Document text
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 August 2021 Follow -up Information Request Regarding
Postmarketing Commitment S tudy C4591014
20August 2021
090177e197dc8b8a\Approved\Approved On: 20-Aug-2021 12:21 (GMT)
FDA-CBER-2021-5683-0950388
BNT162b2
BLA STN 125742 /0
M 1.11.3 Response to FDA Information Request
PFIZER CONFIDENTIAL
Page 21.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 19August 2021 .
CBER requests are presented in bold italics followed b y Pfizer -BioNTech response in plain
text.
2. CBER REQUEST AND SPONSOR RESPONSE
We received the responses to our August 19, 2021 questions on the PMR and PMC studies
and we have another questi on for you regarding the Study Completion Date and Final
Report Submission date for PMC Study C4591014.
The Study Completion Date listed in the amendment received today is June 30, 2023.
However, the Final Report Submission date listed in amendment 51 received on August 16,
2021, is also June 30, 2023. Please clarify if this is correct and provide corrections as
needed.
Sponsor Response
Pfizer/BioNTech confirm the Final Report Submission Date for Study C4591014, 30 June
2023, is correct.
Pfizer/BioNTech acknowledge that the Study Completion Date for Study C4591014 is
incorrect. This date will be revised to 31 December 2022 in the next version of the
Pharmacovigilance Plan. Submission of the updated Pharmacovigilance Plan is anticipated to
be post -approva l given our understanding of the imminence of approval of the BLA.
090177e197dc8b8a\Approved\Approved On: 20-Aug-2021 12:21 (GMT)
FDA-CBER-2021-5683-0950389
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