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BNT162b 2BLA STN 125742/0
Module 1.11.3 Response to FDA Request for Information
PFIZER CONFIDENTIAL
Page 1BNT162b2
BLA STN 1257 42/0
Response to CBER 06July 2021 Clinical Information Request
July2021
090177e197918386\Approved\Approved On: 15-Jul-2021 16:12 (GMT)
FDA-CBER-2021-5683-0950085
BNT162b 2BLA STN 125742/0
Module 1.11.3 Response to FDA Request for Information
PFIZER CONFIDENTIAL
Page 21.INTRODUCTION
On 06July2021, Pfizer /BioNTech received the following C linical Information R equestfrom
the FDAregarding Stud y C4591001 submitted toSTN 125742/0.
The FDA’s request in bold italics isfollowed by Pfizer/BioNTech’s response below.
2.CLINICAL INFORMATION REQUEST
2.1.FDA Information Request Item1
Please provide a description of the nature of the severe AEs and the AEs which lead to
withdrawal from the stable HIV cohort at any time during the study. (e.g., in
section12.2.3.1.1.1. Participants with Confirmed Stable HIV Disease – Blinded Placebo -
Controlled Follow -UpPeriod From Dose 1 to 1 Month After Dose 2 and 12.2.3.2.1.1.
Participants with Confirmed Stable HIV Disease – Blinded Placebo -Controlled Follow -Up
Period From Dose 1 to the Unblinding Date. There were 2 SAEs in the BNT162b2 group
(1 severe and 1 life -threatening) and 2 SAEs in the placebo group (1 life- threatening).
There were 2 AEs leading to withdrawal in the BNT162b2 group (1 life -threatening) and
1 AE (life -threatening) leading to withdrawal in the placebo group). Or if this information
is available in the submission, please provide a reference to the location of the requested
information.
Response
There were 5 participants in the stable HIV cohort whoreported severe, serious,
life-threatening, or leading to withdrawal AEs from Dose 1 to the unblind ing date(inclusive
of Dose 1 to 1 month after Dose 2) (Appendix 1). Narratives describing the events for 4 of
these participants are available in the submission and also provided in the appendix :
C4591001 1015 10151238 : BNT162b2 group, SAE (severe) of pneumonia (Appendix 2),
C4591001 1156 11561160 : BNT162b2 group , SAE (life -threatening) of road traffic
accident; participant was withdrawn (Appendix 3)
C4591001 1230 12301045 : BNT162b2 group, AE of e xposure during pregnancy;
participant wa s withdrawn (Appendix 4)
C4591001 1229 12291083 : Placebo group , 2 SAEs (both life-threatening) of diabetes
mellitusand COVID-19 pneumonia; participant was withdrawn (Appendix 5)
A narrative that was not included in the submission is provided in Appendix 6for the
following participant :
C4591001 1226 12262255: BNT162b2 group, AEs of nausea, vomiting, chills, injection
site pain, pyrexia, and myalgia (all severe)
090177e197918386\Approved\Approved On: 15-Jul-2021 16:12 (GMT)
FDA-CBER-2021-5683-0950086
BNT162b 2BLA STN 125742/0
Module 1.11.3 Response to FDA Request for Information
PFIZER CONFIDENTIAL
Page 33.APPENDIX
Appendix 1. Listing of Severe, Serious, L ifeThreatening, or Leading to Withdrawal
Adverse Events From Dose 1 to Unblinding Date –Blinded Placebo -Controlled Follow-up
Period–Phase 2/3 HIV -Positive Subjects ≥ 16 Years of Age –Safety Population
Appendix 2. Narrative for Subject ID: C4591001 1015 10151238
Appendix 3. Narrative for Subject ID: C4591001 1156 11561160
Appendix 4. Narrative for Subject ID: C4591001 1230 12301045
Appendix 5. Narrative for Subject ID: C4591001 1229 12291083:
Appendix 6. Narrative for Subject ID: C4591001 1226 12262255
090177e197918386\Approved\Approved On: 15-Jul-2021 16:12 (GMT)
FDA-CBER-2021-5683-0950087
Document Approval Record
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090177e197918386\Approved\Approved On: 15-Jul-2021 16:12 (GMT)
FDA-CBER-2021-5683-0950088