125742 S131 M1 2253
FDA-CBER-2021 5683 0952143 Digitally signed by DN o=Pfizer Inc cn Reason I am signing on behalf of Donna Boyce Location Date 2021.10.09 09 23 0 0800' (b) (6) (b) (6) (b) (6) (b) (6) FDA-CBER-2021-5683-0952144
Pfizer Documents (PHMPT/FDA)
The court-ordered FDA release of Pfizer's COVID-19 vaccine BLA submission (~450K pages across 4 sub-collections), mirrored from PHMPT.org. Searchable with AI explain.
🧠 Ask this record
Get an AI answer drawn only from the Pfizer Documents (PHMPT/FDA) documents indexed here — every claim cited back to the filing or proceeding it came from. It will tell you plainly when the record doesn't cover your question, rather than guessing.
125742 S131 M1 lab 1448 1 0
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…
125742 S131 M1 lab 1451 10 0
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…
125742 S131 M1 lab 1457 14 0
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…
125742 S131 M1 pp cvv usa 0391
THERMAL SHIPPING CONTAINER DRY ICE REPLENISHMENT INSTRUCTIONS Pfizer-BioNTech COVID-19 Vaccine, also known as COMIRNATY® (COVID-19 Vaccine, mRNA)* Please see Important Safety Information and Indication & Authorized Use on pages 5 and 6. Before administration of the vaccine, please see full Prescribing Information (16+ years of age), EUA Fact Sheet for Vaccination Providers (12+ years of age), and Recipients and Caregivers Fact Sheet (12+ years of age).* The licensed COMIRNATY®…
125742 S131 M1 pp cvv usa 0431
GLOBAL: Drives to http://labeling.pfizer.com/ShowLabeling.aspx?id=15623 GLOBAL Drives to http://labeling.pfizer.com/ ShowLabeling.aspx?id=14471&format=pdf GLOBAL Drives to http:// labeling.pfizer.com/ ShowLabeling.aspx? id=14472&format=pdf…
125742 S131 M1 pp cvv usa 0432
for storage, handling, and preparation of the Pfizer-BioNTech COVID-19 Vaccine, also known as COMIRNATY® (COVID-19 Vaccine, mRNA)*CHECKLIST 1 of 5Please see Important Safety Information and Indication & Authorized Use on pages 4 and 5. Before administration of the vaccine, please see full Prescribing Information (16+ years of age), EUA Fact Sheet for Vaccination Providers (12+ years of age), and Recipients and Caregivers Fact Sheet (12+ years of age).Selected Safety Information Known…
125742 S136 M1 cover
PFIZER CONFIDENTIAL Page 1Global Regulatory Affairs - Vaccines Pfizer Inc. 235 East 42nd Street New York, NY 10017 Global Product Developm ent 15 October 2021THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE SECRET INFORMATION THAT IS DISCLOSED ONL Y IN CONNECTION WITH THE LICENSING AND/OR REGI STRATION OF PRODUCTS FOR PFIZER INC OR ITS AFFILIATED COMPANIES. THIS DOCUMENT SHOULD NOT BE DISCLOSED OR USED, I N WHOLE OR IN PART, FOR ANY OTHER PURPOSE WITHOUT THE PRIOR WRITTEN CONSENT…
125742 S138 M1 2253
FDA-CBER-2021 5683 0950426 D gi a ly signed by o=Pf zer Inc. ou=PPLS - Shangh i ou Submiss ons and Operations Support c Reason I am s gning on beha f of Donna Boyce Da e 2021.10.22 1 2 12 0800 (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) FDA-CBER-2021-5683-0950427
125742 S138 M1 lab 1448 1 0
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…
125742 S138 M1 lab 1451 11 0
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…
125742 S138 M1 lab 1457 15 0
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…
125742 S138 M1 pp cvv usa 0416
BioNTech and Pfizer In-Store Audio Network :30s Radio 9/29/21 VO: There’s nothing like going up and down the aisles and knocking the items off your shopping list. While you’re in list checking -off mode, here’s something else you can consider doing here in the store - Talking to your pharmacist about Comirnaty® (COVID- 19 Vaccine, mRNA). This reminder brought to you by BioNTech and Pfizer. PP-CVV-USA-0416 © 2021 Pfizer Inc. All rights reserved. October 2021 …
125742 S141 M1 2253
FDA-CBER-2021 5683 0950505 D gi a ly signed by o Pf zer Inc. ou=PPLS - C l ege lle ou Submissions and Operations Support cn Reason I am signing on behalf Donna Boyce D te 2 21 10.25 0 22 3 0 00 (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) FDA-CBER-2021-5683-0950506
125742 S141 M1 lab 1448 1 0
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…
125742 S141 M1 lab 1451 11 0
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…
125742 S141 M1 lab 1457 15 0
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…
125742 S141 M1 pp cvv usa 0473
Tray remains consistent on every page of website Drives to: http:// labeling.pfizer.com/ ShowLabeling.asp x? id=14471&format= pdf FDA-CBER-2021-5683-0950583 drive to: http:// labeling.pfizer.com/ ShowLabeling.asp x? Drive to: http:// labeling.pfizer.c om/ ShowLabeling.a spx? id=14472&forma t=pdf Drives to: http:// labeling.pfi zer.com/ ShowLabe ling.aspx? id=15623 FDA-CBER-2021-5683-0950584 FDA-CBER-2021-5683-0950585 FDA-CBER-2021-5683-0950586 FDA-CBER-2021-5683-0950587 All mobile…
125742 S144 M1 2253
DEPARTMENT OF HEAL TH AND HUMAN SERVICES Form Approved: 0MB No. 0910-0001 Food and Drug Administration Expiration Date: March 31, 2024 See PRA Statement on last page. TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL 1.Date Submitted LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE 10/27/2021 2.Application Information X Single product Multiple products For multiple products, submit completed form and Application Type: BLAspecimen of advertising/promotional materials to one application of…
125742 S144 m1 lab 1448 1 0
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…