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Introduction –ADRG •The Analysis Data Reviewer’s Guide (ADRG) provides context for ADaM datasets and terminology that benefit from additional explanation beyond the Data Definition document in a regulatory submission •A high quality ADRG is essential to a smooth regulatory review process 3

ADRG covers • Updated efficacy analyses in blinded placebo -controlled follow-up evaluated duration of protection (data cutoff date: 02Sep2021). • Updated sequencing analysis for SARS-CoV-2 Variants of Concern or Variants of Interest. • Safety data presented for Blinded placebo-controlled period: Dose 1 to unblinding date .

Section 2.3 ( Analysis Data Reviewer’s Guide) – Clarification on ADRG : Section 4.1.1.3 ( SDTM Domain Specifications) – Clarification on DS Domain

ADRG does not include asymptomatic surveillance, asymptomatic infection analysis, manufacturing process 1 process 2 lot analysis, Phase 1 booster analysis and Phase 2/3 booster and new variant strain analysis. This ADRG covers: • Updated Efficacy analyses in blinded placebo-controlled follow-up evaluated duration of

The ADRG provides FDA reviewers with context for analysis datasets and terminology, received as part of a regulatory product submission, additional to what is presented within the data definition folder (i.e., define.xml). The ADRG also provides …

The ADaM Reviewer’s Guide (ADRG) consists of seven sections (Introduction, Protocol Description, Analysis Considerations Related to Multiple Analysis Datasets, Analysis Data Creation and Processing Issues, Analysis Dataset Overview, Data Conformance Summary, Submission of Programs) and optional appendices.

Analysis Data Reviewer’s Guide (ADRG) • An ADRG • Recommended in a standards‐compliant analysis data submission • Provides FDA reviewers with context for analysis datasets and terminology, • In additional to what is presented within define.xml • CSS (not CDISC) has developed a template ADRG

The PHUSE Analysis Data Reviewer’s Guide (ADRG) applies to a single study. Sponsors have been adopting this template and making amendments when creating a reviewer's guide for an integrated analysis data submission. PHUSE recognized the need for a new, standardized template and completion

ADRG is a supplement to the primary ADRG already submitted for the BLA and covers the efficacy sequencing data analyses in blinded placebo-controlled follow-up period for the COVID-19 cases data (cutoff date:13Mar2021).