“I was always told that vaccines are safe. And if a product is safe, why do you need to give the manufacturer … essentially immunity to liability for the injuries that that product causes? Because if it’s safe, certainly in the way that our public health authorities project it safe to the public, there shouldn’t be any injuries, or there should be one in a million, as you often hear.”
Previously, in part one of my interview with Aaron Siri, managing partner at Siri and Glimstad, he broke down how vaccine manufacturers secured unprecedented protections from liability three decades ago.
“COVID vaccines didn’t enter into a vacuum. They were rolled into a very long established paradigm and way things are done,” says Siri. “They had a narrative around natural immunity that they determined fit in with their policy. And then the studies followed to make it fit.”
In part two, we discuss natural immunity from COVID-19 and what he discovered in the clinical safety trials of other vaccines, such as one of the Hepatitis B products: “147 kids. Five days of safety monitoring after injection. There’s no indication there was a control group,” says Siri.
“COVID-19 vaccines—they were called ‘rushed.’ They said the clinical trials were rushed. They said development was rushed. But the reality is the clinical trials for the COVID-19 vaccines that the average American received, compared to the clinical trials for almost every childhood vaccine, were the most robust studies that have been done on vaccines.”
We also look at the conflicts of interest between America’s health agencies and pharmaceutical companies.
“Think about this business model. You have a vaccine. You can’t be sued for harms. You have a guaranteed market because kids are required to get it for school. And your health agencies promote it for you and defend against any harm,” says Siri.
You’re flipping the way I’ve been thinking about all of this on its head. Let me explain why. You have all these doctors out there that are saying, “I was doing early treatment, I was saving people. My hospital stopped me. I had better results than hospital protocols. They stopped me, they did not let me.” Doctors were in tears.
Dr. Paul Marik, who created the sepsis protocol used around the world, couldn’t do his work. Their world has been shattered in many ways. Their whole paradigm and their view of medicine has changed. You’re telling me that this has happened in the past, just on a much smaller scale, and that what we’ve seen is not that different. Is this what you’re telling me?
From my vantage point, what is happening with the COVID vaccine is not very different from what has happened with other vaccines in the past. The difference is the public’s interest in this particular vaccine and also the media’s willingness to cover alternatives, I’ll call it, or the views of those that are not just in lock step with pharma and the health agencies involved with these products.
I just have to stress these are medical products sold by pharmaceutical companies for profit that have immunity to any injury. They’re not given by Moses at Sinai. They have no magical properties. They’re just a medical product. They have a certain safety profile and a certain efficacy profile. There’s a reality to that. And then, there’s what you’re taught to think. Those are the two things.
With that said, COVID vaccines didn’t enter into a vacuum. They were rolled into a very long established paradigm and way things are done with regards to vaccines in America. People are shocked that you can’t sue a COVID manufacturer for injuries from their vaccine. Doesn’t that create a moral hazard?
That disincentivizes them from doing a proper clinical trial because their interest is to make as much money as possible. That disincentivizes them from studying safety. Sure it does, of course it does. But that’s the same with every other vaccine. And those vaccines are given to babies who can’t talk, who can’t describe their symptoms, and it’s given to a very small cohort. And it’s rolled out over time.
But presumably because you will see a safety signal early on in that small cohort, you can stop the use, which has obviously happened.
See a signal where?
Well, you tell me.
Let’s step all the way back then, and let’s just look at product safety. We talked about this a lot earlier when we started here, but there are basically two ways you can assure product safety. The way you really assure it is letting class action and product liability attorneys sue the manufacturer if their product has a problem, if it has an efficacy issue or it has a safety issue.
That is how you assure products are safe in America. That is what makes products safe in America. That is why your car is safer. That normal market force has gone away. All the class action attorneys, all the product label attorneys have been neutered. They can’t do anything. They have no incentive to sue the pharmaceutical companies to make them safer.
It is not only the suits that assure the products are safer, it is the threat. It is the potential of those suits, of that liability that assures the products are safer. So, you have taken away the primary way we can really assure product safety in this country, and it has been gone since 1986.
There’s a secondary way we assure products are safe in America. It’s a far weaker way, and that is regulatory oversight. There are regulators, and even in the car industry, there are regulators. They do some good. But in this case those regulators are completely conflicted for two reasons.
Number one, the very same department of the United States government, the Department of Health and Human Services, that is the department under which you have the CDC, the FDA, the NIH, and go down the list of over 20 health agencies, they all live in that one department. That department is responsible for promoting vaccines, and yet, they also made it responsible for the safety of vaccines. Those two things are in conflict.
