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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CX-024414 (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): *Serious adverse events are defined as: FULL EUA PRESCRIBING INFORMATION: CONTENTS* 11 USE IN SPECIFIC POPULATIONS 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 Months Through 5 Years of Age 18.3 Immunogenicity in Solid Organ Transplant Recipients 19 HOW SUPPLIED/STORAGE AND HANDLING 20 PATIENT COU

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 magenta border containing a volume of 2.5 mL. These multiple-dose vials are supplied as follows: NDC 80777-279-99           Carton of 10 multiple-dose vials, each containing 10 doses of 0.25 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 PRESENTATION
6 MONTHS THROUGH 5 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.
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 MAGENTA
BORDER
(SEE IMAGE BELOW) WHICH IS AUTHORIZED FOR USE TO PROVIDE A TWO-DOSE
PRIMARY
SERIES TO INDIVIDUALS 6 MONTHS THROUGH 5 YEARS OF AGE. THE VACCINE IS
ALSO
AUTHORIZED TO PROVIDE A THIRD PRIMARY SERIES DOSE TO INDIVIDUALS 6
MONTHS
THROUGH 5 YEARS OF AGE WHO HAVE BEEN DETERMINED TO HAVE CERTAIN KINDS
OF
IMMUNOCOMPROMISE.
1
MODERNA COVID-19 VACCINE SUPPLIED IN MULTIPLE-DOSE VIALS WITH A DARK
BLUE
CAP AND A LABEL WITH A MAGENTA BORDER INTENDED FOR USE IN INDIVIDUALS
6
MONTHS THROUGH 5 YEARS OF AGE SHOULD NOT BE USED IN INDIVIDUALS 6
YEARS OF
AGE AND OLDER BECAUSE OF THE POTENTIAL FOR VACCINE ADMINISTRATION
ERRORS,
INCLUDING DOSING ERRORS.
,
1
2
3
SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS
Vaccination providers enrolled in the federal COVID-19 Vaccination
Program must report
all vaccine administration errors, all serious adverse events, cases
of myocarditis, cases
of pericarditis, cases of Multisystem Inflammatory Syndrome (MIS) in
adults and
children, and cases of COVID-19 that result in hospitalization or
death following
administration of the Moderna COVID-19 Vaccine. See “MANDATORY
REQUIREMENTS
FOR MODERNA COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE
AUTHORIZATION” for reporting requirements.
The Moderna COVID-19 Vaccine is a suspension for intramuscular
injecti