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Interim Clinical Study Report Protocol C4591001 CLINICAL STUDY REPORT SYNOPSIS CONFIDENTIAL Page 1Vaccine Name and Compound Number: BNT162 RNA -Based COVID -19 Vaccines, Compound Number: PF-07302048 Report Title: Interim Report – 6 Month Update : A Phase 1/2/3, Placebo -Controlled, Randomized, Observer -Blind, Dose -Finding Study to Evaluate the Safety , Tolerability , Immunogenicit y, and Efficacy of SARS -COV -2 RNA Vaccine Candidates Against COVID -19 in Healthy Individuals…
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Interim Clinical Study Report Protocol C4591001 CONFIDENTIAL 1.TITLE PAGE Vaccine Name and Compound Number:BNT162 RNA -Based COVID -19 Vaccines, Compound Number: PF -07302048 Report Title: Interim Report –6 Month Update : A Phase 1/2/3, Placebo- Controlled, Randomized, Observer -Blind, Dose - Finding Stud y to Evaluate the Safet y, Tolerability, Immunogenicit y, and Efficacy of SARS -COV -2 RNA Vaccine Candidates Against COVI D-19 in Healthy Individuals Protocol Number: Protocol…
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InterimClinical Study Report Protocol C4591001 CLINICAL STUDY REPORT SYNOPSIS CONFIDENTIAL Page 1Vaccine Name and Compound Number: BNT162 RNA -Based COVID -19 Vaccines, Compound Number: PF-07302048 Report Title: Final Analy sis Interim Report: A Phase 1/2/3, Placebo -Controlled, Randomized, Observer -Blind, Dose -Finding Study to Evaluate the Safety , Tolerability , Immunogenicit y, and Efficacy of SARS -COV-2 RNA Vaccine Candidates Against COVID - 19 in Healthy Individuals Protocol…
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Interim Clinical Study Report Protocol C4591001 CONFIDENTIAL 1.TITLE PAGE Vaccine Name and Compound Number:BNT162 RNA -Based COVID -19 Vaccines, Compound Number: PF -07302048 Report Title: Final Anal ysis Interim Report: A Phase 1/2/3, Placebo- Controlled, Randomized, Observer -Blind, Dose -Finding Study to Evaluate the Safety , Tolerability , Immunogenicit y, and Efficacy of SARS -COV -2 RNA Vaccine Candidates Against COVI D-19 in Healthy Individuals Protocol Number: Protocol…
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VACCINE RESEARCH TEST MET HOD PEA RL RI VER, NY TITLE: Test Met hod for the SARS CoV-2 Nucleocap sid(N) Antigen Dete ction AssayDoc. Number: VR-TM-10304 Version: 3.0 Doc. Alias: NA PFIZER CONFIDENTI AL Page1 TABLE OF CONTENTS LIST OF TABLES ................................ ................................ ................................ ..................... 2 LIST OF FIGURES ................................ ................................ ................................…
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VACCINE RESEARCH TEST METHOD PEARL RIVER, NY TITLE: Manual 96 -well Micron eutralization Assay for the Detection of Functional Antibodies to SAR S-CoV -2 in Test SerumDoc Numbe r: VR-TM-10298 Version: 3.0 Doc. Alias: NA PFIZER CONFIDENTIAL Page 1TABLE 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-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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PF-07302048: BNT162b2 (V9) Immunogenicity and Evaluation of Protection against SARS -CoV- 2 Challenge in Rhesus Macaques VR-VTR -10671, Ver. 2.0 PFIZER CONFIDENTIAL Page 1Title: BNT162b2 (V9) Immunogenicity and Evaluation of Protection against SARS -CoV -2 Challenge in Rhesus Macaques Study Number: COVID Rh2020- 01 (NI RC study #: 8725-2005) (SNPRC S tudy #: Covid -1778) Parent Compound Number(s): PF-07302048 Alternative Compound Identifiers: N/A Pfizer Vaccine Research and Development 401…
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PF-07302048RatPharmacokinetics PF-07302048_06Jul20_07242 4 PFIZERCONFIDENTIAL Page 1of 15A SINGLE DOSE PHARMA COKINETICS STUDY OF ALC-0315 AND ALC -0159 FOLLOWING INTRAVENOU S BOLUS INJECTION OF PF-07302048 NANOPARTICLE FORM ULATION IN WISTAR HA N RATS This document contains co nfidential information belonging to Pfizer. Except as may be otherwise agreed to in writing, by accepting or reviewing these materials, you agree to hold such information in confidence and not to disclose it t o…
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PF-07302048 : Structural and Biophysical Char acterization of SARS -CoV -2 Spike Glycoprotein (P2 S) as a Vaccine Antigen VR-VTR -10741 , Ver. 2.0 PFIZER CONFIDENT IAL Page 1 Title: Structural and Bioph ysical Characterization of SARS -CoV -2 Spike Gly coprotein (P2S) as a Vaccine Antigen Study Number: N/A Parent Compound Number(s): PF-07302048 Alterna tive Compound Identifiers: N/A Pfizer Discovery Sciences Easte rnPoint Road Groton , CT 090177e195e446ea\Approved\Approved On: 27-Dec-2020…
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BioNTech SE An der Goldgrube 12 55131 Mainz, Germany Phone: +49 (0)6131 9084 -0 Telefax: +49 (0)6131 9084 -390 R&D DATA REPORT N o. R-20-0211 In Vitro Expression of BNT162b2 Drug Substance and Drug Product Version 0 2 Date: 17 SEP 2020 Reported by Test item: BNT162b2 Key words: COVID19, modRNA, ATM material, Western blot, immunofluorescence , FACS This R&D report consists of 22 pages. Confidentiality Statement: The information contained in this document is the…
