COMIRNATY - Who got it? - UPDATE PAGE 3- La Reps Send letter to Governor

Paging GumboPot.

Is this a serious question? Comirnaty is Pfizer. They just have to continue to use the EUA because of the doses not labeled that will not expire until 2022, and the patients that are not covered by the FDA approval. They are the exact same thing.

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Don't Care if its been mentioned, i've called all over and can't find the "COMIRNATY" vaccine.

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There is a lot of confusion about this but it is relatively simple.

The Pfizer vaccine and the Comirnaty vaccine are physically the same product. The only difference is the label and the package insert. They do have a not-so-subtle legal distinction but it is temporal, not label-based.

The Pfizer vaccine was given prior to August 23rd under EUA only and continues to be EAU approved for ages 12-15 and third doses for immunocompromised people 12 or older. This goes for doses from a vial labeled Comirnaty as well.

When the FDA approved the biologics licences on 8/23 all the doses of the Phizer vaccine no matter what lot or what packaging became FDA approved for 2 doses ages 16 and up.

The legal distinction is any doses given before the BL approval will have any adverse event claims administered under the CICP, doses after the BL approval will be administered under the VICP. Under both systems the vaccine manufacturers have the same immunity they have had since the 1980's and the funds are funded by a surcharge on every dose of every vaccine sold in the US.

Again or more simply one does not have to have a dose of the Pfizer vaccine labeled Comirnaty in order for it to be considered FDA approved for use with ages 16 or older.

The reason behind the use of Comirnaty is that prior to the BL being approved vaccines are not allowed to advertise or market the vaccine so when vaccines or drugs are approved companies usually use a brand name.

The situation is really only confusing if you are attempting to make it confusing. There was a lot of the Pfizer vaccine not labeled Comirnaty in the supply chain and it makes no sense to waste those doses when the package inserts are available both to the public and healthcare workers that administer it.

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Paging GumboPot.

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People are catching on. The approval was a shell game.

your mumble jumble, dude "legally distinct with certain differences" go to the link in the OP and read the September 22,2021 Fact Sheet for Recipients and Caregivers

The EUA is for 12 and over, you are wrong pointing out 12-15...

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The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide: • a two-dose primary series in individuals 12 years of age and older; • a third primary series dose for individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise; and • a single booster dose in individuals: o 65 years of age and older [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

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All this crap about interchangeability and same formulation with no impact to safety and effectiveness has ZERO bearing on the legality of the EUA vs FDA approval.

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The situation is really only confusing if you are attempting to make it confusing

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Or if you outright do not bother to read the documentation provided to recipients of an EUA product.

Go read up on what criteria must be met to grant issuance of an EUA, your feeble mind likely can't handle the truth.

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WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)? The FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives. In addition, the FDA decision is based on the totality of scientific evidence available showing that the product may be effective to prevent COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the product outweigh the known and potential risks of the product. All of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19 pandemic

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Same September 22, 2021 Fact Sheet you did not bother to read.

22 September 2021 Letter of Authorization(reissued) EUA Pfizer BioNTech
pg 13

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Conditions With Respect to Use of Licensed Product AA. COMIRNATY (COVID-19 Vaccine, mRNA) is now licensed for individuals 16 years of age and older. There remains, however, a significant amount of Pfizer- BioNTech COVID-19 Vaccine that was manufactured and labeled in accordance with this emergency use authorization. The authorization remains in place with respect to the Pfizer-BioNTech COVID-19 Vaccine.

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MANUFACTURED AND LABELED in accordance with this EMERGENCY USE AUTHORIZATION

pg 13 also

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Conditions Related to Printed Matter, Advertising, and Promotion X. All descriptive printed matter, advertising, and promotional material, relating to the use of the Pfizer-BioNTech COVID-19 Vaccine shall be consistent with the authorized labeling, as well as the terms set forth in this EUA, and meet the requirements set forth in section 502(a) and (n) of the FD&C Act and FDA implementing regulations. Y. All descriptive printed matter, advertising, and promotional material relating to the use of the Pfizer-BioNTech COVID-19 Vaccine clearly and conspicuously shall state that: • This product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and • The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

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This product has not been approved or licensed by FDA,

The simplicity of these printed FDA documents

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Here is the really un-confusing thing; employers mandating vaccines can shove it their own arse

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yeah pretty simple

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your mumble jumble, dude "legally distinct with certain differences" go to the link in the OP and read the September 22,2021 Fact Sheet for Recipients and Caregivers

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I tried to make it as simple but yet complete as possible for someone that hasn't practiced law in the medical/pharma sector for over 20 years.

