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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VACCINE RESEA RCH TEST METHOD PEARL RIVER, NY TITLE:Single-plex Luminex Assay for Qu antitation of IgGAntibodies toSARS-CoV-2 S1 Proteinin 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 ................................ ................................…
C4591001 Page 1of 78 CONFIDENTIAL 19-Nov-2020 13:39:50 GMT16.1.4.1 LIST OF INVESTIGATORS AND NUMBER OF SITES AND SUBJECTS BY THE COUNTRY Total Number of Sites (Per Study ):153 Total Number of Subjects Screened (Per Study ): 45330 Total Number of Subjects Randomized/Entered (Per Study ):43888 ARGENTINA Number of Sites (Per Country ): 1 Number of Subjects Screened (Per Country ): 5896 Number of Subjects Randomized/Entered (Per Country ): 5776 Coordinating Investigator: <None Entered> Study …
C4591001 Page 1of 89 CONFIDENTIAL 19-Mar-2021 16:13:09 GMT 16.1.4.1 LIST OF INVESTIGATORS AND NUMBER OF SITES AND SUBJECTS BY THE COUNTRY Total Number of Sites (Per Study ):153 Total Number of Subjects Screened (Per Study ): 48092 Total Number of Subjects Randomized/Entered (Per Study ):45121 ARGENTINA Number of Sites (Per Country ): 1 Number of Subjects Screened (Per Country ): 5896 Number of Subjects Randomized/Entered (Per Country ): 5615 Coordinating Investigator: <None Entered>…
Listing 7.7.7 Page 3of 72 BNT162b2 Protocol C4591008 Participant Reported Non -Hospitalization Safety Events of Interest 1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed. PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADEVENT, FA Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1618 of 1689 Subject ID Age/Sex/RaceVaccination Date…
CT05 -GSOP- RF15 1 .0PHA SE 2/3 CLINICA L STUDY ASSENT TEMPLA TE FOR YOUNGER CHILDREN 15-Feb-2021 Assent Version Date: 13Sep2021 | Assent Version Number: 1Assent Level: Study (Phase 2/3 Obtaining Serum Samples for Potential Troponin I Testing ) Site #: N/A | Protocol No. C4591007 | Protocol Date: 10S2021 Country: N/A | Derived From: 05 Mar 2021 The official version of this form is located in the electronic document management system. This document was created based on QMS04 -GSOP -SD-GL06…
CT05 -GSOP- RF15 1 .0PHA SE 1/2/3/4 CLINICA L STUDY ASSENT TEMPLA TE FOR YOUNGER CHILDREN 15-Feb-2021 Assent Version Date: 09Aug 2021 | Assent Version Number: 1 Assent Level: Study (Phase 1 Evaluation of Lower Dose Levels )Younger children Site #: N/A | Protocol No. C4591007 | Protocol Date: 06Aug 2021 Country: N/A | Derived From: N/A 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…
Listing 7.7.4 Page 1of 270 BNT162b2 Protocol C4591008 Demographic Data PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL Generated from /dcri/ct/hero_together/lists/l_demog.sas on 24MAY2021 12:45 Page 19of 1689 Subject ID Age/Sex/Race Ethnicity C4591008 -1000222784 28/F/WHITE NOT HISPANIC OR LATINO C4591008 -1003079744 34/M/WHITE NOT HISPANIC OR LATINO C4591008 -1003225152 34/F/WHITE NOT HISPANIC OR LATINO C4591008 -1006879296 45/M/WHITE NOT…
CT05-GSOP-RF05 7.0 PHASE 1/2/3 INFORMED CONSENT PEDIATRIC STUDY TEMPLATE 01-Jul-2019 Protocol Number: C4591007 ICD Version Date : 06 Aug 13 Sep 2021 Phase 2/3 Placebo-Controlled Selected Dose Study Country Site Language: English Center ID: N/A Country: N/A ICD Derived From: 062 AugJul 2021 CT05-GSOP-RF05 7.0 Phase 1/2/3/4 Informed Consent Pediatric Study Template (01-Jul-2019) TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site) Sponsor Consent Version…
CT05 -GSOP- RF15 1 .0PHA SE 2/3 CLINICA L STUDY ASSENT TEMPLA TE FOR YOUNGER CHILDREN 15-Feb-2021 Assent Version Date: 06 Aug 2021 | Assent Version Number: 3Assent Level: Study (Phase 2/3 Placebo Controlled Selected Dose) Site #: N/A | Protocol No. C4591007 | Protocol Date: 06August 2021 Country: N/A | Derived From: 05 Mar 2021 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…
Pfizer Global Regulatory Affairs Pfizer Inc . 235 East 42ndStreet /New York , NY 10017 -5755 Global Product Developm ent 06 July 2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research Document Control Center 10903 New Hampshire Avenue WO71, G112 Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE SECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING…
PF-07302048 : QCS Data Listin g VR-MQR- 10214-ATT02, Ver. 1.0 PFIZER CONFID ENTIAL Page 1 Title: QCS Data L isting Study Number: N/A Parent Compound Number(s): PF-07302048 Alternative Compound Identifiers: N/A Pfizer Vaccine Research and Development 401 N. Middletown Rd. Pearl River, NY 090177e194744851\Approved\Approved On: 28-Jul-2020 13:57 (GMT) FDA-CBER-2021-5683-1072926 PF-07302048 : QCS Data Listin g VR-MQR- 10214-ATT02, Ver. 1.0 PFIZER CONFID ENTIAL Page 2TABLE OF CONTENTS LIST OF…
