Document text
From: Smith, Michael (CBER)
Sent: Saturday, August 21, 2021 10:33 AM
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: STN 125742.0: IR RE PMR's and PMC's
Elisa,
Sorry, be we had two minor revisions to our IR after I sent it. We revised the
beginning of the first sentence for the second paragraph and we also revised the
final protocol submission date for study C4591007.
Regards,
Mike
- Please confir m receipt of this e -mail and let us know if you have any
questions.
From: Smith, Michael (CBER)
Sent: Saturday, August 21, 2021 10:22 AM
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: STN 125742.0: IR RE PMR's and PMC's
Elisa,
There have been numerous information requests and amendments regarding the
PMR’s and PMC’s for this BLA. I have a generated the below list of PMR’s and
PMC’s that we have received from you. Please review and submit the list of
studies and dates in an amendment to the BLA by COB today containing your commitment to conduct all of these studies in the timeframes noted.
Based on our preliminary review, we do not consider the amendment you submitted on August 10, 2021 as adequate for the final protocol for PMC Study
C4591007 substudy to evaluate the immunogenicity and safety of lower dose
FDA-CBER-2021-5683-1024863
levels of COMIRNATY in individuals 12 through <30 years of age. Therefore, we
are using the future date of September 30, 2021 for Final Protocol Submission. In
the coming weeks we will provide comments on the amendment submitted on
August 10, 2021. Please acknowledge our revision to the Final Protocol
Submission date for this PMC (highlighted in yellow below for #11). Please also
propose any revisions that you anticipate may be needed for Study Completion
Date and Final Report Submission for this PMC.
1. Deferred pediatric Study C4591001 to evaluate the safety and effectiveness of
COMIRNATY in children 12 years through 15 years of age.
Final Protocol Submission: October 7, 2020
Study Completion Date: May 31, 2023
Final Report Submission: October 31, 2023
2. Deferred pediatric Study C4591007 to evaluate the safety and effectiveness of
COMIRNATY in infants and children 6 months to <12 years of age.
Final Protocol Submission: February 8, 2021
Study Completion: October 31, 2023
Final Report Submission: March 31, 2024
3. Deferred pediatric Study C4591023 to evaluate the safety and effectiveness of COMIRNATY in infants <6 months of age.
Final Protocol Submission: January 31, 2022
Study Completion: July 31, 2024
Final Report Submission: October 31, 2024
4. Study C4591009,
entitled “A Non-Interventional Post -Approval Safety Study of
the Pfizer -BioNTech COVID -19 mRNA Vaccine in the United States,” to evaluate
the occurrence of myocarditis and pericarditis following administ ration of
COMIRNATY.
We acknowledge the timetable you submitted on August 16, 2021, which states that you will conduct this study according to the following schedule:
Final Protocol Submission: August 31, 2021
FDA-CBER-2021-5683-1024864
Monitoring Report Submission: October 31, 2022
Interim Report Submission: October 31, 2023
Study Completion Date: June 30, 2025
Final Report Submission: October 31, 2025
5. Study C4591021, entitled “Post Conditional Approval Active Surveillance Study
Among Individuals in Europe Receiving the Pfizer -BioNTech Coronavirus
Disease 2019 (COVID -19) Vaccine,” to evaluate the occurrence of myocarditis
and pericarditis following administration of COMIRNATY.
We acknowledge the timetable you submitted on August 16, and 19, 2021, which
states that you will conduct this study according to the following schedule:
Final Protocol Submission: August 11, 2021
Progress Report Submission: September 30, 2021
Interim Report 1 Submission: March 31, 2022
Interim Report 2 Submission: September 30, 2022
Interim Report 3 Submission: March 31, 2023
Interim Report 4 Submission: September 30, 2023
Interim Report 5 Submission: March 31, 2024
Study Completion Date: March 31, 2024
Final Report Submission: September 30, 2024
6. Study C4591021 substudy to describe the natural history of myocarditis and
pericarditis following administration of COMIRNATY.
We acknowledge the timetable you submitted on August 16, and 19, 2021, which
states that you will conduct this study according to the following schedule:
Final Protocol Submission: January 31, 2022
Study Completion Date: March 31, 2024
Final Report Submission: September 30, 2024
FDA-CBER-2021-5683-1024865
7. Study C4591036, a 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).
We acknowledge the timetable you submitted on August 16, and 19, 2021, which
states that you will conduct this study according to the following schedule:
Final Protocol Submission: November 30, 2021
Study Completion Date: December 31, 2026
Final Report Submission: May 31, 2027
8.
Study C4591007 substudy to prospectively assessthe incidence of subclinical
myocarditis following administration of the second dose of COMIRNATY in a
subset of participants 5 through 15 years of age.
We acknowledge the timetable you submitted on August 18,
and 19, 2021, which
states that you will conduct this assessment according to the following schedule:
Final Protocol Submission: September 30, 2021
Study Completion Date: November 30, 2023
Final Report Submission: May 31, 2024
9. Study
C4591031 substudy to prospectively assess the incidence of subclinical
myocarditis following administration of a third dose of COMIRNATY in a subset of participants 16 to 30 years of age.
We acknowledge the timetable you submitted on August 16, 2021, which states that you will conduct this study according to the following schedule:
Final Protocol Submission: November 30, 2021
Study Completion Date: June 30, 2022
Final Report Submission: December 31, 2022
10. Study C4591022, entitled “Pfizer -BioNTech COVID -19 Vaccine Exposure during
Pregnancy: A Non-Interventional Post -
Approval Safety Study of Pregnancy and
Infant Outcomes in the Organization of Teratology Information Specialists
(OTIS)/MotherToBaby Pregnancy Registry.”
Final Protocol Submission: July 1, 2021
FDA-CBER-2021-5683-1024866
Study Completion Date: June 30, 2025
Final Report Submission: December 31, 2025
11. Study C4591007 substudy to evaluate the immunogenicity and safety of lower
dose levels of COMIRNATY in individuals 12 through <30 years of age in.
Final Protocol Submission: September 30, 2021
S
tudy Completion Date: November 30, 2023
Final Report Submission: May 31, 2024
12. Study C4591012, entitled “Post -emergency Use Authorization Active Safety
Surveillance Study Among Individuals in the Veteran’s Affairs Health System
Receiving Pfizer -BioNTech Coronavirus Disease 2019 (COVID -19) Vaccine.”
Final Protocol Submission: January 29, 2021
Study Completion Date: June 30, 2023
Final Report Submission: December 31, 2023
13.
Study C4591014, entitled “Pfizer -BioNTech COVID -19 BNT162b2 Vaccine
Effectiveness Study - Kaiser Permanente Southern Califor nia.”
Final Protocol Submission: March 22, 2021
Study Completion Date: December 31, 2022
Final Report Submission: June 30, 2023
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
FDA-CBER-2021-5683-1024867
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-2021-5683-1024868