David Gortler knows the system, is extremely bright and no-nonsense. He served near the top of the FDA, as well as having been in Academe (unlike Peter Marks he knows his stuff)--SAVE this article.
Sasha Latypova and Katherine Watt have clearly documented that in the case of the C19 shot as an EUA product, that there is absolutely no legal requirement for any testing, good manufacturing processes, or disclosures of any kind. In the case of this inoculation there is a total legal fortress that permits fraud, injury, death etc. with no liability. In fact in this case the FDA has no requirement to be involved and in their opinion, the sham trials, mmeant to give the appearance for marketing purposes that the rules for regulated products were being followed. One must realize that these are not regulated products and that instead they are military countermeasures. It is the entire legal wall or regulations, acts etc. such as the PREP act which must be addressed.
Not only Sasha, but I have pointed out (since 2009) that the PREP Act requires only a guess by the FDA Commissioner that the product does more good than harm under EUA.
However, some COVID vaccines are licensed (the current one is) and so all the FDA rules should have been followed for a LICENSED product.
The FDA Commish may think he can turn a licensed product into an EUA; well see us see what the courts say about that.
It is not true that any Covid vaccines have been licensed.
All FDA activity that appeared to be license-related, pertaining to all biological products manufactured since May 2019, has been fraudulent, performative, charade, pretextual, and any other word or phrase that means not real, not substantive, not legally relevant.
And all biological product development, manufacturing and use since February 4, 2020, has had an additional layer of non-regulation and liability exemption (license-to-kill) through the PHE-EUA-MCM-PREP structure and the Defense Production Act structure.
Until litigants properly identify the toxic products as unregulated poisons, biochemical weapons, or other accurate terms, no court cases are going to move things along toward ending the 'vaccination' and 'biological products' programs in their entirety and bringing the medicalized mass murder chapter of American history to a close.
Litigation that erroneously identifies the toxic products as regulated biological products or vaccines is a waste of time and money, and only serves to extend the mass murder programs.
I totally agree that licensing of any of these products was done in a fraudulent manner. Unfortunately, under current US law and the Chevron doctrine, federal agencies have deference over we mere mortals in deciding what is kosher and what is fraud. So while anyone in their right mind would agree that the FDA ignored all its customary procedures and gave a license to covid quackzines in an arbitrary and capricious manner, we get nowhere until we prove this in a. court of law. Until then, they are licensed products. David Gortler helps us fight that.
That, JVM, is the crux of the issue. Every action the FDA took to appear to license these products was a charade, and I am sure that the DoD/HHS/ nexus paid the FDA very well to engage in this fraudulent charade. Until we address the legal walls that Katherine and Sasha point out, there will be mo accounting and these kinds of charades will become SOP.
Part of the problem is that, if I recall correctly, the argument made by Brook Jackson was that the government, rather than the American people, had been defrauded. Big mistake! Of course Big Pharma and the captured regulators colluded. They do that even with licensed products, resulting in extensive unnecessary death and suffering. But this is indeed a whole new level of institutionalized fraud and mass murder. Why is it so hard for the attorneys for plaintiffs in these matters to see what's really going on and call it what it is? Every time there's another Holocaust, everybody says "Never Again" ... and then they turn right around and let it happen again.
I will be very curious to see the motion to dismiss the Paxton lawsuit to see if they DOJ gets involved citing the EUA law again. Truncale ruled that the fraud was "immaterial" to the govt because of the EUA LAW. This is what everyone is not getting except for Sasha and Katherine and it's taken them over a year to flesh this out.
What they did was license an EUA product under PHE laws (21 USC 360 bbb) that explicitly did NOT REQUIRE INVESTIGATION, IRB, CGMP and is CONSIDERED AN MEDICAL COUNTERMEASURE NOT A PHARMACEUTICAL.
Dr Nass, I'm having trouble reconciling your view with the conclusion of Judge Truncale in the Jackson case (and of course the work of Katherine and Sasha). Seems orthogonal to me.
Is there not another level of deceit in that there is indeed a fully licensed Pfizer transfections product, called “Commirnaty”, however it was never available in the US? Whenever someone demanded they be given Commirnaty, they were told that it was identical to the EUA product? The complaint Wright v DoD is about that….
"I totally agree that licensing of any of these products was done in a fraudulent manner" - translation - they ARE NOT licensed products. There were no clinical trials. The EUA laws are immoral laws - 90% of the "leaders" in DC have no idea what is going on - See Toby Rogers Substack "What We Are Up Against". Peace.
They are licensed because you, Steve do not have the authority to withdraw the license. We went to court in 2003 and got the anthrax vaccine license revoked in a court of law. Until then it was licensed. After that it was not licensed. Until you Subject the license to the scrutiny of a court and it is revoked, the license stands. That is the law in the United States. We all wish it was different, but it isn’t.
Yes, the Watt/Latypova information appears to be the key to understanding what is really going on and who is actually in charge. The FDA seems to be nothing more than a smoke screen, in this case, and definitely not in the business of protecting the people.
I came here to say the same thing. There is no FDA approved covid vaccine outside of one tiny head fake batch (produced to force the military to accept the injections.) They are all EUA and EUA says that the products cannot be deemed adulterated or mislabeled, which means there are ZERO purity standards.
All this focus on the FDA seems to suggest the FDA is negligent and the vax manufacturer are liable for cheating the system, but the legal reality seems to be that pharma was hired specifically to produce an unlicensed, unlicensable substance for the military.
