The U.S. Food and Drug Administration’s announcement Monday that it had granted “full approval” to the Covid shots being offered by Pfizer is riddled with deceptions meant to trick the American public into thinking they have no choice but to take the jab while at the same time protecting a major pharmaceutical company from legal liability.
What was actually given full approval was a separate Pfizer-BioNtech vaccine product which goes by the name Comirnaty.
But Comirnaty is not even currently available in the U.S.
This is part of a cynical plot to protect Pfizer from broad legal liability and also to snooker U.S. employers into mandating the vaccine for their employees.
Watch Dr. Robert Malone, inventer of the mRNA technology on which the Covid vaccines are based, explain the chicanery the FDA is using to fool the American people.
The FDA on Monday approved a biologics license application for the Pfizer Comirnaty vaccine. The Biden White House, with cover from its corporate media shills, immediately reported that vaccine mandates are now legal for military, healthcare workers, college students and employees of just about any business.
But as Children’s Health Defense reports, “there are several bizarre aspects to the FDA approval that will prove confusing to those not familiar with the pervasiveness of the FDA’s regulatory capture, or the depths of the agency’s cynicism.”
The FDA acknowledges that while Pfizer has insufficient supplies of the newly licensed Comirnaty vaccine actually available, there is “a significant amount” of the Pfizer-BioNTech COVID vaccine — which has been produced under Emergency Use Authorization (EUA) and will continue to be offered under the same EUA status, CHD reports.
The FDA in its convoluted letter of approval for the Pfizer vaccine under the EUA should remain unlicensed but can be used “interchangeably” (page 2, footnote 8) with the newly licensed Comirnaty product [which is currently unavailable].
According to the FDA, the newly licensed Pfizer Comirnaty vaccine and the existing vaccine, while “legally distinct,” are not any different in terms of their “safety or effectiveness.”
Here is the pertinent quote from footnote 8 that proves we are talking about two separate shots and not just a “rebranding” of the same shot as the mainstream media is reporting:
“The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.”
The “certain differences” are not specified, but it is perfectly clear that the two jabs are legally distinct.
The below analysis by Children’s Health Defense explains the trickery in which the FDA has engaged — all for the legal benefit of the Big Pharma giant Pfizer and the detriment of American citizens.
There is a huge real-world difference between products under an EUA compared with those that FDA has fully licensed. EUA products are experimental under U.S law.
Both the Nuremberg Code and Federal Regulations provide that no one can force a human being to participate in this experiment. Under 21 U.S. Code Sec.360bbb-3(e)(1)(A)(ii)(III), “authorization for medical products for use in emergencies,” it is unlawful to deny someone a job or an education because they refuse to be an experimental subject. Instead, potential recipients have an absolute right to refuse EUA vaccines.
U.S. laws, however, permit employers and schools to require students and workers to take licensed vaccines.
EUA-licensed vaccines have an extraordinary liability shield under the 2005 Public Readiness and Preparedness Act. Vaccine manufacturers, distributors, providers and government planners are immune from liability. The only way an injured party can sue is if he or she can prove willful misconduct, and if the U.S. government has also brought an enforcement action against the party for willful misconduct. No such lawsuit has ever succeeded.
The government has created an extremely stingy compensation program, the Countermeasures Injury Compensation Program, to redress injuries from all EUA products.
The program’s parsimonious administrators have compensated under 4% of petitioners to date — and not a single COVID vaccine injury — despite the fact that physicians, families and injured vaccine recipients have reported more than 600,000 COVID vaccine injuries.
At least for the moment, the Pfizer Comirnaty vaccine has no liability shield. Vials of the branded product, which say “Comirnaty” on the label, are subject to the same product liability laws as other U.S. products.
When the Centers for Disease Control and Prevention’s (CDC) Advisory Committee for Immunization Practices places a vaccine on the mandatory schedule, a childhood vaccine benefits from an generous retinue of liability protections.
But licensed adult vaccines, including the new Comirnaty, do not enjoy any liability shield. Just as with Ford’s exploding Pinto, or Monsanto’s herbicide Roundup, people injured by the Comirnaty vaccine could potentially sue for damages.
And because adults injured by the vaccine will be able to show that the manufacturer knew of the problems with the product, jury awards could be astronomical.
Pfizer is therefore unlikely to allow any American to take a Comirnaty vaccine until it can somehow arrange immunity for this product.
Given this background, the FDA’s acknowledgement in its approval letter that there are insufficient stocks of the licensed Comirnaty, but an abundant supply of the EUA Pfizer BioNTech jab, exposes the “approval” as a cynical scheme to encourage businesses and schools to impose illegal jab mandates.
The FDA’s clear motivation is to enable Pfizer to quickly unload inventories of a vaccine that science and the Vaccine Adverse Events Reporting System have exposed as unreasonably dangerous, and that the Delta variant has rendered obsolete.
Americans, told that the Pfizer COVID vaccine is now licensed, will understandably assume that COVID vaccine mandates are lawful. But only EUA-authorized vaccines, for which no one has any real liability, will be available during the next few weeks when many school mandate deadlines occur.
