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BNT162b2
BLA STN 125742 /0
M 1.11.3 Response to FDA Information Request
PFIZER CONFIDENTIAL
Page 1Response to CBER 21 August 2021 Information Request Regarding
Postmarketing Requirement/Postmarketing Commitment S tudies
Final List of Studies
21August 2021
090177e197ddf480\Approved\Approved On: 21-Aug-2021 18:36 (GMT)
FDA-CBER-2021-5683-0950407
BNT162b2
BLA STN 125742 /0
M 1.11.3 Response to FDA Information Request
PFIZER CONFIDENTIAL
Page 2FINAL LIST OF STUDIES
1.Deferred pediatric Stud y C4591001 to evaluate the safet y and effectiveness of
COMI RNATY in children 12 y ears 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 Stud y C4591007 to evaluate the safet y and effectiveness of
COMI RNATY in infants and children 6 months to <12 y ears of age.
Final Protocol Submission: February 8, 2021
Study Completion: November 30, 2023
Final Report Submission: Ma y 31, 2024
3.Deferred pediatric Stud y C4591023 to evaluate the safet y and effectiveness of
COMI RNATY 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 Safet y Study of the
Pfizer -BioNTech COVID-19 mRNA Vaccine in the United States,” to evaluate the
occurrence of m yocarditis and pericarditis following administration of COMI RNATY.
Final Protocol Submission: August 31, 2021
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 my ocarditis and pericarditis
following administration of COMI RNATY.
Final Protocol Sub mission: August 11, 2021
090177e197ddf480\Approved\Approved On: 21-Aug-2021 18:36 (GMT)
FDA-CBER-2021-5683-0950408
BNT162b2
BLA STN 125742 /0
M 1.11.3 Response to FDA Information Request
PFIZER CONFIDENTIAL
Page 3Progress 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 m yocarditis and pericarditis
following administration of COMI RNATY.
Final Protocol Submission: January 31, 2022
Study Completion Date: March 31, 2024
Final Report Submission: September 30, 2024
7.Study C4591036, a prospective cohort study with at least 5 y ears of follow -up for
potential long -term sequelae of my ocarditis after vaccination (in collaboration with
Pediatric Heart Network).
Final Protocol Submission: November 30, 2021
Study Completion Date: December 31, 2026
Final Report Submission: May 31, 2027
8.Study C4591007 substudy to prospectivel y assess th e incidence of subclinical
myocarditis following administration of the second dose of COMI RNATY in a subset of
participants 5 through 15 y ears of age.
Final Protocol Submission: September 30, 2021
Study Completion Date: November 30, 2023
Final Report Submission: May 31, 2024
090177e197ddf480\Approved\Approved On: 21-Aug-2021 18:36 (GMT)
FDA-CBER-2021-5683-0950409
BNT162b2
BLA STN 125742 /0
M 1.11.3 Response to FDA Information Request
PFIZER CONFIDENTIAL
Page 49.Study C4591031 substudy to prospectivel y assess the incidence of subclinical
myocarditis following administration of a third dose of COMI RNATY in a subset of
participants 16 to 30 y ears of age.
Final Protocol Submission: Novembe r 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 Stud y of Pregnancy and Infant
Outc omes in the Organization of Teratology Information Specialists
(OTIS)/MotherToBab y Pregnancy Registry .”
Final Protocol Submission: July 1, 2021
Study Completion Date: June 30, 2025
Final Report Submission: December 31, 2025
11.Study C4591007 substudy to ev aluate the immunogenicity and safety of lower dose
levels of COMI RNATY in individuals 12 through <30 y ears of age in.
Final Protocol Submission: September 30, 2021
Study Completion Date: November 30, 2023
Final Report Submission: May 31, 2024
12.Study C45 91012, entitled “Post -emergency Use Authorization Active Safety Surveillance
Study Among Individuals in the Veteran’s Affairs Health Sy stem 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 California.”
Final Protocol Submission: March 22, 2021
Study Completion Date: December 31, 2022
Final Report Submission: June 30, 2023
090177e197ddf480\Approved\Approved On: 21-Aug-2021 18:36 (GMT)
FDA-CBER-2021-5683-0950410
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090177e197ddf480\Approved\Approved On: 21-Aug-2021 18:36 (GMT)
FDA-CBER-2021-5683-0950411