Later, if some 'reforms' were proposed for the FDA and the remote testing were banned, we would be told that everything is okay now and the FDA is fulfilling its mission, but in regards to EUA products they didn't have a mission to begin with. EUA has no informed consent, no investigational drug rules, no clinical trials and cannot be determined adulterated or mislabeled. The only measure of effectiveness needed is that HHS secretary thinks it might help with some emergency. What would fixing testing do about that?
Sorry but you are wrong. All the current XBBB is licensed. I guess you have not been live-blogging the VRBPAC and ACIP meetings on the vaccine like me.
A license conveys certain expectations of the product's safety and efficacy that the FDA and manufacturer are responsible for having assessed--an EUA does not provide this gloss of a major evaluative process and review of documents. Giving a licensed product an EUA (which by my reading of the rules can only be done when it is being used off-label) does not remove the expectation of safety and major review by FDA that the license connotes.
I agree with your principle however it would appear that the US judicial system considers the EUA to override that principle based on Pfizer being able to obtain a favorable judgment to dismiss the recent case taken against them.
Are there definition differences in “safe”, “effective”, “delivery” used within the pharmaceutical industry than what the public uses on a daily basis? My question is based from... are the companies lying when they advertise “safe” and “effective”.
Actually Comirnaty and Spikevax are only licensed for ages 12 and up. And I checked at the pharmacy. It is being distributed as such (“COMIRNATY” on the packaging). But: all COVID-19 vaccines for 11 and under are EUA only. The question that needs to be answered is, to what extent are the manufacturers covered under the PREP act, for not complying with the terms of the license, or for harm caused by the licensed products? Are the licensed products “covered countermeasures” especially after the end of the Public Health Emergency? As long as their activity is “related to a USG agreement” according to the HHS, then yes, Pfizer and Moderna are still covered:
I read one of the US Codes about this a few weeks ago, and it seemed to say that once a product was authorized under an EUA, it retains all the legal protections that it received through that EUA, despite later being called licensed.
I would like to help attorneys strike at the root of all of this, but I've reached out to several of the ones in this field and they do not return my calls or web messages. It's almost like they are controlled opposition.
Does a FDA licensure mean anything now? They have played a bait and switch and announced such stating using the countermeasure pathway they do not need informed consent nor testing. How can fda license a product not properly tested and unavailable to the market place?
You are not reading what I wrote or what I’ve been writing for years
And 58 has rules regulations and standards that it is expected to follow when it issues a license. We all agree that they did not follow them. However, they are required to follow standards if they issue a license. There are no standards for an EUA. That is the law.
What I am saying is that it’s easier to show that FDA behaved lawlessly when looking at the licensed compared to the EUA products
Yep! The Covid con was the initial salvo in the bio warfare push to create injections as the new form of treating disease states. DOD (Barda) and Big Pharma are acting in concert to achieve a revolution in health care treatment that is extremely profitable, proprietary and patentable! The money people are all in, to get their share! When the DAIAD researchers share in the spoils, they rejoice! Gates heads the list. In 2024, more to come at humanities expense.
Yes, thank you for the good comment. Reading Gortlert I thought "He simply hasn't heard of Latypova & Watt and is confirming and illustrating their claims." The Danish Safety Study he cites is far less mysterious to conspiracy theorists. After a while the Danes substituted placebo for the dangerous vaccine, but kept alive the crucial idea that it is imperative to take our vaccines when we are told to do so. This was a compromise between protecting the public from a deadly vaccine while keeping it compliant to future efforts--and demonstrating how even a globally coordinated coup may not be be coordinated as is usually thought. The content of the super-safe vaccine was written up here "Pfizer Vaccine Batches in the EU Were Placebos, Say Scientists" by Robert Kogon, Global Research, June 29, 2023. The forensic "tell" is that it was so safe (because it was placebo) that it was exempted from the internal safety regulatory steps. https://www.globalresearch.ca/pfizer-vaccine-batches-eu-were-placebos-say-scientists/5824154
Keep in mind also the CDC bulletin that states that all the USA Covid vaccines are government property, use of which by any person outside the team of authorized handlers and administrators (e.g., by testing its contents) is at least a federal theft and in fact much, much, more. I would have to track down that archived bulletin but it is quite real.
Sukey, does this suggest that an EUA allows deliberate misleading of Safety and efficacy?
Surely, at best this is FRAUD - at worst, it is negligence and, if continued beyond the point of knowing these consequences, it must be regarded as Pre-meditated mass-murder?
If you read the explanations by Latypova, you will understand that the EUA is totally outside the purview of any regulation. The term was in my opinion deliberately used interchangeable with EAU to obfuscate the meaning and convince everyone that it had the same critical clinical requirements and legal liability as an EAU, but EUA does not. It is entirely above and outside the law according to the legal definition of EUA.
And it was possible to pull off this deceitful strategy because medical professionals had colloquially referred to EAU products (“expanded use”) long since as “emergency use”….so all the good doctors and nurses assumed this was the same. Very clever. Most have still not looked behind the curtain.
Challenge away. 100 years from now, the last surviving humans will still be drugged to death by big pharma and the globalists. The FDA and CDC are immovable in their determination to destroy humanity. They can not be fixed, altered or remade. Like the DC Swamp, they must be plowed over and buried deep, very deep.
