Moderna COVID-19 Vaccine: Package Insert and Label Information

MODERNA COVID-19 VACCINE- cx-024414 injection, suspension
Moderna US, Inc.


7
Vaccination providers administering SPIKEVAX (COVID-19 Vaccine, mRNA) must adhere to the same reporting requirements.
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Vaccination providers administering SPIKEVAX (COVID-19 Vaccine, mRNA) must adhere to the same reporting requirements.

PRIMARY SERIES

For 12 Years 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, 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 red cap and a label with a light blue border which is authorized for use to provide:

a two-dose primary series to individuals 12 years of age and older; and
a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise.1

SPIKEVAX (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by ModernaTX, Inc. that is indicated for active immunization to prevent COVID-19 in individuals 18 years of age and older.2 It is approved for use as a two-dose primary series for the prevention of COVID-19 in individuals 18 years of age and older. It is also authorized for emergency use to provide:

a two-dose primary series to individuals 12 years through 17 years of age; and
a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise.

SPIKEVAX (COVID-19, mRNA) and Moderna COVID-19 Vaccine supplied in multiple-dose vials with a red cap and a label with a light blue border intended for use in individuals 12 years of age and older should not be used in individuals 6 months through 11 years of age because of the potential for vaccine administration errors, including dosing errors.3, 4


1
Certain kinds of immunocompromise refers to individuals who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
2
As described in the Letter of Authorization, the FDA-approved SPIKEVAX (COVID-19 Vaccine, mRNA) and the EUA-authorized presentation of the Moderna COVID-19 Vaccine supplied in multiple-dose vials with red caps and labels with a light blue border can be used interchangeably to provide primary series doses to individuals 12 years of age and older without presenting any safety or effectiveness concerns.
3
Notwithstanding the age limitations for use of the different presentations of the Moderna COVID-19 Vaccine, individuals 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 (each 0.5 mL dose containing 50 mcg mRNA) supplied in multiple-dose vials with dark blue caps and labels with a purple border stating “BOOSTER DOSES ONLY”; (2) SPIKEVAX (COVID-19 Vaccine, mRNA) or the Moderna COVID-19 Vaccine authorized for use in individuals 12 years of age and older (each 0.5 mL dose containing 100 mcg mRNA) supplied in multiple-dose vials with red caps and labels with a light blue border; or (3) the Moderna COVID-19 Vaccine authorized for use in individuals 6 years through 11 years of age (each 0.5 mL dose containing 50 mcg mRNA) supplied in multiple-dose vials with dark blue caps and labels with a teal border (currently not available). The multiple-dose vials with dark blue caps and labels with a purple border are authorized to provide 0.5 mL primary series doses for individuals 6 years through 11 years of age.
4
For primary vaccination of individuals 6 months through 5 years of age and 6 years through 11 years of age, refer to the respective Moderna COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine.

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 injection.

Primary Series 5

Each primary series dose of the Moderna COVID-19 Vaccine for individuals 12 years of age and older is 0.5 mL.

The Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a red cap and a label with a light blue border is administered as a primary series of two doses (0.5 mL each) 1 month apart to individuals 12 years of age or older.

A third primary series dose (0.5 mL) of the Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a red cap and a label with a light blue border is authorized for administration at least 1 month following the second dose to individuals at least 12 years of age with certain kinds of immunocompromise.

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 for active immunization against COVID-19, please see www.clinicaltrials.gov.


5
A primary series dose of SPIKEVAX (COVID-19 Vaccine, mRNA) is 0.5 mL.

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

The information in this Fact Sheet supersedes the information on the vial and carton labels.

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.
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

Primary Series 6

Each primary series dose of the Moderna COVID-19 Vaccine for individuals 12 years of age and older is 0.5 mL.

The Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a red cap and a label with a light blue border is administered as a primary series of two doses (0.5 mL each) 1 month apart to individuals 12 years of age or older.

A third primary series dose (0.5 mL) of the Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a red cap and a label with a light blue border is authorized for administration at least 1 month following the second dose to individuals at least 12 years of age with certain kinds of immunocompromise.


6
A primary series dose of SPIKEVAX (COVID-19 Vaccine, mRNA) is 0.5 mL.

Preparation for Administration

The Moderna COVID-19 Vaccine multiple-dose vial with a red cap and a label with a light blue border is supplied in two volumes:
o
multiple-dose vial containing 5.5 mL
o
multiple-dose vial containing 7.5 mL
The Moderna COVID-19 Vaccine multiple-dose vial with a red cap and a label with a light blue border contains a frozen suspension that does not contain a preservative and must be thawed prior to administration.
Verify that the vial of Moderna COVID-19 Vaccine has a red cap and a label with light blue border.
Thaw each vial before use following the instructions below.

Thawing Instructions for Moderna COVID-19 Vaccine Multiple-Dose Vials with Red Caps and Labels with a Light Blue Border

Multiple-Dose Vial Containing

Thaw in Refrigerator

Thaw at Room Temperature

5.5 mL

Thaw between 2°C to 8°C (36°F to 46°F) for 2 hours and 30 minutes. 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 1 hour.

7.5 mL

Thaw between 2°C to 8°C (36°F to 46°F) for 3 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 1 hour and 30 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.
The Moderna COVID-19 Vaccine 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.
Primary series doses of 0.5 mL may be extracted from vials with red caps and labels with a light blue border, preferentially using low dead-volume syringes and/or needles.
When extracting primary series doses, depending on the syringes and needles used, a maximum of 11 doses (range: 10-11 doses) may be extracted from the vial containing 5.5 mL or a maximum of 15 doses (range: 13-15 doses) may be extracted from the vial containing 7.5 mL.
If the amount of vaccine remaining in the vial cannot provide a primary series dose (0.5 mL), discard the vial and contents. Do not pool excess vaccine from multiple vials.
After the first 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 vial label. Discard vial after 12 hours. Do not refreeze.

Administration

Administer the Moderna COVID-19 Vaccine intramuscularly.

CONTRAINDICATION

Do not administer the Moderna COVID-19 Vaccine to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID-19 Vaccine (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 the Moderna COVID-19 Vaccine.

Monitor Moderna COVID-19 Vaccine 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 data with Moderna COVID-19 Vaccine demonstrate increased risks of myocarditis and pericarditis, particularly within the period 0 through 7 days following the second dose of the primary series. 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 the Moderna COVID-19 Vaccine 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 the Moderna COVID-19 Vaccine.

Limitations of Vaccine Effectiveness

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

ADVERSE REACTIONS

Adverse Reactions in Clinical Trials

Adverse reactions reported in clinical trials following administration of the Moderna COVID-19 Vaccine include pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, erythema at the injection site, and rash. (See Full EUA Prescribing Information)

Adverse Reactions in Post-Authorization Experience

Anaphylaxis and other severe allergic reactions, myocarditis, pericarditis, and syncope have been reported following administration of the Moderna COVID-19 Vaccine outside of clinical trials.

Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Moderna COVID-19 Vaccine.

USE WITH OTHER VACCINES

There is no information on the co-administration of the Moderna COVID-19 Vaccine with other vaccines.

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