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

It's fairly clear that the FDA did not give full authorization to the currently used Pfizer COVID vaccine, but to a product known as COMIRNATY. ("FDA is reissuing the August 12, 2021 letter
of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and
uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA").

What the FDA is saying, to my reading, is that full approval was given to COMIRNATY, and that COMIRNATY is being allowed use under the current emergency use authorization also. So two things happened; approval of COMIRNATY and a revision of the EUA. What did not happen is full approval of the current COVID vaccine.

The footnote notes that COMIRNATY is legally distinct from the currently used vaccine (see #8 ).

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https://childrenshealthdefense.org/defender/mainstream-media-fda-approval-pfizer-vaccine/

Monday, the U.S. Food and Drug Administration (FDA) approved a biologics license application for the Pfizer Comirnaty vaccine.

The press reported that vaccine mandates are now legal for military, healthcare workers, college students and employees in many industries. New York City Mayor Bill de Blasio has now required the vaccine for all teachers and school staff. The Pentagon is proceeding with its mandate for all military service members.

But 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.

First, the FDA acknowledges that while Pfizer has “insufficient stocks” of the newly licensed Comirnaty vaccine available, there is “a significant amount” of the Pfizer-BioNTech COVID vaccine — produced under Emergency Use Authorization (EUA) — still available for use.

The FDA decrees that the Pfizer-BioNTech vaccine under the EUA should remain unlicensed but can be used “interchangeably” (page 2, footnote 8) with the newly licensed Comirnaty product.

Second, the FDA pointed out that the licensed Pfizer Comirnaty vaccine and the existing, EUA Pfizer vaccine are “legally distinct,” but proclaims that their differences do not “impact safety or effectiveness.”

There is a huge real-world difference between products approved under EUA compared with those the FDA has fully licensed.

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(From page 2 of the pdf referenced above)
On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.

On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter
of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and
uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA. In addition, the Fact Sheet for
Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to provide updates on expiration dating of the authorized Pfizer-BioNTech COVID-19 Vaccine and to update language regarding warnings and precautions related to myocarditis and pericarditis. The Fact Sheet for Recipients and Caregivers was updated as the Vaccine Information Fact Sheet for Recipients and Caregivers, which comprises the Fact Sheet for the authorized Pfizer-BioNTech
COVID-19 Vaccine and information about the FDA-licensed vaccine, COMIRNATY (COVID-19 Vaccine, mRNA). Pfizer-BioNTech COVID‑19 Vaccine contains a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 formulated in lipid particles. COMIRNATY (COVID-19 Vaccine, mRNA) is the same formulation as the Pfizer-
BioNTech COVID-19 Vaccine and can be used interchangeably with the Pfizer-BioNTech COVID-19 Vaccine to provide the COVID-19 vaccination series.8

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5 In the May 10, 2021 revision, FDA authorized Pfizer-BioNTech Vaccine for the prevention of COVID-19 in
individuals 12 through 15 years of age, as well as for individuals 16 years of age and older. In addition, FDA
revised the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) to include the
following Warning: “Syncope (fainting) may occur in association with administration of injectable vaccines, in
particular in adolescents. Procedures should be in place to avoid injury from fainting.” In addition, the Fact Sheet
for Recipients and Caregivers was revised to instruct vaccine recipients or their caregivers to tell the vaccination
provider about fainting in association with a previous injection.

6 In the June 25, 2021 revision, FDA clarified terms and conditions that relate to export of Pfizer-BioNTech
COVID‑19 Vaccine from the United States. In addition, the Fact Sheet for Healthcare Providers Administering
Vaccine (Vaccination Providers) was revised to include a Warning about myocarditis and pericarditis following
administration of the Pfizer-BioNTech COVID-19 Vaccine. The Fact Sheet for Recipients and Caregivers was
updated to include information about myocarditis and pericarditis following administration of the Pfizer-BioNTech
COVID‑19 Vaccine.

7 In the August 12, 2021 revision, FDA authorized a third dose of the Pfizer-BioNTech COVID-19 Vaccine
administered at least 28 days following the two dose regimen of this vaccine in individuals 12 years of age or older
who have undergone solid organ transplantation, or individuals 12 years of age or older who are diagnosed with
conditions that are considered to have an equivalent level of immunocompromise.

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.

 

Meet.google.com/hgh-gyug-mie

If you want to see a toxicologist talk about what’s wrong with the FDA approving the vaccine live right now

 

What a waste of bandwidth!

I just love to open new apps with no information of any kind about the app or its authors!







NOT!