Godless roting nations won't rot their way to health, happiness & prosperity in an entropic environment that goes from order to disorder! As per Einstein's 2nd law of thermodynamics! OR God's holy Bible tells us!
I agree with this sentiment but unfortunately, reversal is not possible from my perspective. They have too much power and too much of our population is comfortable and complacent. Also people change their minds after being duped, very slowly. Time is something we do not have on our side. The question we should be asking ourselves, in my view, is what do we do about saving our families the most pain and suffering possible. I am not a proponent of "grin and bare it" especially when children are involved which they clearly are. How do we "dig in" as they put it in the military? I am very serious about this--not just expressing an opinion. Where can we go, what do we do, how can we survive in the coming dictatorship of our entire existence?
Never disregard the inertia of rest, either. Americans are constantly salved by the enormous propagandizing that goes on 24/7. "It can't be "this" bad, can it"?
good point but I am not going to hold my breath. I have some very good friends that are well educated and are very resistant to any of the information we think of as obvious and horrible. They are very well taken care of by the current established order so not too interested in disruption of their status in life.
But you see, what's presented here is rational evidence of malfeasance, at least, which can't be denied. Eventually the weight of the evidence will make denying what's happened untenable.
The main problem as I see it as that many people simply can't believe that everything is so corrupted and even evil, to allow such things to happen.
The Great Awakening, such as it is-- and yes, I think it is-- is that through Covid and the highly irrational state action towards it, many people are beginning to realize that something is deeply wrong with any state that would act in such a way, and abuse the population and then lie about it. People aren't as stupid as many suppose.
The most resistant people are those wedded to the narrative of NPR. I see this in my own highly-leftist state, where many are fanatical against "misinformation" that NPR warns them of.
Brook Jackson's case against Pfizer was exactly based on this malfeasance and was defeated because The government ordered exactly what was provided and knew it was fraudulent so they could not be sued and they have immunity from liability. There are some loopholes to be exploited to have a successful case but no one is aware of them yet (except Sasha Latypova and Kathrine Watt). This crap has been in the development stage for decades and has legislation on their side as unbelievable as that may sound. We are being inundated with a tsunami of well planned, thought out, devised, and supported by marxists, leftists, the CCP, and tons of their supporters with straight jackets in all aspects of our lives including the judiciary. It is totally frightening. According to Edward Dowd the next emergency is in the works as a financial crises (& in my opinion a double whammy with climate emergency to seal our fate). We are like ducks in a barrel that they have created while we were not looking. And we are preoccupied with the harms of the past crisis (CoVid & vaccines, two wars, and an impending war). They orchestrate it all. Sounds crazy but some people have documented all parts of this.
I don't disagree with anything you said, except that we are like ducks in a barrel.
We must do what we can. We must put sand in their tanks in any way we can.
There is no climate emergency. It's completely fake. The financial crisis, if and when it arrives, will be fabricated as well. Yes I know the system is running on fumes, but still ....
Either we throw up our hands up or we put sand in their tanks. The choice is ours. The choice is ours, also, whether to despair or to go on living the best we can, knowing that we're doing what we can. As for those completely brainwashed, I think we need to have some understanding that the propaganda and censorship have been relentless, but despite that we're overall much more aware of what's happening than we were say, five years ago. In my experience it's generally the common working person who has a better grasp of things, while the educated have been schooled to believe everything that the CDC and FDA and CIA, etc., tell them, but even that's cracking.
There are, after all, people like Meryl and Sasha and Katherine out there. And you, and me.
True, so true. Yet, despite knowledge of these startling facts, the American public is still doddering around and has not yet turned the corner when fact intersects with violent anger. We are being taken to the cleaners bigtime, it's high time we get angry and vindictive- and functionally potent. Unless we harness the innate potential in all of us to fight back hard, we will have no chance to fight off the devils who bedevil us. We are not yet organized enough to create the critical mass we need so badly. Yet, jackass "comedians" like Colbert side with the cretinoid Biden as we watch America go down the Kohler vortex.
I personally think that taking a Covid vaccine, whose only indication is for Covid and calling a licensed product an EUA doesn’t seem to me to be within the letter or the meaning of the law
But I must admit, I have not studied this since 2021. And there were no cases back then.
Remember I am no lawyer. I am someone who has read the prep act many times, and tried to make sense of it.
From the perspective of someone in a postion to know and understand the issues. And he is far from convinced that the current "Regulatory" regime is fit for purpose.
The majore "Regulatory" Agencies globally heve expressed the wish to be "facilitators" not "regulators" and I think many of us would take issue with this. I, personally, want and expect my drug regulator to BE a REGULATOR, not a paid "facilitator" for Big Pharma.
there's something very, very wrong with the present system, which appears to be riddled with corruption and deliberate ambiguity.
Secrecy is the name of the game now. And for awhile it was fine because the people trusted our prestigious institutions such as the CDC, FDA, NIH, clinical leaders and practitioners. The TRUST is BROKEN. It is obvious that the intent is to harm, not help.
Selling patent man made drugs is,is "The name of the game!" Ridiculing and jailing all God's food for medicine promoters is, is our modern "First do harm" "medicine" (using toxic non DBPC tested, aluminum mercury squlaine laced & forced MMR style vaccines! "For the good of the people." as they say in Godless Marxist slave nations! Satan wouldn't have it anyother way!
