Document text
www.fda.gov
___________________________________________________________________________
Memorandum
DATE: August 6, 2021
TO: Ramachandran Naik, OMPT/CBER/OVRR/DVRPA
Laura Montague, OMPT/CBER/OVRR/DVRPA
Michael Smith, OMPT/CBER/OVRR/DVRPA
Susan 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 injection
BLA 125742/0
Sponsor: Pfizer Inc.
The sponsor submitted:
Original Application
Major Amendment
Prior Approval Supplement (PAS)
Changes Being Effected (CBE) Supplement
he Submission contains:
Prescribing Information (PI) – version submitted on August 2, 2021
Patient Package Insert (PPI)
Package and Container - labels - submitted May 18 , 2021
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BLA 125742
2 | PageBACKGROUND
On May 6, 2021, Pfizer initiated their rolling Biologics License Application (BLA 125742) for
their COVID- 19 vaccine . The proprietary name, COMIRNATY, was found acceptable on July 2,
2021. This decision was relayed to Pfizer in official correspondence dated July 6, 2021. The
application was filed on July 15, 2021.
On J
uly 28, 2021, FDA requested prescribing information revisions, excluding Section 6
(adverse reactions) and Section 14 ( clinical studies ) for which comments will be provided after
this review. Pfizer submitted a revised Package Insert (PI) on August 2, 2021. APLB has
reviewed the revised PI , as well as the package and container labels submitted to date. We
offer the following comments from a promotional and comprehension perspective.
GENERAL
•Use active voice and command language whenever possible.
•Do not
bullet when there only is one concept. Over -bulleting deemphasizes the
importance of a concept and reduces readability .
•Av
oid using research terms, such as “Phase I” or “Phase 3” studies .
HIGHLIGHTS
DOSA
GE AND ADMINISTRATION
Include the following bolded statement directly beneath the section heading:
For
intramuscular injection only.
FULL PRESCRIBING INFORMATION: CONTENTS
Ens
ure any changes in the table of contents are consistent with the FULL PRESCRIBING
INFORMATION.
FULL PRESCRIBING INFORMATION
2 DOSA
GE AND ADMINISTRATION
•Use the following standard bolded statement directly beneath the section heading:
For i
ntramuscular injection only.
•To im
prove readability and comprehension, use active voice in the instructions.
•Del
ete references to diluents that are not recommended, as they may be
read quickly as alternative diluents.
•In t
he panel entitled DILUTION , revise the 4th bullet as follows:
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3 | Page
Inject Ad d 1.8 mL of 0.9% Sodium Chloride Injection,
USP into the vaccine vial.
6 A
DVERSE REACTIONS
• A statement regarding the most common adverse reactions, along with a cut -off
frequency, belongs directly beneath the section heading before 6.1 Clinical Trials Experience. This usually is the same statement as in the HIGHLIGHTS.
• The description of the study population(s) is difficult to find in the dense paragraphs of
this section. Consider pooling the safety data and providing an overarching description
of the study populations. It is not necessary to separate data from study phases and using this terminology minimizes the comprehension and readability of this section.
• Use whole numbers when reporting adverse reactions.
11 DESCRIPTION
Consider listing the below statements as separate lines :
The product contains no preservatives. The vaccine vial stopper is not made with natural rubber latex.
12 CLINICAL PHARMACOLOGY
• 12.2 Pharmacodynamics is a required sub section. (see 21CFR 201.57(c)(13) )
o Describe any biochemical or physiologic pharmacologic effects of the product or active metabolites, with respect to its clinical effect or to its adverse reactions or toxicity.
o Include data on exposure- response relationship (e.g., concentration- response,
dose- response) and time course of respons e (including short term clinical
response if known). If this is not known, include statement about lack of information.
o May include pharmacodynamic effects outside of the approved dosage range for a complete understanding of the exposure- response relations hip.
o Cross -reference detailed pharmacodynamic information on dosing or monitoring
that may appear in other sections of the PI. Do not repeat such information here.
• 12.2 Pharmacokinetics is a required subsection. (see 21CFR 201.57(c)(13))
o Describe clinically significant pharmacokinetics of the product or its active
metabolites under the following headings in this subsection
• Absorption
• Distribution
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• Metabolism
• Excretion
o Additional descriptive subheadings may be added (e.g., Specific Populations, Drug Interaction Studies, etc.).
o Cross -reference detailed pharmacokinetic information on dosing or monitoring
that may appear in other sections of the PI. Do not repeat such information here.
14 CLINICAL STUDIES
• Do not subsection unless there is more than one subsection (e.g., more than one
indication or indicated population).
• 14.1 Efficacy in Participants 16 Years of Age and Older should include only data
from those in age groups of approval.
• Ensure that pediatric data are included in 8.4 Pediatric Use.
16 HOW SUPPLIED/STORAGE AND HANDLING
• Dense paragraphs in this section reduce readability the entire section would benefit from subsectioning to
16.1 How Supplied 16.2 Storage and Handling
• A table with the product presentations identified by NDC numbers would improve the
readability of How Supplied information.
• To improve overall readability, use active voice and bullet relevant tasks associated with
storage and handli ng.
17 PATIENT COUNSELING INFORMATION
The intent of this section is to give the healthcare provider a list of topics to discuss with the
patient , specifically what to expect and what to report . For readability, consider a parallel list
structure . For example,
Inform the individual receiving the vaccine of the following:
• COMIRNATY vaccination requires two doses, three weeks apart.
• It is important that patients protect themselves from exposure to COVID- 19, using
masks and social distancing.
• Report any adverse reactions to their healthcare provider or to the Vaccine Adverse
Event Reporting System at 1- 800-822-7967 and www.vaers.hhs.gov.
PACKAGE AND CONTAINER L
ABELS
• To reduce the potential for medication error, revise 1.0 to 1 mL on both the package and
container labels.
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• Include the l ot number and expiration date on both package and container labels .
• Ensure that the proper name is consistent with that in the final PI .
• On the package, revise the bolded statement “Inject intramuscularly” to “For
intramuscular use only.” Similarly, on the container, replace the statement “Intramuscular Use” with the bolded statement, “ For intramuscular use only.”
If you have any questions regarding this review, please contact Oluchi Elekwachi, Regulatory
Review Officer at 240- 402-8930.
FDA-CBER-2021-5683-1024859
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6 | Page
Firm: Pfizer Inc.
STN: 125742
Document type: Review Memorandum
Bcc: OElekwachi APLB Chronologic File
APLB Historical File
History:
Prepared: OElekwachi 7/30/21
Comments : LStockbridge 8/3/21
Finalized: OElekwachi 8/6/21
File name: LR_COMIRNATY_ BLA_FINAL
Concurrence box:
MailCode
or Office Name
Date
APLB
APLB
FDA-CBER-2021-5683-1024860