Document text
BNT162b2
BLASTN 125742/0
M 1.11.3 Response to FDA Information Request
PFIZER CONFIDENTIAL
Page 1BNT162b2 (COMIRNATY)
BLA STN 125742/0
Response to 16 August2021 CBER Information Request
Regarding Diluent Packaging Labels
August 2021
090177e197d4ab2d\Approved\Approved On: 17-Aug-2021 13:48 (GMT)
FDA-CBER-2021-5683-0950352
BNT162b2
BLASTN 125742/0
M 1.11.3 Response to FDA Information Request
PFIZER CONFIDENTIAL
Page 2TABLE OF CONTENTS
1. INTRODUCTION ................................ ................................ ................................ ................. 3
2. CBER REQUESTS ................................ ................................ ................................ ................ 3
2.1. CBER Request Regarding the Diluent Vial and Carton Labels:............................... 3
2.1.1. CBER Request 1 ................................ ................................ ........................... 3
2.1.2. CBER Request 2 ................................ ................................ ........................... 3
2.1.3. CBER Request 3 ................................ ................................ ........................... 4
2.1.4. CBER Request 4 ................................ ................................ ........................... 4
2.2. CBER Re quest Regarding the COMIRNATY Carton Labels:................................ .5
2.2.1. CBER Request 5 ................................ ................................ ........................... 5
2.2.2. CBER Request 6 ................................ ................................ ........................... 5
2.2.3. CBER Request 7 ................................ ................................ ........................... 5
090177e197d4ab2d\Approved\Approved On: 17-Aug-2021 13:48 (GMT)
FDA-CBER-2021-5683-0950353
BNT162b2
BLA STN 125742/0
M 1.11.3 Response to FDA Information Request
PFIZER CONFIDENTIAL
Page 31.INTRODUCTION
Reference is made to BLA STN 125742/0 for the Pfizer-BioNTech COVID -19 Vaccine for
active immunization to prevent COVID -19 caused by SARS-CoV-2 in individuals ≥16 years
of age.
The purpose of this document is to respond to CBER’s Information R equest (IR)
communicated from Captain Michael Smith,PhD (CBER) to Elisa Harkins (Pfizer Inc.)via
emailon 16August2021, with questions regarding proposed diluent packaging labels.
CBER’s comments/ requestsin bold italics are followed b y the Sponsor’s responses below.
2.CBER REQUEST S
Our review of the information provided in your BLA STN 125742/0 for COMIRNATY
(COVID- 19 Vaccine, mRNA), for active immunization to prevent COVID- 19 caused by
SARS-CoV-2 in individuals 16 years of age and older, is ongoing. We refer you to
Amendment 46 of your BLA (dated August 13, 2021) in which you responded to our
August 9, 2021 comments on your carton and container labels. We have the following
additional requests for information regarding your proposed carton and contai ner labels:
2.1.CBER Request Regarding the Diluent Vial and Carton Labels:
2.1.1.CBER Request 1
In our August 9, 2021 communication, we requested that you provide the vial labels for the
diluent; however, no vial labels were submitted. We continue to request that you submit
vial labels for the diluents as this information should be included in your B LA.
Response
The vial label for Hospira diluent and the vial label for Fresen ius Kabi diluent are provided in
Module1.14.1.1.
2.1.2.CBER Request 2
In your original BLA submission, you included a single picture of the outside of each
multi-vial diluent carton. Please provide copies of the full carton labels for the diluent
manufactured at both Fresenius Kabi and Hospira as this information should be included
in your BLA. Each carton label should include a lot number and expiration date for the
packaged diluent.
Response
The carton label for Hospira diluent and the carton label for Fresenius Kabi diluent are
provided in Module 1.14.1.1. Both carton labels include a lot number and expiration date for
the packaged diluent.
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FDA-CBER-2021-5683-0950354
BNT162b2
BLA STN 125742/0
M 1.11.3 Response to FDA Information Request
PFIZER CONFIDENTIAL
Page 42.1.3.CBER Request 3
In Amendment 46, you included a “Diluent Sticker.” Our understanding is this sticker is
the same as the previously submitted “Fresenius Kabi Diluent Stamp” and the “Hospira
Diluent Label”. Please confirm. For each diluent carton, please provide a graphical
presentation of the carton label and clearly show where the sticker/stamp will be located.
