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AUTHORIZED USE

  • Emergency uses of the vaccine have not been approved or licensed by the FDA, but have been authorized by the FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019
    (COVID-19). The Moderna
    COVID-19 Vaccine is authorized in individuals
    6 months of age and older as a primary series. The Moderna COVID-19 Vaccine, Bivalent is authorized as a booster dose in individuals

    6 months through 5 years of age at least 2 months after the Moderna COVID-19 Vaccine primary series and is authorized in individuals 6 years of age and older at least 2 months after any authorized or approved vaccine.

  • The EUA for these products is in effect for the duration of the COVID‑19 EUA declaration justifying emergency use of the product, unless the declaration is terminated or the authorization is revoked sooner.

  • For more information on the EUA authorized uses of the vaccine, refer to the Vaccine Fact Sheets for Recipients and Caregivers.

Who Is Eligible for a Bivalent Booster Dose?

Moderna COVID‑19 Vaccine, Bivalent has received EUA from the FDA to provide:

  • A single booster dose to individuals 6 years of age and older at least 2 months after completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine
  • A single booster dose to individuals 6 years of age and older at least 2 months after receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine

The CDC has the most current information on who can get a booster dose.

Are Children Eligible for COVID‑19 Vaccination?

A two-dose primary vaccination series of the Moderna COVID‑19 Vaccine may be administered to individuals 6 months of age and older with 1 month between doses.

A third primary series dose of the Moderna COVID‑19 Vaccine may be administered to individuals 6 months of age and older with certain kinds of immunocompromise.

Children 6 months of age and older are also able to receive a single booster dose of Moderna COVID‑19 Vaccine, Bivalent after completion of primary vaccination with any authorized or approved monovalent COVID‑19 vaccine.

For more information see the recipient fact sheets.

Who Should Not
Get the Vaccine?

Any adult or child should not get the Moderna COVID-19 Vaccine if they have had a severe allergic reaction after a previous dose of this vaccine, or if they had a severe allergic reaction to any ingredient of this vaccine. Let your vaccination provider know about any allergies you and/or your child have.

What if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, discuss your options with your healthcare provider.

Where Do I Get the Vaccines?

Distribution of vaccines, including availability, is being managed by the US Government in coordination with state, territorial, tribal, and local health departments.

For the most current information on vaccine administration sites, contact your healthcare provider or your local health department, or visit https://www.vaccines.gov.

2 doses one month apart

How are the vaccines given?

The Moderna vaccines will be given to you or your child as an injection into the muscle. Moderna COVID‑19 Vaccine Primary Series is two doses given 1 month apart. If you or your child receive one dose of the Moderna COVID-19 Vaccine, you or your child should receive a second dose of the same vaccine 1 month later to complete the vaccination series. A third primary series dose may be administered at least one month after the second dose to individuals with certain kinds of immunocompromise.

Moderna COVID‑19 Vaccine, Bivalent will be administered as a single booster dose to individuals 6 years and older at least 2 months following:

  • Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine
  • The most recent booster dose with any authorized or approved monovalent COVID-19 vaccine

What Should I Tell My Healthcare Provider Before Being Vaccinated?

Before you or your child receive the Moderna COVID‑19 Vaccine, tell your healthcare provider about all your/your child's medical conditions, including if you or your child:

  • Have any allergies
  • Have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
  • Have a fever
  • Have a bleeding disorder or are on a blood thinner
  • Are immunocompromised or are on a medicine that affects your immune system
  • Are pregnant or plan to become pregnant
  • Are breastfeeding
  • Have received another COVID‑19 vaccine
  • Have ever fainted in association with an injection
What to expect during and
after your injection

IMPORTANT SAFETY INFORMATION

What should you mention to the vaccination provider before you or your child gets these vaccines?

Tell your vaccination provider about all medical conditions, including if you or your child:

  • have any allergies
  • have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
  • have a fever
  • have a bleeding disorder or are on a blood thinner
  • are immunocompromised or are on a medicine that affects your or your child’s immune system
  • are pregnant or plan to become pregnant
  • are breastfeeding
  • have received another COVID-19 vaccine
  • have ever fainted in association with an injection

Who should not get the vaccine?

Any adult or child who:

  • had a severe allergic reaction after a previous dose of these vaccines
  • had a severe allergic reaction to any ingredient in these vaccines

What are the risks of these vaccines?

Severe allergic reactions: there is a remote chance that these vaccines could cause a severe allergic reaction. A severe allergic reaction would usually happen within a few minutes to one hour after getting a dose of the vaccine. Signs of a severe allergic reaction can include:

  • Difficulty breathing
  • Swelling of your face and throat
  • A fast heartbeat
  • A bad rash all over your body
  • Dizziness and weakness

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have happened in some people who have received the vaccines, most commonly in adult males under 40. The chance of this happening is very low. Seek medical attention right away if you or your child has any of the following symptoms after receiving the vaccine:

  • Chest pain
  • Shortness of breath
  • Feelings of having a fast-beating, fluttering, or pounding heart
  • Fainting
  • Unusual and persistent irritability
  • Unusual and persistent poor feeding
  • Unusual and persistent fatigue or lack of energy
  • Persistent vomiting
  • Persistent pain in the abdomen
  • Unusual and persistent cool, pale skin

Side effects that have been reported in clinical trials with these vaccines include:

  • Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm of the injection or in the groin, swelling (hardness), and redness
  • General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea and vomiting, fever, rash, irritability/crying, sleepiness, and loss of appetite

These may not be all the possible side effects of these vaccines. Serious and unexpected side effects may occur. The possible side effects of these vaccines are still being studied in clinical trials.

What should I do about side effects?

If you or your child experience a severe allergic reaction, call 9‑1‑1, or go to the nearest hospital.

Call the vaccination provider or healthcare provider if you or your child have any side effects that bother you or do not go away.

Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1‑800‑822‑7967 or report online to https://vaers.hhs.gov/reportevent.html. Please include “Moderna COVID-19 Vaccine EUA,” or “Moderna COVID‑19, Bivalent EUA” as appropriate, in the first line of box #18 of the report form.

In addition, you can report side effects to ModernaTX, Inc. at 1‑866‑MODERNA (1‑866‑663‑3762).

Please see the Vaccine Fact Sheets for Recipients and Caregivers for more information: