Pfizer Documents (PHMPT/FDA)

125742 45 S211 M5 c4591001 1009 10091294

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 444 pages

Page 1 of 444 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South Subject No: 10091294 Subject Initials: --- Generated By: Generated Time (GMT): 10-Nov-2021 20:44 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol…

125742 45 S211 M5 c4591001 1009 10091221

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 251 pages

Page 1 of 251 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South Subject No: 10091221 Subject Initials: --- Generated By: Generated Time (GMT): 10-Nov-2021 20:44 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol…

125742 45 S211 M5 c4591001 1007 10071581

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 252 pages

Page 1 of 252 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center Subject No: 10071581 Subject Initials: --- Generated By: Generated Time (GMT): 10-Nov-2021 20:44 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol…

125742 45 S211 M5 c4591001 1007 10071499

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 203 pages

Page 1 of 203 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center Subject No: 10071499 Subject Initials: --- Generated By: Generated Time (GMT): 10-Nov-2021 20:44 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol…

125742 45 S211 M5 c4591001 1005 10051449

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 177 pages

Page 1 of 177 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc. Subject No: 10051449 Subject Initials: --- Generated By: Generated Time (GMT): 10-Nov-2021 20:44 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3…

125742 45 S211 M5 c4591001 A 1mth adrg

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 67 pages

Analysis Data Reviewer ’s Guide sBLA (12-15 Years of Age ) BioNTech SE and PFIZER INC. Study C4591001 090177e198e31cd5\Final\Final On: 15-Dec-2021 18:40 (GMT) FDA-CBER-2022-5812-0491861 Study C4591001 Analysis Data Reviewer’s Guide 2 ANALYSIS DATA REVIEWER’S GUIDE REVISION HISTORY Version Summary of Major Change(s) and Impact Version Date 1.0 First approved version of Analysis Data Reviewer Guide 14-Dec-2021 090177e198e31cd5\Final\Final On:…

125742 45 S211 M5 c4591001 1270 12701237

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 1152 pages

Page 1 of 1152 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento Subject No: 12701237 Subject Initials: --- Generated By: Generated Time (GMT): 10-Nov-2021 20:44 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3…

125742 45 07 08 2022 Memo Other

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 2 pages

Transmittal Memo TO: FROM: Lorrie McNeill Director, OCOD Doran Fink, M.D., Ph.D. $FWLQJ Deputy Director Office of Vaccines Research and Review RE: Action Package for: STN 125742/45, COVI D-19 Vaccine, mRNA (COMIRNATY) DATE: July 8, 2022 Office Point of Contact: Laura Gottschalk, Ph.D. Please update the following information on CBER’s Approval Web page for the product referenced above: Proper Name: COVID-19 Vaccine, mRNA Tradename: COMIRNATY Manufacturer: BioNTech…

125742 45 07 05 2022 Telecon Labeling via FAX

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 1 page

From: Smith, Michael (CBER) Sent: Tuesday, July 5, 2022 10:51 AM To:Mineo, Gosia Cc:Naik, Ramachandra <[email protected]>; Gottschalk, Laura <Laura.G [email protected]>; MaguireThon, Meghan <[email protected]>; Devlin, Carmel M <[email protected]>; Harkins Tull, Elisa <[email protected]>; Co rpuz, Katherine Subject: STN 125742/45: Final Draft Label of PI's Gosia, We have reviewed the Package Inserts that were submitted in Amendment 13 to STN…

125742 45 07 01 2022 Memo Compliance Check Acc

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 3 pages

From: CBER Complicheck <[email protected]> Sent: Friday, July 1, 2022 11:42 AM To: Gottschalk, Laura <[email protected] v>; CBER Complicheck <[email protected]> Cc: Smith, Michael (CBER) <[email protected]>; Naik, Ramachandra <[email protected]>; MaguireThon, Meghan <[email protected]> Subject: RE: OVRR: Expedited Compliance Check Request for STN 125742/45 x Applicant Name: BioNTech Manufacturing GmbH (in partnership with…

125742 45 06 29 2022 Telecon Labeling via FAX

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 2 pages

From: Smith, Michael (CBER) Sent: Wednesday, June 29, 2022 10:35 AM To:'Mineo, Gosia' Cc:Naik, Ramachandra <[email protected]>; Gottschalk, Laura <Laura.G [email protected]>; MaguireThon, Meghan <[email protected]>; 'D evlin, Carmel M' <[email protected]>; 'Harkins Tull, Elisa' <[email protected]>; 'C orpuz, Katherine' Subject: STN 125742/45: Request for resubmission of PI w/ 7/202 2 added for the date under "recent major changes" and…

125742 45 06 27 2022 Memo Request For Complian

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 2 pages

From: Gottschalk, Laura Sent: Monday, June 27, 2022 5:38 PM To: CBER Complicheck <[email protected]> Cc: Smith, Michael (CBER) <[email protected]>; Naik, Ramachandra <[email protected]>; 'MaguireThon , Meghan' <[email protected]> Subject: OVRR: Expedited Compliance Check Request for STN 125742/45 Please execute a compliance check for the following efficacy supplement: x Applicant Name: BioNTech Manufacturing GmbH (in partnership with…

125742 45 06 13 2022 Telecon Covid 19 Delay

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 2 pages

From: Smith, Michael (CBER) Sent: Monday, June 13, 2022 4:28 PM To: Mineo, Gosia Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]>; MaguireThon, Me ghan <[email protected]>; Devlin, Carmel M <[email protected]>; Harkins Tull, Elisa <[email protected]> Subject: STN 125742/45: Delay in the review of this efficacy supplement Dear Ms. Mineo: Please reference the COVID- 19 Vaccine, mRNA (CORMIRNATY)…

125742 45 06 10 2022 Memo Committee Memo BIMO

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 3 pages

www.fda.gov_________________________________________________________________________________________________________________ DATE: June 10, 2022 FROM: Kanaeko R. Ravenell, MS Bioresearch Monitoring Branch (BMB) Division of Inspections and Surveillance (DIS)Office of Compliance and Biologics Quality (OCBQ) THROUGH: Dennis Cato, Chief, BMB THROUGH: Carrie M. Mamp illy, MPH, Director, DIS TO: Ramachandra Naik, PhD, Committee Chair Susan Wollersheim, MD, Clinical Reviewer…

125742 45 05 19 2022 Memo Committee Memo Postm

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 5 pages

1Department of Health and Human Services Food and Drug Administration Center for Biologics Eval uation and Research (CBER) Office of Biostatistics and Pharmacovigilance (OBPV) REAL WORLD EVIDENCE sBLA MEMORANDUM From : Yun Lu, PhD Mathematical Statistician Analytics and Benefit-Risk Assessment Team (ABRA) Office of Biostatistics and Pharmacovigilance (OBPV) CBER, FDA To: Ramachandra Naik, PhD Chair of the Review CommitteeOffice of Vaccines Research and Review Through : Richard Forshee, PhD…