Pfizer Documents (PHMPT/FDA)
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PF-07302048 (BNT162 b2 RNA-Based COVID -19 Vaccine) Protocol C4591007 Final ProtocolAmendment 3 , 10Sep 2021 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 1A PHASE 1 ,OPEN-LABEL DOSE-FINDING STUDY TO EVALUATE S AFETY, TOLERABILITY , AND IMMUNOGENICITY ANDPHASE 2/3 PLACEBO -CONTROLLED, OBSERVER -BLINDED SAFETY, TOLERABILIT Y, ANDIMMUNOGENICITY STUDY OF A SARS-COV-2 RNA VACCI NE CANDIDATE AGAINST CO VID-19 IN HEALTHY CHILDREN AND YOUNG ADULTS Study…
Pfizer Documents (PHMPT/FDA)
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PF-07302048 (BNT162 b2 RNA-Based COVID -19 Vaccine) Protocol C4591007 Final ProtocolAmendment 32, 1006SepAug2021 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 1A PHASE 1 ,OPEN-LABEL DOSE-FINDING STUDY TO EVALUATE S AFETY, TOLERABILITY , AND IMMUNOGENICITY ANDPHASE 2/3 PLACEBO -CONTROLLED, OBSERVER -BLINDED SAFETY, TOLERABILIT Y, ANDIMMUNOGENICITY STUDY OF A SARS-COV-2 RNA VACCI NE CANDIDATE AGAINST CO VID-19 IN HEALTHY CHILDREN AND YOUNG ADULTS…
Pfizer Documents (PHMPT/FDA)
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From: Smith, Michael (CBER) Sent: Friday, June 25, 2021 6:09 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: Clinical IR RE document titled “bnt162- 01-interim3 -report -body” Elisa, The clinical team has the attached IR regarding the document…
Pfizer Documents (PHMPT/FDA)
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From: Gottschalk, Laura <[email protected]> Sent: Thursday, August 19, 2021 12:54 PM To: Harkins Tull, Elisa <[email protected]> Cc: Devlin, Carmel M <[email protected]>; Aghajani Memar, Neda <[email protected]>; Smith, Michael (CBER) <[email protected]>; Naik, Ramachandra <[email protected]> Subject: STN 125742.0: 6th set of PI labeling comments - please respond by COB today Dear Elisa, Attached is the 6 th set of…
Pfizer Documents (PHMPT/FDA)
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From: Smith, Michael (CBER) Sent: Thursday, August 19, 2021 6:32 PM 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]> Subject: RE: [EXTERNAL] RE: STN 125742.0: IR RE PMR's and PMC's Elisa, We received the responses to our August 19, 2021 questions on the PMR and PMC…
Pfizer Documents (PHMPT/FDA)
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From: Smith, Michael (CBER) Sent: Thursday, August 19, 2021 11:35 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]> Subject: STN 125742.0: IR RE PMR's and PMC's Elisa, We have the below comments regarding the August 16, 2021, amendment containing your PMR and PMC…
Pfizer Documents (PHMPT/FDA)
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From: Smith, Michael (CBER) Sent: Wednesday, August 18, 2021 5:18 PM 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]> Subject: STN 125742.0: 5th set of PI labeling comments - please respond by 10:00 AM Thursday Elisa, I attached the 5th set of comments from the review…
Pfizer Documents (PHMPT/FDA)
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· 2 pages
From: Gottschalk, Laura < [email protected] > Sent: Wednesday, August 18, 2021 5:20 PM To: Harkins Tull, Elisa < [email protected] > Cc: Smith, Michael (CBER) < [email protected] >; Naik, Ramachandra <[email protected] >; Devlin, Carmel M <[email protected] >; Aghajani Memar, Neda < [email protected] > Subject: [EXTERNAL] STN 1 25742/0 – COMIRNATY (COVID -19 Vaccine, mRNA) - Comments regarding inclusion of draft carton…
Pfizer Documents (PHMPT/FDA)
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From: Naik, Ramachandra <[email protected]> Sent: Wednesday, August 18, 2021 6:58 PM To: Boyce, Donna <[email protected]> Cc: Smith, Michael (CBER) <[email protected]>; Gottschalk, Laura <[email protected]>; Harkins Tull, Elisa <[email protected]>; Devlin, Carmel M <[email protected]>; Aghajani Memar, Neda <[email protected]>; Ro hlfing, Paul <[email protected]> Subject: BLA STN 125742/0 – COMIRNATY (COVID…
Pfizer Documents (PHMPT/FDA)
