Posted on 12/23/2021 11:24:21 PM PST by zeestephen
Triple wrote: “The fda reported “same formulation” not identical.”
You’re playing with words. Please explain how two things can have the same formulation and interchangeable yet not be identical?
Perhaps you should read this:
FDA Approval of the Pfizer-BioNTech
COVID-19 Vaccine: Frequently Asked
Questions
https://crsreports.congress.gov/product/pdf/R/R46913
And this:
“You asked, we answered: Are Pfizer’s Comirnaty and BioNTech COVID-19 vaccines the same or different?”
You’re just playing word games in a vain attempt to justify not taking the vaccine. Don’t take it if you don’t want it but quit spreading misleading and false information.
“LEGALLY DISTINCT”
It’s not about the formula. The label makes the 2 legally distinct. So, smartypants, can you think of any potential legal differences between an eua product and a fully approved product? Are you you telling us they are the same thing, even under an emergency order.
Let me give you an example. My employer makes me get the shot. I go to the doctor and he gives me the eua warnings. I tell him no, I’m here for comirnaty. I ask him and my employer to sign a paper verifying they are standing behind the vaccine I am being given as an approved fda treatment. Further, they both would verify taking on all liabilities if it is later shown that I was given an eua product instead. Do you think they would sign? You know they wouldn’t. Maybe you would sign for all of us since you are so sure of it.
mongrel wrote: “It’s not about the formula. The label makes the 2 legally distinct. So, smartypants, can you think of any potential legal differences between an eua product and a fully approved product? Are you you telling us they are the same thing, even under an emergency order.”
I’ve posted numerous times the reason for the ‘legally distinct’ wording. ‘Legally distinct’ doesn’t change the fact that those are the same identical and interchangeable product.
They are using the word Comirnaty on every ad on every radio station in the Chicago market.
And yet you fail to answer my questions.
I’m using the fda words :same formulation.
I think the fda has not elaborated on that odd word choice.
What it could mean:
-Similar but different coding nucleoside sequence.
-different modified nucleosides
-different 5 prime or 3 prime sequences that impact expression
There is more… but we don’t know. And Pfizer and the fda are not honoring FOIA rules on information disclosure. Why the secrecy? Why are they hiding FOIA materials? It certainly raises suspicion for people that are asking legitimate questions.
#whyareyoushillingforthem
“ BTW, what you’re calling the ‘EUA version’ and the Fully Approved version are the same product.”
You’re obviously lying, and nobody believes you. Cormirnaty doesn’t exist cupcake, and that’s on purpose. You won’t be able to keep up the lies and shilling for too much longer. It’s hard to pretend they had a years worth of the old stuff lying around. I notice they quietly extended the expiration dates a week or so ago. They know they can’t keep up with the liar too much longer either. Your side is done soon.
I will believe it when I hear it or see it.
90% of Americans would not even know what Comirnaty means.
100% of Americans would struggle to pronounce it or spell it.
After several hours of research...
The authorization for a new EUA product label - Comirnaty - occurred on 09 December 2021.
FDA and Pfizer formal EUA Guidance for Comirnaty use did not occur until 16 December 2021.
In other words, Comirnaty did not receive final HHS approval for use during the Covid Health Emergency until ten days ago.
Anyone who claims that Comirnaty was in use BEFORE 16 December is not telling the truth.
Also, a very interesting paragraph from the formal Comirnaty Guidance from Pfizer on 16 December:
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.
Yet the point is 100% correct. By law, any FDA approved medication can no longer fall under an EUA. You know this. But you enjoy lying about the vax and constantly push it.
What's not "interchangeable" is the legal distinction of who can administer the drugs.
The EUA drug must, by the terms in the EUA, be administered ONLY by approved technicians at approved locations. This means NOT at your preferred doctor's office, unless they registered with an EUA-approved COVID-19 Emergency Response Stakeholder as a Vaccine Provider.
Your family doctor can administer the COMIRNATY drug, but not the Pfizer-BioNTech drug. Why is that?
