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Message
re: COMIRNATY - Who got it? - UPDATE PAGE 3- La Reps Send letter to Governor
Posted on 9/26/21 at 10:05 am to jp4lsu
Posted on 9/26/21 at 10:05 am to jp4lsu
quote:
The way I understand it, the FDA approved Comirnaty comes with the liability and legal ramifications. With the Pfizer gene therapy jab under the EUA you are removing all liability from the company from any adverse effects or it ineffectiveness. You have no legal recourse.
With FDA approval there is legal action that can be taken. It is an entirely different scenario. But the FDA and the media have played the public and made it seem that Comirnaty and Pfizer jab are exactly the same and can be interchanged from a legal perspective. They may be identical in function and contents but not in the legal sense.
A mandate from govt or business can't be forced on to employees or public if it is not approved by FDA. An experimental drug can't be mandated.
This is the proper interpretation.
This argument needs to hit the courts in a lawsuit against employers basing their mandate on FDA approval and not providing COMIRNATY as to get this argument codified in judicial precedent.
We have to prevent this shell game going forward.
0
Posted on 9/26/21 at 10:22 am to GumboPot
quote:
The approval was a shell game.
Are you really this fricking stupid??? How many times does this have to be explained to you???
Posted on 9/26/21 at 10:42 am to mouton
Explain your version until you are blue in the face, the documents on the fda website are clear. Pzifer BioNTech is EUA and can't be mandated. Not only is it EUA, the documents specifically state "This vaccine is not FDA approved" So confusing right? There is no "legally distinct with certain differences" COMIRNATY available. Moderna and J&J also still under active EUAs, so if an available approved alternative is out there, then the EUAs don't get issued.
Posted on 9/26/21 at 10:48 am to mooseofterror
quote:
mooseofterror
Shitty poster back again for this stupid talking point.
Posted on 9/26/21 at 11:27 am to mooseofterror
quote:The Pfizer vaccine is now marketed as Comirnaty. They are one and the same. There is no content difference. None. Zip. Zero. Nada.
Don't Care if its been mentioned, i've called all over and can't find the "COMIRNATY" vaccine.
quote:The “legally distinct” reference relates to the fact Cominarty may be manufactured at approved sites or use approved suppliers in addition to the original Pfizer sources. That's it.
The products are legally distinct with certain differences
Got it?
Posted on 9/26/21 at 11:34 am to NC_Tigah
holy crap! NOW I get it...
"Legally distinct with certain differences" translates to it's the same thing. Ok, go it...
and "this product does not have fda approval" translates to "this product is fda approved" ok, got it...
Now I am convinced, I should've just listened to the main stream media from the start. Thanks for your insightful clarifications.
"Legally distinct with certain differences" translates to it's the same thing. Ok, go it...
and "this product does not have fda approval" translates to "this product is fda approved" ok, got it...
Now I am convinced, I should've just listened to the main stream media from the start. Thanks for your insightful clarifications.
Posted on 9/26/21 at 11:59 am to mooseofterror
quote:Let's try again .... this time in crayon to make it more familiar for you.
"Legally distinct with certain differences" translates to it's the same thing. Ok, go it...
Posted on 9/26/21 at 12:56 pm to Mfdtiger
quote:
They are the exact same thing.
Of course they are. The point is, they are using EUA to bypass lawsuits from people injured by the vax.
Posted on 9/26/21 at 2:50 pm to mooseofterror
Just read the whole thread, a lot of mental gymnastics going on in here. Yes it is correct when said it's a shell game. Let me explain...
Label laws apply here. Just because a product is the same product does not mean the product is treated equally. Anything labeled as Pfizer C19 vax falls under the EUA. It can not be FDA approved under that label. It must be labeled as Comirnaty to be a approved.
I am not a lawyer, but I do understand how how label laws work when it comes to a product from some past work history.
Currently anything labeled as Pfizer, Moderna, Johnson and Johnson C19 vax falls under the EUA. Labeled as Comirnaty is approved by FDA. It's really that simple.
