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Started By
Message
Anyone take the FDA approved BioNTech (COMIRNATY) vaccine?
Posted on 8/25/21 at 1:17 pm
Posted on 8/25/21 at 1:17 pm
Any side effects?
8
Posted on 8/25/21 at 1:19 pm to GumboPot
NONE
Posted on 8/25/21 at 1:21 pm to GumboPot
I took it in March. Sore arm after shot number 2. Nothing other than that. I monitor my heart activity more than most and my FTP, rowing wattage, running have not changed at all when compared to the past couple years of data.
Posted on 8/25/21 at 1:22 pm to billjamin
quote:
I took it in March
So you volunteered in the test trial group?
Posted on 8/25/21 at 1:24 pm to GumboPot
Posted on 8/25/21 at 1:24 pm to GumboPot
quote:
So you volunteered in the test trial group?
No I got it after it was made available under to EUA. And it was late March for shot #1 and Mid April for shot #2.
Posted on 8/25/21 at 1:25 pm to GumboPot
I am in-between doses. Had a sore arm after my first dose, but that was it. I get my second shot Monday.
Posted on 8/25/21 at 1:25 pm to GumboPot
quote:Can't remember. Are you in the none of your business camp or everyone needs to vaccinate group?
GumboPot
Posted on 8/25/21 at 1:26 pm to billjamin
quote:
No I got it after it was made available under to EUA. And it was late March for shot #1 and Mid April for shot #2.
He is trying to make the incorrect point that this is not the same vaccine as what has generally been called Pfizer since last year.
Posted on 8/25/21 at 1:27 pm to Bunk Moreland
I think that's just the name they gave it. Like Viagra is the commercial name.
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-covid-19-vaccine-comirnatyr-receives-full
quote:
COMIRNATY is the first COVID-19 vaccine to be granted approval by the FDA. The vaccine has been available in the U.S. under Emergency Use Authorization (EUA) since December 11, 2020 (as the Pfizer-BioNTech COVID-19 Vaccine)
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-covid-19-vaccine-comirnatyr-receives-full
Posted on 8/25/21 at 1:28 pm to Bunk Moreland
quote:
The FDA handout I got for Pfizer/Biontech
in April/May said nothing about Comirnaty.
Comirnaty is the trade name of the vaccines just live Viagra or Aleve. Until a drug has FDA approval it can not be advertised so there is no need for a trade name. There is ZERO slight of hand it is just the product name.
Posted on 8/25/21 at 1:29 pm to Bunk Moreland
quote:
The FDA handout I got for Pfizer/Biontech
in April/May said nothing about Comirnaty. Now, that's what I see on FDA's website.
I think now that it has full FDA approval they can give the vaccine its official brand name, which is Comirnaty. I don't think they can do that before they get full approval.
Posted on 8/25/21 at 1:30 pm to Roll Tide Ravens
Thanks, guys. I'll take off the tinfoil hat for now.
Posted on 8/25/21 at 1:30 pm to Bunk Moreland
quote:
I posted in another thread that I don't understand this slight of hand. The FDA handout I got for Pfizer/Biontech
in April/May said nothing about Comirnaty. Now, that's what I see on FDA's website.
Pharma products rarely get a marketing name until right before approval. In clinical trials, pharma products are generally referred to by their compound name and not their marketing name. Approval includes the marketing name and the associated marketing materials.
No slight of hand, truly just part of the process.
Edit: I see the question was correctly answered as I was typing my response.
This post was edited on 8/25/21 at 1:32 pm
Posted on 8/25/21 at 1:33 pm to Obtuse1
quote:
He is trying to make the incorrect point that this is not the same vaccine as what has generally been called Pfizer since last year.
I thought that's where he might be going, but was willing to play along and let the hole get deeper.This post was edited on 8/25/21 at 1:37 pm
Posted on 8/25/21 at 1:36 pm to billjamin
quote:
thought that's where he might be going, but was willing t play along and let the hole get deeper.
Hes been trying to make this argument for 2 days and refuses to accept that he is a moron
Posted on 8/25/21 at 1:37 pm to Cosmo
Posted on 8/25/21 at 1:38 pm to Roll Tide Ravens
quote:
I think now that it has full FDA approval they can give the vaccine its official brand name, which is Comirnaty. I don't think they can do that before they get full approval.
They can't use it before approval because the trade name of all drugs have to be approved by the FDA. For example they won't approve a name that is so similar to another drugs name that it could cause confusion.
Posted on 8/25/21 at 1:40 pm to Bunk Moreland
That was actually a good link that clears up a lot of confusion.
Footnote 1:
So it looks like two separate legal entities.
FDA-approved COMIRNATY and the Pfizer-BioNTech under EUA.
Both are physically the same but legally different.
Essentially the Pfizer vaccine can be both approved and have EUA.
Approved to meet the political demands of politicians wanting mandates and legally under EUA to provide legal immunity from injury lability.
quote:
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.[1]
Footnote 1:
quote:
[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.
So it looks like two separate legal entities.
FDA-approved COMIRNATY and the Pfizer-BioNTech under EUA.
Both are physically the same but legally different.
Essentially the Pfizer vaccine can be both approved and have EUA.
Approved to meet the political demands of politicians wanting mandates and legally under EUA to provide legal immunity from injury lability.
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