From the December 16 Revised EUA for the Pfizer-BioNTech vaccine:
II. Scope of Authorization-PJI have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is limited as follows:
- Pfizer Inc. will supply Pfizer-BioNTech COVID‑19 Vaccine either directly or through authorized distributor(s),20 to emergency response stakeholders21 as directed by the U.S. government, including the Centers for Disease Control and Prevention (CDC) and/or other designee, for use consistent with the terms and conditions of this EUA; and
- Pfizer-BioNTech COVID‑19 Vaccine may be administered by a vaccination provider22 without an individual prescription for each vaccine recipient.
20 “Authorized Distributor(s)” are identified by Pfizer Inc. or, if applicable, by a U.S. government entity, such as the Centers for Disease Control and Prevention (CDC) and/or other designee, as an entity or entities allowed to distribute authorized Pfizer-BioNTech COVID‑19 Vaccine.21 For purposes of this letter, “emergency response stakeholder” refers to a public health agency and its delegates that have legal responsibility and authority for responding to an incident, based on political or geographical boundary lines (e.g., city, county, tribal, territorial, State, or Federal), or functional (e.g., law enforcement or public health range) or sphere of authority to administer, deliver, or distribute vaccine in an emergency situation. In some cases (e.g., depending on a state or local jurisdiction’s COVID-19 vaccination response organization and plans), there might be overlapping roles and responsibilities among “emergency response stakeholders” and “vaccination providers” (e.g., if a local health department is administering COVID-19 vaccines; if a pharmacy is acting in an official capacity under the authority of the state health department to administer COVID-19 vaccines). In such cases, it is expected that the conditions of authorization that apply to emergency response stakeholders and vaccination providers will all be met.
22 For purposes of this letter, “vaccination provider” refers to the facility, organization, or healthcare provider licensed or otherwise authorized by the emergency response stakeholder (e.g., non-physician healthcare professionals, such as nurses and pharmacists pursuant to state law under a standing order issued by the state health officer) to administer or provide vaccination services in accordance with the applicable emergency response stakeholder’s official COVID-19 vaccination and emergency response plan(s) and who is enrolled in the CDC COVID-19 Vaccination Program. If the vaccine is exported from the United States, a “vaccination provider” is a provider that is authorized to administer this vaccine in accordance with the laws of the country in which it is administered. For purposes of this letter, “healthcare provider” also refers to a person authorized by the U.S. Department of Health and Human Services (e.g., under the PREP Act Declaration for Medical Countermeasures against COVID-19) to administer FDA-authorized COVID-19 vaccine (e.g., qualified pharmacy technicians and State-authorized pharmacy interns acting under the supervision of a qualified pharmacist). See, e.g., HHS. Fourth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 and Republication of the Declaration. 85 FR 79190 (December 9, 2020).
The Comirnaty radio spots have been playing in east TN as well.
Triple wrote: “I’m using the fda words :same formulation. I think the fda has not elaborated on that odd word choice.”
Here’s a definition of formulation.
https://www.ncbi.nlm.nih.gov/books/NBK562239/
Thanks - by your link same formulation is clearly not the same as identical in every way.
It effectively means that the inactive ingredients are the same.
It does not imply that the mRNA sequence is the same (either coding or regulatory, or that the modified nucleosides are the same or in the same locations.
Thanks again…
Triple wrote: “Thanks - by your link same formulation is clearly not the same as identical in every way.”
Clearly they are. A formulation is a specific recipe for a specific drug.
Big Brother, Big Pharma, Big Media
Three prongs on Satan’s trident.
Same formulation =\= identical
I will agree that the modified RNA is packaged in the same concentration and lipids (and graphene?).
But the RNA sequence and even the coding portion of the sequence does not have to be identical.
I would be happy to see in writing that the coding and regulatory portions of the RNA are identical. Please show me.
Triple wrote: “I would be happy to see in writing that the coding and regulatory portions of the RNA are identical. Please show me.”
I don’t have that information.
This link is sufficient information for me to believe “Pfizer Comirnaty” and “Pfizer BioNTech COVID-19 vaccine” are biologically and chemically the same thing. YMMV
Why doesn’t Pfizer dodging the FOIA requests bother you?
Why doesn’t Pfizer dodging the FOIA requests bother you?
Things like this bother most freepers, why not you?
Triple wrote: “Why doesn’t Pfizer dodging the FOIA requests bother you?”
Because I recognize that there are many reasons to delay release. For example, proprietary information. We don’t have sufficient information to know. Very similar to Trump citing executive privilege.
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