SASHA LATYPOVA: And, in summary, I can say none of it is regulated. The FDA kind of pretend regulates [the vaccines], and that's been the case since forever...

"None of it [vaccines] is regulated. The FDA kind of pretend regulates these things, and that's been the case since forever...up until 1973 there were no regulations and no standards for manufacturing...[then] in '86 there was [The National Childhood Vaccine Injury Act]."… pic.twitter.com/iqX6py1O3a

— Sense Receptor (@SenseReceptor) October 9, 2024

"None of it [vaccines] is regulated. The FDA kind of pretend regulates these things, and that's been the case since forever...up until 1973 there were no regulations and no standards for manufacturing...[then] in '86 there was [The National Childhood Vaccine Injury Act]." Retired pharma R&D executive Sasha Latypova (@sasha_latypova) describes for Dr. Drew (

@drdrew

) how "vaccines" are not actually regulated in the U.S. by the FDA but rather only "pretend regulated." The pharma insider notes that the injections were entirely unregulated prior to 1973, and then, by 1986, protected by The National Childhood Vaccine Injury Act—meaning there's no liability and thus, in effect, still no regulations. "My colleague, Katherine [Watt], traced the relevant US law all the way back to late 1700s. And so, we now have a better understanding of the regulatory frameworks in the US as it applies to all vaccines in general, and then, a much greater understanding about the COVID shots, which are EUA countermeasures and how that's regulated," Latypova says. "And...in summary, I can say none of it is regulated. The FDA kind of pretend regulates these things, and that's been the case since forever..." "In the US, the vaccines have not been under FDA mandate until 1973," Latypova adds. "Many people don't realize that. They were not regulated at all as pharmaceuticals. They were manufactured essentially by public health service, which is predecessor of CDC, the US government, public health service." "After 1973, they technically came under FDA purview. And as you know, in '86, there was [The National Childhood Vaccine Injury Act and] that shielded all the manufacturers from liability; that was under Reagan." "Since then, the manufacturers of vaccines [have] had no liability. And if you have no liability for injuries or deaths that you cause, then it's as if regulations don't exist for you because you have no consequences," Latypova notes. Partial transcription of clip: "So the manufacturing, those remain great concerns. In fact, I've I've gotten additional information that it's even worse, than I thought, and the problem actually goes a long time back. Even my colleague, Katherine [Watt], traced the relevant US law all the way back to late 1700s. And so, we now have a better understanding of the regulatory frameworks in the US, as it applies to vaccines, all vaccines in general, and then, a much greater understanding, about the COVID shots, which are EUA countermeasures and how that's regulated. And...in summary, I can say none of it is regulated. The FDA kind of pretend regulates these things, and that's been the case since forever... "So the law research is ongoing, and, Katherine and one of the colleagues are writing a big report on relevant law tracing back to, as I said, late 1700s when, you know, vaccination as we kind of know it in a modern world has, started being used more or less in mass subjects. Now, in the US, the vaccines have not been under FDA mandate until 1973. Many people don't realize that. They were not regulated at all as pharmaceuticals. They were manufactured essentially by public health service, which is predecessor of CDC, the US government, public health service. And, they were sort of, you know, you could order order the samples or whatever you needed, the box. You could even, like, order it in the mail from the US government, and they would send it to you. "And so up until 1973, there were no regulation and no standards for manufacturing, for purity testing, for contaminants, for, characterizing what you have made in the pharmaceutical process, which is standard for anybody who works in pharma making drugs. That didn't exist, really. It wasn't anything codified. After 1973, they technically came under FDA purview. And as you know, in '86, there was a national vaccine, I forget the correct name of the law, but basically, the act that came in that, shielded all the manufacturers from liability that was under Reagan. "And since then, the manufacturers of vaccines had no liability. And if you have no liability, for injuries or deaths that you cause, then it's as if regulations don't exist for you because you have no consequences."

REP. THOMAS MASSIE: Why does the FDA and the Dept of Education need weapons of war, like AR-15s?

Democrats want to ban citizens from owning AR15s, but they insist the Department of Education can’t complete its mission without AR15s. I say the Second Amendment guarantees the right of the people to own AR15s, and the Dept of Education should be banned!  pic.twitter.com/K7kQN9nt9W

— Thomas Massie (@RepThomasMassie) August 13, 2024

6:06, MASSIE.  When you enter these agencies, you have to go through a metal detector.  These agencies have a civilian mission; they do not have a military mission.  And I think Dan Bishop said it well, "How can you say that these are weapons of war and then argue that they need to go to agencies that are not engaged in war and should never be engaged in war?"

7:33, GAETZ.  The entire reason we have the Bill of Rights is because there are certain rights that have to be reserved to the people, not government.  And Mr. Massey's amendment shows how this legislation has turned the Constitution, the Bill of Rights on its head.  It takes powers reserved to the people and it deprives the people of those powers and rights and then it reserves explicitly the very same rights for government, not for the military but for like the Deputy Commissar of Pencil Erasers at the Department of Education.  They want you weak and the government strong.  They want you disarmed and the government armed to the teeth.  I'm reminded of a quote from Austin Powers, where Austin Powers introduces one of his colleagues as a representative from the militant wing of the Salvation Army.  I didn't know we had a militant wing of the Department of Education or the USDA.  But I am certainly aware that our fellow Americans are concerned about a very troubling trend where these bureaucracies are getting their own militias and arsenals.  It would probably surprise most Americans that just this year the IRS has purchased $700,000 worth of ammunition.  So when you peel back all the layers of the onion, the party of big government isn't actually against guns and ammo; they're just against you having them because they want a citizenry that is repressed and dominated and ultimately subjected.  And by the way, our founders were so brilliant they knew this would happen and they knew that the Second Amendment wasn't going to be about hunting or self-defense, but about curating an appropriate balance that is necessary for a free society where we don't have to live in fear, that one day some Deputy Administrator from the Department of Education is going to knock our door down and that as a result of us not having the appropriate protractor that we are somehow going to be in a disadvantageous position regarding our safety, and far more important, regarding our Liberty.  I yield back to the gentleman from Ohio.

