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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…