2 Things Mainstream Media Didn’t Tell You About FDA’s Approval of Pfizer Vaccine

[Steve]

2 Things Mainstream Media Didn’t Tell You About FDA’s Approval of Pfizer Vaccine

Buried in the fine print of Monday’s approval by the U.S. Food and Drug Administration of the Pfizer Comirnaty COVID vaccine are two critical facts that affect whether the vaccine can be mandated, and whether Pfizer can be held liable for injuries.

childrenshealthdefense.org

"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."

"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."

"The FDA appears to be purposefully tricking American citizens into giving up their right to refuse an experimental product."

"And the FDA has not licensed any Moderna vaccine, nor any vaccine from Johnson & Johnson — so the vast majority, if not all, of vaccines available in the U.S. 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."

 

[haidut]

2 Things Mainstream Media Didn’t Tell You About FDA’s Approval of Pfizer Vaccine

Buried in the fine print of Monday’s approval by the U.S. Food and Drug Administration of the Pfizer Comirnaty COVID vaccine are two critical facts that affect whether the vaccine can be mandated, and whether Pfizer can be held liable for injuries.

childrenshealthdefense.org

"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."

"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."

"The FDA appears to be purposefully tricking American citizens into giving up their right to refuse an experimental product."

"And the FDA has not licensed any Moderna vaccine, nor any vaccine from Johnson & Johnson — so the vast majority, if not all, of vaccines available in the U.S. 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."

I am not sure the vaccine has even been approved. All the FDA did is extend the EUA, as per their own documents. The FDA never gave public interviews/statements saying "the vaccine has now been fully approved". Their official document is pretty clear it has NOT been fully approved. All the claims of full approval are coming from mainstream media, not the FDA.

BREAKING: FDA is pushing to "Fully Approve" Pfizer COVID19 "Vaccine" on Monday August 23rd

View: https://twitter.com/TanyaRo58329998/status/1430212200065556485

raypeatforum.com

 

[Happycat]

FDA Approves First COVID-19 Vaccine

FDA approved the first COVID-19 vaccine, now marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older.

www.fda.gov

 

[Steve]

So it sounds like it is approved, but it's only the new version, Comirnaty, which you won't find in the US because Pfizer doesn't have a liability shield yet for the new version. I love how they hide all of these details on the mainstream media. Pick any random person and ask them if they ever heard of Comirnaty.

 

[tankasnowgod]

FDA Approves First COVID-19 Vaccine

FDA approved the first COVID-19 vaccine, now marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older.

www.fda.gov

Despite their misleading press release, there is no listing for "COMIRNATY" on this list of approved drugs for the FDA for the month of August-

Drugs@FDA: FDA-Approved Drugs

Even if "COMIRNATY" is approved, it's not available anywhere, at the moment. "Pfizer BioNTech Covid 19 Vaccine" is the same formulation, but continues to enjoy EUA status.

 

[sweetpeat]

The FDA is saying the 2 versions can be used interchangeably. The following is from Q&A for Comirnaty (COVID-19 Vaccine mRNA) on the FDA website:

"How is Comirnaty (COVID-19 VACCINE, mRNA) related to the PFIZER-BIONTECH COVID-19 VACCINE?

The FDA-approved Pfizer-BioNTech product Comirnaty (COVID-19 Vaccine, mRNA) and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under EUA have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns. Therefore, providers can use doses distributed under EUA to administer the vaccination series as if the doses were the licensed vaccine. For purposes of administration, doses distributed under the EUA are interchangeable with the licensed doses. The Vaccine Information Fact Sheet for Recipients and Caregivers provides additional information about both the approved and authorized vaccine."

Also, from VACCINE INFORMATION FACT SHEET FOR RECIPIENTS AND CAREGIVERS

"The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under Emergency Use Authorization (EUA) have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.[1]
COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.
• It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older.
• It is also authorized under EUA to be administered to: o prevent COVID-19 in individuals 12 through 15 years, and o provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise.

The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to:
• prevent COVID-19 in individuals 12 years of age and older, and
• provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise."

 

[amd]

VACCINE INFORMATION FACT SHEET FOR RECIPIENTS AND CAREGIVERS ABOUT COMIRNATY (COVID-19 VACCINE, mRNA) AND PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19)

Revised: 23 August 2021

https://www.fda.gov/media/144414/download

[1] 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.

 

[Kozak]

I am not sure the vaccine has even been approved. All the FDA did is extend the EUA, as per their own documents. The FDA never gave public interviews/statements saying "the vaccine has now been fully approved". Their official document is pretty clear it has NOT been fully approved. All the claims of full approval are coming from mainstream media, not the FDA.

