Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
BNT162b2 3.2.A.3.1.1 Nomenclature [ALC -0159] PFIZER CONFIDENTIAL Page 13.2.A.3.1.1. NOMENCLATURE [ALC -0159] Information on the nomenclature of ALC-0159 is provided in Table 3.2.A.3.1.1-1. Table 3.2.A.3.1.1-1. Nomenclature of ALC -0159 Nam e/code Description Com pany or Laboratory Code ALC -0159 Chemical Name s 2-[(polyethylene glycol) -2000] -N,N- ditetradecylacetamide 2-[2-ω-methoxy(polyethyleneglycol -2000) -ethoxy] -N-N- ditetradecylacetamide CAS: Poly(oxy-1,2-ethanediyl), α -[2-…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
BNT162b2 3.2.A.3 Excipients [ALC -0315] PFIZER CONFIDENTIAL Page 13.2.A.3. EXCIPIENTS [ALC -0315] Information regarding the novel excipient ALC-0315 ((4-hydroxybutyl)azanediy l)bis(hexane -6,1- diyl)bis(2 -hexyldecanoate) is provided in this section. 090177e1955703de\Approved\Approved On: 24-Oct-2020 03:41 (GMT) FDA-CBER-2021-5683-1149034
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
BNT162b2 3.2.A.3 Excipients [ALC -0159] PFIZER CONFIDENTIAL Page 13.2.A.3. EXCIPIENTS [ALC -0159] Information regarding the novel excipient ALC-0159 ( 2-[(poly ethyleneglycol)-2000]- N,N- ditetradecy lacetamide) is provided in this section. 090177e19557260c\Approved\Approved On: 24-Oct-2020 03:26 (GMT) FDA-CBER-2021-5683-1149033
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 4 pages
BNT162b2 3.2.A.2. Adventitious Agents Safety Evaluation [Puurs] PFIZER CONFIDENTIAL Page 13.2.A.2. ADVENTITIOUS AGENTS SAFETY EVALUATION [PUURS] Multiple mechanisms, procedures, and assay s are used to minimize the entry of adventitious agents into the process stream and detect those agents that do enter the process stream. The adventitious agent control program includes the . 3.2.A.2.1. Introduction The main theoretical risk associated with these ingredients is a contamination of the…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 4 pages
BNT162b2 3.2.A.2. Adventitious Agents Safety Evaluation [Kalamazoo ] PFIZER CONFIDENTIAL Page 13.2.A.2. ADVENTITIOUS AGENTS SAFETY EVALUATION [KALAMAZOO] Multiple mechanisms, procedures, and assay s are used to minimize the entry of adventitious agents into the process stream and detect those agents that do enter the process stream. The adventitious agent control program includes the . 3.2.A.2.1. Introduction The main theoretical risk associated with these ingredients is a…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 6 pages
BNT162b2 3.2.A.2. Adventitious Agents Safety Evaluation [Andover ] PFIZER CONFIDENTIAL Page 1TABLE OF CONTENTS LIST OF TABLES ................................ ................................ ................................ ..................... 1 3.2.A.2. ADVENTITIOU S AGENTS SAFETY EVAL UATION ................................ ............ 2 3.2.A.2.1. Introduction ................................ ................................ ................................ .....2 3.2.A.2.2. N on-Viral…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 10 pages
BNT162b2 2.3 Introduction PFIZER CONFIDENTIAL Page 1TABLE OF CONTENTS LIST OF TABLES ................................ ................................ ................................ ..................... 1 2.3. INTRODUCTION ................................ ................................ ................................ .............. 4 2.3.1. General Information ................................ ................................ ............................... 4 2.3.2. Module 3 Lay out…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 23 pages
BNT162b2 2.3.P.8 Stability PFIZER CONFIDENTIAL Page 1TABLE OF CONTENTS LIST OF TABLES ................................ ................................ ................................ ..................... 2 2.3.P.8. STABILITY ................................ ................................ ................................ .................. 3 2.3.P.8.1. Stability Summary and Conclusion ................................ ................................ ..3 2.3.P.8.1.1. Shelf L ife at…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
BNT162b2 2.3.P.6 Reference Standards or Materials PFIZER CONFIDENTIAL Page 12.3.P.6. REFERENCE STANDARDS OR MATERIALS 2.3.P.6.1. Clinical Reference Material The drug substance reference material detailed in Section 3.2.S.5.1 Reference Standards or Materials is used for DP release and stability testing in the Fluorescence assay . Lipid reference mate rials, and used for the release and stability testing of drug product arepresented in Table 2.3.P.6 -1. Table 2.3.P.6 -1. Summary of Lipid…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 2 pages
BNT162b2 2.3.P.1. Description and Composition of the Drug Product PFIZER CONFIDENTIAL Page 12.3.P.1. DESCRIPTION AND COMPOSITION OF THE D RUG PRODUCT The BNT162b2 drug product is supplied as a preservative -free, multi -dose concentrate to be diluted for intramuscular injection, containing 6 doses. The drug product is a sterile dispersion of RNA -containing lipid nanoparticles (LNPs) in aqueous cry oprotectant buffer. Each vial, containing 0.45 mL of the drug product at pH 7.4 is designed…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 3 pages
