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BNT162b2
BLA STN 125742/0
M 1.11.3 Response to FDA Information Request
PFIZER CONFIDENTIAL
Page 1BNT162b2 (COMIRNATY)
BLA STN 125742/0
Response to CBER 19 August2021 Information Request Regarding
Postmarketing Requirement/Postmarketing Commitment S tudies
19August 2021
090177e197daf1b4\Approved\Approved On: 19-Aug-2021 19:38 (GMT)
FDA-CBER-2021-5683-0950378
BNT162b2
BLA STN 125742/0
M 1.11.3 Response to FDA Information Request
PFIZER CONFIDENTIAL
Page 2TABLE OF CONTENTS
1. INTRODUCTION ................................ ................................ ................................ ................. 3
2. CBER REQUESTS AND SPONSOR RESPONSES ................................ ............................ 3
2.1. CBER Request 1 -Study C4591021 ................................ ................................ .........3
2.2. CBER Request 2 -Substudy C4591021 ................................ ................................ ....3
2.3. CBER Request 3 -Prospective Assessment of Subclinical My ocarditis.................. 4
2.4. CBER Request 4 -Prospective Cohort Study for Potential L ong-term
Sequelae of M yocarditis................................ ................................ .............................. 4
2.5. CBER Request 5 - Study C4591022 ................................ ................................ .........4
2.6. CBER Request 6 -Study C4591012 ................................ ................................ .........5
2.7. CBER Request 7 -Study C4591014 ................................ ................................ .........5
090177e197daf1b4\Approved\Approved On: 19-Aug-2021 19:38 (GMT)
FDA-CBER-2021-5683-0950379
BNT162b2
BLA STN 125742/0
M 1.11.3 Response to FDA Information Request
PFIZER CONFIDENTIAL
Page 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 Information Request received via email on 19August2021.
CBER requests are presented in bold italics followed by Pfizer-BioNTech response in plain
text.
2.CBER REQUESTS AND SPONSOR RESPONSES
We have the below comments regarding the August 16, 2021, amendment containing your
PMR and PMC commitments.
2.1.CBER Request 1 -S tudy C4591021
Regarding PMR study C4591021: We notice that the Study Completion Date and Final
Report Submission have the same dates (September 30, 2024). Please clarify if this is
correct and provide corrections as needed.
Sponsor Response
Pfizer/BioNTech confirm the Final Report Submission Date for Study C4591021, 30
September 2024, is correc t.
Pfizer/BioNTech acknowledge that the Study Completion Date for Study C4591021 is
incorrect. This date will be revised to 31 March 2024 in the next version of the
Pharmacovigi lance Plan. Submission of the updated Pharmacovigilance Plan is anticipated to
be post-approval given our understanding of the imminence of approval of the BLA.
2.2.CBER Request 2 -Substudy C4591021
Regarding PMR substudy C4591021: We notice that the Study C ompletion Date and Final
Report Submission have the same dates (September 30, 2024). Please clarify if this is
correct and provide corrections as needed.
Sponsor Response
Pfizer/BioNTech confirm the Final Report Submission Date for Study C4591021 substudy,
30 September 2024, is correc t.
Pfizer/BioNTech acknowledge that the Study Completion Date for Study C4591021 substudy
is incorrect . This date will be revised to 31 March 2024 in the next version of the
Pharmacovigilance Plan. Submission of the updated Pharmacovigilance Plan is anticipated to
be post-approval given our understanding of the imminence of approval of the BLA.
090177e197daf1b4\Approved\Approved On: 19-Aug-2021 19:38 (GMT)
FDA-CBER-2021-5683-0950380
BNT162b2
BLA STN 125742/0
M 1.11.3 Response to FDA Information Request
PFIZER CONFIDENTIAL
Page 42.3.CBER Request 3 - Prospective Assessment of Subclinical Myocarditis
Regarding the PMR for a prospective assessment of the incidence of subclinical
myocarditis following administration of the second dose of Comirnaty in a subset of
participants 5 through 15 years of age enrolled in Study C4591007, please provide the date
for submission of the protocol amendment .
Sponsor Response
The protocol amendment will be submitted by 30 September 2021.
2.4.CBER Request 4 - P rospective C ohort Study forPotential Long -term Sequelae of
Myocarditis
Regarding the PMR prospective cohort study with at least 5 years of follow -up for potential
long-term sequelae of myocarditis after vaccination (in collaboration with Pediatric Heart
Network): Please change the dates for the Study Completion Date and Final Report
Submission to the last day of the month, December 31, 2026 and May 31, 2027,
respectively. A lso, please provide a study number for this study.
Sponsor Response
Pfizer/BioNTech agree to change the Study Completion Date and Final Report Submission to
the last day of the month, 31 December 2026 and 31 May 2027, respectively . These changes
will be re flected in the next version of the Pharmacovigilance Plan. Submission of the
updated Pharmacovigilance Plan is anticipated to be post- approval given our understanding
of the imminence of approval of the BLA.
This study has been assigned study number C4591 036.
2.5.CBER Request 5 -S tudy C4591022
Regarding PMC study C4591022: Please change the dates for the Study Completion Date
and Final Report Submission to the last day of the month, June 30, 2025 and December
31, 2025, respectively.
Sponsor Response
Pfizer/BioNTech agree to change the Study Completion Date and Final Report Submission to
the last day of the month, 30 June 2025 and 31 December 2025 , respectively . These changes
will be reflected in the next version of the Pharmacovigilance Plan. Submission of the
updated Pharmacovigilance Plan is anticipated to be post- approval given our understanding
of the imminence of approval of the BLA.
090177e197daf1b4\Approved\Approved On: 19-Aug-2021 19:38 (GMT)
FDA-CBER-2021-5683-0950381
BNT162b2
BLA STN 125742/0
M 1.11.3 Response to FDA Information Request
PFIZER CONFIDENTIAL
Page 52.6.CBER Request 6 -S tudy C4591012
Regarding PMC study C4591012: Please change the date for the Study Completion Da te
to the last day of the month, June 30, 2023.
Sponsor Response
Pfizer/BioNTech agree to change the Study Completion Date to the last day of the month, 30
June 2023. This change will be reflected in the next version of the Pharmacovigilance Plan.
Submission of the updated Pharmacovigilance Plan is anticipated to be post -approval given
our understanding of the imminence of approval of the BLA.
2.7.CBER Request 7 -S tudy C4591014
Regarding PMC study C4591014: We note that there wasn’t a Study Completion Date
provided, please provide a Study Completion Date for the last day of the month that the
study will be completed.
Sponsor Response
The Study Completion Date is 30 June2023.
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