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Pfizer Global Regulatory Affairs
Pfizer Inc.
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
17August2021
Marion Gruber, Ph.D.
Director
Office of Vaccines Research and Review
Food and Drug Administration
Center for Bi ologics Evaluation and Research
DocumentControl Center
10903 New Hampshire Avenue
WO71, G112
Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL
AND/OR TRADE SECRET INFORMATION
THAT IS DISCLOSED ONLY IN CONNECTION
WITH THE LICENSING AND/OR
REGISTRATION OF PRODUCTS FOR PFIZER
INC OR ITS AFFILIATED COMPANIES. THIS
DOCUMENT SHOULD NOT BE DISCLOSED OR
USED, IN WHOLE OR IN PART, FOR ANY
OTHER PURPOSE WITHOUT THE PRIOR
WRITTEN CONSENT OF PFIZER INC.
Re:BLA 125742
COVID-19 mRNA Vaccine ( BNT162/PF-07302048)
Response to FDA 16August 2021 Information Request Regarding Carton and
Container Labels
Dear Dr. Gruber ,
Reference is made to the Biologics License Applicatio n (BLA) submitted 19 May 2021 for
the COVID -19 mRNA Vaccine (BNT162/PF -07302048) developed by BioNTec h and Pfizer
under BB -IND19736 for the prevention of COVID -19caused by SARS-CoV-2in
individuals ≥16 years of age.
The purpose of thissubmission is to respond to CBER ’s16August2021 information request
regarding the packaging l abelsreceived via email fromCaptain Michael Smith, Ph .D.
(CBER).Response to FDA16August2021Information Requ estis provided in Module
1.11.3.Updated packaging labels to accompan y the response are provided in Module 1.14.1:
COMIRNATY Carton Label(195-Pack) for Puurs; COMIRNATY C arton Label
(195-Pack)forKalamazoo
COMIRNATY Carton Label (25 -Pack) forPuurs; COMIRNATY C arton Label (25-
Pack) for Kalamazoo
Diluent Via l Label for Hospira; Diluent C arton Label for Hospira
Diluent Vial Labelfor Fresenius Kabi; Diluent Carton Label for Fresenius Kabi
FDA-CBER-2021-5683-0950350
Marion Gru ber, Ph.D. , Director Page2of 2
BLA125742 17August2021
Pfizer Confid ential
Page 2Should you have any questions re garding this subm ission, or requireadditionalinformation,
pleasecontact me viaphone at 215-280-5503; via facsimile at 845-474-3500; or via e-m ail at
elisa.hark instull@pfizer. com.
Sincerely,
ElisaHarkins
Global Regulatory Lead
Global Regulatory Affairs –Vaccines
CC: Ramachandra S. Naik, Ph.D.
Captain Micha el Smith, Ph.D.
Laura Gottshalk, Ph.D.
FDA-CBER-2021-5683-0950351