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From: Smith, Michael (CBER)
Sent: Wednesday, August 18, 2021 2:51 PM
To: 'Harkins Tull, Elisa' <[email protected]>; 'Rohlfing, Paul' <[email protected]>
Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura
<[email protected]>; 'Aghajani Memar, Neda' <[email protected] >;
'Devlin, Carmel M' <[email protected]>
Subject: STN 125742.0: DBSQC comments
Elisa and Paul,
Our review of the information provided in your BLA STN 125742/0 for COMIRNATY (COVID -19 Vaccine, mRNA), for active immunization to prevent
COVID -19 cau sed by SARS -CoV-2 in individuals 16 years of age and older, is
ongoing. We have the following comments in response to your recent submissions:
1. In amendment 54 to BLA STN 125742/0 (Seq 0056, dated 08/17/2021),
you agreed to perform an endotoxin test
and explained you will establish the method
and perform verification studies at your drug product release testing facilities. Please submit information and data to support this method
along with a draft updated lot rele ase 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 studies so we can anticipate the submission. If you would like to engage in further discus sions, please let us know.
2. In amendment 50 to BLA STN 125742/0 (Seq 0050, dated 08/16/2021)
you stated that you would include specific parameters/instructions for
in the CGE integrity test method
(TM100010392). Please acknowl edge that you will submit the revised
SOP to your 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 you
include instructions on what actions to take when
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FDA-CBER-2021-5683-1150279
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. Please contact CBER if you wish to discuss your approach.
Please provide an acknowledgement of the above requests in an amendment to your BLA 125742/0 by 12:00pm August 19, 2021.
Regards,
Mike
- Plea se confirm receipt of this e -mail and let us know if you have any
questions.
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-2021-5683-1150280