Document text
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 11Aug 2021 FDA IR1 –Diluent
PFIZER CONFIDENTIAL
Page 1TABLE OF CONTENTS
LIST OF TABLES ................................ ................................ ................................ ..................... 1
QUERY 1 ................................ ................................ ................................ ................................ ...2
QUERY 1 -A................................ ................................ ................................ ............................... 2
RESPONSE 1-A...............................................................................................................2
QUERY 1 -B................................ ................................ ................................ ............................... 3
RESPONSE 1-B...............................................................................................................3
QUERY 1 -C................................ ................................ ................................ ............................... 4
RESPONSE 1-C...............................................................................................................4
FOLL OW-UP TO 05 AUGUST 2 021 I R-DILUENTS -QUE RY 3) ................................ ......... 7
LIST OF TABLES
Table 1. Overview of Shipping Procedures and Contents for the 2 mL and 10 mL
Single Dose Diluent Vials ................................ ................................ ...................... 5
Table 2. 0.9% Sodium Chloride Inje ction Container/Closure Information 10 mL vial .......7
090177e197ce161b\Approved\Approved On: 13-Aug-2021 12:24 (GMT)
FDA-CBER-2021-5683-1149577
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 11Aug 2021 FDA IR1 –Diluent
PFIZER CONFIDENTIAL
Page 2QUERY 1
In reference to the diluent that will be used with your COVID -19 vaccine (sterile 0.9%
Sodium Chloride Injection, USP) “2 mL single dose” and “10 mL single dose” vials:
QUERY 1-A
Please update Section 3.2.P.3.1. MANUFACTURER(S) of your BLA to include the
manufacturers of each vial size, including their address and FEI numbers.
RESPONSE 1-A
A Section 3.2.P.3.1 Manufacturer(s) [DILUENT] has been addedto include the
manufacturers ’ address of sterile 0.9% Sodium Chloride Injection, USP “2 mL single dose”
and “10 mL single dose” vials , including each vial size and FEI numbers .
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
3.2.P.3.1 Manufacturer(s) [DILUENT] -New
Previously submitted supporting documentation
090177e197ce161b\Approved\Approved On: 13-Aug-2021 12:24 (GMT)
FDA-CBER-2021-5683-1149578
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 11Aug 2021 FDA IR1 –Diluent
PFIZER CONFIDENTIAL
Page 3QUERY 1-B
Please update FDA Form 356h to include the information related to y our diluent
manufacturers .
RESPONSE 1 -B
FDA Form 356h will be updated to include information related to the diluent manufacturers.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
090177e197ce161b\Approved\Approved On: 13-Aug-2021 12:24 (GMT)
FDA-CBER-2021-5683-1149579
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 11Aug 2021 FDA IR1 –Diluent
PFIZER CONFIDENTIAL
Page 4QUERY 1-C
Please provide a summary of the shipping procedures for the “2 mL single dose” and “10 mL
single dose” vials including the origin of distribution, shipping responsible party , carton
sizes, description of the shipper (box) and shipping configuration, a nd the established
shipping controls.
RESPONSE 1-C
The diluent isshipped using next day delivery byUnited Parcel Service (UPS) .
See Table 1 for an overview of the origin of distribution, shipping responsible part y, carton
sizes, descr iption of the shipper (box), shipping configuration and shipping controls for the
0.9% Sodium Chloride Injection, USP 2 mL and 10 mL Single Dose Vials .
090177e197ce161b\Approved\Approved On: 13-Aug-2021 12:24 (GMT)
FDA-CBER-2021-5683-1149580
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 11Aug 2021 FDA IR1 –Diluent
PFIZER CONFIDENTIAL
Page 5Table 1. Overview of Shipping Procedures and Contents for the 2 mL and 10 mL Single Dose Diluent Vials
Origin of
DistributionShipping
Responsible
PartyCarton Sizes Description of Shipper
(Box)Shipping
ConfigurationEstablished Shipping
Controls
2 mLFresenius K abi:
Package: 25Vials/
Packsingle wall c orrugateVials packaged in kits
with other ancillary
supplies (masks,
syringes, gloves ,etc.)
Three 25- count or
Eight 25-count packs
per shipperLive 24/7 monitoring of
shipment
10 mLHospira :
Package; 25 vials /packsingle wall c orrugate Vials packaged in kits
with other ancillary
supplies (masks,
syringes, gloves ,etc.)
Eight 25- count packs
per shipperLive 24/7 monitoring of
shipment
090177e197ce161b\Approved\Approved On: 13-Aug-2021 12:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149581
COVI D-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 11 Aug 2021 FDA IR 1 –Diluent
PFIZER CONFIDENTIAL
Page 6Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
None
090177e197ce161b\Approved\Approved On: 13-Aug-2021 12:24 (GMT)
FDA-CBER-2021-5683-1149582
COVI D-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 11 Aug 2021 FDA IR 1 –Diluent
PFIZER CONFIDENTIAL
Page 7FOLLOW -UP TO 05 AUGUST 2021 IR - DILUENTS -QUERY 3)
Additional supplier of the 10 mL container was inadvertentl y omitted. Reference Table 2.
Table 2. 0.9% Sodium Chloride Injection Container/Closure Information 10 mL vial
Primary Packaging
ComponentDirect Solution
Contact (Yes/No)Description 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.
Literature References
None
090177e197ce161b\Approved\Approved On: 13-Aug-2021 12:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149583
COVI D-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 11 Aug 2021 FDA IR 1 –Diluent
PFIZER CONFIDENTIAL
Page 8SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
None
090177e197ce161b\Approved\Approved On: 13-Aug-2021 12:24 (GMT)
FDA-CBER-2021-5683-1149584