Pfizer Documents (PHMPT/FDA)
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· 9 pages
1 Revised: 20 October 2021VACCINE INFORMA TION FACT SHEET FOR REC IPIENTS AND CA REGIVERS ABOUT COMIRNA TY (COVID -19 VA CCINE, mRNA ) ANDPFIZER -BIONTECH COVID -19 VACCINE TO PREVENT CORONA VIRUS DISEA SE 2019 (COVID -19) You are being offered either COMIRNA TY (COVID -19 Vaccine, mRNA ) or the Pfizer-BioNTech COVID- 19 Vaccine to prevent Coronavirus Disease 2019 (COVID -19)caused by S ARS -CoV-2. This Vaccine Information Fact Sheet for Recipients and Caregivers comprises the Fact Sheet…
Pfizer Documents (PHMPT/FDA)
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· 162 pages
Page 1 of 162 ***Confidential*** Header Text: C4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai Subject No: 12041078 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 13:11 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,…
Pfizer Documents (PHMPT/FDA)
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· 47 pages
Revised: 2 0October 2021 1FACT SHEET FOR HEA LTHCA RE PROVIDERS A DMINISTERING VA CCINE (VACCINA TION PROVIDERS) EMERGENCY USE AUTHORIZA TION (EUA) OF THE PFIZER -BIONTECH COVID -19 VA CCINE TO PREVENT CORONA VIRUS DISEA SE 2019 (COVID -19) The U.S. Food and Drug A dministration (FDA ) has issued an Emergency Use Authorization (EUA ) to permit the emergency use of the unapproved product, Pfizer-BioNTech COVID- 19 Vaccine , for active immunization to prevent COVID -19 in ind ividuals…
Pfizer Documents (PHMPT/FDA)
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· 8 pages
1 Revised: 22September 2021VACCINE INFORMA TION FACT SHEET FOR REC IPIENTS AND CA REGIVERS ABOUT COMIRNA TY (COVID -19 VA CCINE, mRNA ) ANDPFIZER -BIONTECH COVID -19 VACCINE TO PREVENT CORONA VIRUS DISEA SE 2019 (COVID -19) You are being offered either COMIRNA TY (COVID -19 Vaccine, mRNA ) or the Pfizer-BioNTech COVID- 19 Vaccine to prevent Coronavirus Disease 2019 (COVID -19)caused by S ARS -CoV-2. This Vaccine Information Fact Sheet for Recipients and Caregivers comprises the Fact Sheet…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 48 pages
Revised: 22 September 2021 1 FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION PROVIDERS) EMERGENCY USE AUTHORIZATION (EUA) OF THE PFIZER -BIONTECH COVID- 19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID -19) The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer -BioNTech COVID- 19 Vaccine, for active immunization to prevent COVID -19 in individuals 12…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 16 pages
Drives to http:// labeling.pfizer.com/ ShowLabeling.aspx? id=14471&format=pdf Drives to pg 2 Tray remains consistent on every page of website URL Flat annotations are provided at first mention FDA-CBER-2021-5683-0951699 Upon hovering, the pop up on pg 3 will appear FDA-CBER-2021-5683-0951700 FDA-CBER-2021-5683-0951701 Opens tray (see following page) FDA-CBER-2021-5683-0951702 Drives to: http:// labeling.pfizer.co m/ ShowLabeling.a spx? id=14472&forma t=pdf Drives to: http://…
Pfizer Documents (PHMPT/FDA)
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· 2 pages
FDA-CBER-2021 5683 0951715 Digitally signed by DN o=Pfizer Inc cn Reason I am signing on behalf of Donna Boyce Location Date 2021.09.26 09 33 27 0800' (b) (6) (b) (6) (b) (6) (b) (6) FDA-CBER-2021-5683-0951716
Pfizer Documents (PHMPT/FDA)
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· 20 pages
1HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use COMI RNATY safely and effectively. See full prescribing information for COMIRNATY . COMIRNATY®(COVID -19 Vaccine , mRNA )suspension for injection , for intramuscular use Initial U.S. Approval: 2021 --------------------------- INDICATIONS AND USAGE ---------------------------- COMI RNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVI D-19) caused…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 8 pages
1 Revised: 22September 2021VACCINE INFORMA TION FACT SHEET FOR REC IPIENTS AND CA REGIVERS ABOUT COMIRNA TY (COVID -19 VA CCINE, mRNA ) ANDPFIZER -BIONTECH COVID -19 VACCINE TO PREVENT CORONA VIRUS DISEA SE 2019 (COVID -19) You are being offered either COMIRNA TY (COVID -19 Vaccine, mRNA ) or the Pfizer-BioNTech COVID- 19 Vaccine to prevent Coronavirus Disease 2019 (COVID -19)caused by S ARS -CoV-2. This Vaccine Information Fact Sheet for Recipients and Caregivers comprises the Fact Sheet…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 48 pages
Revised: 22 September 2021 1 FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION PROVIDERS) EMERGENCY USE AUTHORIZATION (EUA) OF THE PFIZER -BIONTECH COVID- 19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID -19) The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer -BioNTech COVID- 19 Vaccine, for active immunization to prevent COVID -19 in individuals 12…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 8 pages
