125742 45 S252 M5 c4591001 S 1mth suppl arg

Document text

Supplemental Analysis 
Reviewer Guide  
 
sBLA for 12-15 Years of Age  
 
BioNTech  SE and PFIZER INC. 
Study C4591001
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
090177e19939f708\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492642
Study C4591001   
2   
Table of Contents  
Contents  
1. Introduction  ................................ ................................ ................................ ................................ . 3 
 
090177e19939f708\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492643
Study C4591001   
3   
1. Introduction  
This document provides  details on the supplemental analysis package created as a supplement to the 
sBLA for “12-15 Years of Age ” 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.  
 
Tabulation package and Analysis Package were sent under application number 125742 sequence 
number 0001 on 06May2021.  The following are provided to address FDA query STN 125742/45: 
IR RE the datasets for adolescents 1 2 through 15 Years of Age item 3 . Use the AGEGR1N  
=1 to subset for 12 -15 years old.  
• A roadmap describing  the SDTM dataset updates  
• Table summary of changes  (CSR vs Update)  
• Updated reactogenicity TLFs 
• Final reactogenicity tables with  track changes  
 
 
090177e19939f708\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0492644