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Form Approved: OMB No. 0910 - 0297 Expiration Date: March 31, 2022. See instructions for OMB Statement, below. DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATIONPRESCRIPTION DRUG USER FEE COVERSHEET FY 2021 A completed form must be signed and accompany each new drug or biologic product application. If payment is sent by U.S. mail or courier, please include a copy of thiscompleted form with payment. Payment instructions and fee rates can be found on FDA'swebsite:…
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BNT162b2 2.7.6 Synopses of Individual Studies CONFIDENTIAL Page 12.7.6 SYNOPSES OF IN DIVIDUAL STUDIES The table entitled Tabular L isting of All Clinical Studies is located in Module 5.2. The left hand column of this table contains a hy pertext link to the location of each Clinical Study Report Bod y. The right hand column contains a h ypertext link to the location of each Stud y Synopsis. 090177e195aa9672\Approved\Approved On: 01-Dec-2020 23:58 (GMT) FDA-CBER-2021-5683-0013923 Document…
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BNT162b2 Module 1.3.1.4 Transfer of Obligations Pfizer Confidential 1 TRANSFER OF OBLIGATIONS In compliance with 21 CFR 312.52, Table 1 below lists the Spons or responsibilities* that were transferred from BioNTech SE to Pfizer Inc. in the conduct of t he C4591001 clinical study, with the specific obligations that we re transferred. Any obligation not provided in the written description below shall be deemed not to have been transferred. Table 1. Sponsor Obligations…
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BNT162b2 2.7.5Literature References CONFIDENTIAL Page 12.7.5 LITERATURE REFERENCE S References are listed in the clinical summary documents as indicated below: Module 2.7.1 Summary of Biopharmaceutic Studies and Associated Anal ytical Methods -None Module 2.7.2 Summary of Clinical Pharmacology Studies -Not Applicable Module 2.7.3 Summary of Clinical Efficacy , References Module 2.7.4 Summary of Clinical Safety , References Copies of the literature references are provided in Module 5.4…
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U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 w ww.fda.gov Our Reference: IND 19736 AGREED INITIAL PEDIATRIC STUDY PLAN-AGREEMENT April 23, 2021 BioNTech SE/Pfizer, Inc. Attention: Neda Aghajani Memar235 East 42nd Street, 219/9/69New York, NY 10017 Dear Ms. Aghajani Memar:Please refer to your Investigational New Drug Application (IND) submitted under section 505(i) of the Federal Food, Drug, and Cosmetic Act for “Human Coronavirus mRNA Vaccines…
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Fonn Approved: OMB No. 0910-0396 Report Date: 03/31/2021 BLA CERTIFICATION: FINANCIAL INTERESTS AND ARRANGEMENTS OF CLINICAL INVESTIGATORS TO BE COMPLETED BY APPLICANT With respect to all covered dinical studies (or specific clinical studies listed below (if appropriate)) submitted in support of this application, I certify to one of the statements below as appropriate. I understand that this certification is made in…
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PFIZER CONFIDENTIAL Page 1 BNT162b2 1.3.4 Financial Certification and Disclosure 1.3.4 FINANCIAL CERTIFICATION AND DISCLOSURE – BIAS STATEMENT Protocol Number: C4591001 Study Title: A Phase 1/2/3, Placebo -Controlled , Randomized , Observer -Blind, Dose- Finding Study To Evaluate The Safety , Tolerability , Immunogenicity, And Efficacy Of SARS -COV -2 RNA V accine Candidates Against COVID -19 In Healthy Individuals STEPS TAKEN TO MINIMIZE THE POTENTIAL…
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U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov Our Reference: IND 19736 GRANT FAST TRACK DESIGNATION July 7, 2020 BioNTech RNA Pharmaceuticals GmbH Attention: Ms. Elisa HarkinsPfizer, Inc.500 Arcola RoadCollegeville, PA 19426 Dear Ms. Harkins:Please refer to your Investigatio nal New Drug Application (IND) submitted under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FDCA) for “ Human Coronavirus mRNA Vaccines (SARS-CoV-2 Spike…
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COVID -19 Vaccine (BNT162; PF -07302048) Module 1.3.5.3 Exclusivity Claim PFIZER CONFIDENTIAL Page 1NOTICE OF CLAIMED EX CLUSIVITY A.BioNTech Manufacturing GmbH hereb y requests a determination that the licensure of Pfizer - BioNTech- COVID -19constitutes the “first licensure” of Pfizer -BioNTech -COVID -19and that BioNTech Manufacturing GmbH is entitled to exclusivity from the date of licensure pursuant to section 351(k)(7) of the Public Health Service Act. B.There are no licensed…
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Pfizer Global Regulatory Affairs Pfizer Inc. 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 06May2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologicsEvaluation and Research DocumentControl 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 AND/OR …
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Form Approved: OMB No. 0910-0616. Expiration Date: 3/31/2021. See PRA Statement below. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Certification of Compliance Under 42 U.S.C. § 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (For submission with an application/submission, including amendments, supplements, and resubmissions, under §§ 505, 515, 520(m), or 510(k) of the Federal Food, Drug, and Cosmetic Act or § 351 of the Public Health Service Act.)…
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E-Diary Transmission (Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population ............................................................................. 2 Local Reactions, by Maximum Severity, Within 7 Days After Each Dose, by Age Group (Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population …
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Page 1 of 364 ***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: 1128 Site Name: (1128) Ventavia Research Group Subject No: 11281009 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 11:25 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS ST AGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE…
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Page 1 of 492 ***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: 1096 Site Name: (1096) Ventavia Research Group Subject No: 10961017 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and ST AGE 2 from thi s CRF. As per protocol amendment 5,…
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Page 1 of 460 ***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn Subject No: 10811026 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS ST A GE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol…
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Section 1 - 125742/0/0 Section 2 - 125742/0/0 Section 5.3.1 - 125742/0/0 1Page ***THIS REPORT MAY CONTAIN CONFIDENTIAL INFORMATION***License Action Recommendation Documents for Submissions and FDA Communication December 20, 2021 8:32 AM ***FOR OFFICIAL USE ONLY*** Exclude Inspection Related Order: FDA/Appl, Then Date Ascending L 125742/0STN: BioNTech Manufacturing GmbH #2229 Applicant: 13-MAY-2021 18-MAY-2021 20-MAY-2021 03-JUN-2021 08-JUN-2021 09-JUN-2021…
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BNT162b2 2.7.4 Summary of Clinical Safety CONFIDENTIAL Page 12.7.4 SUMMARY OF CLI NICAL SAFETY 090177e196f5180a\Approved\Approved On: 05-May-2021 14:36 (GMT) FDA-CBER-2021-5683-0002897 BNT162b2 2.7.4 Summary of Clinical Safety CONFIDENTIAL Page 2TABLE OF CONTENTS LIST OF IN -TEXT TABL ES................................ ................................ ................................ ....5 LIST OF IN -TEXT FIGU RES................................ ................................…
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BNT162b2 2.7.3 Summary of Clinical Efficacy CONFIDENTIAL Page 12.7.3 SUMMARY OF CLINICAL E FFICAC Y 090177e196e789be\Approved\Approved On: 30-Apr-2021 20:14 (GMT) FDA-CBER-2021-5683-0002715 BNT162b2 2.7.3 Summary of Clinical Efficacy CONFIDENTIAL Page 2TABLE OF CONTENTS LIST OF TABLES ................................ ................................ ................................ ..................... 3 LIST OF FIGURES ................................ ................................…