Today’s FDA letter explains that they are only revising the original scope of authorization to add the Comirnaty shot. No where does it say any shot has been granted approval now...
This is as of today. What’s going on here?
My understanding is full approval for 16 y/o and over.
The EUA has been extended for 12 - 15, and for the booster shot.
Are we being lied to? The most rhetorical question of all time.
Dude, you need to learn how to read.
The EUA was extended for 12-15 year olds and for third doses.
It was granted full approval for 16+.
Here is the actual approval:
https://www.fda.gov/media/151710/download
Cutting and pasting sentences out of context from a press release doesn’t change what happened.
I don’t like it, but it is what it is.
Conditions Related to Printed Matter, Advertising, and Promotion
All descriptive matter advertising,and promotional material,relating to the use of the Pfizer-BioNTech COVID‐19 Vaccine shall be consistent with the authorized labeling, as well as the terms set forth in this EUA, and meet the requirements set forth in section 502(a) and (n) of the FD&C Act and FDA implementing regulations.
Y. All descriptive material pertaining to advertising,and promotional use of the Pfizer-BioNTech COVID‐19 Vaccine clearly and conspicuously shall state that:
Page 12 – Pfizer Inc.
• 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
• The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner
BLA(biologics license application) approved for 16+ years old
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.
Re-authorizing and revising the EUA for "uses that are not included in the approved BLA"
If only it was a lie. They are really approving an experimental treatment with less than a year safety study (on human ferrets). Still experimental for 12 year olds I guess.
The good news is you’ll still be able to use the “experimental treatment” line. For 12-15-year-olds.
Same product under two different names. One is approved, the other is not.
EUA was extended to allow ages 12-16 to continue.
You are posting a link to an EUA for 12-15 year olds and vaccine produced prior to full approval.
Here is the actual FDA Approval
https://www.fda.gov/media/151710/download
This misinformation has been posted on numerous threads.
Go back and read it again. Ask a lawyer friend to help you if the terms are confusing.
The FDA issued full approval for 16 and up as of today.
Here is the actual text.
“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.”
The BLA is the full approval licence. It’s a done deal for all people 16 years of age and over.
The second part is the extension of the EUA for children 12 and up and also the continued authorization to test and then approve for us via the secondary EUA that was extended for children younger than 12.
Page 6 - Pfizer Inc.:
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 yes, it does look like we are being lied to. Good catch.
A revision of the EUA to include a 3rd dose for immunocompromised individuals....full approval still ongoing.
“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.”, (and other revisions).
Approved and with an EUA for young people.
Maybe try another line of work. Gaslighting, it’s not good.
Typical government flim flam.
Bmk
extension eua renewed august 2021 signed by denise hint RADM fda chief scientist
https://www.thefemword.world/her-story/a-talk-with-radm-denise-hinton-fda-chief-scientist
.................................
guess who signed revocation of hydroxycholorquine eua..
https://www.fda.gov/media/138945/download
.....................................
Memorandum Explaining Basis for Revocation of Emergency Use Authorization for
Emergency Use of Chloroquine Phosphate and Hydroxychloroquine Sulfate
https://www.fda.gov/media/138945/download
https://www.fda.gov/media/138946/download