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From: Smith, Michael (CBER)
Sent: Thursday, August 19, 2021 6:32 PM
To: Harkins Tull, Elisa <[email protected]>
Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura
<[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin,
Carmel M <[email protected]>
Subject: RE: [EXTERNAL] RE: STN 125742.0: IR RE PMR's and PMC's
Elisa,
We received the responses to our August 19, 2021 questions on the PMR and
PMC studies and we have another question for you regarding the Study
Completion Date and Final Report Submission date for PMC Study C4591014.
The Study Completion Date listed in the amendment received today is June 30,
2023. However, the Final Report Submission date listed in amendment 51 received on August 16, 2021, is also June 30, 2023. Please clarify if this is correct
and provide corrections as needed.
Please conf irm receipt of this information request and submit the response to this
additional question to the BLA as soon as possible and no later than 12:00 PM
Friday, August 20, 2021.
Regards,
Mike
From: Harkins Tull, Elisa < [email protected] >
Sent: Thursday, August 19, 2021 11:42 AM
To: Smith, Michael (CBER) < [email protected] >
Cc: Naik, Ramachandra < [email protected] >; Gottschalk, Laura
<[email protected] >; Aghajani Memar, Neda < [email protected] >; Devl in,
Carmel M <[email protected] >
Subject: [EXTERNAL] RE: STN 125742.0: IR RE PMR's and PMC's
CAUTION: This email originated from outside of the organization. Do not click links or open attachments unl ess you
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Hi Mike, I confirm receipt.
Best regards,
Elisa
FDA-CBER-2021-5683-1024831
From: Smith, Michael (CBER) < [email protected] >
Sent: Thursday, August 19, 2021 11:35 AM
To: Harkins Tull, Elisa < [email protected] >
Cc: Naik, Ramachandra < [email protected] >; Gottsch alk, Laura
<[email protected] >; Aghajani Memar, Neda < [email protected] >; Devlin,
Carmel M <[email protected] >
Subject: [EXTERNAL] STN 125742.0: IR RE PMR's and PMC's
Elisa,
We have the below comments regarding the August 16, 2021, amendment
containing your PMR and PMC commitments. Please submit your responses in an
amendment to the BLA by COB Thursday, August 19, 2021.
1. Regarding PMR study C4591021: We notice that the Study Completion
Date and Final Report Submission have the same dates (September 30, 2024). Please clarify if this is correct and provide c orrections as needed.
2. Regarding PMR substudy C4591021: We notice that the Study Completion
Date and Final Report Submission have the same dates (September 30,
2024). Please clarify if this is correct and provide corrections as needed.
3. Regarding the PMR for a prospective assessment of the incidence of subclinical myocarditis following administration of the second dose of
Comirnaty in a subset of participants 5 through 15 years of age enrolled in
Study C4591007, please provide the date for submission of the protocol
amendment.
4. Regarding the PMR prospective cohort study with at least 5 years of follow -
up for potential long -term sequelae of myocarditis after vaccination (in
collaboration with Pediatric Heart Network): Please change the dates for
the Study Completion Date and Final Report Submission to the last day of
the month, December 31, 2026 and May 31, 2027, respectively. Also,
please provide a study number for this study.
5. Regarding PMC study C4591022: Pleas e change the dates for the Study
Completion Date and Final Report Submission to the last day of the month, June 30, 2025 and December 31, 2025, respectively.
FDA-CBER-2021-5683-1024832
6. Regarding PMC study C4591012: Please change the date for the Study
Completion Date to the last day of the month, June 30, 2023.
7. Regarding PMC study C4591014: We note that there wasn’t a Study
Completion Date provided, please provide a Study Completion Date for the last day of the month that the study will be completed.
Regards ,
Mike
- Please 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-2021-5683-1024833