 

If you don’t want to educate yourself, that’s fine with me

 

This is credible and provides credit to the FDA for not bending to the will of the white house. It is impossible for FDA properly to provide full approval without analyzing after effects and side effects over time. There hasn't been enough time to do that. When the white house announced full approval it was lying. It is what they do. I have no problem with the white house recommending vaccination. It is the right thing to do. But lying in order to achieve its goals always leaves me cold and skeptical.

 

Yep, they were lying. So far this lie hasn't seeped out. The media is just acting as an echo chamber.

The FDA notes that there is not enough of the fully approved formulation (which is the same as the current formulation) to go around, so the current formulation, under the EUA, can still be used. See what they did there?

Under full approval, the vaccine is not shielded from liability as it is under the EUA. And that's what you need to know. It's all wordplay, but nothing's changed.

Do you really think Pfizer will release a product that doesn't have a shield of liability when it can still use one that does? Since Moderna and J&J haven't been approved yet, they are still operating under the EUA. No way Pfizer will open itself up to liability when it doesn't have to, especially since the competition doesn't have to operate under the same rules.

So, despite what is being said, nothing had changed.

 

LOL. It matters whether the person trying to educate you is a whack-o or not. One thing trump proved for sure is that there are a lot of stupid Americans.

 

True, they voted for Biden.

 

The person trying to educate you has a PhD in toxicology and pharmacology, is a CSO for multiple pharma and clinical trial companies and she has been published more than 100 times

 

No, the unknown and now very suspicious entity who refuses to even mention the source is "trying to educate" me.

Sorry, I guess I failed. Your desire to give me a graduate degree of BS is a failure. I imagine you get alot of that

 

Yes of course, one of the primary duties outlined in the Constitution is for POTUS and the government to tell the citizens what they should take into their bodies.

It's the American Way, right? Our illustrious government leaders determine what we ingest.

 

Lol like I said remain as you are

 

Kindly stop using my posts to interject your nonsense. It wastes my time.

 

Do my posts make you have to consider things you would rather not? Suggestion: put me on ignore.

 

Sorry, you're comparing apples and oranges. The amount of education a person has doesn't have a thing to do with how smart they are.

 

All that changed is the name.

That does not affect certification. All drugs get minor changes that science based medicine judges to be too insignificant to require retesting.

 

This really isn't about "smart".

It is about subject knowledge.

 

Our government does have a stated requirement to promote the general welfare of Americans.

Thus we see legislation and executive branch actions oriented to the safety of the people.

You should read our founding documents and look around.

 

What the FDA gave approval to is a product named COMIRATY. It states that COMIRATY and the current Pfizer vaccine have the same formulation. So, yes, you could say that all that changed is the name.

However, that does not equal the current Pfizer vaccine being approved. Had it been approved, there would have been no need to extend the EUA for the current vaccine, which the FDA did. The FDA had this to say:

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.

So, what does it mean to have the same formulation but be legally distinct? What it means is that a fully approved vaccine is not shielded from liability such as one under an EUA is. So, the FDA has essentially approved the Pfizer vaccine without really approving it. Giving it the mask of approval has allowed the government to go forward with vaccine mandates, but extending the EUA allows it to be shielded from liability.

See, you can't mandate something that isnt fully approved, but full approval removes exemption from liability. The government is trying to have it both ways. It's giving Pfizer the prestige of being fully approved for mandates and all the money that will flow from that while shielding it from liability.

The FDA is blowing smoke up our asses with this non-approval approval. It just illustrates how much our government is in cahoots with certain corporate players. It leaves me with not more but less confidence in these vaccines.

 

If the current Jab had the full approval of the FDA then the Moderna and J&J jabs would lose there EUA rights....

This is a way around that.. claim it has approval when it does not but allow the EUA to stand.

 

You mean how it was stupid for Trump to promote hydroxychloroquine as an effective treatment? Oh wait, that turned out to be true... Which means that all the media pundits' and Democrats' downplaying and big tech censorship over it ensured a lot of unnecessary suffering and death. All for the goal of demonizing Trump. Was it worth it? Will there be apologies?

 

All Pfizer did was to name the vaccine that the FDA approved.

You can not claim there is any difference.

And, no the Pfizer COVID vaccine IS approved, as is fully justified. The full completion of the final test phase demonstrates that the vaccine is both safe and effective.

One doesn't even have to rely on the huge success of this exact vaccine through the last many months of emergency approval that followed phase 3 testing.

 

Did you sign in with your login and password?

 

Shame it doesn't really do anything Maybe it's a new category FDA approved for "Scam only" usage..