: Background.
Kraus, Eric M.; Schmidt Jr., John G. (26 May 2021). "PREP Act Immunity and Its Application in Shareholder Derivative Litigation: A Modest Proposal". The National Law Review. No. Volume XI, Number 146. Phillips Lytle LLP. Retrieved 5 June 2021.
https://www.dictionary.com/browse/device