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Pfizer Global Regulatory Affairs
Pfizer Inc .
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
13August 2021
Marion Gruber, Ph.D.
Director
Office of Vaccines Research and Review
Food and Drug Administration
Center for Bi ologics Evaluation and Research
Document Control 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 ( BNT1 62/PF-0 7302048)
Response to FDA 09 August 2021 Information Request Regarding Draft
COMIRNATY Vial and Carton 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 Pfize r
under BB -IND 1 9736 for the prevention of COVID -19caused by SARS -CoV -2in
individuals ≥16 y ears of age.
The purpose of this submission is to respond to CBER ’s09 August 2021 request for
additional information and updates regarding the proposed COMI RNATY Draft Vial and
Draft Carton Labels ,received via email from Captain Michael Smith, PhD (CBER ).The
updated Vial Labels , Carton Labels and Diluent Sticker are provided in Module 1.14.1 :
Carton Label (195-Pack) f or Puurs ; Carton Label(195-Pack) forKalamaz oo
Carton Label (25-Pack) for Puurs ; Carton Label (25-Pack) for Kal amaz oo
Diluent Sticker
Vial La belforPuurs ; Vial L abel forKalamazoo
Additionally , reference isalso made specificall y to CBER ’s comment 5, Pfizer/BioNTech
can confirm ,as pre viously agreed with CBER that serialization w ould not be a requirement
on the carton for the duration of the global pandemic.
FDA-CBER-2021-5683-0950313
Marion Gru ber, Ph.D. , Director Page 2of 2
BLA 125742 13August 2021
Pfizer Confid ential
Page 2Should y ou have any questions re garding this subm ission , or re quireadditional information,
please contact me vi aphone at 215-280-5503 ; via facsi mile at 845 -474-3500; or via e-m ail at
elisa.hark instul [email protected] .
Sincerel y,
Elisa Harkins
Global R egulatory Lead
Global R egulator y Aff airs –Vaccine s
CC: Ramac handr a S. Naik, Ph.D.
FDA-CBER-2021-5683-0950314