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Started By
Message
re: No FDA Approved Covid 19 shot is available
Posted on 10/12/21 at 10:05 am to Indefatigable
Posted on 10/12/21 at 10:05 am to Indefatigable
page 1
quote:
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use
Authorization (EUA) to permit the emergency use of the unapproved product,
Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent
COVID-19 in individuals 12 years of age and older. Pfizer-BioNTech COVID-19
Vaccine is authorized for use to provide:
• a two-dose primary series in individuals 12 years of age and older;
2
Posted on 10/12/21 at 10:07 am to Robin Masters
page 37 how to report adverse reactions...
quote:
The following steps are highlighted to provide the necessary information for safety tracking:
1. In Box 17, provide information on Pfizer-BioNTech COVID-19 Vaccine and any other vaccines
administered on the same day; and in Box 22, provide information on any other vaccines received within
one month prior.
2. In Box 18, description of the event:
a. Write “Pfizer-BioNTech COVID-19 Vaccine EUA” as the first line.
b. Provide a detailed report of vaccine administration error and/or adverse event. It is important to
provide detailed information regarding the patient and adverse event/medication error for
ongoing safety evaluation of this unapproved vaccine. Please see information to include listed
above.
Posted on 10/12/21 at 10:07 am to Robin Masters
quote:
Fda website clearly states Pfizer bionet has EUA.
You are either really dumb, or willfully ignoring any reasonable evidence you don't like.
Posted on 10/12/21 at 10:07 am to mooseofterror
I am aware. I referenced that fact in the immediately preceding post...
Pfizer got an extension of the EUA, and full approval under a trade name. It is not complicated.
Pfizer got an extension of the EUA, and full approval under a trade name. It is not complicated.
Posted on 10/12/21 at 10:08 am to mooseofterror
Funny how many here will read that and think it means it’s fda approved and then claim we are conspiracy theorists for taking it to mean exactly what it says.
Clown world.
Clown world.
Posted on 10/12/21 at 10:09 am to mooseofterror
EUA reissued - dated 22 Sept 2021
page 13
page 13
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; and
Posted on 10/12/21 at 10:10 am to Fun Bunch
quote:
You are either really dumb, or willfully ignoring any reasonable evidence you don't like.
The fda explicitly says it is EUA. At no point do they say it’s fda approved. The evidence couldn’t be more clear.
Posted on 10/12/21 at 10:10 am to Robin Masters
quote:
Funny how many here will read that and think it means it’s fda approved and then claim we are conspiracy theorists for taking it to mean exactly what it says.
You guys keep thinking you really are on to something here. It isn't complicated, there is no conspiracy, and there is no significance whatsoever to the differing labels. But keep on keeping on I guess.
This post was edited on 10/12/21 at 10:11 am
Posted on 10/12/21 at 10:10 am to Robin Masters
quote:
The evidence couldn’t be more clear.
And yet, you are wrong. The two are not mutually exclusive, and yet you just want to keep believing.
This post was edited on 10/12/21 at 10:12 am
Posted on 10/12/21 at 10:11 am to Pelican fan99
look mate the issue is pretty confusing
If you get a shot the point is what is labeled is important from a legal stand point
Right now COMIRNATY is approved
but none of the vials have COMIRNATY labels
So whether COMIRNATY/Pfizer are the same, which they are apparently
The FDA approved for 16 and up to get the COMIRNATY shot
Those vials with those FDA approved labels are currently not avaiable
that is the vaccine producers fault
If you get a shot the point is what is labeled is important from a legal stand point
Right now COMIRNATY is approved
but none of the vials have COMIRNATY labels
So whether COMIRNATY/Pfizer are the same, which they are apparently
The FDA approved for 16 and up to get the COMIRNATY shot
Those vials with those FDA approved labels are currently not avaiable
that is the vaccine producers fault
Posted on 10/12/21 at 10:11 am to SirWinston
quote:
I’m starting to believe this is true.
When you are lied to repeatedly, research shows that you may come to believe the lie to be true based solely upon the fact that it is repeated consistently.
The Phizer COVID vaccine is approved.
Right wingers are just repeating a lie.
Edit: the only emergency use authorization is for people between 12-15, as a booster shot, and in one or two other special circumstances. For adults 1- and up as a two shot vaccine, it is fully approved.
This post was edited on 10/12/21 at 10:19 am
Posted on 10/12/21 at 10:12 am to Mbeloso
quote:
If you get a shot the point is what is labeled is important from a legal stand point
No it isn't.
Posted on 10/12/21 at 10:16 am to Pelican fan99
quote:
Are we still pretending this is actually a thing?
It is a thing because of how FDA approval works. If it doesn't have the Comirnty label on it, it is not FDA approved. They dont just approve a product. They approve specific product production lines within facilities and their batch quality testing reports. Any vial coming out with a Pfizer/biontech production line is not FDA approved and has not provided the required quality testing.
Posted on 10/12/21 at 10:17 am to mooseofterror
Footnote 10
quote:
The
products are legally distinct with certain differences
Posted on 10/12/21 at 10:31 am to NC_Tigah
quote:
They did.
You sure?
How do you square this circle with our patients?
This post was edited on 10/12/21 at 10:44 am
Posted on 10/12/21 at 10:43 am to Fun Bunch
quote:
You are either really dumb, or willfully ignoring any reasonable evidence you don't like.
It is you that is slow or willfully going through hoops to pretend Pfizer-BioNTech is FDA approved when the FDA says exactly the opposite. I'll quote the FDA again:
quote:
FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine, which is not an FDA-approved vaccine.
And again:
quote:
FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine, which is not an FDA-approved vaccine.
And just so there is no confusion let's define the word "not": a word used to express negation, prohibition, denial, or refusal.
Do I have to define anymore terms to so youn understand what the FDA is saying?
Again:
quote:
FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine, which is not an FDA-approved vaccine.
Posted on 10/12/21 at 10:43 am to GumboPot
quote:
How to you square this circle with our patients?
If it were me, I'd provide the patients the updated information available obtained via the website included in your post.
Updated Information to Provide Vaccine recipients
Posted on 10/12/21 at 10:47 am to CajunTiger92
Which clearly states the bionet is only EUA.
I can use use OEM ignition coils or cheap Chinese knock-offs interchangeably on my car.
Doesn’t mean they are all OEM.
I can use use OEM ignition coils or cheap Chinese knock-offs interchangeably on my car.
Doesn’t mean they are all OEM.
Posted on 10/12/21 at 10:55 am to CajunTiger92
quote:
If it were me, I'd provide the patients the updated information available obtained via the website included in your post.
Updated Information to Provide Vaccine recipients
Good. At least patients can get fully disclosed of the fact that Pfizer-BioNTech is still under EUA. Note that is a Pfizer document and not an FDA document. From that document, last paragraph:
quote:
This EUA for the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY will end when the Secretary of HHS determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed.
What is now confusing is the Pfizer has made a statement here that not only Pfizer-BioNTech is under EUA but COMIRNATY as well.
Posted on 10/12/21 at 10:59 am to Robin Masters
quote:
Which clearly states the bionet is only EUA.
It also states the following:
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.
and
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
If you are against the vaccine mandate, which I am, I don't think the argument that the vaccine isn't approved is a good one to make.
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