Pfizer Documents (PHMPT/FDA)

125742 S1 M5 CRF c4591001 1087 10871354

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 118 pages

Page 1 of 118 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC Subject No: 10871354 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:22 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3…

125742 S1 M5 CRF c4591001 1087 10871355

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 158 pages

Page 1 of 158 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC Subject No: 10871355 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:22 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3…

125742 S1 M5 CRF c4591001 1087 10871557

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 158 pages

Page 1 of 158 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC Subject No: 10871557 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:22 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3…

125742 S68 M1 356h

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 7 pages

08/19/2021 BioNTech Manufacturing GmbH +49 (0) 6131 9084-7593 +49 (0) 6131 9084-390 An der Goldgrube 12 Mainz N/A Germany 55131 [email protected] 117645848 2229 Elisa Harkins, Global Regulatory Lead, Pfizer Global Regulatory Affairs - Vaccines 500 Arcola Road Collegeville PA 19426215-280-5503 845-474-3500 [email protected] 125742 [COVID-19 mRNA Vaccine (nucleoside modified)] COMIRNATY COVID-19 Vaccine (BNT162, PF-07302048) Liquid 30 mcg Intramuscular Active immunization to…

125742 S64 M1 356h

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 7 pages

08/19/2021 BioNTech Manufacturing GmbH +49 (0) 6131 9084-7593 +49 (0) 6131 9084-390 An der Goldgrube 12 Mainz N/A Germany 55131 [email protected] 117645848 2229 Elisa Harkins, Global Regulatory Lead, Pfizer Global Regulatory Affairs - Vaccines 500 Arcola Road Collegeville PA 19426215-280-5503 845-474-3500 [email protected] 125742 [COVID-19 mRNA Vaccine (nucleoside modified)] COMIRNATY COVID-19 Vaccine (BNT162, PF-07302048) Liquid 30 mcg Intramuscular Active immunization to…

125742 S82 M1 356h

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 7 pages

08/26/2021 BioNTech Manufacturing GmbH +49 (0) 6131 9084-7593 +49 (0) 6131 9084-390 An der Goldgrube 12 Mainz N/A Germany 55131 [email protected] 117645848 2229 Amit Patel, Director, Pfizer Global Regulatory Affairs - Vaccines 235 East 42nd Street New York NY 10017214-918-5262 845-474-3500 Amitkumar.Patel@pfizer 125742 [COVID-19 mRNA Vaccine (nucleoside modified)] COMIRNATY COVID-19 Vaccine (BNT162, PF-07302048) Liquid 30 mcg Intramuscular Active immunization to prevent COVID-19 caused…

019736 S196 M5 c4591011 protocol

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 171 pages

BNT162b2 (COVID -19 vaccine) C4591011NON-INTERVENTIONAL STUDY PROTOCOL Version 1.0, 29 January 2021 PFIZER CONFIDENTIAL Page 1of 170NON-INTERVENTIONAL ( NI) STUDY CONCEPT PR OTOCOL Title Active Safet y Surveillance of the Pfizer - BioNTech COVID -19 Vaccine in the U nited StatesDepartment of Defense Population Following Emergency Use Authorization Protocol number C4591011 Protocol version identifier Final Version 1.0 Date of last version of protocol 29January 2021 EUPost Authori zation…

125742 S15 M1 356h

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 6 pages

07/20/2021 BioNTech Manufacturing GmbH +49 (0) 6131 9084-7593 +49 (0) 6131 9084-390 An der Goldgrube 12 Mainz N/A Germany 55131 [email protected] 117645848 2229 Elisa Harkins, Global Regulatory Lead, Pfizer Global Regulatory Affairs - Vaccines 500 Arcola Road Collegeville PA 19426215-280-5503 845-474-3500 [email protected] 125742 [COVID-19 mRNA Vaccine (nucleoside modified)] COMIRNATY COVID-19 Vaccine (BNT162, PF-07302048) Liquid 30 mcg Intramuscular Active immunization to…

125742 S2 M5 5.4 singh dk 2020

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 88 pages

Title: SARS-CoV-2 infection leads to acute infection with dynamic cellular and inflammatory flux 1 in the lung that varies across nonhuman primate species 2 Authors: Dhiraj Kumar Singh1,2, Shashank R. Ganatra1,2, Bindu Singh1,2, Journey Cole1,2, Kendra J. 3 Alfson2, Elizabeth Clemmons1,2, Michal Gazi2, Olga Gonzalez1,2, Ruby Escobedo1,2, Tae-Hyung 4 Lee1,2, Ayan Chatterjee1,2, Yenny Goez-Gazi2, Riti Sharan1,2, Rajesh Thippeshappa1,2, Maya 5 Gough1,2, Cynthia Alvarez1,2, Alyssa…

19736 S0185 M1 smsr 01dec2020 31dec2020

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 378 pages

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019736 S387 M5 c4591008 interim protocol

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 43 pages

Pfizer -BioNTech COVID -19 Vaccine C4591008 NON- INTERVENTIONAL STUDY PROTOCOL V3.0, 20 April 2021 PFIZER CONFIDENTIAL Page 1of 43NON- INTERVENTIONAL (NI) STUDY PROTOCOL Study Information Title HERO- Together :A post-Emergency Use Authorization observational c ohort s tudy to evaluate the safet y of the Pfizer -BioNTech COVID -19 v accine in US h ealthcare workers , their families, and their communities Protocol number C4591008 Protocol version identifier Version 3.0 Date April 20,…

125742 S55 M1 356h

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 7 pages

08/17/2021 BioNTech Manufacturing GmbH +49 (0) 6131 9084-7593 +49 (0) 6131 9084-390 An der Goldgrube 12 Mainz N/A Germany 55131 [email protected] 117645848 2229 Elisa Harkins, Global Regulatory Lead, Pfizer Global Regulatory Affairs - Vaccines 500 Arcola Road Collegeville PA 19426215-280-5503 845-474-3500 [email protected] 125742 [COVID-19 mRNA Vaccine (nucleoside modified)] COMIRNATY COVID-19 Vaccine (BNT162, PF-07302048) Liquid 30 mcg Intramuscular Active immunization to…

019736 S470 M5 c4591012 protocol

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 195 pages

BNT162b2 (COVID -19 vaccine) C4591012 NON- INTERVENTIONAL STUDY PROTOCOL Version 2.0, 31 Aug 2021 PFIZER CONFIDENTIAL Page 1of 194NON-INTERVENTIONAL ( NI) STUDY CONCEPT PR OTOCOL Title Post-Emergency Use Authorization Active Safety Surveillance Study among Individuals in the Veteran’s Affairs Health Sy stem Receiving Pfizer -BioNTech Coronavirus Disease 2019 (COVID -19) Vaccine Protocol number C4591012 Protocol version identifier Version 2.0 Date of last version of protocol 27January2021…