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BNT162b 2
BLA 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 15July 2021 Clinical Information Request
July2021
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FDA-CBER-2021-5683-0950117
BNT162b 2
BLA STN 125742/0
Module 1.11.3 Response to FDA Request for Information
PFIZER CONFIDENTIAL
Page 21.INTRODUCTION
On 15July2021, Pfizer /BioNTech received the following C linical Information R equestfrom
the FDAregarding Stud y C4591007submitted 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
The review team has the question below for you regarding Study C4591007. The review
team has requested that a response be submitted to the BLA by July 21, 2021.
We note that the goal dates provided for Study C4591007 final protocol submission reflect
the date of the first v ersion of the protocol, which did not include all children 11 years of
age and younger. Please provide updated goal dates for final protocol submission (that will
include participants down to birth), study completion and report submission for Study
C4591007.
Response
Reference is made to the email conversation between Dr. Ramachandra Naik, FDA, CBER,
OVRR and Ms. Elisa Harkins, Pfizer I nc. within which Pfizer/BioNTech proposed to include
a Request for Waiver of Pediatric Studies for infants less than 2 mont hs of age as part of this
response. Pfizer/BioNTech acknowledge CBER’s response (20 July 2021 email from Dr.
Naik to Ms. Harkins) , “Currentl y, you are proposing a deferred study C4591007 to evaluate
the safety and effectiveness of COMI RNATY in children 11 years of age and younger. Due
to time constraints associated with the BLA review, we cannot consider a new request for a
partial waiver without risking delayed approval of the BLA. Please submit a revised pediatric
plan to indicate that study C4591007, fo r which the protocol has already been submitted to
the IND, will enroll subjects 6 months to 11 y ears of age and to propose another study to
enroll infants <6 months of age, with submission milestone dates in the future. Following
approval of your BLA and pending further information about epidemiology of the disease
and safety and effectiveness of your vaccine, we would consider a partial waiver and a
release from the corresponding PREA PMR.”
The present submission provides the amended AgreedPediatric Study Plan(Clean Copy and
Track Changes Copy ) and Request for Deferral of Pediatric Studies( Clean Copy and Track
Changes Cop y)as requested by CBER. These documents have been updated to include the
addition of study C4591023, a dose -finding safet y and effectiveness study in infants less than
6 months of age .They willalso be submitted to BB -IND 019736.
Pfizer/BioNTech propose the following goal dates for study C4591007 (children 6 months to
<12yearsof age):
Final Protocol Submission: 8 February 2021
Study Completion: 3 1 October 2023
090177e197a0ac7b\Approved\Approved On: 22-Jul-2021 22:11 (GMT)
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BNT162b 2
BLA STN 125742/0
Module 1.11.3 Response to FDA Request for Information
PFIZER CONFIDENTIAL
Page 3Final Report Submission: 3 1 March2024
Pfizer/BioNTech propose the following goal dates for study C4591023 (infants < 6 months of
age):
Final Protocol Submission: 31 January 2022
Study Completion: 31 July2024
Final Report Submission: 31 October 2024
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Document Approval Record
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