We are and can be our own lawyers. No courts no lawyers needed for all to serve an affidavit and judical notice against all their leaders and all systems including the fda and the WHO
No one would listen- and then you even might receive another injection quietly behind a building somewhere never to be seen again. The CIA is known for that, aren’t they!!!!!
Dr Nass, I am disappointed that this article wasted so many people's time and energy. I thought you knew what several of the commenters (Sukey Watson & Carmen von Richthofen are two) shared, these products are not dependent upon FDA approval because they are legally "countermeasures" manufactured through DoD contracts with no studies or investigations even allowed, no good manufacturing procedures necessary, and no liability protections for consumers. All of David Gortler's wonderful knowledge and comments are totally useless and unrelated to what has been rolled out as a medical product but is actually a military biodefence product aka a bioweapon. How is Mr Gortler's information suppose to be useful at all? If you want to help us with your expertise and passion, you must get more plugged in to Sasha Latypova's and Kathrine Watts' knowledge about what this jab is all about. IT IS NOT A VACCINE OR MEDICAL PRODUCT OF ANY KIND BY LAW OR HOW THEY WERE PRODUCED AND DISTRUBUTED. Pretending we should be concerned with anything to do with our medical community is useless except how they were all duped. Are you duped too? I did not think so.
No matter how transparent and verifiable the manufacturing or ingredients, the idea of using a prophylactic product to prevent or minimize a cold or flu is ridiculous. Full stop.
Sunshine, laughter, good food and fresh air, mixed with exercise. Whether you are talking about 1800s cure all concoctions or 2000s chemotherapy drugs and everything in between.
Very scary about pharmaceutical products being manufactured in India and China, but how much better would the quality control be in Atlanta, Chicago, New York or Los Angeles?
It’s a scary world and kinda sad that we all need the intestinal constitution of a junkyard dog to survive all the potential food and drug manufacturing mishaps and slack hygiene in preparation.
Why hasn’t congress made this a priority? They ask specialists to testify but to what end? It seems to make sense that different batches have caused extreme adverse reactions while others have not. This leads to people to not understanding the possible danger and Russian roulette that they are participating in when getting a shot. Congress should make decisions that will change something instead of just spinning their wheels and getting nowhere, constantly, about everything !
And they are rewarded when they "play ball" and defend/protect the "authorized narratives" ... which, as far as I can tell, are all bogus (and dangerous).
Answer: The same reason Adam Eve listened to the snake in the garden of Eden! Satan is a good salesman, he tells us what we want to hear! Like "we can be our our own god" Or our man/ god government can be our god, "for the good of the people." i.e. like the 110 million kill Godless commie Marxist nations have demonstrated! I.E. to teach us, "Death is the wages of sin, vs. the gift of God is eternal life, through Jesus Christ our lord." [Romans 6:23]
Answer, the same people who pay for all other "free" benefits! i.e. Taxpayers! A Gov. "benefit" is like giving you a transfusion from your right arm to your left, using a Leakey hose.
Good idea! i.e. WARNING this government agency has watched our medical cartel bring Death to 2,500,000 to 800,000,000 Americans [in just the last 50 years,] (According to the Johns Hopkins iatrogenic study, or the book Death by Medicine.) (Not to mention all the suffering & harm they caused!) Demonstrating that Death is Not a concern to our FDA CDC WHO, it's all about Control of the Godless dumb downed sheeple!
What is written here makes total sense to me. I am reminded of a book I read a few years back, entitled, "Bottle of Lies." It is the story of a whistleblower in an Indian lab giving information about the horrible manufacturing processes in an Indian lab. The book tells all about the in person inspections and in the end how the FDA was complicit. It's a page turner and it is chilling to read. Here's a link: https://www.amazon.com/Bottle-Lies-Inside-Story-Generic/dp/0062338781
Sasha Latypova and Katherine Watt have clearly documented that in the case of the C19 shot as an EUA product, that there is absolutely no legal requirement for any testing, good manufacturing processes, or disclosures of any kind. In the case of this inoculation there is a total legal fortress that permits fraud, injury, death etc. with no liability. In fact in this case the FDA has no requirement to be involved and in their opinion, the sham trials, mmeant to give the appearance for marketing purposes that the rules for regulated products were being followed. One must realize that these are not regulated products and that instead they are military countermeasures. It is the entire legal wall or regulations, acts etc. such as the PREP act which must be addressed.
Not only Sasha, but I have pointed out (since 2009) that the PREP Act requires only a guess by the FDA Commissioner that the product does more good than harm under EUA.
However, some COVID vaccines are licensed (the current one is) and so all the FDA rules should have been followed for a LICENSED product.
The FDA Commish may think he can turn a licensed product into an EUA; well see us see what the courts say about that.
It is not true that any Covid vaccines have been licensed.
All FDA activity that appeared to be license-related, pertaining to all biological products manufactured since May 2019, has been fraudulent, performative, charade, pretextual, and any other word or phrase that means not real, not substantive, not legally relevant.
https://bailiwicknews.substack.com/p/legalized-fda-non-regulation-of-biological
And all biological product development, manufacturing and use since February 4, 2020, has had an additional layer of non-regulation and liability exemption (license-to-kill) through the PHE-EUA-MCM-PREP structure and the Defense Production Act structure.
Until litigants properly identify the toxic products as unregulated poisons, biochemical weapons, or other accurate terms, no court cases are going to move things along toward ending the 'vaccination' and 'biological products' programs in their entirety and bringing the medicalized mass murder chapter of American history to a close.