BREAKING: FDA is pushing to "Fully Approve" Pfizer COVID19 "Vaccine" on Monday August 23rd

View: https://twitter.com/TanyaRo58329998/status/1430212200065556485

raypeatforum.com

They both approved and extended EUA. Original post explained well why.

 

[Peatness]

Does the FDA think these data justify the first full approval of a covid-19 vaccine? - The BMJ

The FDA should demand adequate, controlled studies with long term follow up, and make data publicly available, before granting full approval to covid-19 vaccines, says Peter Doshi On 28 July [...]More...

blogs.bmj.com

Peter Doshi, senior editor, The BMJ.

 

[achillea]

The ten points of the Nuremberg Code​

The ten points of the code were given in the section of the judges' verdict entitled "Permissible Medical Experiments":[6]

1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs, or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.[13]
2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.
4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.
9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

Importance​

 

[blob69]

A good one about the new Pfizer study from Anthony Colpo: New Trial Data Reveals Higher Death Rate with Pfizer COVID-19 ‘Vaccine’

 

[Birdie]

Did the FDA Pull a Bait-and-Switch on the American People?

My notes on this article -
Which vaccine will they use? The approved one (Comirnaty labeled) or the Emergency Use one? Pfizer has lots of the EUA vaccine on hand. But this is not the approved and licensed vaccine. If the EUA vaccine is used people will not have much grounds to sue if anything goes wrong. And that vaxx cannot be mandatory, only the branded one, Comirnaty labeled, can be mandated. And it is the one Pfizer will be liable for.

Did the FDA Pull a Bait-and-Switch on the American People?

 

[sweetpeat]

Did the FDA Pull a Bait-and-Switch on the American People?

My notes on this article -
Which vaccine will they use? The approved one (Comirnaty labeled) or the Emergency Use one? Pfizer has lots of the EUA vaccine on hand. But this is not the approved and licensed vaccine. If the EUA vaccine is used people will not have much grounds to sue if anything goes wrong. And that vaxx cannot be mandatory, only the branded one, Comirnaty labeled, can be mandated. And it is the one Pfizer will be liable for.

I think they will use as much of the old stock as they can get away with, partly because a lot of it is expiring soon. But also many people will now associate the name "Pfizer" with "approved vaccine" not realizing that only the new one has legal liability.

Something I haven't seen anyone address though is shouldn't Moderna and J&J vaxxes now be disqualified under EUA for ages 16 and up? At least in the US? I though the EUA was only granted so long as there was no approved vaccine. Now that Pfizer is approved aren't they supposed to stop using non-approved ones? @haidut @tankasnowgod

 

[tankasnowgod]

Something I haven't seen anyone address though is shouldn't Moderna and J&J vaxxes now be disqualified under EUA for ages 16 and up? At least in the US? I though the EUA was only granted so long as there was no approved vaccine. Now that Pfizer is approved aren't they supposed to stop using non-approved ones? @haidut @tankasnowgod

I think we're long past the FDA and other agencies breaking their own rules, at this point.

Technically, none of the "vaccines" should have ever been given EUA status, because Remdesivir was approved in October 2020-

FDA Approves First Treatment for COVID-19

FDA approved Veklury (remdesivir) for adults and pediatric patients 12 years of age and older for the treatment of COVID-19 requiring hospitalization

www.fda.gov

 

[sweetpeat]

I think we're long past the FDA and other agencies breaking their own rules, at this point.

Technically, none of the "vaccines" should have ever been given EUA status, because Remdesivir was approved in October 2020-

FDA Approves First Treatment for COVID-19

FDA approved Veklury (remdesivir) for adults and pediatric patients 12 years of age and older for the treatment of COVID-19 requiring hospitalization

www.fda.gov

Yep, good points. There seems to be no end to the ridiculousness. It's unbelievable to me sometimes how they continually undermine their own credibility. But I guess why not? since no one holds them accountable.

 

[Peatness]

View: https://twitter.com/MerkabaFilmGrp/status/1432370206698057730/photo/1

 

[Peatness]

No sure if this document has been posted already. UK column discusses the content 50mins into this video




View: https://www.bitchute.com/video/3ncEKJlUpPzD/

 

[Rinse & rePeat]

.

VACCINE INFORMATION FACT SHEET FOR RECIPIENTS AND CAREGIVERS ABOUT COMIRNATY (COVID-19 VACCINE, mRNA) AND PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19)

Revised: 23 August 2021

https://www.fda.gov/media/144414/download

[1] 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.

Does the "EUA-authorized" stand for euthanasia? ?

 

[Peatness]

.

Does the "EUA-authorized" stand for euthanasia? ?

If not it should be renamed

 

[Rinse & rePeat]

If not it should be renamed

It really sticks out to me like Evian water spelled backwards and nobody notices it ?