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BNT162b2
BLA STN 125742/0
M 1.11.3 Response to FDA Information Request
PFIZER CONFIDENTIAL
1BNT162b2 (COMIRNATY)
BLA STN 125742/0
Response to CBER 22 July 2021 Information Request Regardin g
Clinical ShellTables for Study C4591001
Follow -Up #3 (Efficacy 508 Tables)
Response to CBER 03 August 2021 Information Request Regarding
Subject C4591001 1001 10031167 and SAS programs
July 2021
090177e197bda631\Approved\Approved On: 05-Aug-2021 14:41 (GMT)
FDA-CBER-2021-5683-0950192
BNT162b2
BLA STN 125742/0
M 1.11.3 Response to FDA Information Request
PFIZER CONFIDENTIAL
2TABLE OF CONTENTS
1. INTRODUCTION ................................ ................................ ................................ ................. 3
2. CBER INFORMATION REQUESTS AND SPONSOR RESPONSES ............................... 3
2.1. CBER Request 6 from 22 July 2021 Information Request ................................ .......3
2.2. CBER Request 1 from 03 August 2021 Information Request ................................ ..4
2.3. CBER Request 2 from 03 August 2021 Information Request ................................ ..4
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BNT162b2
BLA STN 125742/0
M 1.11.3 Response to FDA Information Request
PFIZER CONFIDENTIAL
31.INTRODUCTION
Reference is made to BLA STN 125742/0 for COVID -19 mRNA Vaccine (COMI RNATY),
for active immunization to prevent COVID -19 caused by SARS -CoV -2 in individuals
≥16years of age and to CBER’s 22 July 2022 Information Request received via email from
Laura Gottshalk, Ph D (CBER) regarding c linical shell tables for Study C4591001 .
Further reference is made to the Response to CBER 22 July 2021 Information Request
submitted to BL A 125742 /0 on 26 July 2021 (Sequence Number 0018), the Response to
CBER 22 July 2021 Information Request Follow -up #1 submitted to BL A 125549/0 on 28
July 2021 (Sequence Number 0020) and the Response to CBER 22 July 2021 I nformation
Request Follow -up # 2submitted to BL A 125549/0 on 2 August 2021 (Sequence Number
0028).
Please note the following:
Responses to CBER 22 July 2021 Information Request I tems 3, 4, 5, 7, 8 and 9were
submitted to BLA 125549/0 on 26 July 2021.
Responses to CBER 22 July 2021 Information Request I tems 1 and 2 were submitted
to BLA 125549/0 on 28July 2021.
Further response to CBER 22 July 2021 Information Request I tem 5b was submitted
to BLA 125549/0 on 2 August 2021.
The present response addresses CBER 22 July 2021 Information Request Item 6 in
part: The 508 efficacy tables are provided herein, while the sa fety 508 tables will be
provided on 13 August 2021.
Additional reference is made to CBER’s 03 August 2021 I nformation Request received via
email from Michael Smith, PhD (CBER) regarding Subject C4591001 1001 10031167 and
SAS programs used to generate effic acy anal yses according to CDC definition . Response sto
CBER’s 03 August 2021 requests are provided herein as well.
CBER requests are provided below in bold italics with Sponsor responses in plain text.
2.CBER INFORMATION REQUESTS AND SPONSOR RESPONSES
2.1.CBER Request 6 from 22 July 2021 Information Request
Please complete the following tables, based on the Study C4591001 Phase 2/3 populations,
limited to participants 16 years of age and older (please exclude participants 12 -15 years of
age) from the March data cutoff, unless otherwise specified. Please add rows, as needed to
list additional items.
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BNT162b2
BLA STN 125742/0
M 1.11.3 Response to FDA Information Request
PFIZER CONFIDENTIAL
4Sponsor Response
The requested efficacy 508 tables are provided in Module 5.3.5.1 C4591001 508 Compliant
Efficacy Table s(PDF) and Module 5.3.5.1 C4591001 508 Compliant Efficacy Table s
(Word) .
The requested safety 508 tables will be provided on 13 August 2021.
2.2.CBER Request 1 from 03 August 2021 Information Request
In your response submitted in STN 125742/0.17 dated July 26, 2021 (to CBER’s comment
4 sent on July 22, 2021), you clarified that Episodes B and C were merged into one single
COV ID-19 case for Subject C4591001 1001 10031167 because this subject had the severe
symptom of hospitalization from 22 November 2020 to 23 December 2020. While
hospitalization is a criterion for severe COVID -19 according to the CDC definition, it is
not a symptom or criterion defined in the study protocol for COVID -19 case definition. In
addition, the first positive PCR result was obtained on 19 December 2020, which was ~1
month after the hospitalization, making it difficult to corroborate that the hospitalization
was due to COVID -19. Therefore, we disagree with the mergence of these two episodes
based on hospitalization. Please provide updated efficacy analyses accordingly, to exclude
this subject, and participants 12 through 15 years of age for the shell tables requested.
Sponsor Response
The efficacy 508tables for participants ≥16 y ears of age provided in Module 5.3.5.1 in
response to CBER’s 22 July 2021 request (see response in Section 2.1) have been updated
accordingl yto remove mer ging of Episodes B and C for Subject C4591001 1001 10031167 .
As a result, this subject is no longer counted as aCOVID -19 case during the blinded placebo-
controlled follow -up period in the efficacy tables.
2.3. CBER Request 2 from 03 August 2021 Information Request
Please submit the SAS programs used to generate efficacy analyses according to the CDC -
definition, i.e., adc19ef- ve-sev-7pd2 -cdc-wo-eval and adc19ef -ve-sev-7pd2- cdc-eval.
Sponsor Response
The requested SAS programs are provided in Module 5.3.5.1.
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Document Approval Record
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