Vaccine Information: Moderna COVID-19 Vaccine, Bivalent

MODERNA COVID-19 VACCINE, BIVALENT- elasomeran and cx-034476 omicron (ba.4/ba.5) injection, suspension
Moderna US, Inc.

EMERGENCY USE AUTHORIZATION (EUA)

MODERNA COVID-19 VACCINE, BIVALENT

(ORIGINAL AND OMICRON BA.4/BA.5)

BOOSTER DOSE FOR 6 YEARS OF AGE AND OLDER

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, Bivalent (Original and Omicron BA.4/BA.5), for active immunization to prevent COVID-19 in individuals 6 years of age and older.

Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is hereafter referred to as Moderna COVID-19 Vaccine, Bivalent.

Moderna COVID-19 Vaccine, Bivalent is authorized for use in individuals 6 years of age and older as a single booster dose administered at least 2 months after either:

completion of primary vaccination with any authorized or approved monovalent 1
COVID-19 vaccine, or
receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

Moderna COVID-19 Vaccine, Bivalent is supplied in a multiple-dose vial with a dark blue cap and a label with a gray border.


1
Monovalent refers to any authorized or approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2.

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 Moderna COVID-19 Vaccine, Bivalent. See “MANDATORY REQUIREMENTS FOR MODERNA COVID-19 VACCINE, BIVALENT, ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION” for reporting requirements.

Moderna COVID-19 Vaccine, Bivalent is a suspension for intramuscular injection.

A single booster dose of Moderna COVID-19 Vaccine, Bivalent may be administered at least 2 months after completion of primary vaccination or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

For individuals 12 years of age and older, a single booster dose is 0.5 mL.
For individuals 6 years through 11 years of age, a single booster dose is 0.25 mL.

See this Fact Sheet for instructions for preparation and administration. This Fact Sheet may have been updated. For the most recent Fact Sheet, please see www.modernatx.com/covid19vaccine-eua.

For information on clinical trials that are testing the use of the Moderna COVID-19 Vaccine, Bivalent for active immunization against COVID-19, please see www.clinicaltrials.gov.

DESCRIPTION OF COVID-19

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the novel coronavirus, SARS-CoV-2, that appeared in late 2019. It is predominantly a respiratory illness that can affect other organs. People with COVID-19 have reported a wide range of symptoms, ranging from mild symptoms to severe illness. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle and body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.

DOSAGE AND ADMINISTRATION

Storage and Handling

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

Storage at 2°C to 8°C (36°F to 46°F):
o
Vials may be stored refrigerated between 2°C to 8°C (36°F to 46°F) for up to 30 days prior to first use, provided the expiration date is not exceeded.
o
Vials should be discarded 12 hours after the first puncture.
Storage at 8°C to 25°C (46°F to 77°F):
o
Vials may be stored between 8°C to 25°C (46°F to 77°F) for a total of 24 hours.
o
Vials should be discarded 12 hours after the first puncture.
o
Total storage at 8°C to 25°C (46°F to 77°F) must not exceed 24 hours.

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.

Dosing and Schedule

A single booster dose of Moderna COVID-19 Vaccine, Bivalent may be administered at least 2 months after completion of primary vaccination or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

For individuals 12 years of age and older, a single booster dose is 0.5 mL.
For individuals 6 years through 11 years of age, a single booster dose is 0.25 mL.

Preparation for Administration

Moderna COVID-19 Vaccine, Bivalent is supplied as a frozen suspension that does not contain a preservative and must be thawed prior to administration.
Verify that the vial label states Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5).
Thaw each vial before use following the instructions below.

Thawing Instructions for Moderna COVID-19 Vaccine, Bivalent

Thaw in Refrigerator

Thaw at Room Temperature

Thaw between 2°C to 8°C (36°F to 46°F) for 2 hours. Let each vial stand at room temperature for 15 minutes before administering.

Alternatively, thaw between 15°C to 25°C (59°F to 77°F) for 45 minutes.

After thawing, do not refreeze.
Swirl vial gently after thawing and between each withdrawal. Do not shake. Do not dilute the vaccine.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Moderna COVID-19 Vaccine, Bivalent is a white to off-white suspension. It may contain white or translucent product-related particulates. Do not administer if vaccine is discolored or contains other particulate matter.
A booster dose for individuals 12 years of age and older is 0.5 mL.
A booster dose for individuals 6 years through 11 years of age is 0.25 mL.
If withdrawing only 0.5 mL doses, each multiple-dose vial contains 5 booster doses.
If withdrawing only 0.25 mL doses, each multiple-dose vial contains 10 booster doses.
Both 0.5 mL doses and 0.25 mL doses may be withdrawn from the same multiple-dose vial.
If the amount of vaccine remaining in the vial cannot provide a full dose of 0.5 mL or 0.25 mL, discard the vial and contents. Do not pool excess vaccine from multiple vials.
After the first booster dose has been withdrawn, the vial should be held between 2°C to 25°C (36°F to 77°F). Record the date and time of first use on the Moderna COVID-19 Vaccine, Bivalent vial label. Discard vial after 12 hours. Do not refreeze.

Administration

Administer Moderna COVID-19 Vaccine, Bivalent intramuscularly.

CONTRAINDICATION

Do not administer Moderna COVID-19 Vaccine, Bivalent to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of Moderna COVID-19 Vaccine, Bivalent (see Full EUA Prescribing Information).

WARNINGS

Management of Acute Allergic Reactions

Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Moderna COVID-19 Vaccine, Bivalent.

Monitor Moderna COVID-19 Vaccine, Bivalent recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention (CDC) guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).

Myocarditis and Pericarditis

Postmarketing safety data with Moderna COVID-19 Vaccine are relevant to Moderna COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process.

Postmarketing data with authorized or approved monovalent mRNA COVID-19 vaccines demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following receipt of the second primary series dose or first booster dose, with most booster doses likely administered at least 5 months after completing primary vaccination. For the Moderna COVID-19 Vaccine, the observed risk is highest in males 18 through 24 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae.

Some, but not all, observational analyses of postmarketing data suggest that there may be an increased risk of myocarditis and pericarditis in males under 40 years of age following the second dose of Moderna COVID-19 Vaccine primary series relative to other authorized or approved mRNA COVID-19 vaccines.

The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis

(https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).

Syncope

Syncope (fainting) may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.

Altered Immunocompetence

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to Moderna COVID-19 Vaccine, Bivalent.

Limitations of Vaccine Effectiveness

Moderna COVID-19 Vaccine, Bivalent may not protect all vaccine recipients.

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