The FDA appears to be purposefully tricking American citizens into giving up their right to refuse an experimental product.
While the media has trumpeted that the FDA has approved COVID vaccines, the FDA has not approved the Pfizer BioNTech vaccines, nor any COVID vaccines for the 12- to 15-year age group, nor any booster doses for anyone.
And FDA has not licensed any Moderna vaccine, nor any vaccine from Johnson & Johnson — so the vast majority of vaccines available in the U.S., if not all, remain unlicensed EUA products.
Here’s what you need to know when somebody orders you to get the vaccine:; Ask to see the vial. If it says “Comirnaty,” it’s a licensed product. If it says “Pfizer-BioNTech,” it’s an experimental product, and under 21 U.S. Code 360bbb, you have the right to refuse.
If it comes from Moderna or Johnson & Johnson (marketed as Janssen), you have the right to refuse.
The FDA is playing bait and switch with the American public — but we don’t have to play along. If it doesn’t say Comirnaty, you have not been offered an approved vaccine.
Source: Children’s Health Defense
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This is interesting
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I believe this article was published on Aug 25, 2021. It you state that the footnote on page 8 of the approval letter dated Aug 23,2021 that the two shots can be used interchangeably.
The link to the letter that you provide in that paragraph is a link to the letter dated Oct 29,2021. https://www.fda.gov/media/150386/download
How is this possible? Did the FDA swap links, or did you update something and and not note it? The word “interchangeably” is not found in the copy of the letter I can find dated Aug 23,2021. There is also no footnote on page 2 of the letter.
I am not against you in any matter. I just want to have my facts straight. Did the FDA change the letter and give it the same date without any edit notes? I did not download a copy of the letter back in August, so I am stuck with what I can find today.
Please respond to this because if what you posted back then is correct and what I can find today, they are also playing fast and loose with historical facts (shock! not really).
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The answer to your question is, no, I did not update that link since the article was posted Aug. 25 and was not aware of this change until just now reading your comment. So the link now going to a letter dated Oct. 29 was obviously swapped out, and that must have been done no earlier than two days ago. Astonishing!
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Very helpful.
I was aware of the different names, but could not figure out what the difference was since they are supposedly made with the same ingredients and can be used interchangeably. This makes perfect sense. Thank you.
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My understanding is that the U. S. Congress passed 2 Bills in 1986 which were signed into law by Pres.Reagan, which [1] -first Bill, legally freed vaccine manufacturers from liability for harm done to recipients from the vaccines and [2] created a Vaccine Court
rarely mentioned, which adjudicates all legal claims of harm resulting from vaccines.
The US government, -presumably taxpayers, but probably borrowed money from Communist China and Japan in taxpayers name, pays for costs of harm done to health by vaccines, which is said to be substantial.
Many assert that the Vaccine Court is highly unsatisfactory in its ministrations.
Robert Kennedy Jr. in his public interviews and such might touch upon these matters
regularly,[that’s where I first learned this] and he also claims that any vaccine that is on the US gov. recommended list is virtually guaranteed to produce at least a billion dollar annual PROFIT.
Not directly related, but relevant: Google/Alpha co. bought into some aspect of the vaccine industry in or about 2014 and is a player in the BIG PHARMA agenda and brings it’s ability to censor search results on Google; as well as YouTube information that is unfavorable, which it has been doing.
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Thank you for all the information about Pfizer’s ??? FDA ??? approval. It was an enlightening read. Since I have already had two doses, guess now all I can do is hope not to get sick.
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Dr. Lee Merritt spoke for what seemed almost two hours today going over so many of the lies from the beginning. And yet I am sure she did not cover them all. Imagine that! It has been straight up pure deceit in our face. And now this latest from the FDA is just more icing on the fraud cake. They must have totally redefined the terms “safe” and “effective” along with all other science terminology if indeed they did approve the toxic Pfizer injection. It certainly does not meet my definition of safe and effective. It defies logic to say it is safe and effective when so many including children have been harmed and killed by their radical experiment. It defies logic also because there is no way they could have done long term studies when it was developed only over the course of approximately March 2020 to December 2020. Long term has not passed. To think they would release such a confusing quasi approval while interjecting the names of other products and use extreme legalese when the subject is so extremely controversial amongst the population. The FDA has now shamed itself along with the CDC and other managing alphabet agencies. On one hand I laugh in their face with incredulity at their disgusting attempts to deceive myself and the rest of humanity. On the other I realize how dangerous psychopaths such as these are while acknowledging the child abuse and murder that has taken place and continues under their illegitimate power seized. Thank you Leo for yet another great and informative article. https://www.brighteon.com/2e057579-e109-4753-b32e-4cde344b1a24
https://www.brighteon.com/2e057579-e109-4753-b32e-4cde344b1a24
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Reblogged this on boudica.us.
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I am age 64 and in excellent health, with all my own teeth and I take zero medications. I have outlived both my parents, who died with artificial teeth and their medications lined up in rows in the medicine cabinet…
Educated in Biology, I will not even consider receiving this appalling inoculation for at least a half-dozen reasons! And here in Canada my friends grow wide-eyed. “Aren’t you afraid?”
