Document text
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 05 Aug 2021 FDA IR – Diluent
PFIZER CONFIDENTIAL
Page 1TABLE OF CONTENTS
LIST OF TABLES ................................ ................................ ................................ ..................... 1
QUERY 1 ................................ ................................ ................................ ................................ ...2
RESPONSE 1 ................................ ................................ ................................ ................... 2
QUERY 2 ................................ ................................ ................................ ................................ ...3
RESPONSE 2 ................................ ................................ ................................ ................... 3
QUERY 3 ................................ ................................ ................................ ................................ ...4
RESPONSE 3 ................................ ................................ ................................ ................... 4
QUERY 4 ................................ ................................ ................................ ................................ ...6
RESPONSE 4 ................................ ................................ ................................ ................... 6
LIST OF TABLES
Table 1. 0.9% Sodium Chloride Injection Container/Closure Information 10 mL vial.......4
Table 2. 0.9% Sodium Chloride Injection Container/Closure Information 2 mL Vial ........ 5
090177e197c34b54\Approved\Approved On: 09-Aug-2021 13:48 (GMT)
FDA-CBER-2021-5683-1149517
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 05 Aug 2021 FDA IR – Diluent
PFIZER CONFIDENTIAL
Page 2QUERY 1
The BLA includes 4 pictures of the saline diluent that will be provided but shipped separately
from the vaccine vials. Additional, information regarding the diluent does not appear to be
included in the BLA. Based on the pictures provided, the saline diluent is provided in “2 mL
single dose” and “10 mL single dose” vials.
a.With respect to the 2 mL single dose vial of saline, we assume that the end user will
extract 1.8 mL to reconstitute a single vial of vaccine. Please confirm and provide the
instructions provided with the diluent.
b. With respect to the 10 mL single dose vial, please submit any instructions provided to
healthcare providers .
RESPONSE 1
Pfizer confirms that t he saline diluent is provided in “2 mL single dose” and ’10 mL single
dose” vials.
Pfizer confirms FDA’s assumption in point “a” is correct. The end user will extract 1.8 mL
toreconsti tutea single vial of vaccine.
The two diluent vials are intended to be used and stored according to their respective
approved product labeling .The follow ing text is included in the draft USPI regarding the use
of the provided diluent; the same in structions are provided regardless of vial size .
Dilute the vial contents using 1.8 mL of sterile 0.9% Sodium Chloride I njection, USP
to form COMI RNATY. Do not add more than 1.8 mL of diluent.
ONLY use sterile 0.9% Sodium Chloride I njection, USP as the diluent. Do not use
bacteriostatic 0.9% Sodium Chloride I njection or any other diluent.
Vials of sterile 0.9% Sodium Chloride I njection, USP are provided but shipp ed
separately . Use the provided diluent or an alternate brand of sterile 0.9% Sodium
Chloride I njection, USP as the diluent.
Thetext below is newly proposed and will be provided in the updated draft USPI .
“Provided diluent vials are single -use onl y and should be discarded after 1.8 mL is
withdrawn. Do not use provide d diluent vials to dilute multiple vials of COMI RNA TY.”
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation -
None
090177e197c34b54\Approved\Approved On: 09-Aug-2021 13:48 (GMT)
FDA-CBER-2021-5683-1149518
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 05 Aug 2021 FDA IR – Diluent
PFIZER CONFIDENTIAL
Page 3QUERY 2
Also, please clarify if providers can reconstitute 2 or more vials of vaccine with saline from a
10mL single dose vial.
RESPONSE 2
Providers should not reconstitute 2 or more vials of the vaccine with saline from a 10 mL
single dose vial. The provided 10 mL single use diluent vials are intended to be used to
dilute a single vial of vaccine, and the remainder should be discarded. The following
statement has been proposed as an addition to the USPI :
“Provided diluent vials are single -use onl y and should be discarded after 1.8 mL is
withdrawn. Do not use provided diluent vials to dilute multiple vials of COMI RNATY.”
Literature References
None
SUP PORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
None
090177e197c34b54\Approved\Approved On: 09-Aug-2021 13:48 (GMT)
FDA-CBER-2021-5683-1149519
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 05 Aug 2021 FDA IR – Diluent
PFIZER CONFIDENTIAL
Page 4QUERY 3
Lastl y, please provide the container/closure information for each of these vials and
information regarding the number of permissible punctures of the vial stopper.
RESPONSE 3
Both diluent vials are single use plastic vials with elastomeric stoppers. The intended use of
both diluent vials allows for a single puncture of the vial stopper.
Table 1.0.9% Sodium Chloride Injection Container/Closure Information 10 mL vial
Primary Packaging
ComponentDirect Solution
Contact
Yes/NoDescription Manufacturer Name and
Address
Container Yes Plastic Vial, 10 mL
Closure Yes Stopper, 20 mm Gray
Compound, Snap Plug
SealaNo Seal, 20 mm, Flip -Off,
Green, Matte Top
a.While integral to the drug product packaging, the aluminum seal is not considered a primary packaging
component, as it does not have direct contact w ith the solution. The seal keeps the elast omeric closure in its
proper position in the neck of the vial. It does not have solution contact.
090177e197c34b54\Approved\Approved On: 09-Aug-2021 13:48 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149520
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 05 Aug 2021 FDA IR – Diluent
PFIZER CONFIDENTIAL
Page 5Table 2.0.9% Sodium Chloride Injection Container/Closure Information 2 mL Vial
Primary Packaging
ComponentDirect Solution
Contact
Yes/NoDescription Manufacturer Name and
Address
Container Yes Plastic Vial 3ml
Closure Yes Stopper, 20 mm Gray ,
Stopper, 20 mm
Stopper, 20 mm Gray,
Seal No Seal,13mm ,
Aluminum Crimp Flip
Cap Seal
Seal 13mm ,
Aluminum Flip- off
Seal
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
None
090177e197c34b54\Approved\Approved On: 09-Aug-2021 13:48 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149521
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 05 Aug 2021 FDA IR – Diluent
PFIZER CONFIDENTIAL
Page 6QUERY 4
If the requested information above is provided in the BLA, please provide the section(s).
RESPONSE 4
The requested information above was not provided in the BLA. Instructional text as above is
now added to the draft USPI .
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
None
090177e197c34b54\Approved\Approved On: 09-Aug-2021 13:48 (GMT)
FDA-CBER-2021-5683-1149522