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BNT162b2
BLA STN 125742/0
M 1.11.3 Response to FDA I nformation Request
PFIZER CONFIDENTIAL
1BNT162b2 (COMIRNATY)
BLASTN 125742/0
Response to CBER 22 July2021Information Request Regardin g
ClinicalShellTablesfor Study C4591001
Follow-Up #1
July2021
090177e197a8b052\Approved\Approved On: 27-Jul-2021 19:43 (GMT)
FDA-CBER-2021-5683-0950135
BNT162b2
BLA STN 125742/0
M 1.11.3 Response to FDA I nformation Request
PFIZER CONFIDENTIAL
2TABLE OF CONTENTS
1. INTRODUCTION ................................ ................................ ................................ ................. 3
2. CBER INFORMATION REQUESTS AND SPONSOR RESPONSES ............................... 3
2.1. CBER Request 1 ................................ ................................ ................................ ........3
2.2. CBER Request 2 ................................ ................................ ................................ ........5
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BNT162b2
BLA STN 125742/0
M 1.11.3 Response to FDA I nformation 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 Requestreceived 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 125549/0 on 26 July 2021.
Please note the following:
Responses to CBER 22 July 2021 Information Request I tems3, 4, 5, 7, 8 and 9were
submitted to BLA 125549/0 on 26 July 2021.
This first follow -up Response addresses C BER 22 July 2021 Information Request
Items 1 and 2.
CBER 22 July 2021 Information Request I tem 6 will be the subject of separate,
future, follow-up Response that will be submitted by 13 August 2021 (as indicated in
the 28 July 2021submission).
CBER reques ts are provided below in bold italics with Sponsor responses in plain text.
2.CBER INFORMATION REQUESTS AND SPONSOR RESPONSES
2.1.CBER Request 1
Please provide the number and percentage of clinical COVID cases that meet the case
definition but not confirmed by PCR for any reason (e.g., not done, sample lost, out of
window), by study arm.
Sponsor Response
The requested information is provided in Table 1and Table 2.
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BNT162b2
BLA STN 125742/0
M 1.11.3 Response to FDA I nformation Request
PFIZER CONFIDENTIAL
4Table 1.Subjects With Symptoms of COVID -19 but not Confirmed Cases by PCR –
Subjects With or Without Evidence of Infection Prior to 7 Days After Dose
2 –Blinded Placebo -Controlled Follow -up Period – Evaluable Efficacy (7
Days) Population
Vaccine Group (as
Randomized)
BNT162b2 (30
μg) Placebo Total
na(%) na(%) na(%)
Subjects developed protocol defined symptoms after 7 days post
dose 2 but not confirmed cases by PCRb2285 2646 4931
PCR Results Negative 2026 (88.7) 2305 (87.1) 4331
(87.8)
PCR Results unavailable or unknown 303 (13.3) 396 (15.0)699 (14.2)
Swab not taken 210 (9.2) 267 (10.1) 477 (9.7)
Swab taken but results not available 13 (0.6) 41 (1.5) 54 (1.1)
Swab taken outside of symptom window 80 (3.5) 88 (3.3) 168 (3.4)
Note: If a subject develops unconfirmed protocol defined symptoms multiple times, they may be classified
under both negative and unavailable or unknown rows depending on the status of swab associated w ith each
illness.
a. n = Number of subjects with the specified characteristic.
b. The values in this row are the denominators for the percentage calculations.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (19:22) Source Data: adsympt Table Generation:
26JUL2021 (12:49)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File :
./nda2_unblinded/C4591001_BLA_RR/adsympt_sympt_pcr_7pd2_eval
090177e197a8b052\Approved\Approved On: 27-Jul-2021 19:43 (GMT)
FDA-CBER-2021-5683-0950138
BNT162b2
BLA STN 125742/0
M 1.11.3 Response to FDA I nformation Request
PFIZER CONFIDENTIAL
5Table 2.Subjects With Symptoms of COVID -19 but not Confirmed Cases by PCR –
Subjects Without Evidence of Infection Prior to 7 Days After Dose 2 –
Blinded Placebo-Controlled Follow -up Period – Evaluable Efficacy (7
Days) Population
Vaccine Group (as
Randomized)
BNT162b2 (30
μg) Placebo Total
na(%) na(%) na(%)
Subjects developed protocol defined symptoms after 7 days post
dose 2 but not confirmed cases by PCRb2164 2513 4677
PCR Results Negative 1926 (89.0) 2194 (87.3) 4120
(88.1)
PCR Results unavailable or unknown 279 (12.9) 369 (14.7) 648 (13.9)
Swab not taken 192 (8.9) 248 (9.9) 440 (9.4)
Swab taken but results not available 13 (0.6) 37 (1.5) 50 (1.1)
Swab taken outside of symptom window 74 (3.4) 84 (3.3) 158 (3.4)
Note: If a subject develops unconfirmed protocol defined symptoms multiple times, they may be classified
under both negative and unavailable or unknown rows depending on the status of swab associated w ith each
illness.
a. n = Number of subjects with the specified characteristic.
b. The values in this row are the denominators for the percentage calculations.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (19:22) Source Data: adsympt Table Generation:
26JUL2021 (12:49)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File:
./nda2_unblinded/C4 591001_BLA_RR/adsympt_sympt_pcr_7pd2_w o_eval
2.2.CBER Request 2
Please provide the cumulative incidence rates for the vaccine group as compared to the
placebo group at 2, 4, and 6 months post dose 1 to complement the cumulative incidence
curve submitted (Figure 2, pg 104, from c4591001- interim-mth6-report-body.pdf).
Sponsor Response
The requested information is provi ded in Table 3.
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BNT162b2
BLA STN 125742/0
M 1.11.3 Response to FDA I nformation Request
PFIZER CONFIDENTIAL
6Table 3.Cumulative Incidence of COVID -19 Occurrence After Dose 1 –Blinded
Placebo-Controlled Follow -up Period – Dose 1 All -Available Efficacy
Population
Vaccine Group (as Rando mized)
BNT162b2 (30 μg) Placebo
Efficacy EndpointCumulative Incidence
of COVID -19
OccurrenceaCumulative Incidence
of COVID -19
Occurrencea
First COVID -19 occurrence upto 2 Months after Dose 1 0.0024 0.0139
First COVID -19 occurrence upto 4 Months after Dose 1 0.0041 0.0358
First COVID -19 occurrence upto 6 Months after Dose 1 0.0076 0.0601
a. Cumulative Incidence of COVID -19 Occurrence is derived based on the Kaplan -Meier Method.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (19:19) Source Data: adc19ef Table Generation:
23JUL2021 (15:54)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File:
./nda2_unblinded/C4591001_BLA_RR/adc19ef_kmci_pd1
090177e197a8b052\Approved\Approved On: 27-Jul-2021 19:43 (GMT)
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Document Approval Record
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