Document text
www.fda.gov___________________________________________________________________________
Memorandum
DATE: May 11, 2022
TO: Ramachandra Naik, OMPT/CBER/OVRR/DVRPA
Laura Gottschalk, OMPT/CBER/OVRR/DVRPA
Michael Smith, OMPT/CBER/OVRR/DVRPASusan Wollersheim, Medical Officer, OMPT/CBER/OVRR/DVRPA
FROM : Oluchi Elekwachi, Regulatory Reviewer
OCBQ/DCM/APLB
THROUGH: Lisa Stockbridge, Branch Chief
OCBQ/DCM/APLB
SUBJECT: COMIRNATY (COVID-19 vaccine, mRNA)
Suspension for intramuscular injectionBLA 125742/245
Sponsor: Pfizer Inc.
The sponsor submitted:
Original Application
Major Amendment
Prior Approval Supplement (PAS)
Changes Being Effected (CBE) Supplement
Submission contains:
Prescribing Information (PI) – version submitted on December 16, 2021
Patient Package Insert (PPI)
Package and Container - labels
FDA-CBER-2022-5812-0500479
BLA 125742/45
2|Page
BACKGROUND
On December 16, 2021, BioNTech Manufacturing GmbH (in partnership with Pfizer, Inc.)
submitted an efficacy supplement for COMIRNATY to extend the indication to adolescents 12 through 15 years of age. The action due date (ADD) is June 17, 2022.
On April 20, 2022, FDA requested prescribing information revisions. The sponsor submitted a
revised Package Insert (PI) on April 29, 2022, concluding an extensive iterative review between the review team and the sponsor. APLB has participated in reviewing the revised PIand all revisions submitted to date. At this time, we offer the following comments from a
promotional and comprehension perspective.
GENERAL
xUse active voice and command language whenever possible.
xDo not bullet when there only is one concept. Over-bulleting deemphasizes the
importance of a concept and reduces readability.
xDo not bold headings, subheadings, or statements unless required by the regulations. Underline or italics may be used for additional subheadings (use consistent style throughout).
xAvoid using research terms, such as “Phase I” or “Phase 3” studies.
FULL PRESCRIBING INFORMATION: CONTENTS
Ensure any changes in the table of contents are consistent with the FULL PRESCRIBING INFORMATION.
FULL PRESCRIBING INFORMATION
17 PATIENT COUNSELING INFORMATION
Include the following statement:
Prior to administering the vaccine, give the vaccine recipient the Vaccine Information Fact Sheet
for Recipients and Caregivers about COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-
BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for Use in
Individuals 12 Years of Age and Older. The Vaccine Information Fact Sheet for Recipients and Caregivers is available at www.cvdvaccine.com.
If you have any questions regarding this review, please contact CAPT Oluchi Elekwachi,
PharmD, MPH, Regulatory Review Officer at 240-402-8930.
FDA-CBER-2022-5812-0500480
BLA 125742/45
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Firm: Pfizer Inc.
STN: 125742/45
Document type: Review Memorandum
Bcc: OElekwachi
APLB Chronologic File
APLB Historical File
History:
Prepared: OElekwachi 5/01/22
Concur: LStockbridge 5/11/22
Finalized: OElekwachi 5/11/22
File name: LR_125742_45_FINAL
Concurrence box:
MailCode
or OfficeNameDate
APLB
APLBOluchi Elekwachi -SDigitally signed by Oluchi Elekwachi -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9 2342.19200300.100.1.1=1300216724, cn=Oluchi Elekwachi -S Date: 2022.05.11 11:42:41 -04'00'
Lisa L. Stockbridge -SDigitally signed by Lisa L. Stockbridge -S Date: 2022.05.11 13:22:18 -04'00'
FDA-CBER-2022-5812-0500481