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From: Smith, Michael (CBER) Sent: Tuesday, August 17, 2021 6:11 PM 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]> Subject: STN 125742.0: 4th set of PI labeling comments Elisa, I attached the 4th set of comments on the Package Insert (PI). Please e- mail us the …
Pfizer Documents (PHMPT/FDA)
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· 2 pages
From: Naik, Ramachandra <[email protected]> Sent: Tuesday, August 17, 2021 6:19 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]>; Rohlfing, Paul <[email protected]> Subject: STN 125742/0 – COMIRNATY (COVID -19 Vaccine, mRNA) – Follow -up comments…
Pfizer Documents (PHMPT/FDA)
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From: Smith, Michael (CBER) Sent: Monday, August 16, 2021 1:22 PM 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]> Subject: STN 125742.0: Second set of comments and questions on the carton and container labels Elisa, Our review of the information provided in your BLA…
Pfizer Documents (PHMPT/FDA)
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· 2 pages
From: Smith, Michael (CBER) Sent: Friday, August 13, 2021 6:22 PM To: Aghajani Memar, Neda <[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: 3rd set of PI labeling comments Neda, We have the attached 3rd set of comments on the Package Insert (PI). Please e - mail us the…
Pfizer Documents (PHMPT/FDA)
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From: Smith, Michael (CBER) Sent: Friday, August 13, 2021 10:31 AM To: Aghajani Memar, Neda <[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: Three questions from the clinical te am Neda, The clinical team has three questions for Pfizer – see below. Please respond by …
Pfizer Documents (PHMPT/FDA)
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· 3 pages
From: Smith, Michael (CBER) Sent: Friday, August 13, 2021 6:49 PM To: Aghajani Memar, Neda <[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: One clinical question Neda, The clinical team has one question for Pfizer - see below. They requested a response as soon as…
Pfizer Documents (PHMPT/FDA)
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From: Smith, Michael (CBER) Sent: Wednesday, June 9, 2021 2:12 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 1275742.0: Request for dates associated with PREA deferred studies Elisa, The clinical team has an information request regarding the…
Pfizer Documents (PHMPT/FDA)
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· 4 pages
From: Naik, Ramachandra <[email protected]> Sent: Friday, August 13, 2021 7:12 PM To: Harkins Tull, Elisa <[email protected]> Cc: Smith, Michael (CBER) <[email protected]>; Gottschalk, Laura <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]> Subject: STN 125742/0 – COMIRNATY (COVID -19 Vaccine, mR NA) - Safety -related Postmarketing Requirement/Postmarketing Commitment…
Pfizer Documents (PHMPT/FDA)
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· 3 pages
From: Smith, Michael (CBER) Sent: Friday, August 13, 2021 3:40 PM To: Aghajani Memar, Neda <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]>; Harkins Tull, Elisa <[email protected]>; Devlin, Carmel M <[email protected]> Subject: RE: [EXTERNAL] RE: STN 125742.0: Three questions f rom the clinical team Neda, The clinical team has the below response to your clarification…
Pfizer Documents (PHMPT/FDA)
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Pfizer Global Regulatory Affairs Pfizer Inc . 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 7 June 2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics 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 …
Pfizer Documents (PHMPT/FDA)
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· 8 pages
*********************************************************************************** ******************************;** Program Name : adxb.sas **; ** Date Created : 01Jun2021 **; ** Programmer Name: **; ** Purpose : Create adxb dataset **; ** Input data : xb adsl adc19ef **; ** Output data : adxb.sas7bdat **; *****************************************************************************************************************; %let …