FDA-CBER-2021-5683-1148982 BNT162b2 2.3.A.2 Adventitious Agents Safety Evaluation PFIZER CONFIDENTIAL Page 22.3.A.2.2. Adventitious Agents Safety Evaluation [Kalamazoo] 2.3.A.2.2.1. Introduction The main theoretical risk associated with these ingredients is a contamination of the product by Transmissible Spongiform Encephalopathy (TSE) agents. A multifaceted program has been established to ensure the viral safet y of the drug product, including dev elopment of a formulation process that…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 4 pages
BNT162b2 Section 1.3.4 Fi nancial Disclosure PFIZER CONFIDENTIAL Page 1 1.3.4 FINANCIAL CERTIFICATION AND DISCLOSURE – SUMMARY N OTE In accordance with 21 CFR Part 54 and Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators (Final , February 2013 ), Pfizer Inc . is submitti ng financial disclosure information on the Covered Studies listed in Table 1 . The financial disclosure information covers the time period from the…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 18 pages
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Fonn Approved: OMB No. 0910-0396 Report Date: 03/31/2021 BLA DISCLOSURE: FINANCIAL INTERESTS AND ARRANGEMENTS OF CLINICAL INVESTlGATORS TO BE COMPLETED BY APPLICANT The following information concerning (see who participated as clinical investigators in the submitted study (see is submitted in accordance with 21 CFR part 54. The named individuals have participated in one or more of the following financial…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 23 pages
COVID -19Vaccine (BNT162 ,PF-07302048 ) BB-IND 019736 Agreed Initial Pediatric Study Plan PFIZER CONFIDENTIAL Page 1of 22AGREED INITIAL PEDIATRIC ST UDY PLAN ( iPSP) Product :COVID -19 Vaccine (BNT162, PF -07302048) Dosage Form : Liquid formulation for intramuscular injection IND # : 019736 Drug Class : Vaccine Approved Indication : Not applicable Proposed Initial Indication : Active immunization against COVI D-19 in individuals ≥16yearsof age Proposed Supplemental Indication s: Active…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 3 pages
COVID -19Vaccine (BNT162 ,PF-07302048 ) BB-IND 019736 Agreed Initial Pediatric Study Plan PFIZER CONFIDENTIAL Page 1ATTACHMENT A—DEFERRAL REQUEST Product Name COVID -19 Vaccine (BNT162, PF -07302048) IND number 019736 Applicant BioNTech Proposed Initial Indication Active immunization against COVI D-19 in individuals ≥16years of age Future Supplemental Indications Active immunization against COVI D-19 in children and adolescents 12through 15 years of age; Active immunization against COVID…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 7 pages
(b) (4) (b) (4) (b) (4) FDA-CBER-2021-5683-1150746 (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2021-5683-1150747 (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2021-5683-1150748 (b) (4 (b) ( (b) ( (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2021-5683-1150749 (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4)…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 6 pages
James L. Kenney -SDigitally signed by James L Kenney S DN: c US o U S Government ou HHS ou FDA ou People 0 9 2342 19200300 100 1 1 1300431652 cn James L Kenney S Date: 2021 08 18 15:12 10 04 00' Nadine S. Kaelber -SDigitally signed by Nadine S. Kaelber -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=2002096592, cn=Nadine S. Kaelber -S Date: 2021.08.18 17:31:14 -04 00 (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4)…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 2 pages
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administrat ion Silver Spring MD 209 03 MEMORANDUM Date: September 23, 2021 From: Anil Choudhary, Ph.D. , MBA. CMC Reviewer Laboratory of Biochemistry, Virology and Immunochemistry (LBVI) Division of Biological Standards and Quality Control (DBSQC) Office of Compliance and Biologics Qualit y (OCBQ) Center for Biologics Evaluation and Research (CBER) Food and Drug Administration (FDA) To:…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 25 pages
FDA-CBER-2022-5812-0236002 FDA-CBER-2022-5812-0236003 3 Preparation Instructions COMIRNATY Multiple Dose Vial with Gray Cap and Label with Gray Border – Thawin g Prior to Use • Thaw vial(s) of COMIRNAT Y before use either by: o Allowing vial(s) to thaw in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)]. A carton of 10 vials may take up to 6 hours to thaw, and thawed vials can be stored in the refrigerator for up to 10 weeks. o Allowing vial(s) to sit at room temperature [up to 25ºC…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 4 pages
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring, MD 20993 CENTER FOR BIOLOGICS EVALUATION AND RESEARCH OFFICE OF VACCINES RESEARCH AND REVIEW DIVISION OF VACCINES AND RELATED PRODUCTS APPLICATIONS DATE: September 24, 2021 PAGES: 4 TO: BioNTech SE/Pfizer., Inc. Attention: Amit Patel 235 East 42ndStreet New York, NY 10017 Phone: 214-918-5262 Fax number: 845-474-3500 E-mail: [email protected] FROM: Ramachandra Naik, Ph.D. Division of Vaccines…