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

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/pfizer-biontech-covid-19-vaccine-frequently-asked-questions

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

https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine#comirnaty

Pfi*zer Bio*ntech Fact sheet

https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine#additional

Fact sheet Translation

https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine

https://www.stopworldcontrol.com/downloads/en/vaccines/vaccinereport.pdf