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1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TRADENAME safely and effectively. See full prescribing information for TRADENAME . TRADE NAME ( COVID- 19 mRNA vaccine [nucleoside -modified] ) suspension for intramuscular injection Initial U.S. Approval: YYYY ------------------------------- INDICATIONS AND USAGE ------------------------------ TRADENAME is a vaccine indicated for active immunization to prevent coronavirus…
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090177e196a0ee47\Approved\Approved On: 26-Mar-2021 06:11 (GMT) FDA-CBER-2021-5683-0950771
Pfizer Documents (PHMPT/FDA)
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BNT162b2 1.16 Risk Management Plan (Non-REMS) for Biologic License Application # 125742 CONFIDENTIAL Page 1PHARMACOVIGILANCE PLAN FOR BIOLOGIC LICENSE APPLICATION #125742 OF COVID-19 mRNA vaccine (nucleoside modified) (BNT162b2, PF -07302048) Date of Report: 17MAY2021 Version 1.0 090177e1970d7583\Approved\Approved On: 17-May-2021 19:14 (GMT) FDA-CBER-2021-5683-0950772 BNT162b2 1.16 Risk Management Plan (Non-REMS) for Biologic License Application # 125742 CONFIDENTIAL Page 2TABLE OF CONTENTS…
Pfizer Documents (PHMPT/FDA)
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Page 1 of 384 ***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: 1088 Site Name: (1088) PMG Research of Hickory LLC Subject No: 10881126 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…
Pfizer Documents (PHMPT/FDA)
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Page 1 of 352 ***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: 1088 Site Name: (1088) PMG Research of Hickory LLC Subject No: 10881139 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…
Pfizer Documents (PHMPT/FDA)
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Page 1 of 144 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC Subject No: 10881220 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…
Pfizer Documents (PHMPT/FDA)
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Page 1 of 252 ***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: 1089 Site Name: (1089) PMG Research of Salisbury Subject No: 10891042 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 option…
Pfizer Documents (PHMPT/FDA)
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Page 1 of 190 ***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: 1089 Site Name: (1089) PMG Research of Salisbury Subject No: 10891065 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 option…
Pfizer Documents (PHMPT/FDA)
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Page 1 of 211 ***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: 1089 Site Name: (1089) PMG Research of Salisbury Subject No: 10891073 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 option…
Pfizer Documents (PHMPT/FDA)
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Page 1 of 198 ***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: 1089 Site Name: (1089) PMG Research of Salisbury Subject No: 10891088 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 option…
Pfizer Documents (PHMPT/FDA)
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Page 1 of 205 ***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: 1089 Site Name: (1089) PMG Research of Salisbury Subject No: 10891150 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 option…
Pfizer Documents (PHMPT/FDA)
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Page 1 of 139 ***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: 1089 Site Name: (1089) PMG Research of Salisbury Subject No: 10891181 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 option…
Pfizer Documents (PHMPT/FDA)
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Page 1 of 524 ***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: 1089 Site Name: (1089) PMG Research of Salisbury Subject No: 10891182 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 option…
Pfizer Documents (PHMPT/FDA)
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Page 1 of 146 ***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: 1089 Site Name: (1089) PMG Research of Salisbury Subject No: 10891273 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 option…
Pfizer Documents (PHMPT/FDA)
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Page 1 of 139 ***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: 1089 Site Name: (1089) PMG Research of Salisbury Subject No: 10891289 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 option…
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Page 1 of 931 ***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: 1094 Site Name: (1094) LinQ Research, LLC Subject No: 10941112 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:39 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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Page 1 of 164 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1094 Site Name: (1094) LinQ Research, LLC Subject No: 10941155 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:39 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…
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FDA-CBER-2021-5683-0970081 FDA-CBER-2021-5683-0970082 FDA-CBER-2021-5683-0970083 FDA-CBER-2021-5683-0970084 FDA-CBER-2021-5683-0970085 FDA-CBER-2021-5683-0970086 FDA-CBER-2021-5683-0970087 FDA-CBER-2021-5683-0970088 FDA-CBER-2021-5683-0970089 FDA-CBER-2021-5683-0970090 FDA-CBER-2021-5683-0970091 FDA-CBER-2021-5683-0970092 FDA-CBER-2021-5683-0970093 FDA-CBER-2021-5683-0970094 FDA-CBER-2021-5683-0970095 FDA-CBER-2021-5683-0970096 FDA-CBER-2021-5683-0970097 FDA-CBER-2021-5683-0970098…
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Page 1 of 436 ***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway Subject No: 10971017 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:39 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,…
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FDA-CBER-2021-5683-0970889 FDA-CBER-2021-5683-0970890 FDA-CBER-2021-5683-0970891 FDA-CBER-2021-5683-0970892 FDA-CBER-2021-5683-0970893 FDA-CBER-2021-5683-0970894 FDA-CBER-2021-5683-0970895 FDA-CBER-2021-5683-0970896 FDA-CBER-2021-5683-0970897 FDA-CBER-2021-5683-0970898 FDA-CBER-2021-5683-0970899 FDA-CBER-2021-5683-0970900 FDA-CBER-2021-5683-0970901 FDA-CBER-2021-5683-0970902 FDA-CBER-2021-5683-0970903 FDA-CBER-2021-5683-0970904 FDA-CBER-2021-5683-0970905 FDA-CBER-2021-5683-0970906…