Litigation that erroneously identifies the toxic products as regulated biological products or vaccines is a waste of time and money, and only serves to extend the mass murder programs.
I totally agree that licensing of any of these products was done in a fraudulent manner. Unfortunately, under current US law and the Chevron doctrine, federal agencies have deference over we mere mortals in deciding what is kosher and what is fraud. So while anyone in their right mind would agree that the FDA ignored all its customary procedures and gave a license to covid quackzines in an arbitrary and capricious manner, we get nowhere until we prove this in a. court of law. Until then, they are licensed products. David Gortler helps us fight that.
They ignored it because they weren't obligated by PHE Laws that allowed it Meryl. Do you not see that?!
That, JVM, is the crux of the issue. Every action the FDA took to appear to license these products was a charade, and I am sure that the DoD/HHS/ nexus paid the FDA very well to engage in this fraudulent charade. Until we address the legal walls that Katherine and Sasha point out, there will be mo accounting and these kinds of charades will become SOP.
100%
Very, very few people see the truth of the matter. Peace.
The deference was given to the PHE laws by Judge Truncale per the Pfizer motion to dismiss decision. That's the problem.
Part of the problem is that, if I recall correctly, the argument made by Brook Jackson was that the government, rather than the American people, had been defrauded. Big mistake! Of course Big Pharma and the captured regulators colluded. They do that even with licensed products, resulting in extensive unnecessary death and suffering. But this is indeed a whole new level of institutionalized fraud and mass murder. Why is it so hard for the attorneys for plaintiffs in these matters to see what's really going on and call it what it is? Every time there's another Holocaust, everybody says "Never Again" ... and then they turn right around and let it happen again.
I will be very curious to see the motion to dismiss the Paxton lawsuit to see if they DOJ gets involved citing the EUA law again. Truncale ruled that the fraud was "immaterial" to the govt because of the EUA LAW. This is what everyone is not getting except for Sasha and Katherine and it's taken them over a year to flesh this out.
It was a Qui Tam case which is a whistle-blower case.
What they did was license an EUA product under PHE laws (21 USC 360 bbb) that explicitly did NOT REQUIRE INVESTIGATION, IRB, CGMP and is CONSIDERED AN MEDICAL COUNTERMEASURE NOT A PHARMACEUTICAL.
What did I tell you?
https://open.substack.com/pub/sashalatypova/p/tx-v-pfizer?r=db4nq&utm_campaign=post&utm_medium=web
Because they would have to acknowledge the Monster in the room and they are afraid it.
Dr Nass, I'm having trouble reconciling your view with the conclusion of Judge Truncale in the Jackson case (and of course the work of Katherine and Sasha). Seems orthogonal to me.
Is there not another level of deceit in that there is indeed a fully licensed Pfizer transfections product, called “Commirnaty”, however it was never available in the US? Whenever someone demanded they be given Commirnaty, they were told that it was identical to the EUA product? The complaint Wright v DoD is about that….
"I totally agree that licensing of any of these products was done in a fraudulent manner" - translation - they ARE NOT licensed products. There were no clinical trials. The EUA laws are immoral laws - 90% of the "leaders" in DC have no idea what is going on - See Toby Rogers Substack "What We Are Up Against". Peace.
Can we all please stop using the term "vaccines" and call the frankenjabs what they really are - bioweapons.
The current gene-therapy shots are not licensed products.
They are licensed because you, Steve do not have the authority to withdraw the license. We went to court in 2003 and got the anthrax vaccine license revoked in a court of law. Until then it was licensed. After that it was not licensed. Until you Subject the license to the scrutiny of a court and it is revoked, the license stands. That is the law in the United States. We all wish it was different, but it isn’t.
Yes, the Watt/Latypova information appears to be the key to understanding what is really going on and who is actually in charge. The FDA seems to be nothing more than a smoke screen, in this case, and definitely not in the business of protecting the people.
I came here to say the same thing. There is no FDA approved covid vaccine outside of one tiny head fake batch (produced to force the military to accept the injections.) They are all EUA and EUA says that the products cannot be deemed adulterated or mislabeled, which means there are ZERO purity standards.
All this focus on the FDA seems to suggest the FDA is negligent and the vax manufacturer are liable for cheating the system, but the legal reality seems to be that pharma was hired specifically to produce an unlicensed, unlicensable substance for the military.
Later, if some 'reforms' were proposed for the FDA and the remote testing were banned, we would be told that everything is okay now and the FDA is fulfilling its mission, but in regards to EUA products they didn't have a mission to begin with. EUA has no informed consent, no investigational drug rules, no clinical trials and cannot be determined adulterated or mislabeled. The only measure of effectiveness needed is that HHS secretary thinks it might help with some emergency. What would fixing testing do about that?
Sorry but you are wrong. All the current XBBB is licensed. I guess you have not been live-blogging the VRBPAC and ACIP meetings on the vaccine like me.
But that is legally distinct no? Then they'd be liable.
No because it’s on the children’s schedule now
So it's no longer under EUA? ARE YOU SURE?
Hi Meryl,
Can you please let us know the relevance of being licensed or not if the product is still under EUA?
