MODERNA COVID-19 VACCINE injection, suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CX-038839 OMICRON (XBB.1.5) (UNII: 4F9QRS7ZV2) (CX-038839 OMICRON (XBB.1.5) - UNII:4F9QRS7ZV2)

Available from:

Moderna US, Inc.

Administration route:

INTRAMUSCULAR

Therapeutic indications:

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of Moderna COVID-19 Vaccine (2023-2024 Formula) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months through 11 years of age. Justification for Emergency Use of Vaccines During the COVID-19 Pandemic There is currently an outbreak of COVID-19 caused by SARS-CoV-2. The Secretary of the Department of Health and Human Services (HHS) has: An EUA is an FDA authorization for the emergency use of an unapproved product or unapproved use of an approved product (i.e., drug, biological product, or device) in the United States under certain circumstances including, but not limited to, when the Secretary of HHS declares that the use of EUA authority is justified, based on a determination that there is a public health emergency, or a significant potential for a public health emergency, that affects or

Product summary:

How Supplied Moderna COVID-19 Vaccine (2023-2024 Formula): single dose vials with dark blue caps and labels with a green box. NDC 80777-287-92                    Carton of 10 single dose vials NDC 80777-287-07                    Single dose vial Storage and Handling Minimize exposure to room light and avoid exposure to direct sunlight and ultraviolet light. Frozen Storage 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.

Summary of Product characteristics

MODERNA COVID-19 VACCINE- MODERNA COVID-19 VACCINE INJECTION,
SUSPENSION
MODERNA US, INC.
----------
FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE:
EMERGENCY USE AUTHORIZATION OF MODERNA COVID-19 VACCINE (2023-
2024 FORMULA), FOR INDIVIDUALS 6 MONTHS THROUGH 11 YEARS OF AGE
HIGHLIGHTS OF EMERGENCY USE
AUTHORIZATION (EUA)
THESE HIGHLIGHTS OF THE EUA DO NOT INCLUDE ALL
THE INFORMATION NEEDED TO USE MODERNA
COVID-19 VACCINE UNDER THE EUA. SEE THE
FULL FACT SHEET FOR HEALTHCARE
PROVIDERS FOR MODERNA COVID-19 VACCINE.
MODERNA COVID-19 VACCINE
SUSPENSION FOR INJECTION, FOR INTRAMUSCULAR
USE
2023-2024 FORMULA
ORIGINAL EUA AUTHORIZED DATE: 12/2020
MOST RECENT EUA AUTHORIZED DATE: 9/2023
-------------------------------- RECENT MAJOR
CHANGES ------------------------------
Dosage and Administration
•
•
--------------------------------EMERGENCY USE
AUTHORIZATION ------------------------------
The U.S. Food and Drug Administration (FDA) has
issued an Emergency Use Authorization (EUA) for
the emergency use of Moderna COVID-19 Vaccine
(2023-2024 Formula) for active immunization to
prevent coronavirus disease 2019 (COVID-19)
caused by severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) in individuals 6 months
through 11 years of age.
See Full Fact Sheet for Healthcare Providers for the
justification for emergency use of Moderna COVID-
19 Vaccine (2023-2024 Formula), information on
available alternatives, and additional information on
COVID-19.
-------------------------------- DOSAGE AND
ADMINISTRATION ------------------------------
For intramuscular injection only. (2)
INDIVIDUALS 6 MONTHS THROUGH 4 YEARS OF AGE
BY MODERNA COVID-19 VACCINATION STATUS
(2.3)
Individuals with Certain Kinds of Immunocompromise
Individuals with certain kinds of immunocompromise 6
months through 11 years of age should complete at least a
three-dose series with a COVID-19 vaccine, each dose one
month apart. At least 1 dose should be with a COVID-19
vaccine (2023-2024 Formula). Certain kinds of
immunocompromise refers to individ