Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 356 pages
Page 1 of 356 ***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: 1135 Site Name: (1135) Anaheim Clinical Trials Subject No: 11351265 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:34 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 option is…
Pfizer Documents (PHMPT/FDA)
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· 123 pages
FDA-CBER-2021-5683-0938759 FDA-CBER-2021-5683-0938760 FDA-CBER-2021-5683-0938761 FDA-CBER-2021-5683-0938762 FDA-CBER-2021-5683-0938763 FDA-CBER-2021-5683-0938764 FDA-CBER-2021-5683-0938765 FDA-CBER-2021-5683-0938766 FDA-CBER-2021-5683-0938767 FDA-CBER-2021-5683-0938768 FDA-CBER-2021-5683-0938769 FDA-CBER-2021-5683-0938770 FDA-CBER-2021-5683-0938771 FDA-CBER-2021-5683-0938772 FDA-CBER-2021-5683-0938773 FDA-CBER-2021-5683-0938774 FDA-CBER-2021-5683-0938775 FDA-CBER-2021-5683-0938776…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 249 pages
Page 1 of 249 ***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: 1135 Site Name: (1135) Anaheim Clinical Trials Subject No: 11351143 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:34 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 option is…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 195 pages
Page 1 of 195 ***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: 1197 Site Name: (1197) Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten Drescher Subject No: 11971097 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 13:11 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)
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· 652 pages
Page 1 of 652 ***Confidential*** Header Text: C4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck Subject No: 11951132 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 12:55 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 option is…
Pfizer Documents (PHMPT/FDA)
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· 264 pages
Page 1 of 264 ***Confidential*** Header Text: C4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck Subject No: 11951131 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 12:55 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 option is…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 190 pages
Page 1 of 190 ***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck Subject No: 11951059 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 12:55 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 option…
Pfizer Documents (PHMPT/FDA)
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· 641 pages
Page 1 of 641 ***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck Subject No: 11951023 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 12:55 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 option…
Pfizer Documents (PHMPT/FDA)
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· 714 pages
Page 1 of 714 ***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck Subject No: 11951017 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 12:55 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 option…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 202 pages
Page 1 of 202 ***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck Subject No: 11951014 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 12:55 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 option…
Pfizer Documents (PHMPT/FDA)
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· 500 pages
Page 1 of 500 ***Confidential*** Header Text: C4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck Subject No: 11951008 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 12:55 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 option is…
Pfizer Documents (PHMPT/FDA)
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· 528 pages
Page 1 of 528 ***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck Subject No: 11951006 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 12:55 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 option…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 257 pages
Page 1 of 257 ***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck Subject No: 11951003 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 12:55 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 option…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 241 pages
Page 1 of 241 ***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: 1177 Site Name: (1177) East-West Medical Research Institute Subject No: 11771317 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 12:55 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,…
Pfizer Documents (PHMPT/FDA)
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· 201 pages
Page 1 of 201 ***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: 1177 Site Name: (1177) East-West Medical Research Institute Subject No: 11771222 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 12:55 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,…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 157 pages
Page 1 of 157 ***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: 1177 Site Name: (1177) East-West Medical Research Institute Subject No: 11771204 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 12:55 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,…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 294 pages
Page 1 of 294 ***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: 1171 Site Name: (1171) Martin Diagnostic Clinic Subject No: 11711212 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 12:23 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 option…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 213 pages
Page 1 of 213 ***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: 1171 Site Name: (1171) Martin Diagnostic Clinic Subject No: 11711045 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 12:23 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 option…
Pfizer Documents (PHMPT/FDA)
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· 48 pages
Revised: 22 September 2021 1 FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION PROVIDERS) EM ERGENCY USE AUTHORIZATION (EUA) OF THE PFIZER -BIONTECH COVID- 19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID -19) The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer -BioNTech COVID- 19 Vaccine, for active immunization to prevent COVID -19 in individuals 12…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 4 pages
Tray remains consistent on every page of website FDA-CBER-2021-5683-0952139 FDA-CBER-2021-5683-0952140 Drives to: http:// labeling.pfizer.co m/ShowLabeling.as px?id=15623 Drives to: http:// labeling.pfizer.com/ ShowLabeling.aspx ?id=14471&format=pdf Drives to: http:// labeling.pfizer.co m/ShowLabeling.as px?id=14472&format =pdf FDA-CBER-2021-5683-0952141 FDA-CBER-2021-5683-0952142