- Side Effects
- Dosing Schedule
- Pregnancy Safety
What is the Moderna COVID-19 Vaccine?
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.
What are the side effects of the Moderna COVID-19 Vaccine?
- 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 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.
What is the dosage for 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.
What drugs interact with Moderna COVID-19 Vaccine?
There is no information on the co-administration of the Moderna COVID-19 Vaccine with other vaccines.
Is the Moderna COVID-19 Vaccine safe to take while pregnant or breastfeeding?
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.
The Moderna COVID-19 Vaccine has emergency authorization from the FDA for active immunization to prevent COVID-19 in individuals 18 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.
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Related Disease Conditions
COVID-19 (Coronavirus, 2019-nCoV)
Infection with COVID-19 (2019 novel coronavirus, 2019-nCoV) causes respiratory problems in humans. Transmission of COVID-19 occurs mainly through contact with respiratory sections from an infected person, however, fecal contamination may also spread the virus. Symptoms start off flu-like and progress to coughing, fever, shortness of breath, shaking chills, headache, loss of sense of taste and/or smell, muscle pain, and sore throat. Treatment focuses on supportive care and symptom relief.
COVID-19 (Coronavirus) Prevention Tips
COVID-19 is a novel coronavirus that spreads from person to person via infected respiratory droplets. The main symptoms of COVID-19 infection include cough, fever, and shortness of breath. Occasionally, people infected with COVID-19 may experience diarrhea, a sore throat, a runny or stuffy nose, or aches and pains. Avoiding contact with infected people, social distancing, not touching your face, frequent hand washing, cleaning, and disinfecting of frequently touched surfaces can help to reduce your risk of contracting the 2019 novel coronavirus.
COVID-19 vs. Flu vs. Cold
When you're feeling sick, it can be difficult to distinguish the symptoms of a COVID-19 infection from the symptoms of the common cold or the flu (influenza). While fever is common with the flu and COVID-19, sneezing is typically only associated with colds. Though sore throats are typical with colds, they are uncommon with COVID-19 infections and the flu.
COVID-19 vs. Allergies
Though there is some overlap in allergy and COVID-19 signs and symptoms there are also significant differences. Symptoms that they have in common include headache, fatigue, tiredness, shortness of breath, wheezing, and sore throat. Fever does not occur with allergies but is one of the defining symptoms of COVID-19 infections.
Does COVID-19 Affect My Heart?
As per the American Heart Association, COVID-19 may have a long-term effect on the heart. Having a heart condition doesn't make a person more likely to catch COVID-19, but an individual with heart disease or a serious heart condition is more likely to become severely ill from COVID-19 and has a higher risk of death.
Is COVID-19 One of the Causes of Pleurisy?
Pleurisy is a painful lung condition that makes it hard to breathe. Learn what causes it, how it's diagnosed, what you can do to treat it, and if COVID-19 causes it.
Treatment & Diagnosis
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