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The official version of this form is located in the electronic document management system. This document was created based on QMS04 -GSOP -SD-GL06 5.0 CMCD Forms Template WORD 01 -Oct-2020. TMF Doc ID: 173.16 (Study); 173.10 (Country/Central); 173.20 (Site) Sponsor Consent Version Number (Study/Country/Site ): [1/0/0] 09Aug2021 Phase 1 Lower Dose Evaluation, Older Assent PFIZER CONFIDENTIALPage 1 of 8We would like to tell you about a research study and see if you would like to takepart. You…
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PFIZER CONFIDENTIAL Page 1Global Regulatory Affa irs - Vaccines Pfizer Inc. 235 East 42nd Street New York, NY 10017 Global Product Developm ent 15 March 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 OF…
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C4591008 PFIZER CONFIDENTIAL CT24-W I-GL15-R F06 1. 0 Non-I nterventional Study R eport/Manuscript Signatures 15-A ug-2018 Page 1 o f 1 APPENDIX 1. S IGNATURES PROTOCOL NUMB ER: C4591008 TITLE OF STUDY: HERO -Together: A post -Emergency Use Authorization observational cohort study to evaluate the safety of the Pfizer -BioNTech COVID -19 vaccine in US healthcare workers, their families, and their communities FINAL STUDY REPORT VERSION: V 1.0 Confirmation : I confirm that…
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BioNTech SE 07/20/2021 An der Goldgrube 12 Mainz N/A Germany 55131215-280-5503 COVID-19 Vaccine (BNT162, PF-07302048) 019736 Active immunization to prevent COVID-19 caused by SARS-CoV-2 BB-IND 013812, BB-IND 013278, BLA 125549 0 4 1 3 3 FDA-CBER-2021 5683-1072523 Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Neda Aghajani Memar, Pharm.D., Director, Pfizer Global Regulatory Affairs - Vaccines 212-733-2613 (845) 474-3500 235 East 42nd…
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BioNTech SE 06/30/2021 An der Goldgrube 12 Mainz N/A Germany 55131215-280-5503 COVID-19 Vaccine (BNT162, PF-07302048) 019736 Active immunization to prevent COVID-19 caused by SARS-CoV-2 Phase 4 BB-IND 013812, BB-IND 013278, BLA 125549 0 3 8 6 3 FDA-CBER-2021 5683-1072501 Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Neda Aghajani Memar, Pharm.D., Director, Pfizer Global Regulatory Affairs - Vaccines 212-733-2613 (845) 474-3500 235…
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BioNTech SE 02/18/2021 An der Goldgrube 12 Mainz N/A Germany 55131215-280-5503 COVID-19 Vaccine (BNT162, PF-07302048) 019736 Prophylactic immunization against COVID-19 in adults 16 years of age BB-IND 013812, BB-IND 013278, BLA 125549 0 2 2 1 Briefing Document for Type C Written Response Only 3 FDA-CBER-2021 5683-1072485 Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Neda Aghajani Memar, Pharm.D., Director, Pfizer Global Regulatory…
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BioNTech SE 02/15/2021 An der Goldgrube 12 Mainz Rhineland-Palatinate Germany 55131215-280-5503 COVID-19 Vaccine (BNT162, PF-07302048) 019736 Prophylactic immunization against COVID-19 in adults 16 years of age 0 2 1 3 Summary Monthly Safety Report (SMSR) 3 FDA-CBER-2021 5683-1079254 Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Elisa Harkins, Global Regulatory Lead, Pfizer Global Regulatory Affairs - Vaccines 215-280-5503 (845)…
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BioNTech RNA Pharmaceuticals GmbH 12/04/2020 An der Goldgrube 12 Mainz N/A Germany 55131215-280-5503 COVID-19 Vaccine (BNT162, PF-07302048)019736 Prophylactic immunization against COVID-19 in adults 16 years of age BB-IND 013812, BB-IND 013278, BLA 125549 0156 3 FDA-CBER-2021 5683-1072475 Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Elisa Harkins, Global Regulatory Lead, Pfizer Global Regulatory Affairs - Vaccines 215-280-5503 (845)…
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PF-073020 48: Qualificati on of the SARS -CoV -2 mNeon Green Virus Micron eutralization Assay VR-MQR -1021 4, Ver. 2.0 PFIZER CONFIDENTIAL Page 1 Title: Qualification of the SARS- CoV -2 mNeonGreen Virus Microneutralization Assay Study Number: N/A Parent Compound Number(s): PF-07302048 Alternative Compound Identifiers: N/A Pfizer Vacc ine Research and Development 401 N. Mi ddletow n Rd. Pearl River, NY 090177e194a57b00\Approved\Approved On: 18-Aug-2020 17:57 (GMT) FDA-CBER-2021-5683-1072880…
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FDA-CBER-2021-5683-1072602 FDA-CBER-2021-5683-1072603 FDA-CBER-2021-5683-1072604 FDA-CBER-2021-5683-1072605 FDA-CBER-2021-5683-1072606 FDA-CBER-2021-5683-1072607 FDA-CBER-2021-5683-1072608 FDA-CBER-2021-5683-1072609 FDA-CBER-2021-5683-1072610 FDA-CBER-2021-5683-1072611 FDA-CBER-2021-5683-1072612 FDA-CBER-2021-5683-1072613 FDA-CBER-2021-5683-1072614 FDA-CBER-2021-5683-1072615 FDA-CBER-2021-5683-1072616 FDA-CBER-2021-5683-1072617 FDA-CBER-2021-5683-1072618 FDA-CBER-2021-5683-1072619…