Response
The “Diluent Sticker” provided in Amend ment 46 is the updated “Hospira Diluent L abel”.
This is the sticker that will be placed on top of the shrink-wrapped vials within a carton of
Hospira diluent. Please refer to the Hospira Diluent Carton picture submitted in
Sequence 0002 of the initial application. The sticker will be placed on the shrink wrap on top
of the packaged carton , not on the carton label itsel f.
For the Fresenius Kabi diluent, Fresenius Kabi will update the stamp that will be placed on
their carton to contain the same information as that included in the “Diluent Sticker”
provided in Amendment 46 , though it will be in black text. Please refer to the Fresenius Kabi
Diluent Carton picture submitted in Sequence 0002 of the initial application and the carton
labelfor Fresenius Kabi diluent that is provided in Module 1.14.1.1 of the present
submission. The stamp will be on the opposite end of the carton from Fresenius Kabi’s
diluent carton label.
2.1.4.CBER Request 4
In our August 9, 2021 communication we requested that the “Fresenius Kabi Diluent
Stamp” and the “Hospira Diluent Label” include the proper name of the diluent, the lot
number, and exp iration date. However, revised labels were not submitted. Please provide a
revised stamp and label for our review. See also comment 3 above.
Response
Pfizer/BioNTech acknowledge s CBER’s request . Thepurpose of the “ Fresenius Kabi Diluent
Stamp” and the “Hospira Diluent L abel” is specifically to indicate that the product is
designated for use with COMI RNATY. The vials labels and carton labels for both diluent
productscontain the lot number and expiration date for that product. Please see the responses
to Items 1 and 2 of this submission. In addition, for the Fresenius Kabi diluent, the
“Fresenius Kabi Diluent Stamp” will be applied to the actual carton which alread y contains
the lot number and expiration date. For the Hospira di luent, the “Hospira Diluent L abel” will
be manuall y applied from a roll of labels, thus it will not be possible to include the lot
number and expiration date. It will be placed in such a way that does not obscure the lot and
expiry information already printed on the carton label . As the lot number and expiration date
will be clearl y visibleon the carton labels, to avoid potential confusion due to redundancy , it
is preferred to not include this information on the diluent stamp/label.
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FDA-CBER-2021-5683-0950355
BNT162b2
BLA STN 125742/0
M 1.11.3 Response to FDA Information Request
PFIZER CONFIDENTIAL
Page 52.2.CBER Request Regarding the COMIRNATY Carton Labels:
2.2.1.CBER Request 5
The placement of the QR code in the center of the label for the 195 -vial container from
Kalamazoo competes with and distracts from the information provided on the label. Please
revise the label to place the QR code such that it does not compete with, distr act from,
interrupt, or distort the required or recommended content on the carton labeling (see the
draft guidance for industry: Safety Considerations for Container Labels and Carton
Labeling Design to Minimize Medication Errors(April 2013 ).When final, this guidance
will represent the Agency’s current thinking on this topic). For example, placement of the
QR code on the lower left of the label (such as on the carton for the 195 -vial container
from Puurs) would be acceptable.
Response
The carton labels have been updated accordingl y and are provided in Module 1.14.1.1.
2.2.2.CBER Request 6
Please include on the cartons the following instructions, “Please see prescribing
information for additional details including instructions for preparation, dosage and
administration.”
Response
The carton labels have been updated accordingl y and are provided in Module 1.14.1.1.
2.2.3.CBER Request 7
Please revise the temperatures for storage prior to dilution so that they are consistent with
the prescribing information by changing:
-90°C to -60°C (-130°F to -76°F)
to
-80°C to -60°C (-112°F to -76°F).
Response
On 16 August 2021, Pfizer/BioNTech submitted updated prescribing information that
corrected the temperatures for storage prior to dilution to“-90oC to -60oC (-130oF to -76oF)”.
Therefore ,the carton labels do not need to be revised.
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090177e197d4ab2d\Approved\Approved On: 17-Aug-2021 13:48 (GMT)
FDA-CBER-2021-5683-0950357