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COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 17Aug 2021 FDA queries –Drug Substance
PFIZER CONFIDENTIAL
Page 1QUERY 1
In your drug substance (DS) manufacturing process validation studies performed at both
Pfizer and Pfizer the process parameter for the was
validated to be within the range of . However, in y our documents Section
3.2.S.2.2 Manufacturing Process Andover and Section 3.2.S.2.4 Controls of Critical Steps
and Intermediates -Manufacturing Process, the isdescribed as
. Please align the acceptance range of this process control parameter in all the
documents based on your validation study results.
RESPONSE 1
The was studied as with a rang e
of . The study design and results are described in3.2.S.2.6 Manufacturing
Process Development -Process Development and Characterization and Table 3.2.S.2.6- 11 has
been copied below. The full range of the stud y gave acceptable results, with no trends noted.
Table 3.2.S.2.6-11. Study Results
Data in the study was compared with original specifications. The commercial acceptance
criteria for specification have been updated to
respectivel y, but this does not change the conclusion of the study .
090177e197d887db\Approved\Approved On: 18-Aug-2021 23:16 (GMT)
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FDA-CBER-2021-5683-1149917
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 17Aug 2021 FDA queries –Drug Substance
PFIZER CONFIDENTIAL
Page 2Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
3.2.S.2.6 Manufacturing Process Development- Process Development and Characterization
090177e197d887db\Approved\Approved On: 18-Aug-2021 23:16 (GMT)
FDA-CBER-2021-5683-1149918
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 17Aug 2021 FDA queries –Drug Substance
PFIZER CONFIDENTIAL
Page 3QUERY 2
Please update the Tables 3.2.P.3.4 -1 in Sections 3.2.P.3.4 Process Step –
–Puurs and Kalamazoo, to include the validated for DS
using based on your
qualification/validation data submitted to BLA 125742 amendment 33 in response to our
August 3, 2021 In formation Request query 4.
RESPONSE 2
Validated for drug substance using
, were added to Tables 3.2.P.3.4- 1 of Section 3.2.P.3.4
Process Step – [Puurs]
and Section 3.2.P.3.4 Process Step –
[Kalamazoo].
Table 3.2.P.3.3-1, Table 3.2.P.3.3- 2 and Table 3.2.P.3.3 -19 in Section 3.2.P.3. 3
[Puurs] and Section 3.2.P.3. 3
[Kalamazoo] were also updated to reflect
the validated for drug substance
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
Section 3.2.P.3.3 [Puurs] , replaced
Section 3.2.P.3.3 [Kalamazoo] ,
replaced
Section 3.2.P.3.4 Process Step –
[Puurs] , replaced
Section 3.2.P.3.4 Process Step –
[Kalamazoo] , replaced
Previously submitted supporting documentation
None
090177e197d887db\Approved\Approved On: 18-Aug-2021 23:16 (GMT)
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FDA-CBER-2021-5683-1149919