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Vaccines and Related Biological Products Advisory Committee Meeting

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Vaccines and Related Biological Products Advisory Committee Meeting Vaccines and Related Biological Products Advisory Committee Meeting Individuals using assistive technology may not be able to fully access the information contained in this file. For assistance, please send an e-mail to: [email protected] and include 508 Accommodation and the title of the document in the subject line of your e- mail. JANSSEN BIOTECH, INC. (A PHARMACEUTICAL COMPANY OF JOHNSON & JOHNSON) COVID-19 Vaccine Ad26.COV2.S VAC31518 (JNJ-78436735) SPONSOR BRIEFING DOCUMENT VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE MEETING DATE: 26 FEBRUARY 2021 Page 1 of 118 Janssen Biotech, Inc. COVID-19 Vaccine Ad26.COV2.S VRBPAC Briefing Document TABLE OF CONTENTS Table of Contents ........................................................................................................................2 List of Tables ..........................................................................................................................5 List of Figures .........................................................................................................................7 List of Abbreviations...................................................................................................................9 1 Executive Summary .......................................................................................................... 11 2 Background on COVID-19 ................................................................................................ 25 2.1 Overview of COVID-19 ............................................................................................ 25 2.2 Unmet Medical Need ................................................................................................. 25 2.3 Current Vaccine Options ............................................................................................ 26 3 Product Description, Platform Data and Candidate selection .............................................. 27 3.1 Product Description ................................................................................................... 27 3.1.1 AdVac® Platform ................................................................................................. 27 3.1.2 Mechanism of Action ........................................................................................... 28 3.1.3 Vaccine Candidate Selection ................................................................................ 29 3.2 Ad26.COV2.S Dose Selection Rationale .................................................................... 29 3.3 Proposed Emergency Use Authorization (EUA) Indication Statement ........................ 30 4 Supporting Nonclinical Investigations ............................................................................... 31 4.1 Nonclinical Immunogenicity and Efficacy ................................................................. 31 4.2 Nonclinical Safety ..................................................................................................... 31 4.2.1 Biodistribution ..................................................................................................... 31 4.2.2 Toxicology ........................................................................................................... 31 5 Regulatory and Clinical Development Overview ............................................................... 33 5.1 Regulatory Overview ................................................................................................. 33 5.2 Clinical Development Program: Initiated Studies ....................................................... 33 5.3 Clinical Development Program: Planned Studies ....................................................... 34 6 Clinical Immunogenicity ................................................................................................... 35 6.1 Assays Used for Immunogenicity Assessments .......................................................... 35 6.2 Phase 1/2a Study COV1001 ....................................................................................... 36 6.2.1 Study Design ....................................................................................................... 36 6.2.2 Humoral Immunogenicity .................................................................................... 37 6.2.3 Cellular Immunogenicity...................................................................................... 40 Page 2 of 118 Janssen Biotech, Inc. COVID-19 Vaccine Ad26.COV2.S VRBPAC Briefing Document 6.3 Phase 1 Study COV1002............................................................................................ 42 6.4 Phase 2a Study COV2001 .......................................................................................... 42 6.5 Phase 3 Study COV3001 Interim Immunogenicity Results ......................................... 43 7 Clinical Efficacy ................................................................................................................ 45 7.1 Phase 3 Study COV3001 (ENSEMBLE) – Single Dose Ad26.COV2.S...................... 46 7.1.1 Study Design ....................................................................................................... 46 Overall Design .............................................................................................. 46 Enrollment Criteria ....................................................................................... 47 Independent Review of Severe/Critical COVID-19 ....................................... 48 Endpoints ...................................................................................................... 48 Case Definitions ........................................................................................... 49 7.1.1.5.1 Case Definition for Moderate COVID-19 ................................................. 49 7.1.1.5.2 Case Definition for Severe/Critical COVID-19 ......................................... 50 7.1.1.5.3 Case Definition for Mild COVID-19 ......................................................... 51 7.1.1.5.4 US FDA Harmonized Case Definition for COVID-19 ............................... 51 7.1.1.5.5 Case Definition for Asymptomatic or Undetected COVID-19 ................... 51 Statistical Analyses ....................................................................................... 52 7.1.1.6.1 Sample Size Determination ....................................................................... 52 7.1.1.6.2 Analysis Populations ................................................................................ 52 7.1.1.6.3 Efficacy Analysis ...................................................................................... 53 7.1.2 Epidemiological Setting ....................................................................................... 54 7.1.3 Participant Disposition ......................................................................................... 55 7.1.4 Participant Demographics .................................................................................... 56 7.1.5 Primary Endpoint Results – Moderate and Severe Disease ................................... 58 Co-Primary Efficacy Results ......................................................................... 58 7.1.6 Secondary Endpoint Results ................................................................................. 61 Vaccine Efficacy Against Severe/Critical COVID-19 ................................... 61 Prevention of COVID-19 Requiring Medical Intervention ............................ 63 Prevention of COVID-19-Related Death ....................................................... 64 Vaccine Efficacy Against All Symptomatic COVID-19 (BOD) .................... 64 Vaccine Impact on Symptom Severity .......................................................... 64 Vaccine Impact on Asymptomatic COVID-19 Infections as Inferred Through Seroconversion .............................................................................................................. 66 Page 3 of 118 Janssen Biotech, Inc. COVID-19 Vaccine Ad26.COV2.S VRBPAC Briefing Document Effect of Vaccine on SARS-CoV-2 Viral Load ............................................. 66 Vaccine Efficacy Against US FDA Harmonized COVID-19 Definition ........ 66 7.1.7 Efficacy in Subgroups .......................................................................................... 67 Efficacy by Region/Country .......................................................................... 67 Efficacy by Demographic and Baseline Characteristics: Age, Sex, Race, Ethnicity, Comorbidities and Location ........................................................................... 67 Efficacy in HIV-Infected Participants ........................................................... 70 Efficacy in Regions with Newly Emerging SARS-CoV-2 Strains .................. 70 7.2 Proposed Amendment to Study Design for Placebo-controlled Studies with Ad26.COV2.S After Obtaining EUA ..................................................................................... 71 8 Clinical Safety and Reactogenicity .................................................................................... 73 8.1 Introduction and Methodology ................................................................................... 73 8.2 Safety Population ....................................................................................................... 74 8.3 Vaccine Exposure .....................................................................................................
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