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: Naik, Ramachandra <[email protected]> Sent: Monday, July 19, 2021 11:40 AM To: Harkins Tull, Elisa <[email protected]> Cc: Gottschalk, Laura <[email protected]>; Smith, Michael (CBER) <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]>; Rohlfing, Paul <[email protected]> Subject: BLA STN 125742/0 – COMIRNATY - COVID -19 mRNA Vaccine - Issuance of BLA license…
From: Gottschalk, Laura Sent: Friday, July 16, 2021 3:29 PM To: [email protected] Cc: 'Aghajani Memar, Neda' <[email protected]>; [email protected]; Naik, Ramachandra <[email protected]>; Smith, Michael (CBER) <[email protected]>; [email protected] Subject: STN 125742/0: IR RE sterility a nd endotoxin methods Dear Ms. Harkins, Additional information is needed to complete our review of the sterility and endotoxin…
From: Gottschalk, Laura Sent: Friday, July 16, 2021 8:16 AM To: '[email protected]' <[email protected]> Cc: 'Aghajani Memar, Neda' <[email protected]>; '[email protected]' <[email protected]>; Naik, Ramachandra <[email protected]>; Smith, Michael (CBER) <[email protected]>; '[email protected]' <Paul.Rohlfing@ pfizer.com> Subject: STN 125742/0: IR RE LRP template and DS handling instructions Dear Ms.…
CONCURRENCE PAGE This page must be uploaded through CBER Connect. Do NOT send this page to the applicant . Do NOT post this page to the Biological Approvals website. Application #: STN: BL 125742.0 Communication Name: Filing Notification Communication ID: LTR -BLAFILE -02 Instructions for entering communication into the appropriate regulatory system: Letter Type: Filing Notification (FL) ; No Deficiencies Identified (NDI) Drafted by: M. Smith : 5/18/2021,…
From: Smith, Michael (CBER) Sent: Friday, July 9, 2021 4:46 PM 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 the validation of the RNA Integrity by capillary gel electrophoresis (CGE) method Elisa, The review team has three questions for…
From: Naik, Ramachandra Sent: Friday, July 02, 2021 6:34 PM To: 'Harkins Tull, Elisa' <[email protected]> Cc: Gottschalk, Laura <[email protected]>; Smith, Michael (CBER) <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]> Subject: STN 125742/0 – COMIRNATY – CBER comments regar ding CMC information and categorical exclusion for an environment analysis Dear Ms. Harkins, Our…
CMC REVIEW MEMORANDUM Date: December 22, 2021 To: Biologics License Application (BLA) File STN 125742 From: Xiao Wang, CMC Reviewer, OVRR/DVP Through: Anissa Cheung, OVRR/DVP Anissa M. Cheung -S Dig tally signed by Anissa M. Cheung -S DN: c=US o=U.S. Government ou=HHS ou=FDA ou=People 0.9.23 2.19200300.100.1.1=1300155069 cn=Anissa M. Cheung -S Date: 2021.12.22 11:51: -0500 Applicant: BioNTech Manufacturing GmbH (in partnership with…