BROOK JACKSON: What does overturning Chevron mean? Let's consider an actual case involving FDA - Bruesewitz v. Wyeth.

Chevron Deference Aspect: The court acknowledged FDA's expertise & regulatory authority in approving & monitoring vaccines. The court implicitly deferred to the FDA's judgment that vaccines are safe & effective when they meet regulatory standards, thus preempting state law claims based on design defects. What are the implications of overruling Chevron Deference:

Courts would independently interpret the NCVIA & other relevant laws without automatically deferring to the FDA's expertise. WIN!! Brook Jackson

🚨What does overturning Chevron mean? Let's consider an actual case involving FDA - Bruesewitz v. Wyeth

Background: The case involved Hannah Bruesewitz, who suffered seizures & developmental problems after receiving a DTP vaccine manufactured by Wyeth, now a part of Pfizer. The… https://t.co/gMYFfIswbp

— Brook Jackson 💜 (@IamBrookJackson) June 28, 2024

What does overturning Chevron mean? Let's consider an actual case involving FDA - Bruesewitz v. Wyeth. Background: The case involved Hannah Bruesewitz, who suffered seizures & developmental problems after receiving a DTP vaccine manufactured by Wyeth, now a part of Pfizer. The family sued Wyeth, claiming the vaccine was defectively designed. Legal Context: The National Childhood Vaccine Injury Act (NCVIA) of 1986 established a no-fault compensation program for vaccine injury claims & removed the liability of vaccine manufacturers. The FDA's role in approving vaccines & its interpretation of safety standards were central to the case. Court's Decision: In 2011, SCOTUS ruled in favor of Wyeth, holding that the NCVIA preempts all design-defect claims against vaccine manufacturers brought by plaintiffs seeking compensation for injury or death caused by vaccine side effects. Chevron Deference Aspect: The court acknowledged FDA's expertise & regulatory authority in approving & monitoring vaccines. The court implicitly deferred to the FDA's judgment that vaccines are safe & effective when they meet regulatory standards, thus preempting state law claims based on design defects. What are the implications of overruling Chevron Deference: Courts would independently interpret the NCVIA & other relevant laws without automatically deferring to the FDA's expertise. WIN!! Plaintiffs might be more likely to challenge FDA approved vaccines in court, arguing that the FDA's safety standards or approval processes are insufficient or flawed. WIN!!

Courts would scrutinize FDA decisions more closely, likely leading to different outcomes in cases involving vaccine injuries or side effects. WIN!!

Vaccine manufacturers will face more uncertainty regarding liability & regulatory standards impacting vaccine development & availability. WIN!! 

AARON SIRI: [Peter Marks] sat, as I would expect, as a partner with Pfizer, defending them from their misconduct. He should have been outraged. He should have said, "Why didn't you report this?" irrespective of why you thought this was related. You had an obligation to tell us of all injuries"

🚩 Aaron Siri Shares the Heartbreaking Story of a 12-Year-Old Girl Who Was Seriously Injured in the Pfizer Trial & How the FDA Looked the Other Way

"The FDA did finally ask Pfizer about Maddie de Garay but it was only after somebody who's very, very wealthy emailed Janet… pic.twitter.com/v9UBE88ZxL

— Chief Nerd (@TheChiefNerd) June 26, 2024

Though Dr. Peter Marks concedes that the COVID-19 vaccine causes a 5-fold increase of myocarditis in children, he still pushes the vaccines.

LATYPOVA: There are no requirements for inspection of biologics manufacturing facilities by the FDA. This requirement was removed by Scott Gottlieb [per] admin rule change in 2019. Whatever is being produced is entirely open to adulteration, and this applies to all biologics, not just COVID

There are no requirements for inspection of biologics manufacturing facilities by the FDA. This requirement was removed by Scott Gottlieb as admin rule change in 2019. Whatever is being produced is entirely open to adulteration, and this applies to all biologics, not just covid… pic.twitter.com/EoQmMYVh3r

— sashalatypova.substack.com "Due Diligence and Art" (@sasha_latypova) June 15, 2024

Elaborated here at Sasha Latypova's Substack. 

LATYPOVA: ‘We can now have a non-investigational substance and use it in [a] non-medical and non-investigational way… That makes it [an] illicit drug.”

“Now we have this evolution, from expanded access use… where they said, ‘We can now have a non-investigational substance and use it in [a] non-medical and non-investigational way… That makes it [an] illicit drug.”

In this clip from the same interview, Latypova describes how,… pic.twitter.com/kfdvDon6wL

— Sense Receptor (@SenseReceptor) December 6, 2023

LATYPOVA:

“[W]hen you switch the status [of a regulatory pathway for a drug with the FDA]… to the non-investigational one [the EUA countermeasure pathway], the clinical trial becomes not a clinical trial—it’s just a collection of people trying drugs. Just like a recreational party…”

LATYPOVA:

The “first time the emergency use authorized thing came in was November 2003 through the National Defense Authorization Act, not through a bill that had to do with the FDA, or NIH, or public health, or anything like that.”

LATYPOVA:

The FDA lawyers said, in effect, “We want to violate the law, and we can’t, unless we design this new, extrajudicial pathway for ourselves.”