Afraid of the pathogenic inoculation? Of course! But am I afraid of corona viruses…? LoL surely you jest.
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Thanks Leo again for your great work, we’re seeing very few can be trusted today , we need discernment all around . Here in Canada the msm is corrupt to the core . There is a federal election going on and the parties refuse to talk to independent reporters such as Rebel news , so they can spew their lies to bought corporate ones . Stay united all this too shall pass, the end is near.
Maranatha.
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The entire federal machine is corrupt beyond redemption. We can point this out in example after example all day long. The $20 question is: When do we bring in the clorax, the broom and mop ….. and bleach this slime?
Law enforcement as a group is totally silent on the obvious covid fraud even in the face of evidence. Evidence like federal payments for a covid diagnoses and federal payments for putting someone on a ventilator. Examination of the overall death rate and examination of the listed cause of deaths is damning. Likewise, first person, whistle-blower accounts are falling on deaf ears. So, it appears law enforcement is content to be lap dogs to this political machine.
Prosecutors are silent. Judges are silent. The Joint Chiefs are obviously compromised so help will not be coming from that quarter. The Executive Division is the main driver of this crap-show.
Where do we go from here? Who has the power to bring down this cancerous system?
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Great sleuthing! Everyone spread this article around and stand against the diabolical mandates!
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They claimed the biontech shot got renamed. Can y’all explIn that? Amazing Polly did an amazing dig into who is behind that company/ basically the descendents of nazis!!
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That’s a lie. Here is s quote directly from the FDA approval letter (in footnote 8)
“The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.“
The “certain differences” are not specified, but it is perfectly clear that the two jabs are legally distinct.
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Corona virus was never isolated.so the definition of vaccine for this scamdemic genocide does not apply.this is not a.vaccine..its experimental always will be.your eugenics masters of chaos there u.n. agenda 21 agenda2030 agenda2050.has been moved up the time line for human depopulation that goes back decades..good luck to all who have remained nieve and.gullible and.took this extermination shot..dont get sick..this shot is designed to kill when.any sickness like the every year flu comes along.human storms developed cytokine storm.is going to murder10s of millions..quite weapons for silent wars.look it up..taking this shot. When nearly every one recovered from this fake virus 99.875. Percent recovery rate…fear drove the gullible to get a.death shot…good luck..i hope im wrong..im on my 34th year of research..you call a conspiracy theorist..millions have already died..my death rate.numbers for the u.s. 2 weeks ago was around 5.4.million..if the new numbers are correct .it may.be over 12.million
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Thanks Leo for being a sober watchman on the wall with your many lifesaving warnings! I am thankful the Lord Jesus, my Good Shepherd, has led me out of Marxism’s Socially Secured “global City of Destruction” and into the Covid free, socially un-secured ‘wilderness’ where he supernaturally nurtures His faithfully dependent sheep. Revelation 18:4
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Thank you for clarifying a very confusing letter, which has had some of us screaming from the housetops that something is terribly wrong
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Excellent information! Thank you so much for all the hard work you do for us!
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This was new to me. Thank you for writing and sending this out. I just sent it to two of our kids. The news came today that no children under 12 could visit at the nursing home–even outdoors. My dad willbe devastated. (We have 14 grandkids in which half of them are under 12.) His birthday is the 4th. They maydecide that I cannot visit by then. I took him the clothing he wanted from his house Monday morning when I went to visit.. I had washed the clothing that was soiled Sunday night and had his shirts hanging nicely on hangers. They immediately took the clothing to be washed!I told Dad that if I had known that, I would have brought everything he owned! . . . And yet, they still try to put that thermometer with the little wrapper in my mouth. I refuse each time and make them get the head thing. They pulled it out of one ladies mouth, put the new piece of plastic on the tip and tried to put it in my mouth the first time I was there. Yep, a bunch of rocket scientists. Then they try to hand me a filthy pen to initial the paper… Oh, dear! My brother just texted that they sent him a whole new list of restrictions. He will send it to me later. All I knew about was the kids. Anyway, thank you for all you do. I know it isn’t always appreciated.
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He still has a house. He needs to be removed and cared for at his home for his mental well-being. If you care for the man, contact a home services firm, get a contract, and move your father.
People need human contact. There are many studies out there. Find one that fits and print it out. You may need a lot of ammo to fight with the health industry tyranny being instated today.
Pull out the Neuremburg Protocols, a constitution and Bill of Rights for the staff, as well, with a letter from attorney with your father’s name plainly stated to threaten them with whatever the lawyer can come up with. It’s time to fight with all the tools you can.
Then give them no time to put together a coherent defense which would further damage your father’s well-being. And be sure to ask to see in writing any blather they come up with, including a legal basis for the policy-as well as names authorizing parties. And let them know your attorney will be reviewing them while veracity and background checks are performed.
Just a few thoughts from someone who has contemplated the myriad controls being emplaced. The documentation will at least be able to be combined with thousands of other complaints in order to break the chains being forged right now.
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Can you take him out and go somewhere else?
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