PFIZER COVID -19 vaccine, also known as COMIRNATY® IVR & Live Operator Script Greetings PP-CVV -USA-0426 877-829-2619 (877-VAX -CO19) PP-CVV-USA -0426_Pfizer -BioNTech Covid -19 Vaccine also known as Comirnaty_IVR and Live Operator Script_Greetings Page 1 of 8 Confidential Pfizer document - for internal use only. Reproduction and/or distr bution of this document for any purpose without express written consent from Pfizer is prohibited. 1.0 Live Operator…
Pfizer Documents (PHMPT/FDA)
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· 2 pages
FDA-CBER-2021 5683 0951801 D gi a ly signed by DN c= o Pf zer Inc. ou=PPLS - College lle ou=Submissions and Operations Support cn Reason I am signing on behalf Donna Boyce Location Date 2021 09.28 1 21 31 0 '00' (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) FDA-CBER-2021-5683-0951802
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 20 pages
1HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use COMI RNATY safely and effectively. See full prescribing information for COMIRNATY . COMIRNATY®(COVID -19 Vaccine , mRNA )suspension for injection , for intramuscular use Initial U.S. Approval: 2021 --------------------------- INDICATIONS AND USAGE ---------------------------- COMI RNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVI D-19) caused…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 8 pages
1 Revised: 22September 2021VACCINE INFORMA TION FACT SHEET FOR REC IPIENTS AND CA REGIVERS ABOUT COMIRNA TY (COVID -19 VA CCINE, mRNA ) ANDPFIZER -BIONTECH COVID -19 VACCINE TO PREVENT CORONA VIRUS DISEA SE 2019 (COVID -19) You are being offered either COMIRNA TY (COVID -19 Vaccine, mRNA ) or the Pfizer-BioNTech COVID- 19 Vaccine to prevent Coronavirus Disease 2019 (COVID -19)caused by S ARS -CoV-2. This Vaccine Information Fact Sheet for Recipients and Caregivers comprises the Fact Sheet…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 48 pages
Revised: 22 September 2021 1 FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION PROVIDERS) EMERGENCY USE AUTHORIZATION (EUA) OF THE PFIZER -BIONTECH COVID- 19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID -19) The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer -BioNTech COVID- 19 Vaccine, for active immunization to prevent COVID -19 in individuals 12…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 18 pages
URL Flat annotations are provided at first mention Drives to http:// labeling.pfiz er.com/ ShowLabelin g.aspx? id=14472&fo rmat=pdf Tray remains consistent on every page of website Drives to page 2 FDA-CBER-2021-5683-0951879 Opens tray (see following page) FDA-CBER-2021-5683-0951880 Drives to https:// labeling.pfiz er.com/ ShowLabelin g.aspx? id=15623&fo rmat=pdf Drives to http:// labeling.pfiz er.com/ ShowLabelin g.aspx? id=14471&fo rmat=pdf Drives to: http:// labeling.pfiz…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 2 pages
FDA-CBER-2021 5683 0951897 D gi a ly signed by DN c= Pf zer Inc. ou=PPLS - College lle ou=Submissions and Operations Support cn Reason I am signing on behalf Donna Boyce Location Date 2021 10.01 11 5 17 0 '00' (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) FDA-CBER-2021-5683-0951898
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 20 pages
1HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use COMI RNATY safely and effectively. See full prescribing information for COMIRNATY . COMIRNATY®(COVID -19 Vaccine , mRNA )suspension for injection , for intramuscular use Initial U.S. Approval: 2021 --------------------------- INDICATIONS AND USAGE ---------------------------- COMI RNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVI D-19) caused…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 8 pages
1 Revised: 22September 2021VACCINE INFORMA TION FACT SHEET FOR REC IPIENTS AND CA REGIVERS ABOUT COMIRNA TY (COVID -19 VA CCINE, mRNA ) ANDPFIZER -BIONTECH COVID -19 VACCINE TO PREVENT CORONA VIRUS DISEA SE 2019 (COVID -19) You are being offered either COMIRNA TY (COVID -19 Vaccine, mRNA ) or the Pfizer-BioNTech COVID- 19 Vaccine to prevent Coronavirus Disease 2019 (COVID -19)caused by S ARS -CoV-2. This Vaccine Information Fact Sheet for Recipients and Caregivers comprises the Fact Sheet…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 48 pages
Revised: 22 September 2021 1 FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION PROVIDERS) EM ERGENCY USE AUTHORIZATION (EUA) OF THE PFIZER -BIONTECH COVID- 19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID -19) The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer -BioNTech COVID- 19 Vaccine, for active immunization to prevent COVID -19 in individuals 12…