Brook Jackson is SUING @Pfizer + @VRG_FortWorth on behalf of the American people for multiple violations under the False Claims Act

Pfizer Clinical Trial Whistleblower: “They Know That This Product Is Dangerous and Hurting People”

Brook Jackson is SUING @Pfizer + @VRG_FortWorth on behalf of the American people for multiple violations under the False Claims Act, and TODAY is the last day for Pfizer to make a… pic.twitter.com/I5hAyTjoap

— Children’s Health Defense (@ChildrensHD) October 20, 2023

I have followed the COVID-19 condition, the mask mandates, and the made-up 6-foot distancing, it's all been one big con.  Don't get me wrong, I've had fun with it.  Anyone who insisted I wear a mask, I either outright refused or gave them a mindful of their $.69 cents' worth of authority.  But even after 3, nearly 4 years of this war on everything that human beings value, I am still appalled and disgusted with what some of these companies got away with.  

Brooke Jackson says the first thing she noticed was a lack of informed consent.  They weren't consenting patients properly; they weren't consenting patients at all.  So that was really the first thing that she saw.  There was unblinding.  There was no reporting of the adverse events properly.  They were mixing up lab samples.  The better question is what was Ventavia doing correctly?  Which was nothing.  She got a text message that was basically to lie to Pfizer that she never unblinded her patients.  She was removing documents from patients' charts and shredding them so that they wouldn't find out that we'd actually unblinding all these patients.  Just reading through some of the emails that she was getting she recognized there was an obvious rush to get the vaccine study to meet the enrollment goals.  There was just something that was not right, a gut feeling.  So on the 25th of September, she took [her findings] to the FDA, and she got fired about 6 hours after she contacted the FDA.  She feels like it's an effort between big Pharma and big government and she feels betrayed in a lot of ways, especially knowing that this product is dangerous and that it's hurting people.

FDA's Curtis Wright: Sold out a nation of youth for $400,000 a year job from Purdue Pharma, manufacturers of Oxycontin

When we talk about a bureaucracy we are describing the structure of a system, the top-down structure.  Bureaucracies don't change that much.  They might increase or decrease in size, but the direction of power and control is usually the same.  So in that regard, they don't really change that much.  Systems don't change either, so even if you have these whistleblowers coming out and they out someone, know that the system doesn't change.  Curtis Wright, IV, won the lottery.  

‘Painkiller’ Producer Peter Berg on How the FDA & Medical Journals Partnered w/ Purdue Pharma on the Opioid Crisis

“These are the big time, hard hitting drug dealers…they’re f--king gangsters”@joerogan pic.twitter.com/NEp2QyknDV

— Chief Nerd (@TheChiefNerd) August 29, 2023

"The FDA is not your doctor. Their job is to approve drugs to the market and that's it. They should not be prohibiting drugs. They shouldn't be endorsing drugs. That's not their role, and that's the point of our lawsuit"

purpose of our lawsuit, to remind everybody that the FDA is not your doctor.  Their job is to approve drugs to the market and that's it.  They should be neutral.  They should not be prohibiting drugs.  They shouldn't be endorsing drugs. That's not their role, and that's the point of our lawsuit.  --Dr. Mary Talley Bowden.

“Overwhelming and irreversible damage.” We can’t fix the past but are hoping to prevent this from happening in the future. Thank you @EmeraldRobinson for having us on to talk about our lawsuit against the @US_FDA. @drpaulmarik1 https://t.co/Ga4lOo8nZY

— Mary Talley Bowden MD (@MdBreathe) August 14, 2023

Three doctors who were fired for prescribing or promoting the cheap therapeutic drug, Ivermectin, for the treatment of Covid-19, asked the 5th Circuit Court of Appeals to revive a case that a federal judge dismissed back in December 2022.  

[The judge in this case is The Honorable Priscilla Richmond she's the chief judge for the United States Court of Appeals for the Fifth Circuit.  The date of the hearing was August 8th 2023.]

During the hearing, a justice department attorney named Ashley Cheung Honold tried to defend the FDA's strong campaign against Ivermectin including this tweet where they tell people to just stop it to suggest that the only form of ivermectin comes as horse paste listen

They did not purport to require anyone to do anything or to prohibit anyone from doing what about when it said no stop it why isn't that a command that seems to me that if you were in an English class they would say that is a command stop it that is different than we are providing helpful information.

Your honor, the language that was used in these tweets were merely quips, and I don't think these quips change the substance of the FDA's statement as plaintiffs concede.

Is that a command, "Stop it"?

The tweets about the horse Ivermectin were intended to advise consumers that they should not use Ivermectin intended for animals and that this could be unsafe.

Here is the manipulative ad in question.

You are not a horse. You are not a cow. Seriously, y'all. Stop it. https://t.co/TWb75xYEY4

— U.S. FDA (@US_FDA) August 21, 2021

I'm sorry, can you answer the question, please?  Is that a command, "Stop it"?

Senator Ron Johnson took to Twitter about the about-face of the federal government when confronted with the actual law.  Senator Johnson pointed out that the government admitted in court that the doctors indeed have the authority to prescribe Ivermectin off-label.

Here the FDA was not regulating the off-label use of drugs.  These statements are not regulations.  They have no legal consequences.  They don't prohibit doctors from prescribing Ivermectin to treat Covid or for any other purpose.  Quite to the contrary, there are three incidences that I'd like to point the court to in the record that show that FDA explicitly recognizes that doctors do have the authority to prescribe Ivermectin to treat covid.

So then why are your patients still facing backlashes like this at the drug counter?  "Hi.  I had the same prescription filled at the other store."

