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562

They Are Lying!!!!!

The FDA Did Not Approve The Covid-19 Vaccine!!!

They Only "REISSUED" The "Emergency Use Authorization" (EUA)

Read Their Own Statement On From Their Site Titled

"Pfizer-BioNTech COVID-19 Vaccine EUA LOA reissued August 23 2021"

https://www.fda.gov/media/150386/download

They Are Lying!!!!! The FDA Did Not Approve The Covid-19 Vaccine!!! They Only "REISSUED" The "Emergency Use Authorization" (EUA) Read Their Own Statement On From Their Site Titled "Pfizer-BioNTech COVID-19 Vaccine EUA LOA reissued August 23 2021" https://www.fda.gov/media/150386/download

(post is archived)

[–] 2 pts (edited )

Now if you can provide the full document of a fully FDA approval Pfizer jab.

Here you go: https://www.fda.gov/media/150386/download Third paragraph in:

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.

This is the approval for BioNTech COVID-19 Vaccine for those over the age of 16 as specified in the biologics license application.

The fourth paragraph notes that all Emergency Use Authorizations given in the August 12th EUA letter that are NOT covered in the BLA are still in effect (note the bolded section below):

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.

The August 12th letter is covered in footnote 7:

In the August 12, 2021 revision, FDA authorized a third dose of the Pfizer-BioNTech COVID-19 Vaccine administered at least 28 days following the two dose regimen of this vaccine in individuals 12 years of age or older who have undergone solid organ transplantation, or individuals 12 years of age or older who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

Section II then clarifies the EUA parts:

This authorization also covers the use of the licensed COMIRNATY (COVID-19 Vaccine, mRNA) product when used to provide a two-dose regimen for individuals aged 12 through 15 years, or to provide a third dose to individuals 12 years of age or older who have undergone solid organ transplantation or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

So the EUA part still in force is for 2 doses for those 12 through 15 and 3 doses for those 12 through 15 following transplant or immunocompromise. Otherwise, according to this letter the vaccine is fully approved for those 16 or older.

[–] 0 pt

That link no longer works. FDA took it down. Hmmm wonder why

[–] 0 pt

Poal fucked up the link formatting, I think. This link works: https://www.fda.gov/media/150386/download

[–] 0 pt

Ya, poal screwed the link up and won't let me fix it (as a link). I had to remove the link markup code and give the plain URL.