sϰͺϮϬϭϵϭϭϬϳͺ>, WĂŐĞϭŽĨϮOffice of Biostatistics and Epidemiology/Division of Epidemiology 3HULRGLF 6DIHW\ 5HSRUW 5HYLHZ &KHFNOLVW Completed by Reviewer Product Name Manufacturer STN # DCC Login ID # Submission Type PAER PSUR PBRER PADER Submission Format ELECTRONIC PAPER Reporting Period FROM TO Date Received by FDA Date Routed to Reviewer Regulatory Information Specialist (RIS) - Name Reviewer - Name Reviewer Signature (electronic signature) COMMENTSCOVID-19 vaccine, mRNA (BNT162b2)…
sϰͺϮϬϭϵϭϭϬϳͺ>, WĂŐĞϭŽĨϮOffice of Biostatistics and Epidemiology/Division of Epidemiology 3HULRGLF 6DIHW\ 5HSRUW 5HYLHZ &KHFNOLVW Completed by Reviewer Product Name Manufacturer STN # DCC Login ID # Submission Type PAER PSUR PBRER PADER Submission Format ELECTRONIC PAPER Reporting Period FROM TO Date Received by FDA Date Routed to Reviewer Regulatory Information Specialist (RIS) - Name Reviewer - Name Reviewer Signature (electronic signature) COMMENTSPfizer-BioNTech COVID-19 Vaccine…
From: Smith, Michael (CBER) Sent: Friday, June 25, 2021 3:23 PM 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] ov> Subject: STN 125742.0: IR RE LRP template and samples & reagents Elisa, The review team has the below Information Request for you regarding the lot …
sϰͺϮϬϭϵϭϭϬϳͺ>, WĂŐĞϭŽĨϮOffice of Biostatistics and Epidemiology/Division of Epidemiology 3HULRGLF 6DIHW\ 5HSRUW 5HYLHZ &KHFNOLVW Completed by Reviewer Product Name Manufacturer STN # DCC Login ID # Submission Type PAER PSUR PBRER PADER Submission Format ELECTRONIC PAPER Reporting Period FROM TO Date Received by FDA Date Routed to Reviewer Regulatory Information Specialist (RIS) - Name Reviewer - Name Reviewer Signature (electronic signature) COMMENTSPfizer-BioNTech COVID-19 Vaccine…
sϰͺϮϬϭϵϭϭϬϳͺ>, WĂŐĞϭŽĨϮOffice of Biostatistics and Epidemiology/Division of Epidemiology 3HULRGLF 6DIHW\ 5HSRUW 5HYLHZ &KHFNOLVW Completed by Reviewer Product Name Manufacturer STN # DCC Login ID # Submission Type PAER PSUR PBRER PADER Submission Format ELECTRONIC PAPER Reporting Period FROM TO Date Received by FDA Date Routed to Reviewer Regulatory Information Specialist (RIS) - Name Reviewer - Name Reviewer Signature (electronic signature) COMMENTSPfizer-BioNTech COVID-19 Vaccine…
sϰͺϮϬϭϵϭϭϬϳͺ>, WĂŐĞϭŽĨϮOffice of Biostatistics and Epidemiology/Division of Epidemiology 3HULRGLF 6DIHW\ 5HSRUW 5HYLHZ &KHFNOLVW Completed by Reviewer Product Name Manufacturer STN # DCC Login ID # Submission Type PAER PSUR PBRER PADER Submission Format ELECTRONIC PAPER Reporting Period FROM TO Date Received by FDA Date Routed to Reviewer Regulatory Information Specialist (RIS) - Name Reviewer - Name Reviewer Signature (electronic signature) COMMENTSHuman coronavirus mRNA vaccine in…
