MODERNA COVID-19 VACCINE- cx-024414 injection, suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ELASOMERAN (UNII: EPK39PL4R4) (ELASOMERAN - UNII:EPK39PL4R4)

Available from:

Moderna US, Inc.

Administration route:

INTRAMUSCULAR

Therapeutic indications:

There is no information on the co-administration of the Moderna COVID-19 Vaccine with other vaccines. In order to mitigate the risks of using this unapproved product under EUA and to optimize the potential benefit of the Moderna COVID-19 Vaccine, the following items are required. Use of unapproved Moderna COVID-19 Vaccine for active immunization to prevent COVID-19 under this EUA is limited to the following (all requirements must be met): FULL EUA PRESCRIBING INFORMATION: CONTENTS* 11 USE IN SPECIFIC POPULATIONS 11.1 Pregnancy 11.2 Lactation 11.3 Pediatric Use 11.4 Use in Immunocompromised Individuals 13 DESCRIPTION 14 CLINICAL PHARMACOLOGY 14.1 Mechanism of Action 18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA 18.1 Efficacy of Two-Dose Primary Series in Participants 18 Years of Age and Older 18.2 Effectiveness of Two-Dose Primary Series in Participants 6 Years Through 11 Years of Age 18.3 Immunogenicity in Solid Organ Transplant Recipients 19 HOW SUPPLIED/STORAGE AND HANDLING 2

Product summary:

The information in this section applies to the Moderna COVID-19 Vaccine that is supplied in multiple-dose vials with dark blue caps and labels with a teal border containing a volume of 2.5 mL. These multiple-dose vials are supplied as follows: NDC 80777-277-99       Carton of 10 multiple-dose vials, each containing 5 doses of 0.5 mL During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Frozen Storage Store frozen between -50°C to -15°C (-58°F to 5°F). Storage after Thawing Do not refreeze once thawed. Thawed vials can be handled in room light conditions. Transportation of Thawed Vials at 2°C to 8°C (36°F to 46°F) If transport at -50°C to -15°C (-58°F to 5°F) is not feasible, available data support transportation of one or more thawed vials for up to 12 hours at 2°C to 8°C (36°F to 46°F) when shipped using shipping containers which have been qualified to maintain 2°C to 8°C (36°F to 46°F) and under routine road and air transport conditions with shaking and vibration minimized. Once thawed and transported at 2°C to 8°C (36°F to 46°F), vials should not be refrozen and should be stored at 2°C to 8°C (36°F to 46°F) until use.

Authorization status:

unapproved drug other

Summary of Product characteristics

MODERNA COVID-19 VACCINE- CX-024414 INJECTION, SUSPENSION
MODERNA US, INC.
----------
FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE
(VACCINATION PROVIDERS)
EMERGENCY USE AUTHORIZATION (EUA) OF THE MODERNA COVID-19
VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19)
PRIMARY SERIES
6 YEARS THROUGH 11 YEARS OF AGE
THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) HAS ISSUED AN EMERGENCY
USE
AUTHORIZATION (EUA) TO PERMIT THE EMERGENCY USE OF THE UNAPPROVED
PRODUCT, MODERNA COVID-19 VACCINE, FOR ACTIVE IMMUNIZATION TO PREVENT
COVID-19 IN INDIVIDUALS 6 MONTHS OF AGE AND OLDER.
THERE ARE 2 PRESENTATIONS OF MODERNA COVID-19 VACCINE AUTHORIZED FOR
USE
TO PROVIDE PRIMARY SERIES DOSES TO INDIVIDUALS 6 YEARS THROUGH 11
YEARS OF
AGE:
•
THE PRESENTATION SUPPLIED IN A MULTIPLE-DOSE VIAL WITH A DARK BLUE CAP
AND
A LABEL WITH A PURPLE BORDER (SEE IMAGE BELOW). THE CARTONS AND VIAL
LABELS STATE “BOOSTER DOSES ONLY.” THIS PRESENTATION MAY BE USED
TO
PROVIDE PRIMARY SERIES DOSES TO INDIVIDUALS 6 YEARS THROUGH 11 YEARS
OF
AGE. THE MODERNA COVID-19 VACCINE IS NOT AUTHORIZED TO PROVIDE
BOOSTER DOSES.
1
•
THIS FACT SHEET PERTAINS ONLY TO MODERNA COVID-19 VACCINE SUPPLIED IN
A
MULTIPLE-DOSE VIAL WITH A DARK BLUE CAP AND A LABEL WITH A PURPLE
BORDER AND
MODERNA COVID-19 VACCINE SUPPLIED IN A MULTIPLE-DOSE VIAL WITH A DARK
BLUE
CAP AND A LABEL WITH A TEAL BORDER WHICH ARE AUTHORIZED FOR USE TO
PROVIDE A
TWO-DOSE PRIMARY SERIES TO INDIVIDUALS 6 YEARS THROUGH 11 YEARS OF
AGE. THE
VACCINE IS ALSO AUTHORIZED TO PROVIDE A THIRD PRIMARY SERIES DOSE TO
INDIVIDUALS
6 YEARS THROUGH 11 YEARS OF AGE WHO HAVE BEEN DETERMINED TO HAVE
CERTAIN
KINDS OF IMMUNOCOMPROMISE.
THE PRESENTATION SUPPLIED IN A MULTIPLE-DOSE VIAL WITH A DARK BLUE CAP
AND
A LABEL WITH A TEAL BORDER (CURRENTLY NOT AVAILABLE). THE CARTONS
STATE
“FOR AGE 6 YEARS THROUGH 11 YEARS.” THE VIAL LABELS STATE “AGE
6Y
THROUGH 11Y.”
2
MODERNA COVID-19 VACCINE SUPPLIED IN MULTIPLE-DOSE VIALS WITH A DARK
BLUE
CAP AND A LABEL WITH A TEAL BORDER INTENDED FOR USE IN INDIVIDU