Thanks,
Miles
A license conveys certain expectations of the product's safety and efficacy that the FDA and manufacturer are responsible for having assessed--an EUA does not provide this gloss of a major evaluative process and review of documents. Giving a licensed product an EUA (which by my reading of the rules can only be done when it is being used off-label) does not remove the expectation of safety and major review by FDA that the license connotes.
Hi Meryl,
I agree with your principle however it would appear that the US judicial system considers the EUA to override that principle based on Pfizer being able to obtain a favorable judgment to dismiss the recent case taken against them.
Can you please comment on that aspect?
Thanks again,
Miles
Are there definition differences in “safe”, “effective”, “delivery” used within the pharmaceutical industry than what the public uses on a daily basis? My question is based from... are the companies lying when they advertise “safe” and “effective”.
Actually Comirnaty and Spikevax are only licensed for ages 12 and up. And I checked at the pharmacy. It is being distributed as such (“COMIRNATY” on the packaging). But: all COVID-19 vaccines for 11 and under are EUA only. The question that needs to be answered is, to what extent are the manufacturers covered under the PREP act, for not complying with the terms of the license, or for harm caused by the licensed products? Are the licensed products “covered countermeasures” especially after the end of the Public Health Emergency? As long as their activity is “related to a USG agreement” according to the HHS, then yes, Pfizer and Moderna are still covered:
https://www.hhs.gov/about/news/2023/02/09/fact-sheet-covid-19-public-health-emergency-transition-roadmap.html
I read one of the US Codes about this a few weeks ago, and it seemed to say that once a product was authorized under an EUA, it retains all the legal protections that it received through that EUA, despite later being called licensed.
I would like to help attorneys strike at the root of all of this, but I've reached out to several of the ones in this field and they do not return my calls or web messages. It's almost like they are controlled opposition.
Please send me that part of the US Code and I will make sure it gets to people who need to see it.
Does a FDA licensure mean anything now? They have played a bait and switch and announced such stating using the countermeasure pathway they do not need informed consent nor testing. How can fda license a product not properly tested and unavailable to the market place?
I disagree. How do you explain the Brooke Jackson dismissal? There was no legitimate clinical trial.
You are not reading what I wrote or what I’ve been writing for years
And 58 has rules regulations and standards that it is expected to follow when it issues a license. We all agree that they did not follow them. However, they are required to follow standards if they issue a license. There are no standards for an EUA. That is the law.
What I am saying is that it’s easier to show that FDA behaved lawlessly when looking at the licensed compared to the EUA products
Anyone have a link to more information on the elusive “FDA approved” batch made for the US military?
Yep! The Covid con was the initial salvo in the bio warfare push to create injections as the new form of treating disease states. DOD (Barda) and Big Pharma are acting in concert to achieve a revolution in health care treatment that is extremely profitable, proprietary and patentable! The money people are all in, to get their share! When the DAIAD researchers share in the spoils, they rejoice! Gates heads the list. In 2024, more to come at humanities expense.
Yes, thank you for the good comment. Reading Gortlert I thought "He simply hasn't heard of Latypova & Watt and is confirming and illustrating their claims." The Danish Safety Study he cites is far less mysterious to conspiracy theorists. After a while the Danes substituted placebo for the dangerous vaccine, but kept alive the crucial idea that it is imperative to take our vaccines when we are told to do so. This was a compromise between protecting the public from a deadly vaccine while keeping it compliant to future efforts--and demonstrating how even a globally coordinated coup may not be be coordinated as is usually thought. The content of the super-safe vaccine was written up here "Pfizer Vaccine Batches in the EU Were Placebos, Say Scientists" by Robert Kogon, Global Research, June 29, 2023. The forensic "tell" is that it was so safe (because it was placebo) that it was exempted from the internal safety regulatory steps. https://www.globalresearch.ca/pfizer-vaccine-batches-eu-were-placebos-say-scientists/5824154
Keep in mind also the CDC bulletin that states that all the USA Covid vaccines are government property, use of which by any person outside the team of authorized handlers and administrators (e.g., by testing its contents) is at least a federal theft and in fact much, much, more. I would have to track down that archived bulletin but it is quite real.
Things keep changing, to keep as many people confused as possible. And to keep one step ahead of the law, when possible.
Hi Meryl,
Can you please let us know the relevance of being licensed or not if the product is still under EUA?
Thanks,
Miles
Sukey, does this suggest that an EUA allows deliberate misleading of Safety and efficacy?
Surely, at best this is FRAUD - at worst, it is negligence and, if continued beyond the point of knowing these consequences, it must be regarded as Pre-meditated mass-murder?
Mick.
If you read the explanations by Latypova, you will understand that the EUA is totally outside the purview of any regulation. The term was in my opinion deliberately used interchangeable with EAU to obfuscate the meaning and convince everyone that it had the same critical clinical requirements and legal liability as an EAU, but EUA does not. It is entirely above and outside the law according to the legal definition of EUA.
And it was possible to pull off this deceitful strategy because medical professionals had colloquially referred to EAU products (“expanded use”) long since as “emergency use”….so all the good doctors and nurses assumed this was the same. Very clever. Most have still not looked behind the curtain.
Challenge away. 100 years from now, the last surviving humans will still be drugged to death by big pharma and the globalists. The FDA and CDC are immovable in their determination to destroy humanity. They can not be fixed, altered or remade. Like the DC Swamp, they must be plowed over and buried deep, very deep.
