Pfizer Documents (PHMPT/FDA)
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Pfizer Documents (PHMPT/FDA)
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From: Gemignani, Helen S To: [email protected] Subject: COMIRNATY STN 125742 - PMR/PMC Communications Date: Thursday, September 30, 2021 4:49:00 PM Attachments: image002.png Good afternoon Dr. Patel, We are in receipt of your 8/30/2021, PMR/PMC Correspondence Status Update submission, to your COMIRNATY BLA. This submission notified the BLA of the submission of study protocols to the IND for [ PMR# 4, Study C4591009] and [ PMC# 12 , Study C4591012]. Please note, in the BLA Approval…
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From: Patel, Amit To: Okoye, Christopher Cc: Austin-Hansberry, Lori Subject: [EXTERNAL] RE: FDA Waiver - COMIRNATY Date: Wednesday, September 29, 2021 5:04:08 PM Attachments: image001.png CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the sender and know the content is safe. Hi Christopher, I confirm receipt. Thanks Amit From: Okoye, Christopher <[email protected]> Sent: Wednesday, September 29, 2021…
Pfizer Documents (PHMPT/FDA)
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VACCINE RESEARCH SOP PEARL RIVER, NY TITLE: Data Review Procedures for Direct Luminex Immunoassays in LIMS v6Doc. Number: VR-SOP-LC-11120 Version: 3.0 Doc. Alias: NA PFIZER CONFIDENTIAL Page 1 TABLE OF CONTENTS LIST OF TABLES ................................ ................................ ................................ ..................... 2 1. HISTORICAL REVI SION SUMMARY ................................ ................................ ..............3 2. PURPOSE…
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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 : 10 Sep 2021 Phase 2/3 Obtaining Serum Samples for Potential Troponin I Testing Study Country SiteLanguage: English 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…
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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 : 06Aug 2021 Phase 2/3 Placebo -Controlled Selected Dose Study Country SiteLanguage: English Center ID: N/A Country: N/A ICD Derived From: 02 Jul 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring, MD 20993 CENTER FOR BIOLOGICS EVALUATION AND RESEARCH OFFICE OF VACCINES RESEARCH AND REVIEW DIVISION OF VACCINES AND RELATED PRODUCTS APPLICATIONS DATE: September 10, 2021 PAGES: 4 TO: BioNTech RNA Pharmaceuticals GmbH/Pfizer. Inc. Attention: Amit Patel 235 East 42ndStreet New York, NY 10017 Phone: 214-918-5262 Fax number: 845-474-3500 E-mail: [email protected] FROM: Laura Gottschalk, Ph.D.…
Pfizer Documents (PHMPT/FDA)
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PF-07302048 (BNT162b2 RNA -Based COVID -19 Vaccine) Protocol C4591020 Protocol, 18January2021 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 1 A PHASE 3, RANDOMIZE D, OBSERVER -BLIND ST UDY TO EVALUATE THE SAFETY, TOLERABILITY , AND IMMUNOGENICITY OF A LYOPHILIZED FORMULATION OFTHE VACCINE CANDIDA TEBNT162b2 AGAINST COVID-19 INHEALTHY ADULTS 18 T HROUGH 55 YEARS OF A GE Study Sponsor: BioNTech Study Conducted By: Pfizer Study Intervention Number:…
Pfizer Documents (PHMPT/FDA)
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PRIVATE AND CONFIDENTIAL Avon CAP Study Protocol Version 2 .2 | 30thJanuary 2021 IRAS 283899 Page 1of 65 UOB ConfidentialUOB Confidential Avon Community Acquired Pneumonia Study (Avon CAP): APan-pandemic Acute Lower Respiratory Tract Disease Surveillance Study Protocol Version 2.2 Protocol Date 30/01/2021 Sponsor University of Bristol Funder Pfizer Study Co -ordinating Centre Bristol Children’s Vaccine Centre…
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Page 1 of 40Statistical analy sis plan Avon Community Acquired Pneumonia Study (Avon CAP): A Pan- pandemic Acute Lower Respiratory Tract Disease Surveillance Study Sponsor Project Reference Number 2020 -2991 ISRCTN registry number IRAS ID Number 283899 REC Number 20/EE/0157 Pfizer reference number WI255886 -1 090177e1969c5f96\Approved\Approved On: 24-Mar-2021 17:28 (GMT) FDA-CBER-2021-5683-1073634 Page 2 of 40Contents CHAPTER 1 –Study introduction and conduct…
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Listing 7.7.6 Page 3of 4 BNT162b2 Protocol C4591008 Participant Reported Unplanned Hospitalization PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADHOSP, HO, CE Generated from /dcri/ct/hero_together/lists/l_hosp.sas on 24MAY2021 12:45 Page 1614 of 1689 Subject ID Age/Sex/Race Vaccination Date Admission DateDays Hospitalized Condition(s) Causing hospitalization C4591008 -1306785856 35/F/NOT REPORTED2020 -12-23 2021 -01-25 4 COVID -19…