Joining us now to discuss these huge developments in the case are two of the plaintiffs Dr. Paul Merrick and Dr. Mary Bowden.  Welcome to you both.  It's good to see you.  This was really big . . . the line of questioning and the struggle to answer from the government lawyer was just amazing.  I'll start with you, Dr. Bowden.  The main argument here is that the FDA admitted to regulating big Pharma.  It doesn't have the authority, though, right, to tell doctors what they can and cannot do, which they acknowledge in court, but if you talk to a doctor, which I did, some of them pretend as if their hands are tied, that they couldn't prescribe Ivermectin.

4:15. There's a misconception that the FDA has more power than they do I think.  The Judge pointed that out quite nicely.  She said, you know, "People believe that the FDA has this power, this right," and that's sort of the purpose of our lawsuit, to remind everybody that the FDA is not your doctor.  Their job is to approve drugs to the market and that's it.  They should be neutral.  They should not be prohibiting drugs.  They shouldn't be endorsing drugs. That's not their role, and that's the point of our lawsuit.

I was quite struck and I played this for my audience on Friday about the argument of sovereign immunity Dr. Merrick.  Essentially the FDA says that we can put out information that's not exactly correct, or that could even harm American citizens and that they have sovereign immunity.  How did you feel about that statement do you believe that's true?

5:19. Yeah, clearly that's absurd.  It means that they are allowed to do anything illegal under the pretense of sovereign immunity.  So let's be clear that the FDA has been on a campaign, a vigorous campaign to deface and dehumanize the use of Ivermectin, which is a safe effective medication, and as a result of this, as you saw in that clip, patients are being denied access to Ivermectin.  Physicians are losing their licenses because they prescribed Ivermectin.  So the misinformation that is being perpetuated by the FDA continues, and as Mary said that is beyond their jurisdiction.  They should not be interfering with the patient-physician relationship.  Their role is to approve drugs they are not in the business of practicing medicine and from the clips that you saw it seems that they're doing a rapid 360 about turns because clearly they made a mistake.

6:30. Yeah, clearly and it seemed like based on what I heard from the hearing, Dr. Bowden, that the judges will likely rule in your favor.  Where do you see this going?  Is the case going to be reinstated?

6:45. Well, unfortunately, the purpose of the lawsuit is basically to have them take down their tweets and take down the misinformation that they put on their website.  Our attorneys don't anticipate that we will get any sort of retraction, although I feel like that is warranted.  We are not seeking damages. Where this goes from here is at the appeal was over sovereign immunity so what may go back to the district court where then we have to prove standing so it's a little up in the air.

7:20. But the damage is already done.  Look if the information is out there. I tried to get Ivermectin for a different purpose than it's used for off-label and the doctor who was willing to prescribe it told me, "Look, don't take this to a local pharmacy.  You got to tell me what pharmacy you're going to take it to because I don't want to hurt my relationship with a pharmacy that I prescribe other medicines, you know, to my local patients."  And that's just absurd.  The damage is done.  If they don't issue a retraction or put out a statement, do you see this war on Ivermectin, Dr. Marick, ever ending, especially as we're we are being warned this other wave of Covid coming? 

8:00. So to speak, the horses are out of the barn already.  They have caused enormous damage.  As Mary said, the purpose of our suit is to prevent them from doing this going forward.  We can't have the FDA interfering with the practice of medicine and that's really the basis of our suit.  But you are correct: the damage that's been done is overwhelming and irreversible.  As you say there is this profound misconception that Ivermectin is horse paste, that it's made for horses, and that it's an unsafe medication.  And those two premises are completely false.  It is one of the safest medications on this planet.  And over 3 billion doses have been given to humans safely, so this is a highly effective medication.  It's exceedingly safe and the notion that it's a toxic horse dewormer is really complete Lee false and misinformation and so the FDA themselves are perpetuating false information and they're interfering with the patient physician relationship.

9:10. Dr Bowden before we end what can people do to help you all fight? 

9:15. Well we're in an information War so keeping the dialogue alive continuing to talk about it continuing to put the heat on the FDA to correct this continue to put the heat on our legislators.  If we lose this case it really emboldens the FDA so it's important and we need to keep talking about it. 

I feel sick.  

I feel sick because I was wrong about two FDA officials who purportedly resigned from the FDA in protest against the approval of the vaccines.  I was wrong.  I'll say it again, I was wrong.  And it only took me one full year to learn of my mistake and to correct it here. 

I made a post with the headline in bold lettering as a kind of breakthrough from institutional corruption, "MARION GRUBER & PHIL KRAUSE: ACTUAL HEROS AT THE FDA."  At that time, June 22, 2022, I was so eager to look for some good news coming out of government institutions that I posted that without critical research to assess and review it like a principled writer.  

The Federal government is made up of a bunch of Madeline Albrights, John McCains, and Lindsey Grahams.  

Okay, dates help to sort things out.  Pfizer applied for EUA on November 20, 2020.  FDA scientist, Marion Gruber, knew the lipid nanoparticles and their payloads were inflammatory in multiple organs, knew they were toxic, and STILL AUTHORIZED THIS FOR EMERGENCY USE ON DECEMBER 11, 2020.

The inflammatory lipid nanoparticles and their payloads collect in the ovaries and other key organs, are not rapidly cleared from the human body and are toxic.

Pfizer scientists knew this before seeking EUA approval from the FDA through the 11/20/2020 EUA application.

FDA scientists led by Marion Gruber knew this when authorizing the product for emergency use on 12/11/2020.

Pfizer, FDA and Gruber withheld this information from the public and knowingly lied each time they described the products as “safe and effective.”

 

Every drug that has been recalled by the FDA was first proven to be "safe and effective" by the FDA

The cost of meeting #FDA requirements increases exponentially every year. These costs are passed on to consumers as higher #DrugPrices w/o improving safety/effectiveness. Doing more & more studies usually result in higher costs w/ no discernible benefits. #healthcare pic.twitter.com/Dy8E1x8BbV

— Mary J. Ruwart Ph.D. (@MaryRuwart) December 20, 2022

Did you know that Janssen, a J & J division, was from Belgium? Had you known that, would you have taken that, er their, vaccine or any other from a foreign government?

