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STN 125742/45:  BioNTech Manufacturing GmbH’s  COMIRNATY sBLA Documentation Review Memo 
8/2/2022        1  BLA 125742/45:  Documentation Review Memo 
 
Product Information: COMIRNATY  
Indication and Use: Active im munization to prevent coronavi rus disease 2019 (COVID-19) caused by severe acute respiratory 
syndrome coronavirus 2 (SARS-CoV-2) in in dividuals 12 years of age and older. 
 Communications (IRs) from CBER: 
IR # Request  
Date  CBER Rep(s)  Request  CBER 
Requester  for Information  BLA Amendment Response  
1 1/19/22 Mike Smith Three questi ons RE datasets Brenda Baldwin 
and Susan Wollersheim STN 125742.45.2 
2 1/25/22 Mike Smith IR RE EA/CE a nd FDA form 356 Mi ke Smith STN 125742.45.1 
3 2/23/22 Mike Smith OBE IR RE two que stions on Cumulative Analysis of Post-
Authorization Adverse Event Reports Deb Thompson STN 125742.45.3 
4 3/7/22 Mike Smith Two Clinical-sta tistical comments regarding updated 
immunobridging analyses and solicited adverse reaction frequencies. Susan Wollersheim and Ye Yan
g STN 125742.45.4 
5 3/8/22 Mike Smith Follow-up response to Pfizer's March 8, 2022, clarification 
question to the review team's March 7, 2022, IR. Susan Wollersheim and Ye Yan
g STN 125742.45.4 
6 3/14/22 Mike Smith Statistical F/U IR RE Pfizer’s response in STN 125742.45.4 to 
our 3/7/22 clinical and statistical questions. Ye Yang STN 125742.45.7 
7 4/8/2022 Ram Naik IR RE Comirnaty sBLA  to extend the indication to adolescents 
12 through 15 years of age - CBER comment regarding Tris/Sucrose formulation Xiao Wang STN 125742.12 
8 4/20/2022 Mike Smith Request to update the PVP to include both Tris/Sucrose and 
PBS/Sucrose formulations. Deb Thompson STN 125742.45.9 
9 4/20/2022 Laura Gottschalk First se t of labeling comments on PI Susan 
Wollersheim STN 125742.45.8 
10 4/22/2022 Mike Smith IR RE request for a revised study prot ocol for Study C4591022 
- pregnancy registry study ( postmarketing commitment (PMC) 
#10 as described in the STN 125742/0 approval letter) Deb Thompson STN 
125742.45.10 
11 4/26/2022 Mike Smith Follow-up communication RE 4/22/22 IR fro m OBE. Deb Thompson STN 125742.10 Michael J. Smith -
S4Digitally signed by Michael J. Smith -S4 Date: 2022.08.02 13:12:08 -04'00'Elizabeth M. Sutkowski -SDigitally signed by Elizabeth M. Sutkowski -S Date: 2022.08.24 21:28:02 -04'00'
FDA-CBER-2022-5812-0500507
STN 125742/45:  BioNTech Manufacturing GmbH’s  COMIRNATY sBLA Documentation Review Memo 
8/2/2022        2  12 5/4/2022 Mike Smith IR RE placebo recipient information contained in the PI Susan 
Wollersheim   STN 
125742.45.11 
13 5/10/2022 Mike Smith Second set of PI labeling comments. Susan 
Wollersheim STN 125742.45.12 
14 6/29/2022 Mike Smith Third set of PI labeling comments. Susan 
Wollersheim  STN 125742.45.13 
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        Amendments: 
Date/STN Summar
y Reviewed by and date of final review: 
1/28/2022 STN 125742.45.1 Responses to 1/25/22 IR RE EA/CE and FDA form 356 Mike Smith and 
Laura Gottschalk Xiao Wan
g (5/2/2022) 
2/2/2022 STN 125742.45.2 Response to 1/19/22 three questions RE datasets Brenda Baldwin (4 /22/2022), Ye Yang (4/11/2022)  
and Susan Wollersheim (7/8/2022) 
3/1/2022 STN 125742.45.3 Response to 2/23/22 OBE IR Cumulative Analysis of Post-Authorization Adverse Event Reports Deb Thompson (5/6/2022) 
3/11/2022 STN 125742.45.4 Response to 3/7/22 clinical-statist ical comments regarding updated 
immunobrid
ging anal yses and solicited adverse reaction frequencies. Susan Wollersheim (7/8/2022) and  Ye Yan
g (4/11/2022) 
FDA-CBER-2022-5812-0500508
STN 125742/45:  BioNTech Manufacturing GmbH’s  COMIRNATY sBLA Documentation Review Memo 
8/2/2022        3  Date/STN Summar y Reviewed by and date of final review: 
3/15/2022 
STN 125742.45.5 Request from Pfizer for comments on  booster dose for adolescents 12 
through 15 years of age in the same sBLA planned to apply for licensure of a booster dose for in dividuals 16 years of age and older 
as a sin
gle submission. N/A 
3/16/2022 STN 125742.45.6 Withdrawal of STN 125742.45.5 N/A 
3/18/2022 STN 125742.45.7 Response to 3/14/22 Follow-up question regarding Pfizer’s response in 
STN 125742.45.4 to our 3/7/22 clinical  and statistical questions. Ye Yang (4/11/2022) 
4/29/2022 STN 125742.45.8 Response to 4/20/22 first set of labeling comme nts on PI Susan Wollersheim (7/8/2022) and  
RPM labelin
g memo (8/2/2022) 
5/2/2022 STN 125742.45.9 Response to 4/20/22 request to update the PVP to include both 
Tris/Sucrose and PBS/Sucrose formulations. Deb Thompson (5/6/2022) 
5/4/2022 STN 125742.45.10 Response to 4/22/22 request to su bmit a revised study protocol for 
Study C4591022 - pregnancy registry study (postmarketing commitment (PMC) #10 as described in the STN 125742/0 approval letter) Deb Thompson (5/6/2022) 
5/9/2022 STN 125742.45.11 Response to 5/4/2022 IR RE placebo r ecipient information contained in 
the PI. Susan Wollersheim (7/8/2022)   
5/13/2022 STN 125742.45.12 Response to 5/10/22 second set of labeling comments on PI Susa n Wollersheim (7/8/2022) and  
RPM labelin
g memo (8/2/2022) 
7/1/2022 STN 125742.45.13 Response to 6/29/22 third set of  labeling comments on PI Susan Wollersheim (7/8/2022) and  
RPM labelin
g memo (8/2/2022) 
   
   
   
   
   
   
   
     
FDA-CBER-2022-5812-0500509