Document text
BNT162b2
BLA STN 125742/0
M 1.11.3 Response to FDA Information Requ est
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 #4 ( Safety 508 Tables)
August 2021
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FDA-CBER-2021-5683-1007503
BNT162b2
BLA STN 125742/0
M 1.11.3 Response to FDA Information Requ est
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
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BNT162b2
BLA STN 125742/0
M 1.11.3 Response to FDA Information Requ est
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 clinical shell tables for Study C4591001 .
Further reference is made to :
the Response to CBER 22 July 2021 Information Request submitted to BLA
125742 /0 on 26 July 2021 (Sequence Number 0018)
the Response to CBER 22 July 2021 Information Request Follow -up #1 submitted to
BLA 125549/0 on 28 July 2021 (Sequence Number 0020)
the Response to CBER 22 July 2021 Information Request Follow -up # 2submitte d to
BLA 125549/0 on 2 August 2021 (Sequence Number 002 8).
the Response to CBER 22 July 2021 Information Request Follow -up #3 submitted to
BLA 125549/0 on 5 August 2021 (Sequence Number 0033).
Please note the following:
Responses to CBER 22 July 2021 Infor mation 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.
Partial Response to CBER 22 July 2021 Information Request I tem 6 (508 Efficacy
Tables) wassubmitted to BLA 125549/0 on 5August 2021.
The pre sentresponse addresses the remaining information requested by CBER in the
22 July 2021 Information Request for Item 6: The safet y 508 tables are provided
herein.
CBER requests are provided below in bold italics with Sponsor responses in plain text.
2.CBER I NFORMATION 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
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BNT162b2
BLA STN 125742/0
M 1.11.3 Response to FDA Information Requ est
PFIZER CONFIDENTIAL
4age) from the March data cutoff, unless otherwise specified. Please add rows, as needed to
list additional items.
Sponsor Response
The requested safety 508 tables are provided in Module 5.3.5.1 C4591001 508 Compliant
Safety Table s(PDF) and Module 5.3.5.1 C4591001 508 Compliant Safety Table s (Word) .
Table C notes:
Table C is based on the Safet y population and vaccine group as administ ered.
Therefore, the numbers are different from Table B (disposition of all randomized
subjects ), which is based on vaccine group as randomized. Vaccine group as
administered is not identical to vaccine group as randomized because some subjects
received a study intervention that was different from what they were randomized to.
The BNT162b2 and placebo columns do not add up to the ‘Total’ column because the
3 indeterminate subjects were included in the ‘total’ column but not in BNT162b2 or
placebo column s.
Total vaccinated does not equal to safet y population because there were 10 subjects
who received vaccination but were excluded from the safet y population due to
unreliable data (lack of P rincipal Instigator oversight ).
Table T note: The Case Report Form (C RF) collects information only regarding Investigator
assessment of relatedness and not Pfizer assessment of relatedness.
The requested efficacy 508 tables were provided on 5 August 2021.
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Document Approval Record
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