On Aug. 23, the U.S. Food and Drug Administration (FDA) issued its approval (also known as a license) for Pfizer’s Comirnaty COVID vaccine. The FDA documents related to the vaccine’s approval are as difficult to understand as the new brand name is to pronounce.
Also, the approval of the Comirnaty vaccine was limited to adults over age 16 receiving their first two doses.
Vaccination with the EUA Pfizer-BioNTech or the Comirnaty vaccine in the 12- to 15-year age group, or providing a third booster dose of either, are still considered an unapproved use — however, those uses remain authorized under EUA.
FDA made some clear but cagey statements about the differences between the Comirnaty vaccine and the Pfizer-BioNTech EUA vaccine.
“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.”
What does that statement mean? What, specifically, are the “certain differences” that make the two vaccines “legally distinct?”
The FDA did not explain this in any of the documents provided last week to the public.
Here's my latest with @NassMeryl… Buried in fine print of Monday's approval by FDA of Pfizer Comirnaty COVID vaccine are 2 critical facts that affect whether vaccine can be mandated + whether Pfizer can be held liable for injuries.https://t.co/QtpHufCKDI
— Robert F. Kennedy Jr (@RobertKennedyJr) August 25, 2021
Two important facts about EUA drugs and vaccines
We know there are some important differences between EUA drugs and vaccines, and fully licensed drugs or vaccines.
We also know these two facts about EUA products:
- EUA vaccines are designated as experimental or investigational products under U.S. law. As such, they cannot be mandated. You have the right to refuse, without suffering consequences.
- EUA vaccines have a huge liability shield that protects everyone involved with the product from being sued. If you are injured by an EUA vaccine, the only way to obtain compensation for damages is to apply to the Countermeasures Injury Compensation Program (CICP), which might cover unpaid medical expenses and lost wages only. However, only 3% of claims made have been compensated, and so far the program has approved no claims for COVID vaccine injuries.
Some say the CICP, which is run through the U.S. Department of Health and Human Service and does not give petitioners the right to a judge or jury, withholds due process from injured Americans.
Yet this is the only pathway by which an injured party can seek help after receiving an EUA vaccine or drug.
It’s right there in the fact sheet — FDA says it’s ‘your choice’
Legally, in order to mandate a vaccine, the vaccine must be fully approved. However, once a vaccine for use in adults moves from an EUA product to a licensed everyday product, it loses its liability shield.
We believe it is likely the FDA was instructed to find a way to both license the Pfizer vaccine — so mandates would be legally supported — while also retaining the vaccine’s liability shield.
The FDA could not find a way to do this under existing law. So instead, as we reported Aug. 24 in The Defender, the agency chose to create confusion regarding the legal status of the two Pfizer-BioNTech vaccines.
In a document we discuss here for the first time — the fact sheet required to be given to recipients of either the Comirnaty or Pfizer-BioNTech COVID vaccine — the FDA acknowledges the facts we have just presented.
But the FDA also has added something new — the final sentence of the fact sheet states:
“This EUA for the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY will end when the Secretary of HHS determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed.”
According to this fact sheet, the FDA also has designated the licensed Comirnaty vaccine as an EUA product. By doing so, the FDA has guaranteed the Comirnaty vaccine the same liability shield as the EUA Pfizer-BioNTech vaccine.
However, that means the Comirnaty vaccine cannot be mandated. The FDA admits this in the fact sheet, where it states:
“WHAT IF I DECIDE NOT TO GET COMIRNATY (COVID-19 VACCINE, mRNA) OR THE PFIZER-BIONTECH COVID-19 VACCINE?
“Under the EUA, it is your choice to receive or not receive the vaccine. Should you decide not to receive it, it will not change your standard medical care.”
The fact sheet is FDA’s admission, buried in the fine print, that no one can currently be mandated to receive any COVID vaccine in the U.S., as all remain under the EUA.
This fact sheet for vaccine recipients is key to avoid being forced to accept an experimental vaccine.
We suggest you print it out, highlight the relevant passages and present it to anyone who tries to force vaccinations on employees.
© 2021 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.
Plandemic, Voter Fraud, Afghanistan: All Parts of The Great Reset
If you still consider “conspiracy theorist” to be a pejorative, you’re not paying enough attention.
What do Covid-19, 2020 (and beyond) election fraud, and our disastrous abandoning of American citizens in Afghanistan have to do with one another? They’re all parts of the globalist plan to usher in a new era of Neo-Marxism in a depopulated world. This is The Great Reset unfolding before our eyes, and the only way we can stop it (other than through constant prayer) is to stand together and spread the truth.
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Covid-19’s attachment to The Great Reset is obvious, though we continue to post about it daily. Voter fraud is a bit less obvious but nonetheless easy to recognize when we understand that people like Joe Biden, Justin Trudeau, and Emmanuel Macron are pushing to “Build Back Better” under the precepts of Neo-Marxism.
The Afghanistan betrayal in August, 2021, is harder to associate with The Great Reset, but it’s definitely just as attached. We can see this is the unwillingness of the Biden regime to extend the deadline to withdraw despite American lives put clearly in harm’s way. We can see it in the needlessly abandoned military equipment that was conspicuously left intact; disabling a Black Hawk takes minutes but they were given to the Taliban in pristine working condition. Then, there’s the pallets of hundred dollar bills left for them. If you think all of this was just irresponsible governance, you probably think Barack Obama is out of politics, too.
Weakening America’s standing in the world and empowering the Chinese Communist Party and others to engage fully with our enemies in a globalist cabal are beneficial to the architects of The Great Reset, and both happened in one fell swoop in August.
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We Often Feel Like David Taking on Giants
Today’s Goliath is the Mainstream Media Industrial Complex that brainwashes the masses.
Our mission is very straightforward: To counter the false narratives and nefarious agendas destroying America today. It isn’t easy for obvious reasons; despite incredible growth over the last year we are still a very tiny fish in a huge media pond. But we’re fighting and we will continue to do so, Lord willing, for as long as we possibly can. The battle for America’s present and future is too important for us to back down to the giants that stand in our way.
We need help. I don’t want to say “desperately,” but the need is definitely great. If you have the means, please donate through our GivingFuel page, PayPal, or our brand new GiveSendGo page. Your generosity is what keeps these sites running and allows us to get the truth to the masses. We’ve had great success in growing but we know we can do more with your assistance.
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