Document text
Supplemental Analysis
Reviewer Guide
BLA Analysis for Participants ≥16 Years of Age
BioNTech SE and PFIZER INC.
Study C4591001
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FDA-CBER-2021-5683-0023988
Study C4591001
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Table of Contents
Contents
1. Introduction ................................................................................................................................. 3
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1. Introduction
This document provides details on the supplemental analysis package created as a supplement
to the BLA esub package to revise the reactogenicity SDTM and ADaM data to address the
agreement s made with CBER during the teleconference of 08 April 2021 .
SDTM in cludes DM, EX and updated domains (AE, CE, FACE, VS, SUPPAE, SUPPCE,
SUPPFACE, SUPPVS, RELREC), define and aCRF . ADaM includes ADS L and updated
datasets (ADAE, ADCEVD, ADFACEVD) and define in Module 5.3.5.1. The following are
provided in Module 5.3.5.1 as well :
• A roadmap describing the SDTM dataset updates
• Table summary of chan ges (CSR vs Update)
• Updated reactogenicity TLFs
• Final reactogenicity t ables with track changes
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