You tell an agent’s department to promote this product, and then you tell them to ensure it’s safe. Finding any safety issue undermines the promotion function. That is why whenever there has been a department in the United States government that is responsible for promoting an industry, the Congress has taken away the safety function.
The Department of Transportation is responsible for promoting aviation. That’s why the NTSB was created, the National Transportation Safety Board, completely independent of the Department of Transportation. They’re completely independent. They are responsible for safety.
Similarly, for nuclear power, there’s a Department of Energy that promotes nuclear energy. There is a completely separate department, completely independent, that is responsible for regulating nuclear power plant safety. But when it comes to vaccines, it’s one department. That’s the first problem.
The second problem, and I don’t know of any other product that has this problem, and I mentioned this earlier. In 1986 Congress gave vaccine manufacturers immunity for injuries caused by their vaccine products, not just the three that were hurting people back in ’86, but for any of the future ones. And if you go look at a child’s schedule, there’s a lot more, it’s a gold rush in many ways.
One thing provided an avenue for people to get some financial relief, and that was creating the Vaccine Injury Compensation Program, which is within HHS. And who do you sue? I mentioned this earlier. You sue the secretary of the Department of Health and Human Services. That’s what our firm does every day. We sue on behalf of people injured by vaccines.
And when we do, we literally name the plaintiff, their name, versus the name of the Secretary of the Department of HHS in his capacity as the secretary of the Department of Health and Human Services. The very same department that’s responsible for safety. Think about that. You are making it so that if the CDC or FDA or NIH published any study that shows a Hep B vaccine causes X issue or any other vaccine has a problem, you have just created the evidence against yourself.
HHS will have just created evidence to indict itself that then makes it liable in vaccine court. There’s an entire specialized department in the Department of Justice of attorneys who fight against people injured by vaccines bringing a claim. Before we talk about that for a second, I just want you to really put that in perspective. It’s so bad.
Our health agencies are really, in many ways, they’re hopelessly conflicted. They are in a position where they focus on the promotion function really well and the defense function really well. That has subsumed what they do around the safety function, which has basically become a PR issue. That’s what it is.
Anytime they do safety studies, they’re never studies to really show that it’s safe. They are reactionary to a PR issue around a vaccine. If you look at the vaccine safety literature, you’ll find that. When the COVID vaccine came around, it loaded onto this same exact paradigm. Our health agencies for decades now have been so attuned to just promoting vaccines and defending vaccines that the COVID vaccine just slots right into that.
What about this whole natural immunity? This is one of the things that made me question a lot of things early on, when natural immunity was denied, that it was a thing for this disease. Whereas, for every other coronavirus it was fine. Early on I wondered, it did come from China and it likely came from a lab, is this maybe the reason?
I don’t know. But very quickly we found out that natural immunity was a thing, in fact, and it was very effective. Was it just standard operating procedure for the promotion arm of these agencies to basically deny natural immunity?
You found out that natural immunity, which has kept humans alive forever, is a thing?
Yes, well no. I mean the default.
Do you see what I mean? This is the narrative that is being pushed on the American public, this idea that natural immunity is something that needs to be verified, that needs health authority approval, with all of our tax money in the health agencies and billions of dollars of pharmaceutical company revenue every year. That machine is able to turn and there’s really no money on the other side pushing back on any of that.
So, they can push almost any narrative, frankly, with the exception of brave journalists like yourself. And I mean that. You and many others who are willing to actually look critically at these health agencies despite the potential costs that you might pay for doing that.
But to answer your question, do they just deny natural immunity? I found the way that the health authorities dealt with natural immunity to be not uncommon, in that they decided on the narrative they wanted. And then, they have a review process for the studies they put out. The MMWR [Morbidity and Mortality Weekly Report], is the CDC’s equivalent of a science journal. I call it a newsletter, but they call it a science journal.
It doesn’t go through peer review, it goes through CDC’s clearance process. Everything that ends up in the MMWR then gets touted all over the news. CNN and MSNBC pick this up like it’s the holy grail of what is reality in terms of scientific knowledge. The MMWR is used as a tool to assure that CDC’s policy is then reflected in the science.
Their policy comes first. There’s a clearance process to review all studies published in MMWR. That’s not me saying that, you can look it up. The CDC’s available literature explains this. And only if the quote unquote, study, the science, comports with their policy, does it get published.
So, with natural immunity, you’re asking, “Is this standard operating procedure?” In that regard it is. They had a narrative around natural immunity that they determined fit in with their policy, and then the studies followed to make it fit.
There were studies involving millions of people out of Israel and other places that showed natural immunity was more robust than vaccine immunity. And the CDC concocted this ridiculous case control study of one little small data set that they claim showed that natural immunity may not be as good as vaccine immunity.
