For the reading and critical thinking impaired:
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.
That is the Emergency Use Authorization for the third vaxxine shot for the immunocompromised and special case authorization. The new authorization for EUA is towards the same immunocompromised population with new indications for some adverse effects.
Today's statement and authorization:
Full authorization for use
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.
Continued reissue of EUA for third booster from August 12, 2021
For the August 12, 2021 authorization of a third dose of the Pfizer-BioNTech COVID-19
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, FDA reviewed safety and effectiveness data reported in two manuscripts on solid organ transplant recipients.
The re-authorization is still for the third booster for the same immunocompromised population plus solid organ transplant recipients. The 'vaxxine' was authorized separate from this third booster EUA. The document is NOT saying what you want it to say. It is only reinforcing the previous EUA for a specific indication not specified under the full Pfizer FDA authorization (namely the third booster shot). Like it or not, the jew jab was fully and foolishly authorized. And yes, Biden is still your president even though he's a complete Deep State piece of shit. Sorry, this had to be said. Now buckle up buttercup, the rides about to get real bumpy.
Did you read the whole thing? According to this document. The jab is still only approved for emergency use. And it's not the 3rd booster.
Now if you can provide the full document of a fully FDA approval Pfizer jab. That is not just approved for Emergency use. That would be very helpful to us all. As well all what the truth. But as of this document it's saying it's only approved for emergency use.
I did read the whole document. That's why I know that it says both that the jab was approved for general use in non-immunocompromised populations AND has a renewed EUA for the third booster in immunocompromised populations. The authorizations differ based on which population is getting the jab and for which purpose.
This document IS the approval of the jab and it should be helpful to you if you actually READ it and not just interpret it to say what you want it to say based on some random person posting this in a Q forum. You must not be familiar with this kind of medical document because you aren't understanding what it is saying. It doesn't matter though since the government is saying it is FULLY approved now and will start enacting mandates as such. They don't give a rats ass what you interpret this as. They will still move forward with this and the courts will back them up. No one is going to save you and you won't stand a chance in fighting this legally. Get it now?
Q has nothing to do with this. And your opinion of it saying it is fully approved is your opinion of what you believe it says Point out where it says this is for the 3rd booster. Point out where it says that Pfizer says it's fully licensed approved. It's not in this document
Which page says it’s fully authorized for general use? I did some hardcore skimming and everything seemed to be sprinkled with “emergency use” language, but I’m trying to be a second opinion here if you can show me.
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.
That link no longer works. FDA took it down. Hmmm wonder why
Wrong Buddy.
I'm sorry if the repeat sticky notification is annoying. I'm fumbling today.
Thank you for setting the record straight. I'm tired of seeing this bullshit claim it's only the EUA.
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