Label laws apply here. Just because a product is the same product does not mean the product is treated equally. Anything labeled as Pfizer C19 vax falls under the EUA. It can not be FDA approved under that label. It must be labeled as Comirnaty to be a approved.
I am not a lawyer, but I do understand how how label laws work when it comes to a product from some past work history.
Currently anything labeled as Pfizer, Moderna, Johnson and Johnson C19 vax falls under the EUA. Labeled as Comirnaty is approved by FDA. It's really that simple.
Posted on 9/26/21 at 3:03 pm to mouton
These are my favorite threads.
Posted on 9/26/21 at 4:09 pm to billjamin
quote:
These are my favorite threads.
I’ve said it in this thread and many of the other threads on this topic. If Comirnaty is fully approved and employers and governments are basing their mandates on FDA approval then provide the vaccine with the Comirnaty label. And in terms of the BioNTech-Pfizer vaccines that are currently being used just change the labels. Labels are important because they carry legal obligations as outlined by the FDA.
But we all know why Pfizer will not provide their vaccine with the Comirnaty label. They want to continue to enjoy the legal immunity that is provided under EUA for BioNTech-Pfizer.
Posted on 9/26/21 at 4:29 pm to GumboPot
You are correct, see my post 2 spots above yours.
Posted on 9/26/21 at 4:50 pm to DownHome
FDA approved a vax that is not available,probably never will be,just a spin on wording,if you call pfizer consumer line they will tell you that none of their vax`s are FDA approved.
Posted on 9/26/21 at 4:58 pm to FlexDawg
quote:Wait. Pfizer renamed its fully approved Covid-19 vaccine "Comarity" to use EUA to bypass lawsuits from people injured by the vax.
The point is, they are using EUA to bypass lawsuits from people injured by the vax.
I'm curious. How does that work from a legal perspective?
Posted on 9/26/21 at 6:53 pm to jp4lsu
quote:
The way I understand it, the FDA approved Comirnaty comes with the liability and legal ramifications. With the Pfizer gene therapy jab under the EUA you are removing all liability from the company from any adverse effects or it ineffectiveness. You have no legal recourse.
This is an incorrect interpretation of the laws as they pertain to vaccines and even the number of people espousing it I have to assume someone or a group of people are pushing it.
I will be as simple as possible but will be happy to discuss the granular details if anyone in interested.
Since 1986 when Reagan signed the National Childhood Vaccine Injury Act (NCVIA) all US vaccine manufacturers have enjoyed near blanket immunity for vaccines dispensed in the US that had "full" FDA approval. The key here is understanding vaccine manufacturers did not get a different type of immunity under EUAs they got the same immunity that already had given to them for EUA use in this instance.
The only difference in terms of immunity is the fund that administers the adverse event claims. Adverse event claims that result from use during EUA are handled by the CICP (Countermeasures Injury Compensation Program) and adverse event claims during full approval are handled by the VICP (Vaccine Injury Compensation Fund). They are both funded by a surcharge placed on each dose of US sold/administered vaccine. Now the CICP and VICP on a 30k foot view are very similar on a granular level they are different in terms of the administrative bodies and the compensation schedule.
I think at least some of the confusion about this issue is that the Pfizer vaccine is still being administered under 2 EUAs (12-15 and 3rd dose for 12 and up immunocompromised) this leaves two sets of active FDA directives and muddies the waters if one doesn't realize this because you can find active EUA and active Biologics Licences directives.
The key takeaway from my post is that the type and amount of immunity do not change for a vaccine manufacturer when moving from COVID EUA to dispensing under a BL (Biologics licenses). Vaccine manufacturers have had this immunity since 1986 and they don't hold or administer the funds for adverse event claim payments.