That study drew the ire of a lot of scientists, because they actually read it and they thought about it, because it affected them, and not some infant. It affected whether they could keep their job, and whether they could keep going to work if they didn’t want the shot. They actually started looking at that science and it’s amazing what happened, isn’t it?
So, what happened?
Public outrage and public outcry. People were like, “What are you doing, CDC? Don’t you see all these studies?” We had an exchange with the CDC. There’s a formal process where you can petition the CDC under a particular section of law and they must respond. They have to.
On behalf of ICAN [Informed Consent Action Network], we submitted one of these formal requests. You can go to ICAN’s website and look at this. It’s an amazing exchange in my opinion. We did this early on. We submitted a request to the CDC and we said, “Look, here’s all these studies that show that natural immunity is more robust than vaccine immunity in terms of preventing transmission, in terms of hospitalizations, and in every category.”
“So, why does your guidance say if you’re vaccinated, it’s okay for you to X, Y, Z. You can have your civil liberties, and you can participate in American life. But if you have natural immunity you can’t participate in American life.” Obviously, it’s a legal issue and it’s a civil rights issue. Those CDC guidelines affected whether you can go into a restaurant, whether you can have a job, and whether you can go to school. They made it a legal issue.
That’s why we formally petitioned them and said, “You have brought this out of the realm of just science and you’ve made this something that attacks the civil rights and individual rights of everybody in this country. So, answer to this. How in the face of all of this data can you say that vaccine immunity is okay for you to participate in American life, but natural immunity is not sufficient?”
They responded by ignoring all that data and citing that one study of these few hundred people that wasn’t even a cohort study. I don’t want to get into epidemiology. Every epidemiologist who’s got any integrity tells you this one study is garbage and it’s ridiculous. And even if it happened to be correct, it’s a chance finding, and it’s of no weight in the face of the studies involving millions of people. But yet, that’s what they responded with. We then replied to them, and they never responded to our reply pointing out the ridiculous nature of this, and you can read that exchange.
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At this point I have to go back to this incredibly disturbing thing you told me earlier, which was that there are really short safety study times for childhood vaccines. What do you mean by a very, very short time period? I’ll tell you why I’m asking, because people typically say, “It takes 10 years or many years to develop a vaccine. People said, “There’s no way they’ll be able to develop these COVID-19 shots because how will we know? These safety studies take a long time. Please explain to me what you’re saying here.
The COVID-19 vaccines, they were called rushed. They said the clinical trials were rushed. They said the development was rushed. But the reality is the clinical trials for the COVID-19 vaccines that the average American received were, compared to the clinical trials for almost every childhood vaccine, were the most robust studies that have been done on vaccines. Let me tell you why.
One, when people talk about other vaccines and they say, “Oh, it took a decade to develop it,” they’re not talking about the clinical trial done in human beings to assure that it was safe and effective. They’re talking about the timeline it took to develop the technology needed to create the vaccine. Take Recombinant Hep B vaccines, which are DNA vaccines. It took a long time to create that technology of taking the DNA from hepatitis B and then putting it into a yeast, growing it in yeast, and getting that DNA to multiply and then injecting it in. It took a long time to create that technology.
But that’s different from how long the clinical trial then assessed its safety and efficacy before you licensed it. When it comes to COVID vaccines, the technology needed to actually create the mRNA vaccines, that also had been going on for decades. In the same way, it took over a decade to create the recombinant technology to create the hepatitis B vaccines, as an example.
What’s critical though, is not how long it takes to create the technology. It’s that once you’ve created it, what is its effect on human beings? That is what’s critical. And how do you assess that? You assess it in a clinical trial where you give one group of people the product, the experimental product, and you don’t give it to another group of people. Instead, you give them a placebo control, a saline injection. And then, you compare the total health outcomes between those groups. That’s how you study the efficacy and how you study the safety.
There are three critical components when you think about a clinical trial and assessing whether it was a good clinical trial? Was it able to really assess those two things, efficacy and safety? The first component is how long did it review safety in the clinical trial? COVID vaccine trials reviewed safety for over six months.
The second thing you looked at, how many people are in the trial, meaning how well powered is it? The more people in the trial, the more likely you are to pick up a safety signal or an issue. That’s the second factor you look at.
The third factor you look at is what did the control group receive, or was there a control group? Because if you don’t have one that’s basically getting something inert, or something that has a clearly defined, well known, well established safety profile, if you don’t have that, what are you comparing?
If I compare giving you anthrax with another anthrax, or giving you arsenic with giving you arsenic, or compare arsenic with shooting you, maybe they’re equally as safe. They both cause the same amount of harm. But that’s why you need a proper control group.
