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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…
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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…
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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…
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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…
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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…
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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 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…
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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)…
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FORM FDA 1571 (0 /1 )35(9,286 (',7,21 2%62/(7( Page 1 of 12. For Originals, is the product a combination product (21 CFR 3.2(e))?Next Page Export Data Import Data Reset Form DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration INVESTIGATIONAL NEW DRUG APPLICATION (IND) (Title 21, Code of Federal Regulations (CFR) Part 312) 5. Name of Drug (Include all available names: Trade, Generic, Chemical, or Code) 8. Phase of Clinical Investigation to be conducted 11. This…
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CONCURRENCE PAGE This page must be uploaded into the EDR. Do NOT send this page to the applicant. Do NOT post this page to the Biological Approvals website. Application #: STN: BL 125742 /8 Communication Name: Notification Communication ID: WR LTR- OBE Safety Related Drafted by: Christopher Okoye : 09/27/2021 Review /Concurrence History: Craig Zinderman: 09/29/2021 Lori Austin -Hansberry : 09/29/2021 cc: CBER Electronic Repository END OF…
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FDA-CBER-2021-5683-1072439 FDA-CBER-2021-5683-1072440
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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 Number (Study /Country/Site) : [1/0/0] Phase 2/3 Obtaining Serum Samples for Potential Troponin I Testing (allage groups) 13 Sep 2021 Protocol No. C4591007/PFIZER CONFIDENTIALPage: 1of 7 We would like to tell you about a research study and see if you would like to take part. You will need to read this…
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CT05 -GSOP -RF04 7.0PHA SE 3 CLINICA L STUDY INFORMED CONSENT TEMPL ATE01-Jul-2019 Protocol Number: C4591020 ICD Version Date : 02 Feb 2021 Study Country SiteLanguage: English Center ID: Not Applicable Country: US ICD Derived From: C4591020, ICD Version Date: 20 -Jan-2021 CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019) TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site) Sponsor Consent Version (Study/ Country/Site) 2/2/0, 02…
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CT05 -GSOP -RF05 7.0PHA SE 1/2/3INFORMED CONSENT PEDIA TRIC STUDY TEMPLA TE01-Jul-2019 Protocol Number: C4591007ICD Version Date : 13Sep 2021 Phase 2/3 Placebo -Controlled Selected Dose Study Country SiteLanguage: English Center ID: N/A Country: N/A ICD Derived From: 06 Aug 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 Number…
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From:Gottschalk, Laura Sent:Monday, September 20, 2021 3:05 PM To:Patel, Amit <[email protected]> Cc:Devlin, Carmel M <[email protected]>; Harkins Tull, Elisa <[email protected]>; ; [email protected]; Smith, Michael (CBER) <[email protected]>; Naik, Ramachandra <[email protected]> Subject:STN 125742/9 -COVID-19 Vaccine, mRNA (COMIRNATY): Product Correspondence -CBER response to plan for reporting Biologic Product Deviation Reports …
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CT05 -GSOP -RF04 7.0PHA SE 2/3CLINICA L STUDY INFORMED CONSENT TEMPLA TE01-Jul-2019 Protocol Number: C4591007ICD Version Date : (Study): Phase 2 3Lower Dose Evaluation (Adult) V1 09Aug2021 Study Country SiteLanguage: English Center ID: N/A Country: N/A ICD Derived From: N/A CT05-GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019) TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site) Sponsor Consent Version Date :(Study ): [1/0/0] Phase 2/3…
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CT05 -GSOP -RF04 7.0PHA SE 1CLINICA L STUDY INFORMED CONSENT TEMPLA TE01-Jul-2019 Protocol Number: C4591007ICD Version Date : (Study): Phase 1 Lower Dose Evaluation (Adult) V1 09Aug2021 Study Country SiteLanguage: English Center ID: N/A Country: N/A ICD Derived From: N/A CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019) TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site) Sponsor Consent Version Date (Study): Phase 1 Lower Dose…
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From:Gottschalk, Laura Sent:Wednesday, September 22, 2021 9:12 AM To:Patel, Amit <[email protected]> Cc:Harkins Tull, Elisa <[email protected]>; Devlin, Carmel M <[email protected]>; Naik, Ramachandra <[email protected]>; Smith, Michael (CBER) <[email protected]>; Stafford, Adrienne Kaye <[email protected]>; Pelt, Rich R < > Subject:RE: [EXTERNAL] RE: STN 125742/5 -COVID-19 Vaccine, mRNA (COMIRNATY): Product Correspondence -CBER…
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CT05 -GSOP -RF05 7.0PHA SE [1/2/3] INFORMED CONSENT PEDIA TRIC STUDY TEMPLA TE01-Jul-2019 Protocol Number: C4591007ICD Version Date :09Aug2021 Phase 2 /3 Lower Dose Evaluation , Parental Consent Study Country SiteLanguage: Center ID: N/A Country: N/A ICD Derived From: N/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 Number (Study/Country/Site) :…
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CT05 -GSOP -RF05 7.0PHA SE [1/2/3] INFORMED CONSENT PEDIA TRIC STUDY TEMPLA TE01-Jul-2019 Protocol Number: C4591007ICD Version Date :09Aug2021 Phase 1 Lower Dose Evaluation, Parental Consent Study Country SiteLanguage: Center ID: N/A Country: N/A ICD Derived From: N/A CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Cons ent Pediatric Study Template ( 01-Jul-2019) TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site) Sponsor Consent Version Number (Study/Country/Site) :…
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Pfizer Global Regulatory Affairs Pfizer Inc. 235 East 42ndStreet/New York , NY 10017 -5755 Global Product Developm ent 30August2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research DocumentControl 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 AN…