Thank you to Dr. Meryl Nass, dated February 27, 2021.

Yesterday, Feb 26, the FDA’s vaccine advisory committee (VRBPAC), an FDA committee called Vaccines and Related Biological Products Advisory Committee, met to give its assent to the third Covid vaccine candidate applying for an Emergency Use Authorization (EUA). And I spent another day listening in. FDA is expected to authorize use of the vaccine today.

This one requires only one dose.  For now.  The company is doing a clinical trial of two doses and they could be recommended in future. The VRBPAC committee comments were lackluster.  The members had little to go on.  There is no adenovirus vaccine in civilian use in the US, just as there were no mRNA vaccines.  The committee members simply don’t know what they have to watch out for.  One admitted it, and asked if FDA would assist and suggest what types of issues the newly licensed Ebola adenovirus vaccine or the military adenovirus vaccine had faced.  FDA responded with stony silence. Clearly this “advisory” meeting was only needed for its rubber stamp.

Most of the sponsor’s (Johnson and Johnson) presenters were from the Janssen division, based in Belgium. Many of the FDA’s presenters were non-native English speakers. The combination of an audio transmission that kept dropping out, and inability to catch many of the words made it a challenge to fully grasp the presentations. Was this intended? 

This here, is it by will or an omission?  Yeah, that's what I thought . . . .  

FDA has refused to inspect the Covid vaccine manufacturing plants before they are “authorized” under EUA.  I suspect FDA administrators were directed not to slow the warp speed down. 

FDA will have to inspect the factories by law before Covid vaccines are fully licensed, but it seems that the game plan is to get the country vaccinated before adequate data become available and licensure can take place. 

Wait, is she saying that the lack of data is precisely the thing that allows the vax manufacturers to have an emergency permission?

Okay, here is the motherload 

While Johnson and Johnson’s Janssen division designed and tested this new adenovirus vectored spike protein vaccine, the vaccine is actually being produced in a factory newly taken out of mothballs, with hundreds of new employees, that has never before produced a vaccine for mass use.  It is owned by Emergent BioSolutions, a company notorious for poisoning soldiers with its anthrax vaccine, which has failed multiple anthrax vaccine inspections.  On Emergent BioSolutions’ board is Kathryn Zoon, a former head of FDA’s Center for Biologics, which regulates vaccines. 

Here is a vague report.  This was interesting.  Turns out that the vaccine that a company will run in a trial may not be the same vaccine that gets made and distributed to the public.  Wow, we all are making way too many assumptions when it comes to how vaccines are made, their testing, distribution, and so forth.  We're all focused on their efficacy only to find ourselves in a 

This factory’s vaccine may not be exactly the same vaccine that about 20,000 subjects in the clinical trial have received. Usually vaccines for clinical trials are made in a pilot plant under stringent conditions. 

So many questions about the vaccines, where it was made, is the company reputable, do they have major lawsuits against previously deadly vaccines, etc.?  So none of these questions are asked let alone addressed.

Does the vaccine work?  The vaccine is said to be 66% effective against moderate to severe disease in the trials, and 100% protective against death. 

Okay, well, according to Fauci, where most of America got its reports on the vaccines, the vaccines started out at 95% effective and went downhill from there.  

In the clinical trials, having a headache and a cough was enough to put subjects in the “moderate to severe” category.  Like the two mRNA vaccines, the vaccine sponsors apparently did not see fit to test whether their vaccines block infection and transmission in humans. This is the fault of the FDA, which sets the standard for the data needed to obtain an EUA.  

Whoever did this deserves an award.
pic.twitter.com/cJFcgpB9Y3

— Rising serpent 🇺🇸 (@rising_serpent) October 17, 2021

You can find the below video here along with a few remarks by Deborah Birx, who admitted that the vaccines were not going to work.  Imagine that.  While Birx is telling the truth in a rare moment, Dr. Fauci doubled down on his "effective" narrative.  Even recently on the Stephen Colbert Show he praised the vaccines again, while giving a thumbs down to Hydroxychloroquine and warning people that Ivermectin was dangerous.  Ha!  

Apparently in the J&J trials, only a subset of participants were evaluated for side effects, "Only a subset of the subjects in the trials were evaluated for side effects.  Why was that?"  See what Dr. Meryl Nass said about the vaccines in general, 

I can’t tell if this vaccine is safe and I doubt anyone else can, either. Nor do I want to be injected with something manufactured by the anthrax vaccine manufacturer, famed for injuring thousands of soldiers twenty years ago, while making 300% profit margins. 

Read Dr. Meryl Nass's background here.  She's amazing.

Meryl Nass, M.D., ABIM, is an internist with special interests in vaccine-induced illnesses, chronic fatigue syndrome, Gulf War illness, fibromyalgia and toxicology. As a biological warfare epidemiologist, she investigated world's largest anthrax epizootic in Zimbabwe, and developed a model for analyzing epidemics to assess whether they are natural or man-made.  Continue reading . . .

"My dad says my mom is addicted to Quaaludes"

This is funny. Watch to till the end pic.twitter.com/Kl5xKuUCmg

— Stanley (@UltraLandlord) July 30, 2022

"Drug companies can sue the FDA without a problem, but citizens often cannot. And we're trying to fix that."

Attorney Robert Barnes: It's Time to Empower Citizens Against Regulatory Capture

"If they're lying about this drug ... how can they trust the FDA on any other drug?"