sϰͺϮϬϭϵϭϭϬϳͺ>, WĂŐĞϭŽĨϮOffice of Biostatistics and Epidemiology/Division of Epidemiology 3HULRGLF 6DIHW\ 5HSRUW 5HYLHZ &KHFNOLVW Completed by Reviewer Product Name Manufacturer STN # DCC Login ID # Submission Type PAER PSUR PBRER PADER Submission Format ELECTRONIC PAPER Reporting Period FROM TO Date Received by FDA Date Routed to Reviewer Regulatory Information Specialist (RIS) - Name Reviewer - Name Reviewer Signature (electronic signature) COMMENTSHuman Coronavirus mRNA vaccine in…
sϰͺϮϬϭϵϭϭϬϳͺ>, WĂŐĞϭŽĨϮ2IILFH RI %LRVWDWLVWLFV DQG (SLGHPLRORJ\'LYLVLRQ RI (SLGHPLRORJ \ 3HULRGLF 6DIHW\ 5HSRUW 5HYLHZ &KHFNOLVW &RPSOHWHG E\ 5HYLHZHU 3URGXFW 1DPH 0DQXIDFWXUHU 671 '&& /RJLQ ,' 6XEPLVVLRQ 7\SH 3$(5 3685 3%5(5 3$'(5 6XEPLVVLRQ )RUPDW (/(&7521,& 3$3(5 5HSRUWLQJ 3HULRG )520 72 'DWH 5HFHLYHG E\ )'$ 'DWH 5RXWHG WR 5HYLHZHU 5HJXODWRU\ ,QIRUPDWLRQ 6SHFLDOLVW 5,6 1DPH 5HYLHZHU 1DPH 5HYLHZHU 6LJQDWXUH HOHFWURQLF VLJQDWXUH &200(1763IL]HU%LR17HFK &29,' 9DFFLQH…
From: Smith, Michael (CBER) Sent: Thursday, May 20, 2021 10:24 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 facilities Elisa , Neda and Carmel, The BLA review committee has the below facilities information requests for you: 1.…
sϰͺϮϬϭϵϭϭϬϳͺ>, WĂŐĞϭŽĨϮ2IILFH RI %LRVWDWLVWLFV DQG (SLGHPLRORJ\'LYLVLRQ RI (SLGHPLRORJ \ 3HULRGLF 6DIHW\ 5HSRUW 5HYLHZ &KHFNOLVW &RPSOHWHG E\ 5HYLHZHU 3URGXFW 1DPH 0DQXIDFWXUHU 671 '&& /RJLQ ,' 6XEPLVVLRQ 7\SH 3$(5 3685 3%5(5 3$'(5 6XEPLVVLRQ )RUPDW (/(&7521,& 3$3(5 5HSRUWLQJ 3HULRG )520 72 'DWH 5HFHLYHG E\ )'$ 'DWH 5RXWHG WR 5HYLHZHU 5HJXODWRU\ ,QIRUPDWLRQ 6SHFLDOLVW 5,6 1DPH 5HYLHZHU 1DPH 5HYLHZHU 6LJQDWXUH HOHFWURQLF VLJQDWXUH &200(1763IL]HU%LR17HFK &29,' 9DFFLQH 3IL]HU…
sϰͺϮϬϭϵϭϭϬϳͺ>, WĂŐĞϭŽĨϮ2IILFH RI %LRVWDWLVWLFV DQG (SLGHPLRORJ\'LYLVLRQ RI (SLGHPLRORJ \ 3HULRGLF 6DIHW\ 5HSRUW 5HYLHZ &KHFNOLVW &RPSOHWHG E\ 5HYLHZHU 3URGXFW 1DPH 0DQXIDFWXUHU 671 '&& /RJLQ ,' 6XEPLVVLRQ 7\SH 3$(5 3685 3%5(5 3$'(5 6XEPLVVLRQ )RUPDW (/(&7521,& 3$3(5 5HSRUWLQJ 3HULRG )520 72 'DWH 5HFHLYHG E\ )'$ 'DWH 5RXWHG WR 5HYLHZHU 5HJXODWRU\ ,QIRUPDWLRQ 6SHFLDOLVW 5,6 1DPH 5HYLHZHU 1DPH 5HYLHZHU 6LJQDWXUH HOHFWURQLF VLJQDWXUH &200(1763IL]HU%LR17HFK &29,' 9DFFLQH 3IL]HU…
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 2099 3 www.fda.gov Our STN: BL 125742 /0 ACKNOWLEDGEMENT BioNTech Manufacturing GmbH Attention: Elisa Harkins May 13 , 2021 500 Arcola Road Collegeville , PA 19426 Dear Ms. Harkins : Please refer to your B iologics License Application (BLA) submitted under section 351(a) of the Public Health Service Act (PHS Act) for the following biological product: Our Submission Tracking…
From: Smith, Michael (CBER) Sent: Wednesday, August 18, 2021 2:36 PM To: Rohlfing, Paul <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]>; Harkins Tull, Elisa <[email protected]> Subject: RE: [EXTERNAL] RE: STN 125742.0: IR on DS Paul, The review team provided me the below response to…