QRD

The Pfizer jab is fully FDA approved and IS NOT still only under EUA. It has EUA for use as a third (booster) shot, and for children between ages 12-15. There is some confusion about the reference to the approved BLA in the EUA revision dated August 23, 2021.

The Full Run-Down

What is Comirnaty?

It is the same shot as Pfizer-BioNTech with a different name. The Pfizer shot has the active ingredient BNT162b2. This is the same active ingredient in Comirnaty.

For all intents and purposes, Pfizer-BioNTech and Comirnaty are interchangeable.

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What is FDA approved?

The active component in the Pfizer mRNA shot (BNT162b2) has been fully FDA approved and marketed under the name Comirnaty:

COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.

• It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older

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What did the August 12, 2021 EUA authorize?

The jab as a third (booster) shot and for children aged 12-15.

The authorizations for these vaccines have been amended to allow for an additional, or third, dose to be administered at least 28 days following the two-dose regimen of the same vaccine to individuals 18 years of age or older (ages 12 or older for Pfizer-BioNTech) who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

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What did the August 23, 2021 EUA revision authorize?

It added Comirnaty (the FDA approved jab) as a third (booster) shot and for children aged 12-15.

• It is also authorized under Emergency Use Authorization (EUA) to be administered for emergency use to:
  • prevent COVID-19 in individuals 12 through 15 years, and
  • provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise

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