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Protocol C4591020 (PF-07302048 ) Statistical Analysis Plan PFIZER CONFIDENTIAL Page 1Protocol C4591020 A PHASE 3, RANDOMIZE D, OBSERVER -BLIND ST UDY TO EVALUATE THE SAFETY, TOLERABILITY , AND IMMUNOGENICITY OF MULTIPLE FORMULATION SOF THE VACCINE CANDIDAT E BNT162b2 AGAINST COVID -19 IN HEALTHY ADULTS 18 THROUGH 55 YEARS OF AGE Statistical Analysis Plan (SAP) Version: 2 Date: 05 May 202 1 090177e19bba3c91\0.1\Draft\Versioned On:03-Nov-2022 16:02 (GMT) (b) (4) (b) (4)…
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VACCINE RESEA RCH TEST METHOD PEA RL RIVER, NY TITLE: Single -plex Luminex Assay for Qu antitation of IgGAntibodi es toSARS -CoV-2RBD Protein in Human SerumDoc Number: VR-TM-10294 Version: 1.0 Doc. Alias: NA PFIZER CO NFIDENTIAL Page 1 TABLE OF CONTENTS LIST OF TABLES ................................ ................................ ................................ ..................... 2 LIST OF FIGURES ................................ ................................…
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VACCINE RESEA RCH TEST METHOD PEA RL RIVER, NY TITLE: Single -plex Luminex Assay for Qu antitation of IgGAntibodi es toSARS -CoV-2 S 1 Protein in Human SerumDoc Number: VR-TM-10293 Version: 1.0 Doc. Alias: NA PFIZER CO NFIDENTIAL Page 1 TABLE OF CONTENTS LIST OF TABLES ................................ ................................ ................................ ..................... 2 LIST OF FIGURES ................................ ................................…
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PF-07302048: Qualification Report for a Single-plex Direct Luminex Ass ay (dLIA) for Quantitation of IgG Antibodies to SARS -CoV-2 S1 Protein in Human Sera VR-MQR-10211, Ver. 2.0 PFIZER CONFIDENTIAL Page 1Title:Qualification Report for a Single-plex Direct L uminex Ass ay (dLIA) for Quantitation of IgG Antibodies to SARS- CoV-2 S1 Protein in Human Sera Study Number: N/A Parent Compound Number(s): PF-07302048 Alternative Compound Identifiers: N/A Pfizer Vaccine Research and Development 401 N.…
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Protocol C4591020 (PF-07302048 ) Statistical Analysis Plan PFIZER CONFIDENTIAL Page 1Protocol C4591020 A PHASE 3, RANDOMIZE D, OBSERVER -BLIND ST UDY TO EVALUATE THE SAFETY, TOLERABILITY , AND IMMUNOGENICITY OF A LYOPHILIZED MULTIPLE FORMULATION SOF THE VACCINE CANDIDAT E BNT162b 2 AGAINST COVID -19 IN HEALTHY ADULTS 18 THROUGH 55 YEARS OF AGE Statistical Analysis Plan (SAP) Version: 21 Date: 1605April May 2021 090177e196f6976e\Approved\Approved On: 06-May-2021 14:37 (GMT) (b) (4) (b) (4)…
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UTMB -Shi Lab SOP TITLE: Manual 96 -well Neutralization Assay for the Detection of Functional Antibodies to SARS -CoV-2 in Test Serum using Cytation 7 Image Reader Doc. Number: SHI -SOP -10011 Version: 2.0 UTMB -Shi Lab CONFIDENTIAL Page 1 TABLE OF CONTENTS 1.HISTORICAL REVISION SUMMARY ............................................................................... 2 Table 1. Chronological Summary of Previous Versions ........................................................ 2 2.PURPOSE…
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CT05 -GSOP -RF07 3.0CLINICA L STUDY INFORMED CONSENT ADDENDUM TEMPLA TE01-JUN-2016 CT05-GSOP -RF07 3.0Addendum ICD Template ( 01-Jun-2016) PFIZER CONFIDENTIALINFORMED CONSENT ADDENDUM FOR : A PHA SE 1, OPEN -LABEL DOSE - FINDING STUDY TO EVA LUATE S AFETY, TOLERA BILITY, AND IMMUNOGENICITY AND PHA SE 2/3 PLA CEBO CONTROLLED, OBSERVER - BLINDED SA FETY, TOLERA BILITY, A ND IMMUNOGENICITY STUDY OF A SARS- COV- 2 RNA VACCINE CA NDIDATE AGAI NST COVID -19 IN HEA LTHY CHILDREN AND YOUNG ADULTS…
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BNT162b2 COVID-19 Case Strain Sequencing Report CONFIDENTIAL Page 1COVID-19 Case Strain Sequencing Report Study C4591001 04 June2021 090177e197356daf\Approved\Approved On: 04-Jun-2021 14:56 (GMT) FDA-CBER-2021-5683-1072377 BNT162b2 COVID-19 Case Strain Sequencing Report CONFIDENTIAL Page 2TABLE OF CONTENTS LIST OF TABLES ................................ ................................ ................................ ..................... 3 ABBREVIAT IONS................................…
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FDA-CBER-2021-5683-1078773 (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) FDA-CBER-2021-5683-1078774 FDA-CBER-2021-5683-1078775 (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) FDA-CBER-2021-5683-1078776 (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) FDA-CBER-2021-5683-1078777 (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) FDA-CBER-2021-5683-1078778 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b)…
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VACCINE RESEA RCH TEST METHOD PEARL RIVER, NY TITLE:Single-plex Luminex Assay for Qu antitation of IgGAntibodies toSARS-CoV-2RBDProteinin Human SerumDoc Number: VR-TM-10294 Version: 1.0 Doc. Alias: NA PFIZER CO NFIDENTIAL Page 1 TABLE OF CONTENTS LIST OF TABLES ................................ ................................ ................................ ..................... 2 LIST OF FIGURES ................................ ................................…