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Pfizer -BioNTech COVID -19 Vaccine C4591008 NON -INTERVENTIONAL INTERIM REPORT 22June 2021 PFIZER CONFIDENTIALNON- INTERVENTIONAL ( NI) INTERIM STUDY REPORT Study Information Title HERO-Together: A Post-Emergency Use Authorization Observational C ohort S tudy to Evaluate the S afety of the Pfizer -BioNTech COVID -19 Vaccine in US Healthcare Workers , Their Families, and Their Communities Protocol number C4591008 Version identifier of the interim study reportv. 1.0 Date 22June 2021 EU…
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Listing 7.7.5 Page 1of 1325 BNT162b2 Protocol C4591008 Medication/Treatment Data PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, EX Generated from /dcri/ct/hero_together/lists/l_vax.sas on 24MAY2021 12:45 Page 289of 1689 Subject ID Age/Sex/Race Dose NumberDate of Dose ManufacturerImputed Date of DoseImputed Manufacturer Lot NumberInjection Site Facility C4591008 -1000222784 28/F/WHITE FIRST DOSE 2020 -12-30Pfizer UNKNOWN Left arm…
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Determining RSV Burden and Outcomes in Pregnant Women and Older Adults Requiring Hosp italization Short Title: RSV in Older Adults and Pregnant Women Study (ROAPS) Version: 10MAR2021; Page 1of 60VERSION 8.0; 23MAR2021 TABLE OF CONTENTS INVESTIGATORS ................................ ................................ ................................ .................... 4 ABBREVIAT IONS ................................ ................................ ................................…
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PF-07302048 (BNT162 RNA- Based COVID- 19 Vaccines) Protocol C4591001 Final Protocol Amendment 17,20July 2021 PFIZER CONFIDENTIAL CT02- GSOP Clinical Protocol Template Phase 1 2 3 4 (05 December 2019) Page 1A PHASE 1/2 /3, PLACEBO -CONTROLLED , RANDOMIZED, OBSERV ER-BLIND, DOSE -FINDING STUDY T O EVALUATE THE SAFETY, TOLERABI LITY, IMMUNOGENICITY, AND EFFICACY OF SARS -COV -2RNA VACCINE CANDIDATES AGAINST C OVID -19 IN HEALTHY INDIVIDUALS Study Sponsor: BioNTech Study Conducted By: Pfizer…
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PF-07302048 (BNT162 RNA- Based COVID- 19 Vaccines) Protocol C4591001 Final Protocol Amendment 1617, 28 May 20July 2021 PFIZER CONFIDENTIAL CT02- GSOP Clinical Protocol Template Phase 1 2 3 4 (05 December 2019) Page 1A PHASE 1/2 /3, PLACEBO -CONTROLLED , RANDOMIZED, OBSERV ER-BLIND, DOSE -FINDING STUDY T O EVALUATE THE SAFETY, TOLERABI LITY, IMMUNOGENICITY, AND EFFICACY OF SARS -COV -2RNA VACCINE CANDIDATES AGAINST C OVID -19 IN HEALTHY INDIVIDUALS Study Sponsor: BioNTech Study Conducted By:…
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BNT162b2 (COVID -19 vaccine) C4591012 NON -INTERVENTIONAL STUDY PROTOCOL Final Version 1.0, 27 January 2021 PFIZER CONFIDENTIAL Page 1of 144NON- 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 Final Version 1.0 Date of last version of…
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Pfizer Global Regulatory Affairs Pfizer Inc . 235 East 42ndStreet /New York , NY 10017 -5755 Global Product Developm ent 30June 2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research Document Control Center 10903 New Hampshire Avenue WO71, G112 Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE SECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AN…
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BNT162b2 (COVID -19 vaccine) C4591012 NON- INTERVENTIONAL STUDY PROTOCOL Final Version 1.0, 27 January 2021 PFIZER CONFIDENTIAL Page 1of 144NON-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 Final Version 1.0 Date of last version of…
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Page 1 of 363 ***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: 1072 Site Name: (1072) Optimal Research, LLC Subject No: 10721064 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:05 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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Page 1 of 153 ***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: 1077 Site Name: (1077) Regional Clinical Research, Inc Subject No: 10771049 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:05 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…
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Page 1 of 178 ***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: 1077 Site Name: (1077) Regional Clinical Research, Inc Subject No: 10771137 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:05 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…
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Page 1 of 371 ***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: 1077 Site Name: (1077) Regional Clinical Research, Inc Subject No: 10771188 Subject Initials: --- Generated By: Generated Time (GMT): 19-Apr-2021 21:04 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…
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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: 1077 Site Name: (1077) Regional Clinical Research, Inc Subject No: 10771194 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:05 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…
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Page 1 of 319 ***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: 1077 Site Name: (1077) Regional Clinical Research, Inc Subject No: 10771226 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:05 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…
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Page 1 of 217 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC Subject No: 10791004 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:05 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…
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Page 1 of 178 ***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC Subject No: 10791044 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:05 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…
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Page 1 of 209 ***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC Subject No: 10791076 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:05 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…
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Page 1 of 128 ***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC Subject No: 10791183 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:05 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…
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Page 1 of 121 ***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC Subject No: 10791199 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:05 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…
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Page 1 of 170 ***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC Subject No: 10791228 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:05 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…