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BNT162b2
BLA 125742
Request for Proprietary & Non -Proprietary Name Revie w
PFIZER CONFIDENTIAL
Page 1REQUEST FOR PROPRIETARY &
NON -PROPRIETARY NAM E REVIEW
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BNT162b2
BLA 125742
Request for Proprietary & Non -Proprietary Name Revie w
PFIZER CONFIDENTIAL
Page 2TABLE OF CONTENTS
1. APPLICANT CONTACT INFORMATION ................................ ................................ ......... 3
2. PROPOSED PRI MARY AND ALTERNATE PROPRI ETARY NAMES .......................... 3
3. INTENDED PRONUNCI ATION................................ ................................ ......................... 3
4. DERIVATION OF PROPRI ETARY NAME ................................ ................................ ........ 3
5. INTENDED MEANING OF PROPRIETARY NAME MODIFIERS ................................ ..3
6. PROPOSED ESTABLISHED NAME ................................ ................................ .................. 3
7. PHARMACOL OGIC/ TH ERAPEUTI C CATEGORY ................................ ........................ 3
8. PROPOSED I NDICATI ON FOR USE ................................ ................................ ................. 3
9. PRESCRI PTION STAT US................................ ................................ ................................ ...4
10. DOSAGE FORM, PRO DUCT STRENGTH(S) ................................ ................................ .4
11. ROUTE OF ADMINIS TRATION ................................ ................................ ...................... 4
12. US UAL DOSAGE, FREQUENC Y OF ADMINI STRATION, MAXIMUM
DAILY DOSE ................................ ................................ ................................ ....................... 4
13. DOSING IN SPECIF IC POPULATIONS ................................ ................................ ........... 4
14. INSTRUCTI ONS FOR USE ................................ ................................ ............................... 4
15. STORAGE REQUIREMENT ................................ ................................ ............................. 4
16. HOW SUPPLIED AND PACKAGING CONFIGURA TION................................ ............ 4
17. LIKELY CARE ENVI RONMENT(S) FOR DI SPENSING AND USE ............................. 5
18. DELIVERY SYSTEM, MEA SURI NG DEVICE ................................ ............................... 5
19. ASSESSMENTS OF P ROPRI ETARY NAME, PAC KAGING, AND/OR
LABELING ................................ ................................ ................................ ........................... 5
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BNT162b2
BLA 125742
Request for Proprietary & Non -Proprietary Name Revie w
PFIZER CONFIDENTIAL
Page 31.APPLICANT CONTACT IN FORMATION
Name and title of contact Elisa Harkins, Senior Director, Global Regulatory
Affairs, Pfizer, Inc. –Authorized US Agent for:
BioNTech Manufacturing GmbH
Company Name Pfizer I nc.
Address 500 Arcola Road
Collegeville, PA 19426
Phone number 215-280-5503
Fax number 845-474-3500
Email address [email protected]
2.PROPOSED PRIMARY AND ALTERNATE PROPRIETA RY NAMES
The primary proposed proprietary name for Agency consideration is COMIRNATY .
The trademark application serial number is 88942267 (filed b y BioNTech SE) for
COMI RNATY . The application was filed at the United States Patent and Trademark Office
on June 1, 2020 by BioNTech SE. The Notice of Allowance has not y et issued.
Should this name not be found acceptable, an alternate name will be provided at that time.
3.INTENDED PRONUNCIATI ON
koh-MER’ nah- tee
4.DERIVATION OF PROPRI ETARY NAME
The proposed proprietary nam e COMI RNATY is an invented word with no inherent
meaning .
5.INTENDED MEANING OF PROPRIETARY NAME MOD IFIERS
Not applicable.
6.PROPOSED ESTABLISHED NAME
COVID -19 mRNA Vaccine (nucleoside modified)
7.PHARMACOLOGIC/ THERA PEUTIC CATEGORY
Prophy lactic vaccine.
8.PROPOSED INDICATION FOR USE
Active immunization to prevent COVID -19 disease caused b y SARS -CoV -2 virus, in
individuals 16 years of age and older.
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BNT162b2
BLA 125742
Request for Proprietary & Non -Proprietary Name Revie w
PFIZER CONFIDENTIAL
Page 49.PRESCRIPTION STATUS
To be administered b y a qualified healthcare professional.
10.DOSAGE FORM, PRODUCT STRENGTH(S)
Concentrate for solution for injection.
5-Dose Vial is supplied as a white to off-white sterile frozen liquid, packaged in a clear glass
2 mL vial with a rubber stopper, aluminum overseal and flip off cap.
A single vial will be used to prepare a dilut ed dosing solution that is used to prepare doses for
multiple individuals. The concentrated solution in the vial requires dilution with sterile 0.9%
Sodium Chloride I njection, USP. After dilution, the vials contain a sufficient volume to
supply 5 doses, wh ere each 0.3 mL dose contains 30 µgvaccine for intramuscular injection.
11. ROUTE OF ADMINISTRAT ION
For intramuscular injection only .
12.USUAL DOSAGE, FREQUE NCY OF ADMINISTRATIO N, MAXIMUM DAILY
DOSE
Administered intramuscularly as a series of two 30 µg doses of the diluted vaccine solution
(0.3 mL each) according to the following schedule: A single 0.3 mL dose followed by a
second 0.3 mL dose 21 day s later.
13.DOSING IN SPECIFIC P OPULATIONS
No specific information will be provided for modifications that are dependent on renal and/or
hepatic function. There will be no gender -based modifications.
14.INSTRUCTIONS FOR USE
After thawing, each vial of vaccine must be diluted with 1.8 mL sterile 0.9% Sodium
Chloride I njection, USP. After dilution, the vial contains fiv e 30 µgdoses of 0.3 mL per
dose. Individual 0.3 mL doses should be withdrawn from the vial and administered
intramuscularl y in the deltoid muscle of the non -dominant arm.
15. STORAGE REQUIREMENT
Vaccine vials must be immediately stored between -80 ºC and -60ºC (-112 ºF to -76ºF),
protected from light and kept in the original packaging until read y for use.
16. HOW SUPPLIED AND PAC KAGING CONFIGURATION
The vaccine will be supplied frozen in -80ºC thermal containers with dry ice, in cartons each
containing 195 vials.
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BNT162b2
BLA 125742
Request for Proprietary & Non -Proprietary Name Revie w
PFIZER CONFIDENTIAL
Page 517.LIKELY CARE ENVIRONM ENT(S) FOR DISPENSING AND USE
This vaccine will be administered by a qualified healthcare professional.
18.DELIVERY SYSTEM, MEA SURING DEVICE
After dilution, each 0.3 mL dose of vaccine should be withdrawn from the vial with a
commer cially available disposable sterile syringe with appropriate graduations and delivered
with a needle appropriate for intramuscular injection.
19.ASSESSMENTS OF PROPR IETARY NAME, PACKAGI NG, AND/OR
LABELING
The Sponsor has evaluated the proposed primary proprie tary name of COMI RNATY for this
vaccine and considers the name safe, not misleading, or over-promising. However, no
information of this nature is included in the current application.
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