For the first thing, with COVID vaccines, for six months of the safety review period, we had 30,000 people, and they had a placebo control group for an average of two months. We know that at some point they vaccinated the placebo control group, but at least they had one for an average of two months.
Let’s look at the hepatitis B vaccine given to babies. There are two hepatitis B vaccines given to babies when they’re first born; first day of life, and then at one month and at six months. One is made by Merck, Recombivax HB, and one is made by GSK, Engerix-B. Before I tell you how long the safety was, before I tell you how many kids were involved, and before I tell you what the control was, let me just say that what I’m about to tell you, if you told me what I’m about to tell you, I’d say no way, I don’t believe it.
Here it is; 147 kids, five days of safety monitoring after injection. There’s no indication there was a control group. COVID vaccines have over six months of safety review in a clinical trial that was relied upon by the FDA to license it. Hepatitis B vaccine given to a newborn had five days of safety monitoring after injection. There were 30,000 people in the COVID 19 vaccine clinical trial for Pfizer, even more for Moderna. Or maybe I have that backwards, one of the two. One had about 45,000. For the Hep B vaccine, it doesn’t appear there was even control. Even if there was, what are you going to get with 147 kids for data, unless the injury is like one in five, one in three kids?
You’re right, it does strain credulity.
For anybody watching this, don’t take my word for it. Go to the FDA website. In fact, can I show it to you right now?
You can go to FDA licensed vaccines. Go to Google and you can search for it, or go to DuckDuckGo, or your search engine of choice and search for FDA licensed vaccines. The first result will be a page on the FDA website called vaccines licensed for use in the United States. And I’ve actually got it open right here.
I’m going to scroll down to hepatitis B and Recombivax HB. I’m going to click on it, and then I’m going to click on the package insert. In the package insert you then go to section 6.1. Section 6.1 in all these package inserts is the clinical trials experience. You know how when you get a drug, there’s a piece of paper inside, and you open it up?
Section 6.1 is where the FDA requires the manufacturer to explain the clinical trial experience. That’s where it will tell you what the clinical trial is. I will read to you exactly what it says regarding the clinical trial in infants. Again, this is on the FDA website. This is Merck’s package insert for the Recombivax HB hepatitis B vaccine approved by the FDA.
It says, “In three clinical studies, 434 doses of Recombivax HB five micrograms were administered to 147 healthy infants and children up to 10 years of age who were monitored for five days after each dose,” period, end quote. Now, I will tell you when I saw that and when the folks at ICAN saw that, we also said, “It cannot be, it can’t be.” So, we FOIA’d the FDA for the actual clinical trial reports submitted to license both this vaccine and Engerix-B, and we have them.
I can confirm to you the monitoring for safety was five days after injection for a product given to a newborn, a one-month-old, and a six-month-old. So yes, I think the word I said was ridiculously short. Yes, I stand by that. I would say five days is ridiculously short.
And by the way, the other Hep B vaccine, Engerix-B, for the safety review period, and again, everybody can look this up just like I did for Recombivax HB—four days of safety monitoring after the shot. Four days. These are the only two shots that a newborn can get in America. That’s the first shot they get in life. So yes, I’d say ridiculous might be too soft of an adjective to describe that safety review period.
And again, we FOIA’d the FDA, we have the clinical trial documents for both of these vaccines, just like we did for the Pfizer clinical trial docs, and it is that safety review. In fact, on behalf of ICAN, we have actually filed a formal petition with the FDA to either do a proper clinical trial of this product or withdraw the licensure. They have six months under the law to respond. That six months has long come and gone. Despite our constant follow up, they have not given us a formal response.
We will soon be suing them in federal court over this exact issue. Either do the proper clinical trial because Congress said you are only to license products that are proven as safe and effective. That clinical trial cannot do that. How long do you need to review safety? How many kids, and what should the control receive? There is probably a gray area, but four or five days, that is definitely in the area that is not sufficient. That is probably why, despite it being well over a year at this point, the FDA has no response to our formal petition. Because what are they going to say? How do you justify that?
Has anyone tried to justify it to you?
I’ll tell you the answer because I pondered this for a long time. It really troubled me. My presumption is that most people in quote, unquote, public health, are good people. How could the FDA have done this? Why would the FDA have done this? It doesn’t make sense.
The best I could come up with is the following. When you look back at the ’80s and ’90s when pretty much half of the vaccines on the current childhood schedule were added, and in the early 2000s when the most of the rest of them were added, when you look at the people who sat on the FDA and CDC vaccine committees, many of them had serious pharma conflicts.