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To: TexasGurl24

“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.”

It’s been FDA approved for emergency use. And has NOT been FDA approved for a 3rd dose except for those “who have undergone solid organ transplantation or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.”


151 posted on 08/23/2021 12:59:45 PM PDT by nuconvert ( Warning: Accused of being a radical militarist. Approach with caution.)
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To: nuconvert

The reissued the EUA for 12-15 year olds. Full approval for those 16 and older. It’s as clear as day in the letter. I don’t like it, but it is there.


159 posted on 08/23/2021 1:47:27 PM PDT by TexasGurl24
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