Pfzier Jabberwocki Approved
Pfzier Jabberwocki Approved
Comirnaty and Pf*izer-Bio*NT*ech C O V Vaxxine
August 23, 2021:
FDA approves Comirnaty
(C O V Vaxxine, m*RNA),
which was previously known as P*fizer-Bio*NTe*ch C O V Vaxxine,
for the prevention of C O V disease in individuals 16 years of age and older.
On August 23, 2021, the FDA approved the first C O V vaxxine.
The vaccine has been known as the Pf*izer-Bi*oNTech C O V Vaxxine,
and will now be marketed as Comirnaty, for the prevention of C O V disease in individuals 16 years of age and older.
The va**ine also continues to be available under emergency use authorization (EUA),
including for individuals 12 through 15 years of age and for the
administration of a third dose in certain immunocompromised individuals.
Package insert
https://www.fda.gov/media/151707/download
Summary basis for regulatory action
https://www.fda.gov/media/151733/download
Approval letter
https://www.fda.gov/media/151710/download
FAQ for Comirnaty (C O V Vaxxine mR*NA)
https://www.fda.gov/vaccines-blood-biologics/qa-comirnaty-covid-19-vaccine-mrna
Fact Sheet for Healthcare Providers Administering Va**ine
https://www.fda.gov/media/144413/download
Fact Sheet for Recipients and Caregivers
https://www.fda.gov/media/144414/download
Frequently Asked Questions on the Pf*izer-Bio*NT*ech C O V Va**ine
Letter of Authorization (Reissued) August 23, 2021
https://www.fda.gov/media/150386/download
Concurrence Letter August 22, 2021
https://www.fda.gov/media/151731/download
Decision Memorandum August 12, 2021
https://www.fda.gov/media/151613/download
Letter Granting EUA Amendment May 19, 2021
https://www.fda.gov/media/148877/download
FDA Decision Memorandum May 10, 2021
https://www.fda.gov/media/148542/download
Letter Granting EUA Amendment April 6, 2021
https://www.fda.gov/media/147390/download
Letter Granting EUA Amendment January 22, 2021
https://www.fda.gov/media/145493/download
Letter Granting EUA Amendment January 6, 2021
https://www.fda.gov/media/144955/download
FDA Decision Memorandum December 11, 2020
https://www.fda.gov/media/144416/download
Advisory Committee Meeting Information December 10, 2020
Comirnaty Prescribing Information
Pfi*zer Bio*ntech Fact sheet
Fact sheet Translation
https://www.stopworldcontrol.com/downloads/en/vaccines/vaccinereport.pdf
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