Document text
Memorandum
Date: July 2, 2021
From: Oluchi Elekwachi, PharmD, MPH, Regulatory Review Officer
OCBQ/DCM/APLB
Through: Lisa Stockbridge, PhD, Branch Chief
OCBQ/DCM/APLB
Robert A. Sausville, Division Director
OCBQ/DCM
To: Michael Smith, RPM,OVRR\DVRPA\CMC3
Susan Wollersheim, Medical Officer, CBER/OVRR/DVRPA/CRB1
Subject: Review of Proposed Proprietary Name COMIRNATY (Pfizer-BioNTech
COVID-19) Vaccine
STN: BLA 125742
Applicant: Pfizer, Inc.
Recommendation: COMIRNATY –Acceptable
_
Executive Summary
APLB has completed the proprietary name review (PNR) for the proposed proprietary name,
COMIRNATY , for Pfizer-BioNTech’s COVID-19 vaccine. We recommend that the proposed
proprietary name, COMIRNATY , be found Acceptable .
According to SOPP 8001.4 Review of CBER Regulated Product Proprietary Names, the
product office, Office of Vaccine Research and Review (OVRR), makes the final decision on
the acceptability of a proposed proprietary name. To meet the PDUFA performance goal,
OVRR must communicate this decision to the applicant within 90 days of the receipt of the
proprietary name review (PNR) submission. The PDUFA goal date for this PNR is August 17,
2021.
If OVRR accepts our recommendation that the proposed primary proprietary name,
COMIRNATY , be found Acceptable , we offer the following communication-ready language:
In consultation with CBER’s Advertising and Promotional Labeling Branch, we conclude
that under the Federal Food, Drug, and Cosmetic Act and applicable regulations your
proposed proprietary name, COMIRNATY , is Acceptable.
www.fda.gov
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OVRR is responsible for communicating CBER’s decision to the applicant and should enter the
communication issuance date into the FDA electronic record before August 17, 2021, in order
to meet the deadline and stop the performance clock. Please notify APLB when this action has
been completed.
Background
On May 19, 2021, Pfizer, Inc. submitted a PNR request for its COVID-19 vaccine (BLA
125742). The proposed proprietary name is COMIRNATY (pronounced koh-MER’ nah-tee ).
The proposed indication is for the active immunization against COVID-19.
According to the sponsor, COMIRNATY is an invented word with no inherent meaning. The
sponsor did not propose an alternative name.
COMIRNATY will be supplied in 0.45 mL multiple dose vials containing a frozen, concentrated
liquid suspension with no preservative. Each vial must be thawed and diluted prior to
administration. Vials may be thawed in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)] or at room
temperature [up to 25ºC (77ºF)], then the concentrated liquid in the vial will require dilution with
sterile 0.9% Sodium Chloride Injection, USP. After dilution, 0.3 mL doses of vaccine may be
withdrawn from the vial, using commercially available disposable sterile syringes with
appropriate graduations. Each vial contains sufficient volume to provide 6 individual doses,
where each 0.3 mL dose contains 30 vaccine for intramuscular injection.
COMIRNATY will be administered intramuscularly as a series of two 30 doses (0.3 mL each)
according to the following schedule: A single 0.3 mL dose followed by a second 0.3 mL dose 21
days later.
Cartons of COMIRNATY multiple dose vials will be shipped in thermal containers over dry ice.
Once received, cartons should be removed immediately from the thermal container and stored
in an ultra-low temperature freezer between -80ºC to -60ºC (-112ºF to -76ºF) until the expiry
date printed on the label. Alternatively, vials may be stored at -25°C to -15°C (-13°F to 5°F) for
up to 2 weeks.
Vials must be kept frozen and protected from light, in the original cartons, until ready to use.
Vials stored at -25°C to -15°C (-13°F to 5°F) for up to 2 weeks may be returned one time to the
recommended storage condition of -80ºC to -60ºC (-112ºF to -76ºF). Total cumulative time the
vials are stored at -25°C to -15°C (-13°F to 5°F) should be tracked and should not exceed two
weeks.
