Vaccine Information: Moderna COVID-19 Vaccine, Bivalent (Page 11 of 11)


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You may receive this Fact Sheet even if your child is 5 years old. Children who will turn from 5 years to 6 years of age between doses in the primary series may receive, for any dose, either: (1) the Moderna COVID-19 Vaccine authorized for use in individuals 6 months through 5 years of age; or (2) Moderna COVID-19 Vaccine authorized for use in individuals 6 years through 11 years of age. Children who will turn from 11 years to 12 years of age between doses in the primary series may receive, for any dose in the primary series, either: (1) the Moderna COVID-19 Vaccine authorized for use in individuals 6 years through 11 years of age; or (2) Moderna COVID-19 Vaccine authorized for use in individuals 12 years of age and older; or (3) SPIKEVAX (COVID-19 Vaccine, mRNA).
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FDA-approved SPIKEVAX (COVID-19 Vaccine, mRNA) and one presentation of the EUA-authorized Moderna COVID-19 Vaccine (supplied in vials with red caps and labels with a light blue border) can be used interchangeably for the primary series for individuals 12 years of age and older without presenting any safety or effectiveness concerns.
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Monovalent refers to any authorized or approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2.
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FDA-approved SPIKEVAX (COVID-19 Vaccine, mRNA) and one presentation of the EUA-authorized Moderna COVID-19 Vaccine (supplied in vials with red caps and labels with a light blue border) can be used interchangeably for the primary series for individuals 12 years of age and older without presenting any safety or effectiveness concerns.

Package/Label Display Panel

Moderna COVID-19 Vaccine, Bivalent Suspension for Intramuscular Injection
(click image for full-size original)

NDC 80777-282-05

Moderna COVID-19 Vaccine, Bivalent

Original and Omicron BA.4/BA.5

Suspension for Intramuscular Injection

For use under Emergency Use Authorization

BOOSTER DOSES ONLY

Multi-Dose Vial

Booster dose: 0.5 mL or 0.25 mL based on age

Package/Label Display Panel

Moderna COVID-19 Vaccine, Bivalent Suspension for Intramuscular Injection
(click image for full-size original)

NDC 80777-282-99

Moderna COVID-19 Vaccine, Bivalent

Original and Omicron BA.4/BA.5

Suspension for Intramuscular Injection

For use under Emergency Use Authorization

BOOSTER DOSES ONLY

STORE FROZEN between -50° to -15°C (-58° to 5°F).

Protect from light

Ten multi-dose vials each containing 2.5 mL

Booster dose: 0.5 mL or 0.25 mL based on age

MODERNA COVID-19 VACCINE, BIVALENT moderna covid-19 vaccine, bivalent injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:80777-282
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ELASOMERAN (ELASOMERAN) ELASOMERAN 25 ug in 0.5 mL
CX-034476 OMICRON (BA.4/BA.5) (CX-034476 OMICRON (BA.4/BA.5)) CX-034476 OMICRON (BA.4/BA.5) 25 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SM-102
CHOLESTEROL
1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE
1,2-DIMYRISTOYL-RAC-GLYCERO-3-METHOXYPOLYETHYLENE GLYCOL 2000
TROMETHAMINE
TROMETHAMINE HYDROCHLORIDE
ACETIC ACID
SODIUM ACETATE
SUCROSE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:80777-282-99 10 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE (80777-282-05)
1 NDC:80777-282-05 2.5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (80777-282-99)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Emergency Use Authorization 07/28/2022
Labeler — Moderna US, Inc. (117626450)
Establishment
Name Address ID/FEI Operations
ModernaTX, Inc. 116912313 ANALYSIS (80777-282), API MANUFACTURE (80777-282)
Establishment
Name Address ID/FEI Operations
Catalent Indiana, LLC 172209277 MANUFACTURE (80777-282), ANALYSIS (80777-282), LABEL (80777-282), PACK (80777-282)
Establishment
Name Address ID/FEI Operations
Patheon Manufacturing Services, LLC 079415560 MANUFACTURE (80777-282), ANALYSIS (80777-282), LABEL (80777-282), PACK (80777-282)

Revised: 10/2022 Moderna US, Inc.

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