Document text
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 16July2021 FDA QueriesRe: LRP template IR and Samples for STN 125742/0
PFIZER CONFIDENTIAL
Page 1LRPTEMPLATE FOR STN 125742/0 :
QUERY 1:
The lot release protocols previously submitted in amendments 125742/0.4 (dated May 24,
2021) and 125742/0.10 (dated July 9, 2021) need to be modified to be templates for use for
all lots submitted to CBER. L ot release templates should be a preset format th at does not
state results.
Please submit a lot release protocol template (no results stated) for the COVID -19 mRNA
Vaccine for CBER review containing onl y the assay s performed and acceptance criteria for
the drug product.
The header on each page of the template should state the following:
cc: 000000 _0/L ic #/FC Page 1 of total # of pages
Lot Number:
License Name of Product:
Please note; upon CBER review of the lot release protocol template, additional information
may be requested.
RESPONSE 1
A templated lot release protocol (L RP) is provided. Requested information is located at the
topof each page. Please note page numbers are in the footer .
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
Lot Release Protocol
Previously submitted supporting documentation
Lot ReleaseDocumentation Package
090177e19799c048\Approved\Approved On: 20-Jul-2021 14:44 (GMT)
FDA-CBER-2021-5683-1149339
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 16July2021 FDA QueriesRe: LRP template IR and Samples for STN 125742/0
PFIZER CONFIDENTIAL
Page 2QUERY 2
We received three different lots of drug substance (DS) on July 09, 2021 to conduct testing at
CBER. You provided one tube of frozen DS for each lot. Please provide instructions for
thawing and an y other conditions that we need to consider in making aliquots. Also, please
state how man y freeze-thaw cycles are acceptable. We would appreciate this response as
soon as possible, but no later than July 20, 2021.
RESPONSE 2
Thaw DS samples at °C and invert gently to mix. Avoid vigorous mixing.
To avoid multiple freeze-thaws, it is recommended to thaw and aliquot material into single-
use sterile polypropylene vials stored at °C. Data to support up to freeze/thaw
cycles were studied
in studies and can be found documented in 3.2.S.7.3 Stability Data.
Note that clinical, primary, and working reference materials are stored in single-
use
polypropylene vials as noted in 3.2.S.5 Reference Standards or Materials.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
3.2.S.5 Reference Standards or Materials
3.2.S.7.3 Stability Data
090177e19799c048\Approved\Approved On: 20-Jul-2021 14:44 (GMT)
(b)
(4)
(b)
(4)
(b) (4)
FDA-CBER-2021-5683-1149340