BREAKING: FDA is pushing to "Fully Approve" Pfizer COVID19 "Vaccine" on Monday August 23rd

ddjd

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I don't think it has been fully approved. The EUA has simply been extended for the 4th or 5th time. They list all the prior EUA dates in the PDF below. I don't see anywhere in the PDF discussion that the vaccine has full approval for 16+ old individuals while remaining EUA for 12-16 age groups. It seems pretty clear to me that the current "authorization" for 16+ age is still under EUA. The only true "authorization" seems to apply to now allowing the trade name of the vaccine (Comirnaty) to be used in public. One of the giveaways, aside from the direct statements, is the last sentence from the quote below. It continues to talk about lack of alternatives to the vaccine as a reason for the "authorization". This is only applicable under EUA. When it comes to full approval, the lack of alternative treatments would not matter as a reason. If anybody has a different understanding/information please chime in, but it seems to me FDA simply extended the EUA.
@Regina @boris @Giraffe @Zpol @J.R.K @sweetpeat @achillea @DrJ

"...Page 1 Paragraph One: On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act or the Act), the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes Coronavirus Disease 2019 (COVID-19). 1 On the basis of such determination, the Secretary of HHS on March 27, 2020, declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to Section 564 of the Act (21 U.S.C. 360bbb-3), subject to terms of any authorization issued under that section.2
Page 2 Paragraph Two: 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.

Page 4 Paragraph Four: Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19, as described in the Scope of Authorization section of this letter (Section II) and subject to the terms of this authorization. Additionally, as specified in subsection III.BB, I am authorizing use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA when used to provide a two-dose regimen for individuals aged 12 through 15 years, or Page 5 – Pfizer Inc. 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.

Page 5 - I. Criteria for Issuance of Authorization I have concluded that the emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19 when administered as described in the Scope of Authorization (Section II) meets the criteria for issuance of an authorization under Section 564(c) of the Act, because: A. SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus; B. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that Pfizer-BioNTech COVID‑19 Vaccine may be effective in preventing COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of Pfizer-BioNTech COVID‑19 Vaccine when used to prevent COVID-19 outweigh its known and potential risks; and C. There is no adequate, approved, and available9 alternative to the emergency use of Pfizer-BioNTech COVID‑19 Vaccine to prevent COVID-19."

View: https://twitter.com/JikkyKjj/status/1487263382340513794?t=mh5T0CjnEJ0CFbGflTvyOA&s=19
 
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