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The EUA is for 12 and over, you are wrong pointing out 12-15...

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No I was accurate. The EUA for 16 and older for two doses ended on August 23rd when the full BL was approved.

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Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

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FDA

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All this crap about interchangeability and same formulation with no impact to safety and effectiveness has ZERO bearing on the legality of the EUA vs FDA approval.

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That is correct. When the Pfizer vaccine moved from being administered under EUA to under a BL there was a legally distinct change. From that point, any adverse event claims would be handled under the VICP versus the CICP. They were also allowed but are not required to use the Comirnaty trade name which also has to be approved during the BLA.

The EUA language has to stay in effect since there are certain classes of patients and certain dosage regimes that are still under EUA. The tripping point for many is they don't understand how the trade names work in Pharma. For therapeutic, vaccines and medical devices a manufacturer is not allowed to advertise or market them prior to receiving FDA approval even if it is approved for EUA use. Any manufacturer wanting to use a trade name has to have it approved but they are never required to use the trade name.

Why don't you approach it this way. In the eyes of the legal system a dose of Pfizer vaccine administered on August 24th is not legally distinct from a dose from a vial labeled Comirnaty. It is just that simple.


Let's approach this a different way. What do you think are the legal and/or physical differences between the Pfizer vaccine and the Comirnaty labeled vaccine?

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practiced law in the medical/pharma sector for over 20 years.

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This makes a lot of sense. Skilled in the art of vocabulary manipulation, specifically as it relates to medical/pharma.

Its like the brainwashing hasn't only convinced people that the vaccine is the way, but its programmed people to defend against anyone that says otherwise.

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The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty

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This is the brainwashed takeaway statement. It trumps every statement mentioning that Pfizer BioNTech is NOT FDA approved. 22 September the FDA is still updating documents that Pfizer BioNTech vaccine is not FDA approved.

Which vaccines in your +20 years of practicing law have been granted EUA, then rushed to FDA approval? Let us hear about your vast knowledge of dealing with situations that have set precedent in such cases? Isn't that what its called in legalese?

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I. Criteria for Issuance of Authorization I have concluded that the emergency use of Pfizer-BioNTech COVID-19 Vaccine11 for the prevention of COVID-19 when administered as described in the Scope of Authorization (Section II) meets the criteria for issuance of an authorization under Section 564(c) of the Act, because:

A. SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus;

B. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of Pfizer-BioNTech COVID-19 Vaccine when used to prevent COVID-19 outweigh its known and potential risks; and

C. There is no adequate, approved, and available alternative12 Pfizer-BioNTech COVID-19 Vaccine to prevent COVID-19.13

12 Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years of age and older, there is not sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA. Additionally, there are no products that are approved to prevent COVID-19 in individuals age 12 through 15, or to provide: an additional dose to the immunocompromised population, or a booster dose to the authorized population described in this EUA.

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Have at it word wizard...

That is exactly my thinking as well.

My OPINION, is that COMIRNATY labeled vaccine will never be produced or available on the market. I could be wrong, but all the Pfizer BioNTECH COVID-19 vaccine batches had their expiration dates were extended 3 months, extending the latest batch expiration into May 2022. Couple this with the fact that the PCR test EUA expires Dec2021, we'll see if current administration tries to claim success against pandemic or we get a whole different scary virus or something else. My opinion...

FDA can't approve the Pfizer-Bio-n-Tech now because it has been used under the EUA.
Comirnaty is not available and won't be for some time so they have to deceive the public into continuing to take the EUA Pfizer, of which there will be no legal recourse or liability for side affects or adverse affects or ineffectiveness of the vax. So the public thinks they can go take the Pfizer vax and it is FDA approved and there is some legal liability for manufacturers. But it is Comirnaty that has the legal liabilities attached to it, and that is not available.
It is continued deception by pharma, CDC, FDA, and NIH that has been operating since Feb 2020.