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From: Gottschalk, Laura
Sent: Saturday, August 21, 2021 10:45 AM
To: Harkins Tull, Elisa <[email protected]>
Cc: Devlin, Carmel M <[email protected]>; Aghajani Memar, Neda
<[email protected]>; Smith, Michael (CBER) <[email protected]>; Naik,
Ramachandra <[email protected]>
Subject: RE: [EXTERNAL] RE: STN 125742/0: Comment regar ding vial labels
Dear Elisa,
We acknowledge that additional information regarding the diluent name will not fit on the vial labels
but is included on the carton labels. Therefore, you do not need to provide a response to our August 20,
2021 comment rega rding the vial labels.
Best,
Laura
Laura Gottschalk, PhD | Regulatory Project Manager/Primary Reviewer
From: Gottschalk, Laura
Sent: Friday, August 20, 2021 5:02 PM
To: Harkins Tull, Elisa < [email protected]
>
Cc: Devlin, Carmel M < [email protected] >; Aghajani Memar, Neda
<[email protected] >; Smith, Michael (CBER) < [email protected] >; Naik,
Ramachandra < [email protected] >
Subject: RE: [EXTERNAL] RE: STN 125742/0: Comment regarding vial labels
Hi Elisa ,
Thanks for the update. We’ll provide a response soon.
Best,
Laura
Laura Gottschalk, PhD | Regulatory Project Manager/Primary Reviewer
From: Harkins Tull, Elisa < [email protected]
>
Sent: Friday, August 20, 2021 3:57 PM
To: Gottschalk, Laura < [email protected] >
Cc: Devlin, Carmel M < [email protected] >; Aghajani Memar, Neda
<[email protected] >; Smith, Michael (CBER) < [email protected] >; Naik,
Ramachandra < [email protected] >
Subject: [EXTERNAL] RE: STN 125742/0: Comment regarding vial labels
FDA-CBER-2021-5683-1150336
CAUTION: This email originated from outside of the organization. Do not click links or open attachments u nless you
recognize the sender and know the content is safe.
Hi Laura,
I just got done meeting with the graphic artists who manage our vial and carton artwork. The additional
information about the diluent that CBER proposed for us to add will definitely not fit on the vial label.
That information is, however, already on the c arton label. Given this, does CBER still need us to formally
respond to this request?
Best regards,
Elisa
From: Gottschalk, Laura < [email protected]
>
Sent: Friday, August 20, 2021 3:11 PM
To: Harkins Tull, Elisa < [email protected] >
Cc: Devlin, Carmel M < [email protected] >; Aghajani Memar, Neda
<[email protected] >; Smith, Michael (CBER) < [email protected] >; Naik,
Ramachandra < [email protected] >
Subject: [EXTERNAL] STN 125742/0: Comment regarding vial labels
Dear Elisa,
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 caused by SARS -CoV-2 in indiv iduals 16 years of
age and older, is ongoing. We refer you to the revised carton and container labels that were submitted to you BLA in amendment 63 (seq 0064, dated August 19, 2021).
Please see the attached pdf of your vial label that contains our comment. Please respond to our
comment by EOD today, August 20, 2021, and follow up with a submission to the BLA.
Please acknowledge receipt of this message and let me know if you have any questions.
Best,
Laura
Laura Gottschalk, PhD
Regulatory Project Manager/Primary Reviewer
Center for Biologics Evaluation and Research
Office of Vaccines Research and Review
U.S. Food and Drug Administration
Tel: 301 -796- 0798
[email protected]
FDA-CBER-2021-5683-1150337
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FDA-CBER-2021-5683-1150338