I THINK the distinction has become an issue due to the incorrect assumption that EUA vaccines can not be mandated by employers. The EEOC gave guidance in the early days of EAU that said that it could be and the E&L division of my firm gave the same guidance to our clients. There are some areas of law that could be used to argue against the mandate of a EUA only vaccine which is what puts us in the situation of concern about what is being dispensed under BL and what is being dispensed under EUA. What the approval process definitely was not is a ploy to keep the immunity afforded by EUA because from a liability and exposure standpoint it is exactly the same under a biologics license.
Now I think mandates for most people in most sectors are bullshite though there is a good chance they will be considered legal when all the dust settles probably via ruling by SCOTUS on the "shadow docket". However, if someone is trying to use the lack of Comirnaty labeled Pfizer vaccine to forestall having to take a vaccine they do not want have at it but be aware this approach will almost certainly crumble in the court system.
Posted on 9/26/21 at 7:51 pm to mooseofterror
An MD friend who trained many AF MD's knows many in the military. Danger of pulmonary embolism and of course the myocarditis cases. You won't see this in the evening news.
Posted on 9/26/21 at 7:54 pm to Mo Jeaux
This is a hilarious thread
Posted on 9/27/21 at 6:09 am to Obtuse1
quote:
I think at least some of the confusion about this issue is that the Pfizer vaccine is still being administered under 2 EUAs (12-15 and 3rd dose for 12 and up immunocompromised) this leaves two sets of active FDA directives and muddies the waters if one doesn't realize this because you can find active EUA and active Biologics Licences directives.
Confusion? Yes.. 2nd time you have stated that the EUA for Pfizer is for 12-15 and for 3rd booster, but the black and white text states...
quote:
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 provide: • a two-dose primary series in individuals 12 through 15 years; • a third primary series dose in 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 o 18 through 64 years of age at high risk of severe COVID-19 o 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19
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
So forgive me if I am wary about your continued insistence that this is false. I mean holy hell - I can read, even in crayon.
If "legally distinct" applies to manufacturing, then there are "certain differences". Part of informed consent is understanding what in the hell, beyond any of this word game bullshite, you are being forced to put into your body. It should be clear and concise and these documents DO NOT provide that at all. NONE of this satisfies informed consent.
And let's just ignore that fact that...
quote:
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;
I mean what f-ing idiot could possibly come to the conclusion that Pfizer BioNTech COVID-19 vaccine is not FDA Approved? I am such a dumbass ...
Posted on 9/27/21 at 8:17 am to mooseofterror
quote:
INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS
As the vaccination provider, you must communicate to the recipient or their
caregiver, information consistent with the “Vaccine Information Fact Sheet for
Recipients and Caregivers” (and provide a copy or direct the individual to the
website www.cvdvaccine.com to obtain the Vaccine Information Fact Sheet) prior to
the individual receiving each dose of Pfizer-BioNTech COVID-19 Vaccine,
including:
• FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19
Vaccine, which is not an FDA-approved vaccine.
• The recipient or their caregiver has the option to accept or refuse
Pfizer-BioNTech COVID-19 Vaccine.
• The significant known and potential risks and benefits of Pfizer-BioNTech
COVID-19 Vaccine, and the extent to which such risks and benefits are
unknown.
• Information about available alternative vaccines and the risks and benefits of
those alternatives
FDA doc
FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE
(VACCINATION PROVIDERS) DATED 22 September 2021
Page 11
Let's break out those crayons
This post was edited on 9/27/21 at 8:20 am
Posted on 9/27/21 at 8:21 am to mooseofterror
quote:
MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE
ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION3
In order to mitigate the risks of using this unapproved product under EUA and to
optimize the potential benefit of Pfizer-BioNTech COVID-19 Vaccine, the following
items are required. Use of unapproved Pfizer-BioNTech COVID-19 Vaccine for
active immunization to prevent COVID-19 under this EUA is limited to the following
(all requirements must be met):
1. Pfizer-BioNTech COVID-19 Vaccine is authorized for use in individuals
12 years of age and older.
Also Page 11 of the above mentioned document
This post was edited on 9/27/21 at 8:22 am
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