Stages of Liability: EUA
In her slide show, Mayer reviews each of the stages of product liability, and whether the mRNA shots can be mandated. As mentioned, vaccine makers have no liability as long as their product is under EUA, as the product is investigational.
“Investigational is a synonym for experimental,” Mayer says. “And the word experimental ties it directly into the Nuremberg Code, which says that we cannot be experimented on [without consent]. We always have the right to accept or refuse a medical treatment.
[The Nuremberg Code] is not a law, but it's a code under which the whole world is supposed to be operating by. And it is actually codified into some local and federal laws as well ... So, what everybody needs to know is that coercion and duress are considered de facto mandates and illegal. De facto means that it's basically the same as an outright mandate.
It's illegal medical segregation, medical apartheid [because that is a form of coercion or duress.] So, if you go to a restaurant and they demand your vaccine passport, only let you eat outside, and they might not let you use the bathroom, that's medical segregation.
That is illegal and I do not support businesses that do that and you shouldn't either. Any access privileges that are different between the vaccinated and unvaccinated are illegal, and any visual indication of vaccine status like a sticker or a bracelet ... that's also illegal because that creates segregation and medical apartheid, [since they are all forms of coercion or duress.]”
Importantly, mass violation of the law does not make something legal.
“If we all drove 100 miles an hour on Interstate 80, would we watch the speed limit signs suddenly changed to 100 miles per hour? No, it's not going to happen. Mass violation of the law has never made anything legal. And just because schools and businesses and our government are mandating these shots, it doesn't make it legal. It's all illegal ...
Now, they know full well that it's illegal to mandate these [COVID shots]. President Biden knows it's illegal. But what they're counting on is that the court cases overturning their illegal mandates will take a while, and in that interim, people are going to be scared enough to get the shots. And unfortunately, it's worked.”
Stages of Liability: Full Licensure and Childhood Scheduling
The next stage is full licensure (FDA approval). Once a product is fully licensed, the company becomes liable for injuries. At that point, the product can be legally mandated. Of course, knowing how dangerous the COVID shots are, no manufacturer wants to be financially liable for injuries. They’d be sued out of business.
This is the holy grail if you're a manufacturer of a COVID vaccine right now. You want it to be fully licensed, but not put on the market until you get it on the children's schedule. ~ Alix Mayer
To get immunity against liability again, the vaccine manufacturers need to get their product onto the childhood vaccination schedule. This will also allow government to mandate the shots. As noted by Mayer:
“This is the holy grail if you're a vaccine manufacturer of a COVID vaccine right now. You want it to be fully licensed, but not put it on the market until you get it on the children's schedule.”
DOJ Redefines Medical ‘Consequence’
In Doe v. Rumsfeld,2 the court held that service members could refuse an EUA product without punitive consequences such as dishonorable discharge or other punishments. Therefore, there were no consequences to refusing an EUA product, other than the natural consequence of possibly getting the disease.
However, in July 2021, the U.S. Department of Justice attempted to redefine the term “consequences” just for the COVID shot, to suggest that punitive consequences, like job loss or being separated from your working or learning location, are legal when a person refuses an EUA vaccine.
“But this type of consequence, a punitive consequence, has never been adjudicated,” Mayer says. “That's not in any law. This is just an opinion from the DOJ. And it absolutely means nothing, except it came from our DOJ, so people give it a lot of authority.
They also stated twice — and this is so hard to understand because it's just beyond reason — that the right to accept or refuse an EUA product is 'purely informational.'
Literally, you can read that you could die by taking it, but it's purely informational. You cannot act on it. That's what the DOJ says. Again, it's not adjudicated, so it doesn't mean anything. It's an opinion. It holds no legal weight at all. So, as we said before, these mandates are starting to be overturned.”
Four Standards for EUA
There are four standards that must be fulfilled for an EUA. If any of these criteria are not met, EUA cannot be granted or maintained. First, the secretary of Health and Human Services has to declare and maintain a state of emergency. If the emergency were to go away, all EUA products would have to come off the market. And that doesn't just mean vaccines. It also includes the PCR tests and even surgical masks.