"Drug companies can sue the FDA without a problem, but citizens often cannot. And we're trying to fix that." pic.twitter.com/zI2IDZkJne

— The Vaccinated Fox 🦊 (@VaxxedFox) July 20, 2022

MARION GRUBER & PHIL KRAUSE: ACTUAL HEROS AT THE FDA

Among the reasons Fauci is so popular with journalists is his delight in spreading fear, the bread and butter of America’s corporate media.

2) it predicts that the childhood vaccine authorization will proceed regardless of the evidentiary basis.@VPrasadMDMPH explains plainly the current absurdity: https://t.co/4hA3bA1rpo

— Alexandros Marinos (@alexandrosM) June 22, 2022

The two FDA officials that he mentions at the 1:25 mark are Marion Gruber, Director of the FDA's Office of Vaccines Research & Review and 32-year veteran of the agency, and her Deputy, Phil Krause, who both resigned due to undue political pressure from the Biden Administration and, you guessed it, Dr. Anthony Fauci. 

Starkmanapproved calls them "Unsung heroes,"

I mention this not to cast judgment on the CDC insiders, but rather to provide context in understanding the bravery and character of Marion Gruber, director of the FDA’s Office of Vaccines Research & Review and a 32-year veteran of the agency, and her deputy, Phil Krause. Gruber and Krause resigned three weeks ago reportedly because of undue political pressure from the Biden Administration and Dr. Fauci to approve Pfizer vaccine boosters for all Americans 16 and over. 

This shocks me.  First time I am hearing of it.  The FDA actually voted in favor of not authorizing the booster.  Wow. 

FDA’s vaccine advisory panel, comprised of the leading vaccine experts in the U.S., on Friday validated the positions of Gruber and Krause, voting overwhelmingly 16-2 not to authorize the boosters, except for people who are 65 and older or at risk of severe disease. 

Unfortunately, the kicker is that the FDA isn't bound by the independent panel's decision. 

The decisive vote gave me hope that doctors and scientists still have some measure of control and influence over America’s pandemic response, although the FDA isn’t bound by the independent panel’s decision. The agency is temporarily overseen by Janet Woodcock, under whose watch an Alzheimer’s drug was approved despite the recommendation of an independent advisory panel. Woodcock is a Biden Administration appointee.

I had no idea that Zients was an Obama aide and that Woodcock was a Biden Administration appointee.  The democrats really are running the asylum.

It’s alarming that politics would figure into decisions impacting the health of Americans and others around the world, as the FDA’s decisions carry considerable weight with regulatory agencies of other countries. Biden’s closest advisor and vaccine czar is Jeffrey Zients, a former Obama aide whose only education credential is an undergraduate degree in political science. Zients made millions serving as a healthcare consultant, an industry rife with conflicts and ethically challenged behaviors. A company Zients oversaw owned a controversial anesthesia outsourcing firm that was involved in so-called surprise billing and other questionable practices. Zients isn’t remotely qualified to make scientific determinations. More on Zients can be found here. 

This is absolutely fascinating. 

Even more alarming is that by Dr. Fauci’s own admission, there’s little science backing up his aggressive advocacy for boosters. As recently as last week, Fauci admitted at a conference that U.S. data so far revealed only an “inkling” that Pfizer’s vaccine lost substantial efficacy after six months. Fauci was relying on Israeli data, which leading experts warn might not be representative of the U.S. experience.

Fauci admittedly is a physician-scientist and immunologist, but interpreting scientific data is a highly specialized function and requires an expertise that the National Institutes of Health, whose infectious disease unit Fauci oversees, doesn’t have.

“It’s no secret that FDA doesn’t have the disease experts in the way that the NIH does,” Diana Zuckerman, a former senior advisor to Hillary Clinton and president of the nonprofit National Center for Health Research in Washington, D.C., told Kaiser Health News. “And it’s no secret that the NIH doesn’t have the experts in analyzing industry data.”   

It has seemed pretty clear to me that Fauci, even when he gets technical on any specifics with the vaccines that, he is mostly about talking points designed to keep people in fear and coralled.  

KHN on Thursday posted a feature that revealed Fauci was scheming as early as January to promote boosters, even before Covid vaccines were widely available. In February, scientists working under Fauci organized an international group of epidemiologists, virologists and biostatisticians to track and sequence covid variants. In March, Fauci’s scientists were experimenting with monkeys and reviewing early data from humans showing that booster shots provided a rapid increase in protective antibodies — even against dangerous variants.

Fauci’s initial thesis was that boosters would be required and he was determined to stick with it regardless of whether real world data supported it. 

Does this say it all about who Anthony Fauci is?  It's not just money, folks, though that too.  It's about power as much as it is about the money.  Why do you think he hasn't retired or even been asked by anyone in authority to retire?  The guy loves power and will do anything, I mean anything, to seize it.  

Among the reasons Fauci is so popular with journalists is his delight in spreading fear, the bread and butter of America’s corporate media. It’s a skill Fauci honed from his AIDS crisis days. In May 1983, after a scientist published a paper in the medical journal JAMA that an infant had contracted AIDS, Fauci created panic with his speculation that the disease could be contracted through household contact, a theory the New York Times and others reported on.

The infant contracted AIDS through pregnancy, but Fauci’s reckless speculation resulted in gays being ostracized because of fears one could contract AIDS from routine contact. Phillip Magness, of the American Institute for Economic Research, has more insights on this. (Be forewarned: the corporate media dismisses the AIER as an irresponsible right-wing think tank. Magness provides links that confirm his allegations.) 

Please read the entire article.  It is a must-read.  

Here is the article he refers to at the 6:30 mark, titled, "BNT162b2 Protection Against the Omicron Variant in Children and Adolescents, . . ."

 

Anything you inject goes straight to vital organs. Things you ingest, they go through the body's natural defense, natural detox pathways

Then I realized we have a sick-care system.  We're just treating symptoms.  That's not health care.  

