125742 S1 M5 5351 c4591001 interim mth6 audit certificates

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1Facsimile of Ori ginal Di gital Si gnatureTemplate Version: January 2021 Confidential Page 1of 3Pfizer Regulatory Quality Assurance
Audit Certificate
I, the undersigned, confirm and certify that the following inves tigator site audit activities were performed.
Study C4591001
Twenty-Four (24) investigator s ite audits were pe rformed between 29- Apr-2020 and 13-Mar-2021 for Study 
C4591001 Phase 2/3*. 
Investigator NameCenter 
NumberCountry Dates of AuditType of 
AuditName of Auditor
Mulligan, Mark Joseph 1001 United States 27 Jul 2020 to 30 Jul 2020 Routine Jefferies, Maria
Neuzil, Kathleen
Maletic1002 United States 10 Aug 2020 to 13 A ug 2020 Routine Cutler, Robe rt
Seger, William
Michael1042 United States 10 Aug 2020 to 13 Aug 2020 Routine Popelca, Bogdan
Rankin, Bruce Glenn 1109 United States 18 Aug 2020 to 21 Aug 2020 Rou tine Patel, Frederic
Zerbini, Cristiano
Augusto de Freitas1226 Brazil 24 Aug 2020 to 27 Aug 2020 Routine Tewes, Elisabeth
Polack, Fernando
Pedro1231 Argentina 27 Aug 2020 to 03 Se p 2020 Routine Mohr, Andrea
Raad, George Louis 1079 Unite d States 01 Sep 2020 to 04 Sep 2020 Ro utine Jefferies, Maria
Arora, Samir 1091 United States 14 Sep 2020 to 17 Sep 2020 Routine Sa muels, Marilyn
Patel, Suchet R. 1077 United Sta tes 29 Sep 2020 to 02 Oct 2020 Routine Tewes, Elisabeth
Fried, David L. 1124 United States 05 Oct 2020 to 07 Oct 2020 Non-
RoutineCutler, Robert
Winkle, Peter John 1135 United States 12 Oct 2020 to 14 Oct 2020 Non-
RoutineCutler, Robert
Polack, Fernando 
Pedro1231 Argentina 13 Oct 2020 to 20 Oct 2020 Non-
RoutineMohr, Andrea
Reynolds, Steven H.  1149 Unite d States 16 Oct 2020 to 20 Oct 2020 Non-
RoutineCutler, Robert
Rankin, Bruce Glenn 1109 Unite d States 19 Oct 2020 to 22 Oct 2020 Non-
RoutineOprisko, Cheryl
Nell, Haylene 1247 South Africa 26 Oct 2020 to 29 Oct 2020 Routine T ewes, Elisabeth
Koch, Mark 1128 Unite d States 03 Nov 2020 to 06 Nov 2020 Non-
RoutineCutler, Robert
Schaefer, Axel 1195 Germany 16 Nov 2020 to 18 Nov 2020 Routine Auner , Dagmar
  090177e1968990d1\Approved\Approved On: 17-Mar-2021 02:12 (GMT)
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Template Version: January 2021 Confidential Page 2of 3Williams, Hayes
Taylor1251 United States 16 Nov 2020 to 18 Nov 2020 Routine Oprisko, Che ryl
Moreira Jr., Edson
Duarte1241 Brazil 24 Nov 2020 to 26 Nov 2020 Routine Mohr, Andrea
Riesenberg, Robert
Alan1162 United States 30 Nov 2020 to 04 Dec 2020 Non-
RoutineTafurth, Maria
Finn, Daniel John 1016 United Sta tes 01 Dec 2020 to 03 Dec 2020 Rou tine Jefferies, Maria
Akhan, Sila 1217 Turkey 01 Dec 2020 to 03 Dec 2020 Routine Clayton, S imon
Jennings, Timothy
William1008 United States 07 Dec 2020 to 10 Dec  2020 Routine Samuels, Marilyn
Christensen, Shane
Glade1009 United States 01 Mar 2021 to 04 M ar 2021 Routine Jilla, Abila sh
*Site 1001 and 1002 audited as part of Phase 1 
Approver:
Cecilia Gabarain
Senior Director, Regulatory Quality Assurance
DocUUID : 8ae50323-55c7-44d4-9a99-886930c6e127 090177e1968990d1\Approved\Approved On: 17-Mar-2021 02:12 (GMT)
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Template Version: January 2021  Confidential Page 3of 3
DocUUID : 8ae50323-55c7-44d4-9a99-886930c6e127REASON: I attest to the
accuracy and integrity ofthis document.
REASON: I approvethis document.
7997eefb-6feb-4dbc-a232-c15936633467
16 Mar 202108:30:041-0400
6809829b-f9ec-4ac9-bc23-e28cfba721dc
16 Mar 202111:17:012-0400090177e1968990d1\Approved\Approved On: 17-Mar-2021 02:12 (GMT)
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FDA-CBER-2021-5683-0029227
MSB
Validation Report as of: 16 Mar 2021 11:20:016-0400
1
Subject CN TAIGLE LLC
Subject DN [email protected],CN=TAIGLE LLC,OU= MSB,O=TAIGLE LLC,L=Irvine,ST=California,C=US
Email [email protected] # 19482482486555712400772614192179934953Issuer DN CN=Entrust Class 3 Client CA - SHA256,OU=(c) 2015 Entrust, Inc. - for authorized use only,OU=See www.entrust.net/legal-
terms,O=Entrust, Inc.,C=US
Signing Time 16 Mar 2021 11:17:012-0400
The Certificate chain was successfully built to a Trusted Root Certificate.
The Signer's identity is valid.
The Document has not been modified since the signature was appl ied.
This page was added to the original document by the MSB Validat ion Service (SVS) as part of the process to convert
active signature block content into inactive text. A full validation report of each signature is generated and cross-
referenced using a numeric footnote annotation.
DocUUID : 8ae50323-55c7-44d4-9a99-886930c6e127 090177e1968990d1\Approved\Approved On: 17-Mar-2021 02:12 (GMT)
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Audit Trail Report
Date User Document Action Details
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