Home What is the Moderna COVID-19 Vaccine

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 Moderna?

Moderna is a biotechnology company founded in 2010. At Moderna, we are pioneering a class of medicines based on messenger RNA (mRNA).

Every cell in your body uses mRNA, which gives instructions to make the proteins your body needs. This affects many aspects of your biology, including health and disease.

We are currently developing mRNA-based vaccines and medicines for a variety of conditions, including COVID‑19.

Founded in 2010
Emergency Use Authorization

Why Is the Vaccine Available Now?

Moderna COVID-19 Vaccine, Bivalent and certain authorized uses of the Moderna COVID-19 Vaccine in children and teens have not yet undergone the same type of review as an FDA‑approved or cleared product. FDA may issue an "Emergency Use Authorization" when certain criteria are met, which includes that there are no adequate, approved, and available alternatives. In addition, the FDA decision is based on the totality of the scientific evidence available showing that the product may be effective to prevent COVID‑19 during the COVID‑19 pandemic and that the known and potential benefits of the product outweigh the known and potential risks of the product.

mRNA in a fatty particle

What Do the Vaccines Do
in the Body?

The Moderna vaccines use mRNA to provide a blueprint for your cells to build your body’s defense against SARS‑CoV‑2, the virus that causes COVID‑19. The Moderna COVID‑19 Vaccines do not contain SARS‑CoV‑2, or any virus—just the blueprint to help fight against it. The Moderna vaccines may not protect everyone.

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: