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2373 documents

125742 S42 M1 356h

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

08/11/2021 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 S12 M1 356h

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

07/15/2021 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 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 prevent…

125742 S10 M1 356h

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

07/02/2021 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 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 prevent…

125742 S7 M1 356h

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

06/16/2021 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 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 prevent…

125742 S9 M1 356h

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

07/02/2021 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 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 prevent…

125742 S5 M1 356h

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

05/24/2021 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 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 prevent…

125742 S13 M1 356h

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

07/16/2021 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 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 prevent…

125742 S24 M1 356h

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

07/30/2021 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 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 prevent…

125742 S16 M1 356h

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

07/23/2021 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 S43 M1 356h

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

08/11/2021 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 S1 M5 CRF c4591001 1231 12312679

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 254 pages

Page 1 of 254 ***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Subject No: 12312679 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 20:20 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…

125742 S1 M5 CRF c4591001 1231 12312660

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 291 pages

Page 1 of 291 ***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Subject No: 12312660 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 16:45 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…

125742 S1 M5 CRF c4591001 1231 12312593

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 188 pages

Page 1 of 188 ***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Subject No: 12312593 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 16:45 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…

125742 S1 M5 CRF c4591001 1231 12312577

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 200 pages

Page 1 of 200 ***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Subject No: 12312577 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 16:45 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…

125742 S1 M5 CRF c4591001 1231 12312576

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 227 pages

Page 1 of 227 ***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Subject No: 12312576 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 16:45 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…

125742 S1 M5 CRF c4591001 1231 12312529

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 215 pages

Page 1 of 215 ***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Subject No: 12312529 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 16:45 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…

125742 S1 M5 CRF c4591001 1231 12312476

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 167 pages

Page 1 of 167 ***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Subject No: 12312476 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 16:45 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…

125742 S1 M5 CRF c4591001 1231 12312420

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 257 pages

Page 1 of 257 ***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Subject No: 12312420 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 16:45 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…

125742 S1 M5 CRF c4591001 1231 12312390

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 208 pages

Page 1 of 208 ***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Subject No: 12312390 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 16:45 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…

125742 S1 M5 CRF c4591001 1231 12312125

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 167 pages

Page 1 of 167 ***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Subject No: 12312125 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 16:45 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…