Document text
BNT162b2
M 1.1 4.1 Draft Labeling
CONFI DENTIAL
1BNT162b2 -BLA 125742
Diluent Labeling
May 2021
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FDA-CBER-2021-5683-0779740
BNT162b2
M 1.1 4.1 Draft Labeling
CONFI DENTIAL
21.INTRODUCTION
Reference is made to the following:
Pfizer/BioNTech Briefing Document sub mitted 18 February 2021 to BB -IND 19736
for a T ype C Meeting regarding the Read y-to-Use (RTU) and l yophilized
formulations of the BNT162b2 vaccine.
CBER’s 10 March 2021 Written Response to Pfizer/BioNTech’s Questions for the
Agency contained in the Briefin g Document
Pfizer/BioNTech’s 19 March 2021 response to CBER’s 10 March 2021 Information
Request , specifically our clarification question to FDA Additional Comment 1,
“Pfizer/BioNTech acknowledges FDA request to co -package the 0.9% Sodium
Chloride I njection, USP diluent with the current frozen liquid Covid -19 vaccine drug
product for licensure. However due to the extremely cold storage conditions required
to maintain requisite stabilit y for the frozen drug product, co -packaging diluent is not
possible at this time, due to the risk to the integrit y of the vials with freezing at very
low temperatures. To address CBER’s request, Pfizer proposes to ship necessary
quantities of 0.9% Sodium C hloride I njection, USP diluent in parallel to shipments of
the Covid -19 vaccine drug product, with arrivals sy nchronized so that diluent is
delivered before vaccine is delivered. The 0.9% Sodium Chloride I njection, USP
diluent will be labelled for exclusive use with the ComirnatyTMCovid -19 vaccine. ”
CBER ’s06 April 2021 agreement with the aforementioned proposal.
Part 1 of the Original Submission of the rolling Biologics License Application (BLA)
for the BNT162b2 vaccine candidate developed by BioNTech and Pfizer under
BB-IND 19736 for the prevention of COVID -19 caused b y SARS -CoV- 2 in
individuals ≥16 years of age submitted on 06 May 2021.
The purpose of this document is to describe and present the proposed labeling of the
0.9% Sodium Chloride Injection, U SP diluent to be used with COMI RNATYTM[COVI D-19
mRNA Vaccine (nucleoside modified)] .
2.IDENTIFICATION OF DI LUENT FOR USE WITH COVID -19 VACCINE DRU G
PRODUCT
Reference is made to the Emergency Use Authorization 27034 for the Pfizer -BioNTech
COVID -19 Vaccine. The0.9% Sodium Chloride Injection, USP diluent for BNT162b2 is
supplied by Pfizer to the US government for distribution to vaccine administrators. C urrentl y,
the diluent i s supplied in 3 mL glass vials manufactured by Fresenius Kabi LLC. There is
also an alternate source of diluent that may be supplied separately in 10 mL vials, if needed,
that are manufactured b y Hospira, Inc.
For the licensed commercial vaccine, a similar approach will be used as was done under the
EUA. Pfizer/ BioNTech will provide the same 0.9% Sodium Chloride I njection, USP diluent
manufactured b y Fresenius Kabi LL C or the Hospira saline diluent (if needed). The saline
090177e19709d21c\Approved\Approved On: 17-May-2021 21:11 (GMT)
FDA-CBER-2021-5683-0779741
BNT162b2
M 1.1 4.1 Draft Labeling
CONFI DENTIAL
3diluent will be supplied separately to healthcare providers (shipped in parallel with shipments
of the Comirnaty , with arrivals sy nchronized so that diluent is delivered before the vaccine is
delivered).
Cartons of the saline diluent will be clearl ylabeled to indicate that it is for use with
COMI RNATYTM[COVID -19 mRNA Vaccine (nucleoside modified)] specificall y:
Cartons of the 0.9% Sodium Chloride I njection, USP diluent supplied by
Fresenius Kabi LLC will be ink print stamped on the side of the carton opposite the
Fresenius Kabi diluent label with the following text : “For Use with COMIRNATYTM
[COVI D-19 mRNA Vaccine (nucleoside modified)].” Attachment 1 shows an image of the
Fresenius Kabi diluent carton. Attachment 2 shows an image of the For Use with
COMI RNATYTM[COVID -19 mRNA Vaccine (nucleoside modified)] stamp. The
information is printed f rom a domino printer in dot matrix font in a default font size of 7. The
ink stamp text isin black . No phy sical label can be applied , as the packaging line is full y
automated and does not have this capabilit y.
Cartons of the 0.9% Sodium Chloride I njection, USP diluent supplied by Hospira Inc., will
be labeled on the side of the carton opposite the Hospira diluent label . The label will state:
“For Use with COMIRNATYTM[COVID -19 mRNA Vaccine (nucleoside modified)].”
Attachment 3 shows an image of the Hospira diluent carton. Attachment 4 shows the artwork
for the “For Use with COMI RNATYTM[COVID -19 mRNA Vaccine (nucleoside modified)]”
label.
090177e19709d21c\Approved\Approved On: 17-May-2021 21:11 (GMT)
FDA-CBER-2021-5683-0779742
Document Approval Record
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