Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 2346 pages
PF-07302048 (BNT162 RNA- Based COVID- 19 Vaccines) Protocol C4591001 Protocol Amendment 14, 02March 2021 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 Study…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 2 pages
Level Term Code SOC PT Acute HIV infection 10000807 INFECTIONS AND INFESTATION S PT Asymptomatic HIV infection 10003581 INFECTIONS AND INFESTATION S PT Blood HIV RNA 10049826 INVESTIGATIONS PT Blood HIV RNA below assay limit 10049829 INVESTIGATIONS PT Blood HIV RNA decreased 10049828 INVESTIGATIONS PT Blood HIV RNA fluctuation 10076287 INVESTIGATIONS PT Blood HIV RNA increased 10049827 INVESTIGATIONS PT Congenital HIV infection 10010504 CONGENITAL, FAMILIAL AND GENETIC DISORDER S PT CSF HIV…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 61 pages
INTERNAL REVIEW COMMITTEE CHARTER PFIZER INTERNAL USE ONLY The official version of this form is located in the electronic document management system. CT22 -GSOP -RF02 6.0 External Data Monitoring Committee and Internal Review Committee Charter T emplate 01-Nov-2019 Page 1 of 26 TMF Doc ID: 64.05 and 713.02 C4591001 Investigational BNT162 Vaccine Program PF-07302048 Version : 2.0 Date: 11-June-2020 090177e1945bf925\Approved\Approved On: 14-Jul-2020 13:56…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1413 pages
PF-07302048 (BNT162 RNA- Based COVID- 19 Vaccines) Protocol C4591001 Protocol Amendment 9, 29 October 2020 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 Study…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 13 pages
16.2.3.1.1 Listing of Subjects Excluded From All -Available and Evaluable Immunogenicity Populations – Phase 1, 2 Doses, 21 Days Apar t Vaccine Candidate Age Group (Years) Vaccine Group (as Randomized) Subject Popula tion Reason for Exclusion BNT162b1 65-85 10 μg C4591001 1002 10021053 Dose 1 evaluable Had major protocol deviation(s) as determined by the clinician. Dose 2 evaluable Had major protocol deviation(s) as determined by the clinician. BNT162b2 18-55…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
C4591001 PFIZER CONFIDENTIALERRATA Not applicable. There are no errata to report . 090177e195830c04\Approved\Approved On: 03-Dec-2020 02:52 (GMT) Page 1 FDA-CBER-2021-5683-0014039
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 63 pages
16.2.6.1.1 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apar t Assay Vaccine Candidate Age Group (Years) Vaccine Group (as Randomized) Subject Dose/ Sampling Time Point Date of Sample Rel Daya NT50 (Titer) NT90 (Titer) S1-Binding IgG Level (U/mL) RBD -Binding IgG Level (U/mL) BNT162b1 18-55 10 μg C4591001 1001 10011004 1/Prevax 04MAY2020 1 10.00 10.00 BLQ BLQ 1/Day 7 11MAY2020 8 10.00 10.00 BLQ BLQ 1/Day 21 …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 3 pages
16.2.5.1.2 Listing of Subjects Who Received Vaccine Not as Randomized – Phase 2 Vaccine Group (as Randomized) Age Group (Years) Subject Randomization Date Vaccination Date Dose No. Vaccine Received No subject meets the reporting criteria. PFIZER CONFIDENTIAL SDTM Creation: 05SEP2020 (14:18) Source Data: adsl Table Generation: 10SEP2020 (21:41) (Cutoff Date: 02SEP2020, Snapshot Date: 04SEP2020) Output File: ./nda2_unblinded/C4591001_IA…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 14 pages
Local Reactions, by Maximum Severity, Within 7 Days After Each Dose (Reactogenicity Subset) – Phase 2/3 Subjects ≥16 Years of Age – Safety Population ...................................................................................................................................................................................................................................... 2 Systemic Events, by Maximum Severity, Within 7 Days After Each Dose (Reactogenicity Subset) – Phase 2/3…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 49 pages
16.2.5.2.1 Listing of Physical Examination With Abnormal Finding – Phase 1, 2 Doses, 21 Days Apar t Vaccine Candidate Age Group (Years) Vaccine Group (as Randomized) Subject Dose No. Rel Daya Body System Descriptio n BNT162b1 18-55 10 μg C4591001 1001 10011006 1 22 SKIN PAPULES ON RIGHT BASE OF THUMB AND WRIST TO FOREARM, AND DERMATITIS ON THE RIGHT HAND. C4591001 1001 10011006 2 7 SKIN BILATERAL ANTERIOR ARM / WRITSTS FAIRLY ERYTHEMATOUS RASH, SCALY…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 37 pages
