The Moderna COVID-19 Vaccine

The Moderna COVID-19 Vaccine has emergency authorization from the FDA for active immunization to prevent COVID-19 in individuals 18 years of age and older. The vaccine uses a new technology; synthetic mRNA directs the body to create harmless virus proteins to train your body to develop coronavirus antibodies.

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 18 years of age and older.

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.

The nucleoside-modified mRNA in the Moderna COVID-19 Vaccine is formulated in lipid particles, which enable delivery of the nucleoside-modified mRNA into host cells to allow expression of the SARS-CoV-2 S antigen. The vaccine elicits an immune response to the S antigen, which protects against COVID-19.

WARNING

• 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 guidelines (https://www.cdc.gov/vaccines/covid-19/).
• Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Moderna COVID-19 Vaccine.
• The Moderna COVID-19 Vaccine may not protect all vaccine recipients.

Adverse Reactions

Adverse reactions reported in a clinical trial 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, and erythema at the injection site.

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

Storage and Handling

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

Storage Prior to Use

The Moderna COVID-19 Vaccine multiple-dose vials are stored frozen between -25° to -15°C (-13° to 5°F). Store in the original carton to protect from light.

Additional Storage Information Not Displayed on the Vial Labels and Cartons

Do not store on dry ice or below -40°C (-40°F).

Vials can be stored refrigerated between 2° to 8°C (36° to 46°F) for up to 30 days prior to first use.

Unpunctured vials may be stored between 8° to 25°C (46° to 77°F) for up to 12 hours. Do not refreeze once thawed.

Storage After First Puncture of the Vaccine Vial

After the first dose has been withdrawn, the vial should be held between 2° to 25°C (36° to 77°F). Discard vial after 6 hours. Do not refreeze.

Dosing and Schedule

The Moderna COVID-19 Vaccine is administered intramuscularly as a series of two doses (0.5 mL each) 1 month apart.

There are no data available on the interchangeability of the Moderna COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of the Moderna COVID-19 Vaccine should receive a second dose of the Moderna COVID19 Vaccine to complete the vaccination series.

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

Available data on Moderna COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.

Ingredients included in a single human dose of Moderna COVID-19 Vaccine were administered to female rats by the intramuscular route on four occasions: 28 and 14 days prior to mating, and on gestation days 1 and 13. No vaccine-related adverse effects on female fertility, fetal development or postnatal development were reported in the study.

Data are not available to assess the effects of Moderna COVID-19 Vaccine on the breastfed infant or on milk production/excretion.