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To: MtnClimber
oday, 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. https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
They are one in the same. No bait and switch.(The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty)as per above. The FDA approved the Pfizer vax for 16+ and that vax has been given a marketing name, Comirnaty. At the same time, they had to revise and re-authorize the EUA usage for 12-15 year olds.
Page 2 para 1 - On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.
Merely reiterating the above announcement but notice the use of biologics license application (BLA)
Page 2 para 2 - On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA. https://www.fda.gov/media/150386/download
Simply states that the EUA is being revised and renewed for certain uses that are not included in the approved BLA

There is some fine print that's oddly worded but that could just be a matter of being written by a young flunky

9 posted on 08/27/2021 5:28:38 AM PDT by Pollard (#*&% Communism)
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To: Pollard

So if I go to get my jab today and say, give me the one that’s been fully approved by the FDA, what will they give me?


11 posted on 08/27/2021 5:50:00 AM PDT by Toad of Toad Hall (nunquam minus solus quam cum solus)
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To: Pollard

My understanding was that the existing doses will be used up under the EUA, and that new doses will fall under the “ full approval”.

https://www.rwmalonemd.com/s/Key-points-to-consider-FDA-letters-and-press-release.pdf

Interesting that since this was written the 8 month boosters became six month boosters.


19 posted on 08/27/2021 6:45:10 AM PDT by dynoman (Objectivity is the essence of intelligence. - Marilyn vos Savant)
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To: Pollard

The switcheroo is not so much about the contents/safety/efficacy of the vaccine, but the legal status.

The current Pfizer vaccine is authorized under EUA and is free from liability. The Comirnaty (Pfizer-BioNTech) vaccine will be fully licensed and not immune from liability.

So....the media is saying that the Pfizer vaccine is fully approved so that people can feel better about getting the jab. However, they’ll be getting it under the EUA and will not have any recourse if injured.

Comirnaty won’t be available for many months if not a year or more, meaning that the vast majority of Americans will receive the vaccine under the EUA and have no legal recourse, but thanks to the media they will be under the impression that they are taking a approved vaccine.

Bait and Switch with cover provided by our government and media.

Also consider that this approval was still fast tracked with several steps being skipped in the normal process. Public commentary being one, where the FDA suggested there was no controversy over the vaccine, so no need for public comment. SURE.

Take all in to consideration before becoming a test monkey.


20 posted on 08/27/2021 7:25:17 AM PDT by Andrewksu
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To: Pollard

The switcheroo is not so much about the contents/safety/efficacy of the vaccine, but the legal status.

The current Pfizer vaccine is authorized under EUA and is free from liability. The Comirnaty (Pfizer-BioNTech) vaccine will be fully licensed and not immune from liability.

So....the media is saying that the Pfizer vaccine is fully approved so that people can feel better about getting the jab. However, they’ll be getting it under the EUA and will not have any recourse if injured.

Comirnaty won’t be available for many months if not a year or more, meaning that the vast majority of Americans will receive the vaccine under the EUA and have no legal recourse, but thanks to the media they will be under the impression that they are taking a approved vaccine.

Bait and Switch with cover provided by our government and media.

Also consider that this approval was still fast tracked with several steps being skipped in the normal process. Public commentary being one, where the FDA suggested there was no controversy over the vaccine, so no need for public comment. SURE.

Take all in to consideration before becoming a test monkey.


21 posted on 08/27/2021 7:25:20 AM PDT by Andrewksu
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