BioNTec h SE An der Goldgrube 12 55131 Mainz, Germany Phone: +49 (0)6131 9084 -0 Telefax: +49 (0)6131 9084 -390 R&D STUDY REPORT No. R-20-0072 EXPRESSION OF LUCIFERASE-ENCODING MODRNA AFTER I. M. APPLICATION O F GMP- READ Y ACUITAS LIPID NANOPARTICLE FORMULATION Version 03 Date: 27 Nov 2020 Reported by Test item : modRNA encoding luciferase Key words: COVID-19 , modRNA, biodistribution , mouse , bioluminescence assay This R&D report consi sts of 36 pages. Confidentiality …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 77 pages
FINAL RE PORT Test Facility Study No. 185350 Sponsor Reference No. ALC- NC-0552 A Tissue Distribution Study of a [3H]-Labelled Lipid Nanoparticle -mRNA Formulation Containing ALC -0315 and ALC-0159 Following Intramuscular Administration in Wistar Han Rats TEST FAC ILITY: SPONSOR: Acuitas Therapeutics Inc. 6190 Agronomy Road, Suite 402 Vancouver, British Columbia V6T 1Z3 Canada Page 1 of 77 090177e195794698\Approved\Approved On: 09-Nov-2020 21:23 (GMT) (b) (4) (b)…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 671 pages
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1 Subject (Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1 N-binding Assay/ Visit 1 NAAT/ Visit 2 NAAT Signs and Symptoms SARS -CoV -2 NAAT Result (Central Lab/Local Labb) C4591001 1005 10051341 (USA/23/F) Dose 1/2 22OCT2020 Unk/Pos/Unk New or increased…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1448 pages
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s Vaccine Group (as Randomized) Age Group (Years) Subject Population Reason for Exclusion BNT162b2 (30 μg) 12-15 C4591001 1007 10071409 Dose 2 all -available efficacy Did not receive 2 vaccinations. Evaluable efficacy (7 days) Did not receive all vaccinations as randomized or did not receive …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 10 pages
BNT162b2 Module 2.6.4. Pharmacokinetics Written Summary CONFIDENTIAL Page 1MODULE 2.6.4. PHARMA COKINETICS WRITTEN S UMMARY This document contains confidential information belonging to BioNTech /Pfizer . Except as may be otherwise agreed to in writing, by accepting or reviewing these materials, you agree to hold such information in confidence and not to disclose it to others (except w here required by applicable law), nor to use it for unauthorized purpos es. In the event of actual or…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 36 pages
BNT162b2 Module 2.4. Nonclinical Overview 2.4 NONCLINICAL OVERVIEW Page 1CONFIDENTIAL 090177e1962c108d\Approved\Approved On: 08-Feb-2021 15:26 (GMT) FDA-CBER-2021-5683-0013861 TABLE OF CONTENTS 2.4 NONCLINICAL OVERVIEW .......................................................................................... LIST OF ABBREVIATIONS AND DEFINITION OF TERMS ................................................... 2.4.1. OVERVIEW OF NONCLINICAL TESTING STRATEGY…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 14 pages
BNT162b2 2.6.5 Pharmacokinetics Tabulated Summary CONFIDENTIAL Page 1MODULE 2.6.5. PHARMA COKINETICS TABULATED SUMMARY This document contains confidential information belonging to BioNTech /Pfizer. Except as may be otherwise agreed to in writing, by accepting or reviewing these materials, you agree to hold such information in confidence and not to disclose it to others (except w here required by applicable law), nor to use it for unauthorized purpos es. In the event of actual or suspected…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 2 pages
BNT162b2 2.2 Introduction CONFIDENTIAL Page 12.2 INTRODUC TION 1. Drug Name Company code: BNT162b2 Dosage form: BNT162b2 is formulated as concentrate for dispersion for injection. Each vial contains 6doses of 30 micrograms of COVID -19 mRNA Vaccine, embedded in lipid nanoparticles (total volume: 0.45 mL ). 2. Pharmacological Class BNT162b2 is ahighly purified single -stranded, 5’- capped messenger RNA produced using a cell-free in vitro transcription f rom the corresponding DNA …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 4 pages
BNT162b 2 Module 1.12.5 Waiver Request for FDA Designated Suffix for B iologics PFIZER CONFIDENTIAL Page 1BLA 125742 COVID -19 mRNA Vaccine (nucleoside modified) WAIVER REQUEST FOR FDA -DESIGNATED SUFFIX FO R BIOLOGICS MARCH 2020 090177e196a337da\Final\Final On: 27-Mar-2021 00:16 (GMT) FDA-CBER-2021-5683-0013738 BNT162b 2 Module 1.12.5 Waiver Request for FDA Designated Suffix for B iologics PFIZER CONFIDENTIAL Page 2TABLE OF CONTENTS 1. INTRODUCTION ................................…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 2 pages
090177e1969f145c\Final\Final On: 25-Mar-2021 15:04 (GMT) FDA-CBER-2021-5683-0013853 090177e1969f145c\Final\Final On: 25-Mar-2021 15:04…