Yes...mistakes were NOT made...they've been at it for decades..... https://sagehana.substack.com/p/the-1969-day-tapes-predicted-the
Amen. Waiting for God’s meteor. Hurry God
We've got to nuke these agencies. It's the only way to "be sure."
Godless roting nations won't rot their way to health, happiness & prosperity in an entropic environment that goes from order to disorder! As per Einstein's 2nd law of thermodynamics! OR God's holy Bible tells us!
I agree with this sentiment but unfortunately, reversal is not possible from my perspective. They have too much power and too much of our population is comfortable and complacent. Also people change their minds after being duped, very slowly. Time is something we do not have on our side. The question we should be asking ourselves, in my view, is what do we do about saving our families the most pain and suffering possible. I am not a proponent of "grin and bare it" especially when children are involved which they clearly are. How do we "dig in" as they put it in the military? I am very serious about this--not just expressing an opinion. Where can we go, what do we do, how can we survive in the coming dictatorship of our entire existence?
Never underestimate the power of a population that realizes it's been duped.
Never disregard the inertia of rest, either. Americans are constantly salved by the enormous propagandizing that goes on 24/7. "It can't be "this" bad, can it"?
good point but I am not going to hold my breath. I have some very good friends that are well educated and are very resistant to any of the information we think of as obvious and horrible. They are very well taken care of by the current established order so not too interested in disruption of their status in life.
But you see, what's presented here is rational evidence of malfeasance, at least, which can't be denied. Eventually the weight of the evidence will make denying what's happened untenable.
The main problem as I see it as that many people simply can't believe that everything is so corrupted and even evil, to allow such things to happen.
The Great Awakening, such as it is-- and yes, I think it is-- is that through Covid and the highly irrational state action towards it, many people are beginning to realize that something is deeply wrong with any state that would act in such a way, and abuse the population and then lie about it. People aren't as stupid as many suppose.
The most resistant people are those wedded to the narrative of NPR. I see this in my own highly-leftist state, where many are fanatical against "misinformation" that NPR warns them of.
Brook Jackson's case against Pfizer was exactly based on this malfeasance and was defeated because The government ordered exactly what was provided and knew it was fraudulent so they could not be sued and they have immunity from liability. There are some loopholes to be exploited to have a successful case but no one is aware of them yet (except Sasha Latypova and Kathrine Watt). This crap has been in the development stage for decades and has legislation on their side as unbelievable as that may sound. We are being inundated with a tsunami of well planned, thought out, devised, and supported by marxists, leftists, the CCP, and tons of their supporters with straight jackets in all aspects of our lives including the judiciary. It is totally frightening. According to Edward Dowd the next emergency is in the works as a financial crises (& in my opinion a double whammy with climate emergency to seal our fate). We are like ducks in a barrel that they have created while we were not looking. And we are preoccupied with the harms of the past crisis (CoVid & vaccines, two wars, and an impending war). They orchestrate it all. Sounds crazy but some people have documented all parts of this.
I don't disagree with anything you said, except that we are like ducks in a barrel.
We must do what we can. We must put sand in their tanks in any way we can.
There is no climate emergency. It's completely fake. The financial crisis, if and when it arrives, will be fabricated as well. Yes I know the system is running on fumes, but still ....
Either we throw up our hands up or we put sand in their tanks. The choice is ours. The choice is ours, also, whether to despair or to go on living the best we can, knowing that we're doing what we can. As for those completely brainwashed, I think we need to have some understanding that the propaganda and censorship have been relentless, but despite that we're overall much more aware of what's happening than we were say, five years ago. In my experience it's generally the common working person who has a better grasp of things, while the educated have been schooled to believe everything that the CDC and FDA and CIA, etc., tell them, but even that's cracking.
There are, after all, people like Meryl and Sasha and Katherine out there. And you, and me.
They need us to survive so they can stay in business! They want us as long term recipients of there injections to stay profitable!
As long as we contribute to their bottom line!
True, so true. Yet, despite knowledge of these startling facts, the American public is still doddering around and has not yet turned the corner when fact intersects with violent anger. We are being taken to the cleaners bigtime, it's high time we get angry and vindictive- and functionally potent. Unless we harness the innate potential in all of us to fight back hard, we will have no chance to fight off the devils who bedevil us. We are not yet organized enough to create the critical mass we need so badly. Yet, jackass "comedians" like Colbert side with the cretinoid Biden as we watch America go down the Kohler vortex.
my snake oil contains trade secrets so i'm not going to tell you what's in it.
what i'm also not telling you is that it's actually not snake oil. it's a chemical weapon
I personally think that taking a Covid vaccine, whose only indication is for Covid and calling a licensed product an EUA doesn’t seem to me to be within the letter or the meaning of the law
But I must admit, I have not studied this since 2021. And there were no cases back then.
Remember I am no lawyer. I am someone who has read the prep act many times, and tried to make sense of it.
highly informative and comprehensive analysis by Gortler. He raises excellent points.
From the perspective of someone in a postion to know and understand the issues. And he is far from convinced that the current "Regulatory" regime is fit for purpose.
The majore "Regulatory" Agencies globally heve expressed the wish to be "facilitators" not "regulators" and I think many of us would take issue with this. I, personally, want and expect my drug regulator to BE a REGULATOR, not a paid "facilitator" for Big Pharma.
there's something very, very wrong with the present system, which appears to be riddled with corruption and deliberate ambiguity.
And our tax dollars pay for it!