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Appendix 7 List of Subject Data Listings 090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) Page 1 FDA-CBER-2021-5683-1075881 TABLE OF CONTENTS Listing 7.7.1 -Withdrawn Subjects ................................................................................................................................................................................................... 1 Listing 7.7.2 -Participant Reported Death…
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TELECONFERENCE SUMMARY Application number: BLA STN 125742/0 Product name: COVID -19 Vaccine, mRNA (COMIRNATY) Proposed Indication: Active immunization to prevent COVID -19 caused by SARS-CoV -2 in individuals 16 years of age and older Applicant: BioNTech Manufacturing GmbH (in partnership with Pfizer, Inc.) Teleconference date & time: August 16 , 2021; 4:00 PM - 4: 16 PM EDT FDA Participants: Maryna Eichelberger , Ph.D. Mary Malarkey Ramachandra Naik , Ph.D. …
Pfizer Documents (PHMPT/FDA)
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From: Naik, Ramachandra <[email protected]> Sent: Monday, August 16, 2021 5:26 PM To: Harkins Tull, Elisa <[email protected]> Cc: Gottschalk, Laura <[email protected]>; Smith, Michael (CBER) <[email protected]>; Rohlfing, Paul <[email protected]>; Aghajani Memar, Neda <[email protected]>; Boyce, Donna <[email protected]> Subject: STN 125742/0 – COMIRNATY – Submission of CMC information to support extension of shelf…
Pfizer Documents (PHMPT/FDA)
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From: Smith, Michael (CBER) Sent: Monday, August 16, 2021 10:38 AM To: Harkins Tull, Elisa <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]>; Rohlfing, Paul <[email protected]> Subject: STN 1 25742.0: IR RE diluent suppliers Elisa, The review team has the below information request for…
Pfizer Documents (PHMPT/FDA)
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We have the following requests and instructions regarding test methods, the lot release process, and the lot release protocol template: A. Regarding the RNA integrity assay by CGE: Please explain how the If available, provide the work instructions for CGE or commit t o generating these instructions. B. Regarding lot release of the 7 EUA lots: 1. Please send samples (20 vials) of each lot to the address noted below as soon as possible. We can receive them any day and prefer…
Pfizer Documents (PHMPT/FDA)
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We have the following requests and instructions regarding test methods, the lot release process, and the lot release protocol template: A. Regarding the RNA integrity assay by CGE: Please explain how the If available, provide the work instructions for CGE or commit t o generating these instructions. B. Regarding lot release of the 7 EUA lots: 1. Please send samples (20 vials) of each lot to the address noted below as soon as possible. We can receive them any day and prefer…
Pfizer Documents (PHMPT/FDA)
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From: Smith, Michael (CBER) Sent: Friday, August 13, 2021 12:32 PM To: Aghajani Memar, Neda <[email protected]>; Rohlfing, Paul <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]>; Harkins Tull, Elisa <[email protected]>; Devlin, Carmel M <[email protected]> Subject: STN 125742.0: Requests and instructions regarding test methods, the lot release process, and the lot…
Pfizer Documents (PHMPT/FDA)
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From: Smith, Michael (CBER) Sent: Friday, August 13, 2021 3:36 PM To: Aghajani Memar, Neda <[email protected]>; Rohlfing, Paul <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]>; Harkins Tull, Elisa <[email protected]>; Devlin, Carmel M <[email protected]> Subject: STN 125742.0: 7 facility questions from the DMPQ team Neda and Paul, The DMPQ review team has the…
Pfizer Documents (PHMPT/FDA)
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From: Zubkova, Iryna Sent: Friday, August 13, 2021 5:46 PM To: DeCiero, Daniel Cc: Peters, Lori; Zubkova, Iryna; Naik, Ramachandra; Smith, Michael (CBER); Gottschalk, Laura; Ertel, Donald Subject: Request for Compliance Check BLA STN 125742/0 Importance: High Hello Daniel ! Please execute the Compliance Check for BLA 125742/0. The PD UFA ADD is January 16, 2022. But the internal ADD is August 20, 2021 or August 27, 2021. Facilities table has been updated and…