If an ultra-low temperature freezer is not available, the thermal shipping may be used as
temporary storage when consistently re-filled to the top of the container with dry ice. The thermal
container maintains a temperature range of -90ºC to -60ºC (-130ºF to -76ºF). Storage within this
temperature range is not considered an excursion from the recommended storage condition.
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The vaccine will be administered by a qualified healthcare professional.
Method
APLB utilized the FDA Phonetic and Orthographic Computer Analysis (POCA) and the
following databases:
1. CBER list of Licensed Products ending June 24, 2021, at
http://www.fda.gov/downloads/BiologicsBloodVaccines/UCM149970.pdf
2. DailyMed at http://dailymed.nlm.nih.gov/dailymed/about.cfm
3. Drugs@FDA current through June 24, 2021, at
http://www.accessdata.fda.gov/scripts/cder/drugsatfda
4. Electronic Orange Book current through June 24, 2021, at
http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm
5. Google Internet search at http://www.google.com
6. Micromedex at http://www.micromedexsolutions.com/micromedex2/librarian
7. United States Patent and Trademark Office (USPTO) at
http://www.uspto.gov/trademarks/index.jsp
8. USAN Stem at
http://www.ama-assn.org/ama1/pub/upload/mm/365/stem-list-cumulative.pdf
APLB also consulted the review team on the proprietary name.
Results
1. Prescreening for Objectionable Naming Practices
The proposed proprietary name, COMIRNATY , was screened against the following:
Obvious similarities in spelling and pronunciation
Manufacturing characteristics
Medical and/or coined abbreviations
Inert or inactive ingredients
Combination of active ingredients
United States Adopted Name (USAN) stems
Same proprietary name for products containing different active ingredients
Reuse of proprietary names
Dosage form or route of administration
Dosing interval
Established or proper name
Modifiers as components of a proprietary name
o Use of numerals as modifiers
o Device-related modifiers
o Descriptive modifiers
Brand name extensions (Umbrella branding)
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Dual proprietary names
Foreign drug proprietary name
Prescription-to-OTC switch
Use of symbols
Incorporation of the applicant’s name
2. Evaluating for Promotional and Safety Concerns
a. Promotional Review [21 CFR 201.10 (c)(3), 202.1 (e)(5)(i), and (e)(6)(i)]
The proposed proprietary name, COMIRNATY , is not regarded to be false, misleading, or
fanciful.
b. Look-alike Sound-alike Safety Review [21 CFR 201.10 (c)(5)]
Since drug products are prescribed through written, verbal, and/or electronic orders, such
forms of communication may lead to medication errors, particularly if proprietary or
established names sound or look alike. APLB conducted a search using POCA, with DPRF,
Drugs@FDA, Cerner US Legend and OTC, CBER Biologic, Orange Book, and RxNorm as
data sources, to identify existing names of concern with potential combined orthographic and
phonetic similarity to COMIRNATY . There were 105 names found to be moderately phonetically or orthographically similar to COMIRNATY . Differences in dose, form, or
strength can mitigate confusion with moderately similar names, and none of the names
shared dose, form, or strength with COMIRNATY .
Recommendation
Given that the moderately similar names had differences in dosage form, dose, and/or strength
to COMIRNATY , APLB recommends that COMIRNATY be found Acceptable at this time.
If you have any questions regarding this review please contact Oluchi Elekwachi, PharmD,
MPH Regulatory Review Officer, at 240-402-8930.
FDA-CBER-2021-5683-0652190
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Firm name: Pfizer Ireland Pharmaceuticals
STN: BLA 125742
Letter type: PNR Memorandum
Bcc: OElekwachi
LStockbridge
RSausville
DCM Files
History:
Prepared: OElekwachi 6/25/2021
Concur w/rev: LStockbridge 7/1/2021
Finalized: OElekwachi 7/2/2021
File name: PNR_COMIRNATY_BLA125742_FINAL
Concurrence box:
MailCode or
Office Name Approval
APLB OElekwachi
APLB LStockbridge
DCM RSausville
FDA-CBER-2021-5683-0652191