Document text
BNT162b2
BLA STN 125742/0
M 1.11.4Response to FDA Information Request
PFIZER CONFIDENTIAL
Page 1BNT162b2 (COMIRNATY)
BLA STN 125742/0
Response to CBER 18 August2021 Information Request Regarding
Identification of BLA CompliantLots and Dear HCP Letter
19August 2021
090177e197da0346\Approved\Approved On: 19-Aug-2021 13:11 (GMT)
FDA-CBER-2021-5683-0951267
BNT162b2
BLA STN 125742/0
M 1.11.4Response 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 18August2021.
CBER requests are presented in bold italics followed b y Pfizer-BioNTech response in plain
text.
2. CBER REQUEST AND SPONSOR RESPONSE
Reference is made your [Donna Boyce , Senior Vice President, Head of Global Regulatory
Affairs, Pfizer Inc.] August 16, 2021 email communication and telephone conversation
with Mary Malarkey, Director, OCBQ/FDA, in which you shared a graphic for
identification of BLA -compliant lots and draft Dear HCP Letter. Please submit these and
any relevant documents as an amend ment to the BLA.
If these documents have already been submitted, please point us to the
amendment/sequence number and when these were submitted.
Sponsor Response
The graphic, Identification of BLA -Compliant Lots,and the Dear HCP Letter -
COMIRNATY Lots areattached. Please note, the version of the Dear HCP L etter attached
here is different from the version emailed to Mar y Malarkey because this is the final draft
version that is intended to be used upon approval of COMI RNATY.Please also note, “BLA -
complaint” as cited in the graphic is a t ypographical error.
090177e197da0346\Approved\Approved On: 19-Aug-2021 13:11 (GMT)
FDA-CBER-2021-5683-0951268
Document Approval Record
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090177e197da0346\Approved\Approved On: 19-Aug-2021 13:11 (GMT)
FDA-CBER-2021-5683-0951269