125742 S46 M1 label comvlabp puurs
Pfizer FDA submission document — 1 pages. PHMPT court-ordered release. Open the PDF to read.
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.
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125742 S46 M1 label comvlabkz kzoo
Pfizer FDA submission document — 1 pages. PHMPT court-ordered release. Open the PDF to read.
125742 S46 M1 carton com195lpus puurs
Pfizer FDA submission document — 1 pages. PHMPT court-ordered release. Open the PDF to read.
125742 S27 M1 response 29jul2021
BNT162b2 BLA STN 125742/0 M 1.11.3 Response to FDA Information Request CONFIDENTIAL Page 1BNT162b2 (COMIRNATY) BLA STN 125742/0 Response to CBER Comment Regarding Analyses for Safety f or the Two Age Groups August 2021 090177e197b300ac\Approved\Approved On: 02-Aug-2021 07:56 (GMT) FDA-CBER-2021-5683-0651469 BNT162b2 BLA STN 125742/0 M 1.11.3 Response to FDA Information Request CONFIDENTIAL Page 31.INTRODUCTION Reference is made to BLA STN 125742/0 for COVID- 19 mRNA Vaccine (COMI RNATY), …
125742 S21 M1 pvp track
BNT162b2 1.16 Risk Management Plan (Non-REMS) for Biologic License Application # 125742 CONFIDENTIAL Page 1 PHARMACOVIGILANCE PLAN FOR BIOLOGIC LICENSE APPLICATION #125742 OF COVID-19 mRNA vaccine (nucleoside modified) (BNT162b2, PF-07302048) Date of Report: 17 MAY28 JULY 2021 Version 1. 01 090177e197ac5206\Final\Final On: 28-Jul-2021 17:01 (GMT) FDA-CBER-2021-5683-0651370 BNT162b2 1.16 Risk Management Plan (Non-REMS) for Biologic License Application # 125742 …
125742 S1 M5 5351 c4591001 interim mth6 sample crf
Annotated Stud y Book for Stud y Desi gn: C4591001 Study Design Version: 16.0 Sponsor: Pfizer Protocol: C4591001 Sponsor Dru g Name: BLINDED THERAPY C4591001 - COVID1 9 Generated by Central Designer TM Februar y 22, 2021 8:10AMPage 1 of 11 5 Annotated Study Book - C4591001 2/22/2021 file:///C:/Users/zhan gd70/A ppData/Local/A pps/2.0/7 QDN0DKX.747/1YNZC0P6.4R Q/orac..03.0 _182cbe9101fd197d _0006.0003 _951f9bb66f2d394e/HtmlResources/AnnotatedStud ybook.htm l 090177e19657e614\Approved\Approved…
125742 S1 M5 5351 c4591001 interim mth6 randomization sensitive
16.1.7.1 Listing of Randomization Scheme and Actual Vaccine Received – All Subjects ≥16 Years of Ag e Vaccine Received Subject Study Identifiera Subject Age Group (Years) Randomization Date Randomization Number Randomization Vacci ne Group Date/ Dose 1 Date/ Dose 2 Date/ Dose 3 Date/ Dose 4 10011004 C4591001 1001 10011004^ 18-55 04MAY2020 1084 BNT162b1 (10 μg) 04MAY2020/ BNT162b1 (10 μg) 26MAY2020/ …
125742 S1 M5 5351 bnt162 01 interim3 sample crf
Visit: Visit 0 CRS Study Code: 049/20 Sponsor Study Code: BNT162-01 07/08/2020 Blank eCRF (CTP 8.0) 1/139 090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT) Page 1 FDA-CBER-2021-5683-0049178 FDA-CBER-2021-5683-0049179 FDA-CBER-2021-5683-0049180 Body Height/Weight + BMI (2.0) No do eReaso o do e Da e e He g (c )We g (kg) Body Mass I dex (kg/ ²)BMI (ca cu a ed) (kg/ ²) 1 Mo e ows: 1 5 10 Please insert new row(s), if you are in visit "Unscheduled Forms" only!BioNTech BNT162…
125742 S1 M5 5351 bnt162 01 interim3 report body
Page 1 of 144 Good Clinical Practice (GCP) statement: The study was conducted according to GCP guidelines, the applic able local laws, and in accordance with the ethical principles that have their origins in the Declaration of Helsinki. Confidentiality statement : The information contained in this document is the property and copyright of BioNTech SE. Therefore, this document is provided in confidence to the recipient. No informa tion contained herein shall be published, disclosed or…
125742 S1 M5 5351 bnt162 01 interim3 protocol deviations
Bi oNTech RNA Pharmaceuticals GmbH / Lis tings - 6. S napshot All TLFs Final 1.0 BNT 162b1 BNT 162-01 Crea ted on 20NOV2020 Stab uro GmbH. Based on clean SDTM data rec eived on 03NOV2020. Data cut -off: 2 3OCT2020. Listi ng 16.2.1 -2-1: Listing of protocol deviations - BN T162b1 Safe ty set Dose group Sub ject nu mber Desc ription Reas on for deviation Code d term Refe rence Date of oc curance 1 µg Younger 10015 Pho ne call was not performed Acc . to…
125742 S1 M5 5351 bnt162 01 interim3 protocol
