Document text
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 18 August 2021 Information Request: DBSQC Comments
PFIZER CONFIDENTIAL
Page 1QUERY 1
In amendment 54 to BLA STN 125742/0 (Seq 0056, dated 08/17/2021), you agreed to
perform an endotoxin test and explained y ou will
establish the method and perform verification studies at y our drug product release testing
facilities. Please submit information and data to support this method along with a draft
updated lot release protocol template, to CBER as a CBE- 30 supplement in accordance with
21 CFR 601.12(c). Please acknowledge our request and keep us updated on the progress of
your stud ies so we can anticipate the submission. If y ou would like to engage in further
discussions, please let us know.
RESPONSE 1
The Sponsor acknowledges this request and commits to submit the new method and
supporting information/data as aCBE -30supplement to the BLA by 06Dec2021.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
None
090177e197da7286\Approved\Approved On: 19-Aug-2021 15:53 (GMT)
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FDA-CBER-2021-5683-1149928
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 18 August 2021 Information Request: DBSQC Comments
PFIZER CONFIDENTIAL
Page 2QUERY 2
In amendment 50 to BLA STN 125742/0 (Seq 0050, dated 08/16/2021) y ou stated that y ou
would include specific parameters/instructions for in the CGE
integrit y test method (TM100010392). Please acknowledge that y ou will submit the revised
SOP to y our IND 19736. The difference in used in assay validation and Lot
Release Protocols submitted to CBER recently (lots FD7220, FE3592 and FF2587) indicates
that a requirement for a specific has not been established, giving the
appearance that your current method allows for
parameters that could potentially result in .Since there is
we recommend y ou include instructions on what actions to take
when
to minimize and ensure consistency of the
method. We encourage you to perform robustness studies with varied sample preparation and
instrument conditions to decide on the optimal parameters. P lease contact CBER if y ou wish
to discuss y our approach.
RESPONSE 2
The Sponsor acknowledges this request and commits to submit additional information and
data as a supplement to the BLA . Potential to include
parameters will expand the scope bey ond what was originall y planned when
proposing a supplement by 30 September 2021, however.
Further discussions between CBER and Pfizer scientists are essential to define the scope of
the changes being requested. We propose to have these discussions by 24 Sept 2021, based
on availability of CBER personnel, and to submit the additional instructions on an
agreed upon timeline, but not later than June 2022.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
None
090177e197da7286\Approved\Approved On: 19-Aug-2021 15:53 (GMT)
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FDA-CBER-2021-5683-1149929