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COMIRNATY (COVID -19 Vaccine, mRNA)
BLA 125742 /45
M 1.11.3 Response to FDA Information Request
CONFIDENTIAL
Page 1COMIRNATY (COVID -19 VACCINE, mRNA)
Response to CBER 22 April 2022 Information Request to Pfizer/BioNTech
Regarding Study Protocol for Study C4591022 ( A Non- Interventional Post -Approval
Safety Study of Pregnancy and Infant Outcomes in the Organization of Teratology
Information Specialists (OTIS)/Mother To Baby Pregnancy Registry)
02 May 2022
090177e19a17e10d\Approved\Approved On: 03-May-2022 15:13 (GMT)
FDA-CBER-2022-5812-0235941
COMIRNATY (COVID -19 Vaccine, mRNA)
BLA 125742 /45
M 1.11.3 Response to FDA Information Request
PFIZER CONFIDENTIAL
Page 21.INTRODUCTION
Reference is made to the Biologics License Application (BLA) 125742 for COMI RNATY
(COVID -19 Vaccine, mRNA) approved 23 August 2021 for the prevention of COVID -19
caused b y SARS -CoV -2 in individuals 16 y ears of age and older. Additional reference is
made to the supplemental BLA (sBLA) to extend licensure of COMIRNATY to adolescents
12 th rough 15 years of age submitted on 16 December 2021 ( sBLA 125742/45; Sequence
0211) with a proposed indication of active immunization to prevent COVID -19 caused b y
SARS -CoV -2 in individuals 12 y ears of age and older.
Reference is also made to CBER’s information request (received 22 April 2022) regarding a
request to revise stud y protocol for Study C4591022 -pregnancy registry study
(postmarketing commitment (PMC) #10 as described in the STN 125742/0 approval letter)
The FDA’s requests in bold italic sare followed by Pfizer/BioNTech’s responses below.
2.FDA REQUEST
The review team has the below Information Request regarding Study C4591022, the
pregnancy registry study.
The current version (version 3.0, dated November 29, 2021) of your protocol for the
pregnancy registry study (postmarketing commitment (PMC) #10 as described in the STN
125742/0 approval letter, dated August 23, 2021 ) includes individuals aged 18 years and
older. In the context of the Pharmacovigilance Plan (PVP, version 1.4) submitted w ith
sBLA 125742/45 to extend the use of COMIRNATY to individuals 12 years of age and
older, please revise the study protocol for C4591022 to include pregnant individuals of all
ages. Please respond to this Information Request under sBLA 125742/45 and submi t a
revised final study protocol and statistical analysis plan (both tracked changes and clean
running versions) to IND 19736 by May 6, 2022.
Response
As per CBER’s request, Pfizer /BioNTech will revise the study protocol for study C4591022
to include preg nant individuals of all ages. Please note, while we have reached the target
enrol lment sample size in the exposed group of pregnant individuals who received the
Pfizer -BioNTech COVID- 19 Vaccine during pregnancy , we will attempt to enroll individuals
<18 y ears of age who may qualify for this group. An amended study protocol and statistical
analysis plan (both tracked changes and clean running versions) will be submitted by 20 May
2022.
090177e19a17e10d\Approved\Approved On: 03-May-2022 15:13 (GMT)
FDA-CBER-2022-5812-0235942
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