PF-07302048 : QCS Infection Ratio Data Listing VR-MQR- 10214-ATT03, Ver. 1.0 PFIZER CONFID ENTIAL Page 1 Title: QCS I nfection Ratio Data L isting Study Number: N/A Parent Compound Number(s): PF-07302048 Alternative Compound Identifiers: N/A Pfizer Vaccine Research and Development 401 N. Middletown Rd. Pearl River, NY 090177e19474664e\Approved\Approved On: 28-Jul-2020 14:01 (GMT) FDA-CBER-2021-5683-1072932 PF-07302048 : QCS Infection Ratio Data Listing VR-MQR- 10214-ATT03, Ver. 1.0 PFIZER…
PF-07302048 : Precision Experiment Data List ing VR-MQR- 10214-ATT01, Ver. 1.0 PFIZER CONFID ENTIAL Page 1 Title: Precision Experiment Data Listing Study Number: N/A Parent Compound Number(s): PF-07302048 Alternative Compound Identifiers: N/A Pfizer Vaccine Research and Development 401 N. Middletown Rd. Pearl River, NY 090177e194744534\Approved\Approved On: 28-Jul-2020 13:56 (GMT) FDA-CBER-2021-5683-1072901 PF-07302048 : Precision Experiment Data List ing VR-MQR- 10214-ATT01, Ver. 1.0 PFIZER…
Pfizer Inc 500 Arcola Road Collegeville, PA 19436 Global Product Developm ent 10July 2020 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologi cs Evaluation and Research Document Control Center 10903 New Hampshire Avenue WO71, G112 Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE SECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR REGIST RATION OF PRODUCTS FOR…
CT05-GSOP-RF05 7.0 PHASE 1/2/3 INFORMED CONSENT PEDIATRIC STUDY TEMPLATE 01-Jul-2019 Protocol Number: C4591007 ICD Version Date : 06 02Aug Jul2021 Phase 2/3 Placebo-Controlled Selected Dose Study Country Site Language: English Center ID: N/A Country: N/A ICD Derived From: 02 Jul 2021N/A CT05-GSOP-RF05 7.0 Phase 1/2/3/4 Informed Consent Pediatric Study Template (01-Jul-2019) TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site) Sponsor Consent Version…
PF-07302048 : Supportive Data for VR -MQR -10212 VR-MQR -10212 -ATT01, Ver. 2.0 PFIZER CONFIDENTI AL Page 1 Title: Supportive Data for VR -MQR-10 212 Study Number: N/A Parent Compound Number(s): PF-07302048 Alternative Compound Identifiers: N/A Pfizer Vaccine Research and Development 401 N. Middletown Rd. Pearl River, NY 090177e19498ee79\Approved\Approved On: 07-Aug-2020 22:23 (GMT) FDA-CBER-2021-5683-1072837 PF-07302048 : Supportive Data for VR -MQR -10212 VR-MQR -10212 -ATT01, Ver. 2.0…
CT05-GSOP- RF15 1.0 PHASE 2/3 CLINICAL STUDY ASSENT TEMPLATE FOR YOUNGER CHILDREN 15-Feb-2021 Assent Version Date: 05 Mar06 Aug 2021 | Assent Version Number: 32 Assent Level: Study (Phase 2/3 Placebo Controlled Selected Dose) Site #: N/A | Protocol No. C4591007 | Protocol Date: 05Mar20210 6 August 2021 Country: N/A | Derived From: 05 Mar 2021N/A The official version of this form is located in the electronic document management system. This document was created based on…
PF-07302048 : Supportive Data for VR -MQR -10211 VR-MQR -1021 1-ATT01, Ver. 2.0 PFIZER CONFIDENTIAL Page 1 Title: Supportive Data for VR -MQR-10 211 Study Number: N/A Parent Compound Number(s): PF-07302048 Alternative Compound Identifiers: N/A Pfizer Vaccine Research and Development 401 N. Middletown Rd. Pearl River, NY 090177e19498b0af\Approved\Approved On: 07-Aug-2020 22:25 (GMT) FDA-CBER-2021-5683-1072763 PF-07302048 : Supportive Data for VR -MQR -10211 VR-MQR -1021 1-ATT01, Ver. 2.0 PFIZER…
PF-07302048 : Qualification Report for a Single -plex Direct Luminex Ass ay (dLIA) for Quantitation of IgG Antibodies to SARS -CoV -2 RBD Protein in Human Sera VR-MQR -10212 , Ver. 2.0 PFIZER CONFIDENTIAL Page 1 Title: Qualification Report for a Single -plex Direct L uminex Ass ay (dLIA) for Quantitation of IgG Antibodies to SARS- CoV -2 RBD Protein in Human Sera Study Number: N/A Parent Compound Number(s): PF-07302048 Alternative Compound Identifiers: N/A Pfizer Vaccine Research and…
Pfizer-BioNTech COVID -19 Vaccine C4591009 NON -INTERVENTIONAL STUDY PROTOCOL 1.0, 19 August 2021 PFIZER CONFIDENTIAL CT24-WI-GL02-RF02 3.0 Non-Interventional Study Protocol Template For Secondary Data Collection Study 20-May-2021 Page 1 of 70Study information Title A Non-Interventional Post -Approval Safet y Study of Pfizer-BioNTech COVID -19 Vaccine in the United States Protocol number C4591009 Protocol version identifier 1.0 Date 19 August 2021 EU Post-Authoriz ation Study (PAS)…