I go to a baby visit.  Let's call it what it is: it's a vaccination visit.  75% of their money off of baby visits is from vaccines.

Please watch and share

Do it for Brandy https://t.co/tS4mQ8h00s

— iWonder🙂🎗🌸💜 (@cfw55cja) June 11, 2022

Up front, you should know that Brandy Vaughn was found dead on December 8, 2019 at her home by her 9-year-old son, Bastien.  That's approximately when rumors about COVID-19 began circulating.  And while many folks like to point to Kary Mullis' death as suspicious event, which I am sure it is, it's clear that Ms Vaughn, former Merck employee and radical critic of vaccines and Big Pharma, was murdered by these pharmaceutical-vaccine cartel who captured governments around the world to finance the COVID hoax and implement their failed great Reset. 

Drug and vaccine companies would love to have Robert Cailiff at the FDA.  Even the New York Times said his drug ties were scaring people. He is the ultimate pharmaceutical industry Insider. He had a conflict of interest section declaring financial support from 20 biotech and pharmaceutical companies, and he's heading the regulatory agency his famous quote is regulation disrupts innovation. 

Here's a sampling if his financial conflicts of interest,

Dr. Califf’s record since then has not dispelled our concerns. Since Dr. Califf left the FDA in 2017, he has received over a million dollars from the pharmaceutical industry, raising serious questions about his ability to separate his future financial opportunities from the decisions he would be charged with making as the FDA Administrator.

In February 2018, Dr. Califf joined the board of Cytokinetics, a biopharma company.2 His compensation as a board member in cash and stock options came to about $347,000 for 2018, $181,000 for 2019, and $427,000 for 2020.

The CDC, Centers of Disease Control, is just as bad.  Julie Gerberding, she ran the CDC for 7 to 8 years, she doubled the [childhood] vaccine schedule. [Also a World Economic Forum member: Executive Vice-President and Chief Patient Officer, Strategic Communications, Global Public Policy and Population Health, MSD] Childhood vaccine schedule was doubled in her tenure.  She got a good reward.  She went to head Merck Global Vaccine Initiative for $5 million dollars.  2 months into it, she cashed in $3 million in stock options from Merck.

Pharmaceutical industry, you guys know this, creates cradle to grave customers.  As adults were already on a ton of meds.  Where's the real money?  It's in the kids.  And it's in vaccines.  Because they create so many diseases and disorders that they're running out of ways to make us more sick.  But they can create vaccines for all those diseases they've already created. We are now the most drugged up country in the world.  But the prescription frug market is saturated.  It's full.  It's overly competitive.  You've got 6 to 8 drugs per disease state, so there's nit a lot of room, not a lot of market there.  And it's full of liabilities, $6 billion paid out on Vioxx.  They can't keep creating diseases and drugs and all of that.  But what a brilliant market strategy to head into vaccines.  That's where they're heading next for profit, and evert single person in here is just another customer.  And if you think they aren't going to get you, just wait.  I'm going to show you how they plan to.

How are they doing on their plans to keep us sick?  Shocking numbers: 1 in 3 men, 1 in 4 women have cancer.  1 in 12 women now have an auto-immune disorder.  I visit my friends in their 30s, lupus, arthritis, gut issues, IBS,

I got IBS right before I went to Merck.  I had to go to the doctor and get a Hepatitis B vaccine.  2 weeks later, I was diagnosed with IBS.  I had hives and I got arrhythmia.  A lot of things going wrong with our healthcare system, and vaccines are a big part of the problem.  All these things on here, they're considered side effects of vaccines. 

60 million have arthritis.  30 million have asthma. These are auto immune disorders.  My friends in Europe say, Brandy, what do you mean you can't bring your kids to school?  Who's allergic to food?  That doesn't make sense.  You're allergic to food and to air, hay fever, right?  Wild animals who aren't part of our medical system, don't get vaccinated, do they gave asthma, do they have hay fever, are they allergic to food?  Are they allergic to air?  What is normal in our country?  This shouldn't be normal.  This is not nirmal.  And it shouldn't be accepted as normal.  We have some of the highest rates of chronic illness, dementia, Alzheimer's, they're all sky-rocketing.  One in three people have a chronic disorder or issue.  The healthy have to get out there on the frontline and connect the dots for everyone who doesn't see this, doesn't get it. That's our job. 

Our kids are even worse off.  1 in 6 kids have developmental issues.  Occupational therapy is one of the biggest growing career opportunities right now.  1 in 7 have asthma right now.  1 in 15 have seizure disorders.  And you know what happens after vaccines right now?  Children go to the ER and are being told it's normal.  Parents are being told that seizure fevers are normal.  That is not normal, and those are the lucky ones that make it to the ER. We have 10,000 babies dying of SIDS every year within days of the vaccines.  This is the first generation of kids who are sicker than their parents, and experts say they will not outlive them.  What is going on?  I'll tell you.

Medical science has made such tremendous progress that there is hardly a healthy human left.  Crazy.  That is crazy.  Cancer and the mutation of genes after birth.  It is not genetic.  Don't let anyone play that argument with you.  After birth mostly due to environmental toxins, chemicals, smoking, pollution, and radiation.  Autoimmune disorders mostly due to environmental factors.  Same thing.  We're poisoning ourselves.  And there are a lot of things that are part of this picture. The air we breathe, the food we eat.  We're under a toxic soup, and we need to reduce any exposures we can and minimize it.  And you know what?  Vaccines are a part of that.  Vaccines contain those same chemicals that we don't want to breathe in.  The formaldehyde in the Chinese wood flooring . . . did you hear about that?  Don't get wood flooring from China guys, it gives off a gas of formaldehyde and that causes cancer according to the EPA.  But don't talk about it in vaccines, or you might be called crazy. 

