Document text
Pfizer Global Regulatory Affairs
Pfizer Inc.
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
19August2021
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 18 August 2021 Information Request Regarding Inclusion of
Draft Carton and Container Labels in a Single Amendment
Dear Dr. Gruber ,
Reference is made to the Biologics License Applicatio n (BLA) submitted 18May 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.
Reference is made to CBER’s 18 August 2021 request to submit, in a single amendment, all
of the draft labels listed in the below amendments . The present submission addresses
CBER’s request.
Amendment 46 (Seq 0046, dated 08/13/2021)
oCOMIRNATY Vial Label (Kalamazoo)
oCOMIRNATY Vial Label (Puurs)
oDiluent St icker (Hospira)
Amendment 53 (Seq 0054, dated 08/17/2021)
oCOMIRNATY Cart on –25 Vial (Kalamazoo)
oCOMIRNATY Carton –25 Vial (Puurs)
oCOMIRNATY Carton –195 Vial (Kalamazoo)
FDA-CBER-2021-5683-0950369
Marion Gru ber, Ph.D. , Director Page2of 2
BLA125742 19August2021
Pfizer Confid ential
Page 2oCOMIRNATY Carton –195 Vial (Puurs)
oDiluent Vial (Fresenius Kabi)
oDiluent Vial (Hospira)
oDiluent Carton –25 Vial (Fresenius Kabi)
oDiluent Carton –25 Vial(Hospira)
As agreed b y the Agency via email from Lau ra Goddshalk, PhD, FDA, CBER,
OVRR to Elisa Harkins, Pfizer I nc. via email o n 19 August 2021 the Diluent Stamp
for Fresenius Kabi will not be provided because Fresenius Kabi would need to stop
their packaging operations for this, which is not feasible in the timefr ame request by
CBER for this response. . The stamp will be updated in alignment with the text
includedin the Diluent Stick er for Hospira (provided in this submission).
Should 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-2021-5683-0950370