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From: Smith, Michael (CBER)
Sent: Tuesday, August 3, 2021 4:55 PM
To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda
<[email protected]>; Devlin, Carmel M <[email protected]>; Rohlfing, Paul
<[email protected]>
Cc: Naik, Ramachandra <[email protected]>; Gottscha lk, Laura
<[email protected]>
Subject: STN 125742.0: CMC -related questions
Elisa,
Our review of the information provided in your BLA STN 125742 for COMIRNATY
(COVID -19 mRNA Vaccine), for active immunization to prevent COVID -19 caused
by SARS -CoV-2 in individuals 16 years of age and older, is ongoing. We have the
following CMC -related comments and requests for additional information.
1. In Section 3.2.S.2.5 Process Validation and/or Evaluation – Shipping
Performance Qualification, you stated tha t the expected transit time for
shipment of the DS from the Pfizer Andover DS manufacturing
site to the Pfizer Kalamazoo and Pfizer Puurs DP manufacturing sites is
, respectively. Please provide supportive data to
demonstrate th at the physicochemical and biological attributes of the
DS are not impacted after exposure to the shipping hazards (e.g., shock,
vibration, pressure, thermal hazards, etc.). Please note that the data should be able to support the worst -case transit time of
DS.
2. Please update the Table 3.2.S.2.5 -2 “Performance Tests for Commercial
Scale Validation and Routine Batches” in Section
3.2.S.2.5 Process Validation and/or Evaluation – Additional Process
Evaluation to include the acceptance criteria/action limit for the
performance -related parameters based on the results from
the initial validation studies and the experience from commercial
production.
3. In document INX100433827: COVID -19 Vaccine Drug Substance Proces s
Validation Final Report, a deviation (PR ID 5222684) described that for
PPQ batches 20Y513C301 – 20Y513C601,
was set ). However, in
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FDA-CBER-2021-5683-1150197
Table 4 -5 Results for Additional Process Inputs,
rate for all the impacted batches was recorded as Please
explain this discrepancy.
4. Regarding the process validation and/or evaluation for the
in Pfizer Kalamazoo and Pfizer Puurs,
please describe any process controls and performance verification
implemented at the DS during PPQ execution and provide
available data to support the use of both
. Please
also confirm that the for all evaluated PPQ lots was within
the target
5. Please update the Table 3.2.A.3.1.1- 1 Nomenclature of ALC -0315 in
Section 3.2.A.3.1.1 Nomenclature [ALC -0315] to include the product
number/code for the lipid ALC -0315 manufactured in
6. Regarding your response (in STN 125742/0.16 dated July 23, 2021) to
our IR query 3 dated July 9, 2021, about the validation of the CGE
Integrity method, we do not agree that a conclusion of a quantification limit of
.
The results as shown in Table 3 may infer a quantification limit for
We acknowledge that the assay is not for the
assessment of impurity and the actual quantification limit for impurity was not determined.
Please provide your response in an Amendment to STN 125742/0 by Friday,
August 6, 2021. If you have any questions about this communication, please feel
free to contact us.
Regards,
Mike
- Please confirm receipt of this e -mail .
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FDA-CBER-2021-5683-1150198
Mike Smith, Ph.D.
Captain, USPHS
Senior Regulatory Review Officer
Food and Drug Administration
Center for Biologics Evaluation & Research
Office of Vaccines Research & Review
Division of Vaccines and Related Products Applications
Tel: 301- 796-2640
[email protected]
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FDA-CBER-2021-5683-1150199