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BioNTec h SE An der Goldgrube 12 55131 Mainz, Germany Phone: +49 (0)6131 9084 -0 Telefax: +49 (0)6131 9084 -390 R&D STUDY REPORT N o. R-20-0112 CHARACTERIZING THE I MMUNOPHENOTYPE IN SPLEEN AND LYMPH NOD E OF MICE TREATED WITH SARS -COV-2 VACCINE CANDIDATES Version 01 Date: 13 AUG 2020 Reported by Test item: BNT162a1, BNT162b1, BNT162b2, BNT162c2 Key w ords: Covid -19, SARS -CoV-2, Vaccine, BALB/c mice, immunophenotyping This R&D report consists of 105 pages. …
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BioNTec h SE An der Goldgrube 12 55131 Mainz, Germany Phone: +49 (0)6131 9084 -0 Telefax: +49 (0)6131 9084 -390 R&D STUDY REPORT N o. R-20-0085 COVID -19: IMMUNOGENI CITY STUDY OF THE LNP- FORMULATED MODRNA EN CODING THE VIRAL S PROTEIN -V9 Version 04 Date: 23 NOV 2020 Reported by Test i tem: BNT162b2 ( animal trial material ) Key words: Coronavirus, COVID -19, modRNA, ATM, mouse, immunogenicity This R&D report consists of 93 pages. Confidentiality Statement: The…
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BNT162b2 2.6.7 Toxicology Tabulated Summary 2.6.7.1 Toxicology: Overview Test Article: BNT162b2 Type of Study Species/ StrainMethod of Administratio nDuration of DosingDose (µgRNA/anim al)Total Volum e (µL)aGLP ComplianceTesting FacilityStudy Number (Sponsor Reference Number) Single-Dose Toxicity Not conducted Repeat-Dose Toxicity 17-Day, 2-or 3-Dose (1Dose/Week) Toxicity With a 3-Week Recovery PhaseRat/ Wistar HanIM Injection 17Days (Dose days 1, 8, 15) or 10Days (Dose days 1, 8)b0…
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BNT162b2 Module 2.6.6. Toxicology Written Summary CONFIDENTIAL Page 1MODULE 2.6.6 TOXICOLOGY WRITTEN S UMMARY This document contains confidential information belonging to BioNTech /Pfizer. Except as may be otherwise agreed to in writing, by accepting or reviewing these materials, you agree to hold such information in confidence and not to disclose it to others (except w here required by applicable law), nor to use it for unauthorized purposes. In the event of actual or suspected breach of…
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BNT162b2 2.6.3 Pharmacology Tabulated Summary PFIZER CONFIDENTIAL Page 12.6.3.1 Pharmacology: Overview Test Article: BNT162b2 Type of Study Test System Method of AdministrationTesting Facility Study Number Prim ary Pharmacodynamics Qualification Report for a Single -plex Direct Luminex Assay (dLIA) for Quantitation of IgG Antibodies to SARS -CoV -2 S1 Protein in Human Sera Direct Luminex immunoassayNA PWRD VR-MQR -10211 Qualification of the SARS -CoV -2 mNeonGreen Virus…
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BNT162b2 Module 2.6.2. Pharmacology Written Summary CONFIDENTIAL Page 1MODULE 2.6.2 PHARMAC OLOGY WRITTEN SUMMARY This document contains confidential information belonging to BioNTech /Pfizer .Except as may be otherwise agreed to in writing, by accepting or reviewing these materials, you agree to hold such information in confidence and not to disclose it to others (except w here required by applicable law), nor to use it for unauthorized purposes. In the event of actual or suspected breach…
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BNT162b2 Module 2.6.1. Introduction CONFIDENTIAL Page 1MODULE 2.6.1. INTRODUCTION This document contains confidential information belonging to BioNTech /Pfizer. Except as may be otherwise agreed to in writing, by accepting or reviewing these materials, you agree to hold such information in confidence and not to disclose it to others (except w here required by applicable law), nor to use it for unauthorized purpos es. In the event of actual or suspected breach of this obligation, BioNTech…
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nature https://doi.org/10 .1038/s41586-020-2324-7 Accelerated Article Preview Respiratory disease in rhesus macaques inoculated with SARS-CoV-2 Received : 22 March 2020 Accepted: 1 May 2020 Accelerated Article Preview Published on line 12 May 2020 Cite this article as: Munster, V. J. et al. Respiratory disease in rhesus macaques inoculated with SARS-CoV-2. Nature https://doi.org/10.1038/s41586-020-2324-7 (2020). Vincent J. Munster, Friederike Feldmann, Brandi N. Williamson, Neeltje…
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Report Amendment 1 for Study 20GR142 PFIZER CONFIDENTIAL Page 1Final Report Amendment 1 17-DAY INTRAMUSCULAR TOXICITY STUDY OF B NT162B2 (V9) AND BNT162B3C IN WISTAR HAN RATS WITH A 3 -WEEK RECOVERY Testing Facility Study Number: 20GR142 Alternative Test Article Identifier(s): PF-07302048: Generic number for COVID -19 vaccine program BNT162b2 (V9): BNT162b2 (Version 9); RBP020.2; PF -07305885 BNT162b3c: BNT162b3; RBP020.8; PF -07315256 TESTI NG FACILITY: Pfizer Worldwide Research & De…