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.
Get an AI answer drawn only from the Pfizer Documents (PHMPT/FDA) documents indexed here — every claim cited back to the filing or proceeding it came from. It will tell you plainly when the record doesn't cover your question, rather than guessing.
From: Smith, Michael (CBER) Sent: Wednesday, August 18, 2021 2:51 PM To: 'Harkins Tull, Elisa' <[email protected]>; 'Rohlfing, Paul' <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]>; 'Aghajani Memar, Neda' <[email protected] >; 'Devlin, Carmel M' <[email protected]> Subject: STN 125742.0: DBSQC comments Elisa and Paul, Our review of the information provided in…
From: Smith, Michael (CBER) Sent: Wednesday, August 18, 2021 4:01 PM To: Rohlfing, Paul <[email protected]> Cc: Gottschalk, Laura <[email protected]>; Naik, Ramachandra <[email protected]>; Aghajani Memar, Neda <[email protected]>; Harkins Tull, Elisa <[email protected]> Subject: RE: [EXTERNAL] FW: STN 125742.0: IR RE sh elf life and date of manufacture Paul, Regarding your question, we expect that it will be sufficient…
From: Jones, Kathleen (CBER) <[email protected]> Sent: Monday, August 30, 2021 5:26 PM To: Smith, Michael (CBER) <[email protected]>; Peters, Lori <[email protected]>; Fontan, Laura <[email protected]>; Price, Gregory <[email protected]>; Lynch, Christian <[email protected]>; Emerson, Debra <[email protected]>; Eltermann, John <[email protected]>; Renshaw, Carolyn <[email protected]>; Allen, Ekaterina…
From: Wang, Hsiaoling <[email protected]> Sent: Monday, August 30, 2021 3:10 PM To: Smith, Michael (CBER) <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]>; Sutkowski, Elizabeth M. <[email protected]>; Eichelberger, Maryna <[email protected]>; Pan, Tao <[email protected]>; Francis, Kori <[email protected]> Subject: RE: STN 125742.0.41: Response to DBSQC…
FDA-CBER-2021-5683-1150219 U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 w ww.fda.gov Our STN: BL 125742/0 UNIQUE INGREDIENT IDENTIFIER (UNII) CODE ASSIGNMENT August 6, 2021 BioNTech Manufacturing GmbH Attention: Elisa Harkins Pfizer Inc. 500 Arcola Road Collegeville , PA 19426 Dear Ms. Harkins : The Food and Drug Administration Amendments Act of 2007 (Pub. L. No. 110-85) (FDAAA) requires that establishment…
From: Smith, Michael (CBER) Sent: Thursday, August 5, 2021 3:13 PM To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]>; Rohlfing, Paul <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottscha lk, Laura <[email protected]> Subject: STN 125742.0: Diluent questions Elisa, The review team has the below questions regarding the…
From: Smith, Michael (CBER) Sent: Thursday, August 5, 2021 1:48 PM To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]>; Rohlfing, Paul <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottscha lk, Laura <[email protected]> Subject: STN 125742.0: 11 Facilities questions Elisa, The review team has the below 11 facilities questions,…
From: Gottschalk, Laura Sent: Thursday, August 5, 2021 11:45 AM To: Harkins Tull, Elisa <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Smith, Michael (CBER) <[email protected]>; Devlin, Carmel M <[email protected]>; Aghajani Memar, Neda <[email protected]> Subject: STN 125742/0 Proper Name Dear Ms. Harkins, Please note that the PROPER NAME to be used for your product in this BLA is “COVID -19 Vaccine,…
From: Smith, Michael (CBER) Sent: Wednesday, August 4, 2021 11:00 AM To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]> Subject: STN 125742.0: IR RE potency assay for determination of IVE by flow cytometry Elisa, The review team has two questions for you regarding the…
ATTACHMENT 1 - Electronic Protocol Page 1 cc: 000000 _0/Lic #/ C or – B or –FC Page 1 of y Lot Number: License Name of Product: Reason For…