The second standard is evidence of effectiveness. Historically, vaccines had to show a 70% or greater effectiveness, as measured by a fourfold increase in antibody levels, in order to qualify. For an EUA vaccine, the efficacy threshold is only 30% to 50%. In another departure from prior vaccine approvals, the COVID vaccine clinical trials relied on the RT-PCR test, not antibodies, to demonstrate effectiveness in the small “challenge phase” of the trials.
Now, you probably heard that the Pfizer shot was 95% effective when it first rolled out, but that was relative risk reduction, not absolute risk reduction. Confounding these two parameters is a common strategy used to make a product sound far better than it actually is. The absolute risk reduction for Pfizer’s shot was just 0.84%.3
For example, if a study divided people into two groups of 1,000 and two people in the group who didn’t get a fictional vaccine got infected, while only one in the vaccinated group got infected, the relative risk reduction would be reported as 100%. In terms of absolute risk reduction, the fictional vaccine only prevented 1 in 1,000 from getting the infection — a very poor absolute risk reduction.
The take-home message here is that even though the minimal threshold for effectiveness is ludicrously low, in terms of absolute risk reduction, these shots still don’t measure up. Within six months, even the relative risk reduction bottoms out at zero. What’s more, there’s evidence that the clinical trials were manipulated as well.
“I remember an analysis very early in lockdowns [that showed] if you added back all the probable cases of COVID to the clinical trial [data], the effectiveness went from 90% to between 19% and 29%,”4 Mayer says.
The third standard is that the known and potential benefits of the product must outweigh the known and potential risks of the product. In the case of COVID shots, there’s overwhelming evidence showing they do more harm than good.
The fourth and last standard that must be met is there can be no adequate, approved and available alternative treatments (drugs or vaccines). “This is why hydroxychloroquine and ivermectin were quashed,” Mayer says. This is also another reason Comirnaty is not treated as a fully approved product in the U.S., because if it were, then all the other COVID shots that are under EUA would have to be removed from the market.
“This is a four-legged stool,” Mayer says. “If any one of these legs goes away, you have to take your EUA products off the market ... by law. I put [state of] emergency and [treatment] alternatives in red, because those are two of the things that they have a stranglehold on; those are things they are guarding like crazy.
This means that every variant that comes out, they have to make it sound super scary to keep the emergency going. So, the variants serve a purpose. You have to think about these variants in the context of this crime, where they have to keep the emergency going to keep their products on the market.
You would think this emergency would stop maybe when we get to herd immunity, maybe if we get 90% vaccination uptake, maybe COVID is just going to go away, like smallpox did in the early 1900s [even though] only 5% of people were vaccinated. [But it won’t] go away [until] the shots get full approval and the manufacturers get a full liability shield.”
Comirnaty’s Quasi Approval
With regard to Comirnaty, is it or is it not fully approved and licensed? The answer is more complex than a simple yes or no. Mayer explains:
“Comirnaty’s quasi approval is just for BioNTech. It doesn't have to do with Pfizer, and this is why I'm doing this presentation because I'm going to explain what’s going on with that.
This is the race to get liability protection. Remember, that's the other stranglehold that they want. They really want to get this liability protection. Once the COVID shots are fully approved, the manufacturer has full liability.
There's all this confusion about Comirnaty. Was it fully approved? Is it on the market? Is it interchangeable with the Pfizer shot? And does it make the COVID shot mandate legal? It's all the same answer. No, no, no, no.
The FDA issued an intentionally confusing biological license application approval for Comirnaty. It was an unprecedented approval to both license the Comirnaty shot, saying it's ‘interchangeable’ with the Pfizer shot. But they also said it's ‘legally distinct.’
In that same approval, they retain the vaccine’s liability shield by designating it EUA as well. They want it to be fully approved, but they want the liability protection, so they did this BS dual approval.
So, [Comirnaty] is licensed to be manufactured, introduced into state commerce and marketed, but it's not licensed to be given to anyone, and it's not available in the United States. It's available in the U.K., New Zealand and other places, but it is not available in the United States because they're really scared of liability.
Now, are you ready for this one? The BLA actually states that Comirnaty is only ‘ready for approval.’5 It doesn’t say it's approved anywhere in the document. And they buried this language in a pediatric section to confuse people even more.
