Posted on 08/23/2021 3:28:09 PM PDT by Enlightened1
What is going on here?
Are we being lied to?
Specifically check page 2 and page 12.
Page 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. In addition, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to provide updates on expiration dating of the authorized Pfizer-BioNTech COVID-19 Vaccine and to update language regarding warnings and precautions related to myocarditis and pericarditis. The Fact Sheet for Recipients and Caregivers was updated as the Vaccine Information Fact Sheet for Recipients and Caregivers, which comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine and information about the FDA-licensed vaccine, COMIRNATY (COVID19 Vaccine, mRNA).
page 12: 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.
https://www.fda.gov/media/150386/download
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.
Exactly. They had to re-auth and rewrite the EAU due to the approval of the shot in certain cases, 16+ etc. Separation of use cases.
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
That is correct. It is licensed for over 16 and fully approved. It can’t have a trade name without official licensing. The EUA was extended for 12-16 and I think the booster is EUA
But we now have a fully licensed vaccine thanks to president trump.
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.
page 12: 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.
Everything after the first paragraph on page 2, is strictly for the EUA, even though they use the term “this product” and it is the same product as now approved for 16+.
Yeah, they could have worded it better.
So with this approval does that open up the pharma company to liability now for harm caused by the “FDA approved vaccine”?
I bet not.
The good news is you’ll still be able to use the “experimental treatment” line. For 12-15-year-olds.
Oh, but it fits the narrative, and that's what is important.
Right - legally the APPROVED Covid vaccine from Pfizer is now called “COMIRNATY” - and that will have no black box warnings on it about non-approved use.
For those under 16 and taking a third booster shot - they’ll be using the off-brand Pfizer Covid-19 vaccine (which in theory is still the same as COMIRNATY but has different distributions and legal bounds) - but it’s use still falls under EUA and the offbrand packaging (which will still be made) must carry the warning.
If anyone wants the vaccine, fine by me.
Want to wear a mask, fine by me.
I have zero comorbidities and will not be taking the shot.
I don’t think approval is a good thing. No vaccine has ever been approved anywhere near this fast, and it’s a new technology.
My biggest concern now is mandated vaccines. Weeks/months ago you stated it wouldn’t become mandatory. Well, here we are...
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.