Anything you inject goes straight to vital organs.  Things you ingest, they go through the body's natural defense, natural detox pathways.  Most of it gets filtered out.  99% of the aluminum gets filtered out of your body.  15:33.  any aluminum that gets injected, like that which is included in vaccines, goes straight to the brain and then to the gut.  Ingestion versus injection.  This is so critical, we have to get people to understand this.  Those same chemicals that are in the food--formaldehyde, aluminum, heavy metals, lead--are in vaccines.  Why aren't people talking about this?  To me, that's crazy.  Why aren't we talking about this?  And I hope after this talk, you will talk about it because we need to . . . somebody needs to . . . because our health has taken a nise dive and Pharma is going to keep pounding us.  They aren't done

So my eyes are wide open, right?  So Vioxx, . . . healthcare system, Pharma is . . . then I went to live in Europe for 8 years, and I saw what health is, what real health is.  Then I realized we have a sick-care system.  We're just treating symptoms.  That's not health care.  Our healthcare system doesn't care about our health.  They profit off of making us sick.  So, lived in Holland, had my son over there, natural birth with midwife . . . they didn't even want to talk about vaccines with me. I said I'm perfectly healthy, why do I want to talk about vaccines?  They said, we don't want to either.  

17:05.  My son is 6 months old, totally vaccine free.  I go to a baby visit.  Let's call it what it is: it's a vaccination visit.  75% of their money off of baby visits is from vaccines.  

Who needs data when you’ve got regulatory capture?

From Dr. Meryl Nass, May 30, 2022

Toby Rogers @ substack, "FDA Announces Updated Schedule for June Meetings Regarding Five Pivotal Vaccine Decisions," Toby Rogers, May 28, 2022

Who needs data when you’ve got regulatory capture?

Here is Dr. Toby Rogers' Substack profile.

May 29

I. The June FDA meetings

This week the Washington Post copied and pasted from a Pfizer press release to announce yet another scientific miracle(TM) that will completely fail in practice. In the process WaPo also got some quotes from the FDA who have now nailed down the schedule for the 4 meetings in June in which they intend to assemble the final pieces for Pharma’s permanent dominance over the American people.

THE NEW VACCINE SCHEDULE IS AS FOLLOWS: 

June 7, Novavax 
June 14, Moderna in kids 6 to 17 years old
June 15, Moderna in kids 6 months to 5 years AND Pfizer in kids 6 months to 4 years
June 28, “Future Framework” (the plan to skip clinical trials in perpetuity)

There is a lot to parse in the WaPo’s brief article.

Contrary to the breathless headline, THEY STILL DON'T HAVE ANY DATA. 

Pfizer and BioNTech said the 80 percent efficacy finding was preliminary and based on 10 cases of Covid-19 in the study population as of the end of April.  Once 21 cases have occurred, the companies will conduct a more formal analysis of efficacy . . . Pfizer and BioNTech said they plan to finish filing data with the FDA this week—and warned that the efficacy number was fluid because results are still arriving.

Let’s recap how we got here:

🚩 The Pfizer clinical trial in kids under 5 failed in December 2021.

🚩 So Pfizer added a third dose and that trial also apparently failed in February (which is why Pfizer was forced to withdraw its application on February 10).

🚩 Now Pfizer is describing a jerry-rigged trial of a third dose in 1,678 kids ages 6 months to four years old. Pfizer did not disclose how the kids were divided between the treatment and control group so it is impossible to run our own calculations on efficacy. Out of that sample, 10 developed Covid — although it is not clear how the 10 were distributed between the    treatment and control group. (I suppose some quant on Twitter will figure out how to work backwards from Pfizer’s claims to calculate the numbers in each of these categories but needless to say, this is not the proper way to do science.) Of course Pfizer also failed to describe the contents of the “placebo.”

As always with “publication by press release” the announcement raised more questions than answers:

“the efficacy finding was preliminary”; just 10 cases; “the companies will conduct a more formal analysis” next month; “the efficacy number was fluid because results are still arriving” — so you’re saying that these numbers are NOT statistically significant and in fact you have no
valid “results” at all? Got it.

How exactly will Pfizer double the number of Covid-19 cases in the clinical trial in the next month given that 74.2% of kids already had natural immunity in February which means that nearly 100% of children likely have natural immunity by now?

Also, is the FDA seriously considering basing national policy, that impacts 18 million children, by relying on a study with only 10 cases?  It appears that the FDA is not even pretending to care about science anymore.

What’s perhaps most troubling about this so-called clinical trial is that Pfizer is NOT looking at health outcomes in the real world (because there are none). Instead, all of their claims are based on antibodies in the blood. That’s strange because the members of the FDA’s Vaccines and Related Biological Products Advisory Committee unanimously acknowledged on April 6 that there are “no correlates of protection” in connection with Covid-19 shots (this means that there are no valid proxy measures, such as antibody counts, that can determine whether someone who has received this shot is immune to the virus or not.)

WaPo dutifully copied Pfizer’s disingenuous description:

While the adult trials recruited tens of thousands of volunteers and waited to see if vaccinated people were better protected, the children’s vaccine trials were primarily designed to measure immune responses using blood tests. 

No they were not “primarily designed to measure immune responses using blood tests.” The studies were intentionally undersize to hide harms from the shots in addition to other tricks that they use to skew the results (such as kicking you out of the trial if you call 911 or go to the emergency room). But when one shrinks the sample size, surprise! it becomes impossible to detect actual health benefits from the shots (the signal would have been tiny if at all, but when one uses a sample that small then any
positive signal can also disappear into statistical insignificance.) . . . 

Click here for the full report.