Here's what they said; ‘We're deferring submission of your pediatric studies for ages younger than 16. For this application, because this product is ready for approval for use in individuals 16 years of age and older, as pediatric studies for younger ages have not been completed.’
Why did they do this? Sixteen is a very important number. You would think the age break would be 18. That's a very typical age break for everything else that we do in this country. Why 16?
The reason they did 16 is because 16- and 17-year-olds are still on the children's vaccination schedule. And then the manufacturer gets full liability protection. That's why this is ready to be approved for 16 and up, not 18 and up.”
Comirnaty Is Not Fully Licensed
This confusion is clearly intentional. On the one hand, the FDA claims Comirnaty is interchangeable with the Pfizer shot, yet it's also legally distinct. Courts have had to weigh in on the matter, and a federal judge recently rejected the DoD claim that the two shots are interchangeable. They're not interchangeable. That means Comirnaty vaccine is still EUA. It doesn't have full approval and it's not on the market.
“Military members involved in lawsuits are challenging the military's COVID vaccine mandate. They filed an amended complaint seeking a new injunction after the judge last month rejected the assertion that the Pfizer COVID shot and BioNTech’s Comirnaty are interchangeable. So, we're still hammering on this legally, but a court has ruled that they're not interchangeable.
[Editor’s note: This information is accurate at the time of the interview, but legal challenges are ongoing and courts may issue new rulings. December 22, 2021, the U.S. Supreme Court announced6 it has slated January 7, 2022, to hear arguments challenging Biden’s vaccine and testing mandates.]
So, how do we know that Comirnaty is not being treated as fully approved? First, the approval states you have the right to accept or refuse the product. That means it's an EUA. Second, it’s not available in the U.S. because Comirnaty doesn't have liability protection. Third, if it were available, it's an alternative [treatment] and all other EUA shots would have to come off the market.
No. 4, the CDC Advisory Committee on Immunization Practices (ACIP) would have to recommend it for ages 16 to 18 and the CDC would have added it to the children's recommended schedule. That's how we know it's not fully approved and on the market.
Here is the label for Comirnaty. It says it's emergency use authorization. It doesn't say it's fully approved, because it's not. But look at the safety information they are recognizing: Myocarditis and pericarditis have occurred in some people who've received the vaccine, more commonly in males under 40 years of age than among females and older males.
So, this is saying that young men are getting heart inflammation. And what we know from all the anecdotal reports is 300 athletes have died or collapsed on the field, and children in schools have died of heart attacks. That's what's going on here.
And the reason they have to declare this is because they know it. They know it's happening. And the only way they can be sued is if they know there's a problem with their vaccine and they don't declare it. So, they declare it here, in very mild language as if it's not that big of a deal, but it's a very big deal. Young people are dying [from the shots] who have a 99.9973% chance of recovering from COVID ...
The holy grail is to get the shot on the CDC recommended schedule for children, because then it gets full liability protection according to the 1986 Act. This is why they're going after our children when they have a 99.9973% recovery rate ...
Every medical intervention is a risk benefit equation, and it doesn't calculate for kids at all. They should never be getting COVID shots. The shots don't prevent transmission. They don't prevent cases. They don't prevent hospitalization or death.”
How You Can Help
Children’s Health Defense has sued the FDA over the approval of Comirnaty, alleging that this is a “bait and switch” to convince people they are receiving a licensed vaccine, when in fact they are getting an EUA vaccine that cannot be lawfully mandated. Unfortunately, these kinds of legal cases can take a long time, and children are being needlessly harmed while we wait for legal clarification.
They also have a couple dozen other legal cases underway. If you want to help, please sign up to become a member on childrenshealthdefense.org. It’s only $10 for a lifetime membership.
“That really helps us with standing in our legal cases, because the more people we represent, the stronger our cases are,” Mayer says. If you're in California, you can join the local chapter at ca.childrenshealthdefense.org. You can also help by purchasing Robert F. Kennedy Jr.’s book “The Real Anthony Fauci: Bill Gates, Big Pharma, and the Global War on Democracy and Public Health.”
Sources and References