From: Smith, Michael (CBER) Sent: Wednesday, August 4, 2021 4:48 PM To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]>; Rohlfing, Paul <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottscha lk, Laura <[email protected]> Subject: STN 125742.0: Comments on LRP template submitted to STN 125742/0.14 on 7/20 Elisa, The review team…
From: Smith, Michael (CBER) Sent: Tuesday, August 3, 2021 4:55 PM To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]>; Rohlfing, Paul <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottscha lk, Laura <[email protected]> Subject: STN 125742.0: CMC -related questions Elisa, Our review of the information provided in your BLA STN…
From: Smith, Michael (CBER) Sent: Monday, August 2, 2021 7:05 PM To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]>; Rohlfing, Paul <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottscha lk, Laura <[email protected]> Subject: STN 125742.0: Questions regarding validation of assay methods and lot release Elisa, The review team…
From: Smith, Michael (CBER) Sent: Tuesday, July 27, 2021 10:01 AM To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]> Subject: STN 125742.0: IR RE assessment of vaccine effectiveness Elisa, The review team has the below Information Request for Pfizer and BioNTech…
From: Gottschalk, Laura Sent: Monday, July 26, 2021 7:19 PM To: Harkins Tull, Elisa <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Smith, Michael (CBER) <[email protected]>; Devlin, Carmel M <[email protected]>; Aghajani Memar, Neda <[email protected]>; Rohlfing, Paul <[email protected]> Subject: STN 125742/0 – COMIRNATY (COVID -19 Vaccine, mRNA) – Comments regarding manufacturing and equipment Dear Ms.…
UTMB -Shi Lab SOP TITLE: Manual 96 -well Neutralization Assay for the Detection of Functional Antibodies to SARS -CoV-2 in Test Serum using Cytation 7 Image Reader Doc. Number: SHI -SOP -10011 Version: 2.0 UTMB -Shi Lab CONFIDENTIAL Page 1 TABLE OF CONTENTS 1.HISTORICAL REVISION SUMMARY ............................................................................... 2 Table 1. Chronological Summary of Previous Versions ........................................................ 2 2.PURPOSE…
Pfizer -BioNTech COVID- 19 Vaccine C4591008 NON- INTERVENTIONAL STUDY PROTOCOL V2.0, 27 January 2021 PFIZER CONFIDENTIAL Page 1 of 42 NON- INTERVENTIONAL (NI) STUDY PROTOCOL Study Information Title HERO Together : A post-Emergency Use Authorization observational cohort study to evaluate the safety of the Pfizer -BioNTech COVID-19 vaccine in US h ealthcare workers Protocol number C4591008 Protocol version identifier Version 2.0 Date 27 January 2021 EU Post…
COVID-19 Vaccine (BNT162, PF -07302048) BB-IND 19736 M 1.11.3 –Clinical Information Amendment PFIZER CONFIDENTIAL Page 1COVID-19 Vaccine (BNT162, PF -07302048) BB-IND 19736 Request for Assay Qualification Information July 09, 2020 090177e19452c4c3\Approved\Approved On: 09-Jul-2020 18:08 (GMT) FDA-CBER-2021-5683-1072446 COVID-19 Vaccine (BNT162, PF -07302048) BB-IND 19736 M 1.11.3 –Clinical Information Amendment PFIZER CONFIDENTIAL Page 2TABLE OF CONTENTS 1.BACKGROUND…
090177e197264d6f.docxCONSENT DOCUMENT COVER LETTER TITLE: HERO Together: A post -Emergency Use Authorization observational cohort study to evaluate the safet y of the Pfizer -BioNTech COVID -19 vaccine in US healthcare workers PROTOCOL NO.: C4591008 IRB Protocol #20204110 SPONSOR: Pfizer, I nc INVESTIGATOR: Emily O'Brien, PhD 200 Morris Street Durham, North Carolina 27701 United States STUDY -RELATED PHONE NUMBER(S): 1-844-846-6747 Dear Sir or Madam, Thank y ou for taki ng the time to…
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: 0 6Aug 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…