Talk about the “Royal Scam” !
This is a must-read article.
Secrecy is the name of the game now. And for awhile it was fine because the people trusted our prestigious institutions such as the CDC, FDA, NIH, clinical leaders and practitioners. The TRUST is BROKEN. It is obvious that the intent is to harm, not help.
Selling patent man made drugs is,is "The name of the game!" Ridiculing and jailing all God's food for medicine promoters is, is our modern "First do harm" "medicine" (using toxic non DBPC tested, aluminum mercury squlaine laced & forced MMR style vaccines! "For the good of the people." as they say in Godless Marxist slave nations! Satan wouldn't have it anyother way!
We are and can be our own lawyers. No courts no lawyers needed for all to serve an affidavit and judical notice against all their leaders and all systems including the fda and the WHO
No one would listen- and then you even might receive another injection quietly behind a building somewhere never to be seen again. The CIA is known for that, aren’t they!!!!!
This is what this country NEED TO DO.
READ: 2Chronicles 7:14.
AND DO WHAT IIT SAYS EVERY DAY.
Our only hope. Don’t doubt it..
Because the FDA has no jurisdiction over these DOD EUA products. It's a sham. Designed to fool us. Latypova and Watt give a master course on this.
Dr Nass, I am disappointed that this article wasted so many people's time and energy. I thought you knew what several of the commenters (Sukey Watson & Carmen von Richthofen are two) shared, these products are not dependent upon FDA approval because they are legally "countermeasures" manufactured through DoD contracts with no studies or investigations even allowed, no good manufacturing procedures necessary, and no liability protections for consumers. All of David Gortler's wonderful knowledge and comments are totally useless and unrelated to what has been rolled out as a medical product but is actually a military biodefence product aka a bioweapon. How is Mr Gortler's information suppose to be useful at all? If you want to help us with your expertise and passion, you must get more plugged in to Sasha Latypova's and Kathrine Watts' knowledge about what this jab is all about. IT IS NOT A VACCINE OR MEDICAL PRODUCT OF ANY KIND BY LAW OR HOW THEY WERE PRODUCED AND DISTRUBUTED. Pretending we should be concerned with anything to do with our medical community is useless except how they were all duped. Are you duped too? I did not think so.
This!
No matter how transparent and verifiable the manufacturing or ingredients, the idea of using a prophylactic product to prevent or minimize a cold or flu is ridiculous. Full stop.
Sunshine, laughter, good food and fresh air, mixed with exercise. Whether you are talking about 1800s cure all concoctions or 2000s chemotherapy drugs and everything in between.
Very scary about pharmaceutical products being manufactured in India and China, but how much better would the quality control be in Atlanta, Chicago, New York or Los Angeles?
It’s a scary world and kinda sad that we all need the intestinal constitution of a junkyard dog to survive all the potential food and drug manufacturing mishaps and slack hygiene in preparation.
Why hasn’t congress made this a priority? They ask specialists to testify but to what end? It seems to make sense that different batches have caused extreme adverse reactions while others have not. This leads to people to not understanding the possible danger and Russian roulette that they are participating in when getting a shot. Congress should make decisions that will change something instead of just spinning their wheels and getting nowhere, constantly, about everything !
They are all threatened and blackmailed
And they are rewarded when they "play ball" and defend/protect the "authorized narratives" ... which, as far as I can tell, are all bogus (and dangerous).
Answer: The same reason Adam Eve listened to the snake in the garden of Eden! Satan is a good salesman, he tells us what we want to hear! Like "we can be our our own god" Or our man/ god government can be our god, "for the good of the people." i.e. like the 110 million kill Godless commie Marxist nations have demonstrated! I.E. to teach us, "Death is the wages of sin, vs. the gift of God is eternal life, through Jesus Christ our lord." [Romans 6:23]
Amen.
We have all somehow ended up in "The Twilight Zone."
A private sector “ FDA “ might be a solution. Free from politics. Nobody getting a fat pension solely based on how long they pushed papers.
We need something lean and mean. Something that fits in nicely with the concepts of capitalism: survival of the fittest.
Who will pay for it and who will stop the CIA from destroying it
Answer, the same people who pay for all other "free" benefits! i.e. Taxpayers! A Gov. "benefit" is like giving you a transfusion from your right arm to your left, using a Leakey hose.
Until we truthfully label government “agencies”, their value must be rigorously questioned.
Good idea! i.e. WARNING this government agency has watched our medical cartel bring Death to 2,500,000 to 800,000,000 Americans [in just the last 50 years,] (According to the Johns Hopkins iatrogenic study, or the book Death by Medicine.) (Not to mention all the suffering & harm they caused!) Demonstrating that Death is Not a concern to our FDA CDC WHO, it's all about Control of the Godless dumb downed sheeple!
We're all living in an episode of "The Twilight Zone."
https://billricejr.substack.com/p/im-caught-in-the-twilight-zone?utm_source=profile&utm_medium=reader2
Yes, we are
What is written here makes total sense to me. I am reminded of a book I read a few years back, entitled, "Bottle of Lies." It is the story of a whistleblower in an Indian lab giving information about the horrible manufacturing processes in an Indian lab. The book tells all about the in person inspections and in the end how the FDA was complicit. It's a page turner and it is chilling to read. Here's a link: https://www.amazon.com/Bottle-Lies-Inside-Story-Generic/dp/0062338781