Page 1 of 112 Stateme nt of Compliance: This trial will be conducted in according to this protocol, the ethical principles that have their origin in the Declaration of Helsinki, good clinical practice (GCP), and applicable regulatory requirements. Confidentiality Statement: The information contained in this document is the property and copyright of BioNTech RNA Pharmaceuticals GmbH. Therefore, this document is provided in confidence to the recipient. No information contained herein shall…
125742 S1 M5 5351 bnt162 01 interim3 patient batches
BioNTech RNA Pharmaceuticals GmbH ConfidentialInterim Clinical Study Report - BNT162-01 Investigational Product Tracking Table for: BNT162b1 Page 1 of 9 Date: 23 NOV 2020 RNA VariantRNADS Batch No.DP Batch No.Packaging Batch No. (kit)Medication No.Sequence No.Expiry Date SO-No. CountryTrial site No. Pharmacy V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10002 2 25. Sep 20 SO-20-0022 Germany #1/Mannheim V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10003 3 25. Sep 20…
125742 S1 M5 5351 bnt162 01 interim3 notes for reader
BioNTech RNA Pharmaceuticals GmbH Confidential Interim Clinical Study Report BNT162 -01 Page 1 of 1 Version: 2.0 Date: 27 NOV 2020 Participant data listings - Notes for the reader To harmonize data reporting across the different BNT162 clinical studies, the following terminology was harmonized in this interim clinical study report (CSR). The protocol, Statistical Analysis Plan (SAP), and the CSR Section 14 tables/figures, and the Section 16 listings use the original BioNTech…
125742 S1 M5 5351 bnt162 01 interim3 synopsis
BioNTech SE Confidential Interim Clinical Study Report - BNT162 -01 Synopsis Page 1 of 20 Version: 3.0 Date: 20 MAR 2021 2 SYNOPSIS Title of study A multi -site, Phase I/II, 2 -part, dose -escalation trial investigating the safety and immunogenicity of four prophylactic SARS -CoV-2 RNA vaccines against COVID -19 using different dosing regimens in healthy and immunocompromised adults Study number BNT162 -01 Protocol version Version 9.0 (dated 05 OCT 2020); the version…
125742 S1 M5 5351 bnt162 01 interim3 sponsor signature
FDA-CBER-2021-5683-0049332 FDA-CBER-2021-5683-0049333
125742 S1 M5 5351 bnt162 01 interim3 sponsor personnel list
BioNTech RNA Pharmaceuticals GmbH Confidential Interim Clinical Study Report BNT162 -01 Page 1 of 1 Version: 2.0 Date: 26 Nov 2020 16.1. 13 List of sponsor personnel who materially affected the trial conduct The following table presents a list of sponsor personnel who materially affected the trial conduct. The full list of all involved sponsor personnel is maintained in the trial master file ( TMF). Name Role Özlem Türeci , MD Chief Medical Officer ( Spons or’s medically…
125742 S1 M5 5351 bnt162 01 interim3 sap
EudraCT No: 2020 -001038 -36 Statistical Analysis Plan Version: Final 4.0 BioNTech_BNT162 -01_SAP_final_V4.0 Confidential 1 Title Page EudraCT Number: 2020 -001038 -36 WHO UTN: U1111 -1249 -4220 Trial Title: A Multi -site, Phase I/II, 2 -Part, Dose -Escalation Trial Investigating the Safety and Immunogenicity of four Prophylactic SARS -CoV-2 RNA Vaccines Against COVID -19 Using Different Dosing Regimens in Healthy and Immunocompromised Adults Protocol Version :…
125742 S1 M5 5351 bnt162 01 interim3 lab measurements
Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t…
125742 S1 M5 5351 bnt162 01 interim3 discontinued patients
Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.1 -3-1: Listing of subjects with premature discontinuation - BNT 162b1 Safety set Dose g roup Subj ect number Date o f last vis it/contact Date o f premature termi nation Mai n reason for premature termination Epi/ Pandemic rela ted 10…
125742 S1 M5 5351 bnt162 01 interim3 demographics
Bi oNTech RNA Pharmaceuticals GmbH / Lis tings - 6. S napshot All TLFs Final 1.0 BNT 162b1 BNT 162-01 Crea ted on 20NOV2020 Stab uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2 3OCT2020. Listi ng 16.2.1 -1-1: Listing of subjects disposition - BN T162b1 Safe ty set Dose gro up Sub ject nu mber Proto col versions Date s of in formed co nsent Date of sc reening Date of prime im munization Date of boost im munization Date of…