Download the Emergency Use Authorization (EUA) Fact Sheet
  • The Moderna COVID‑19 Vaccine has not been approved or licensed by the US Food and Drug Administration (FDA), but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA), to prevent Coronavirus Disease 2019 (COVID‑19) for use in individuals 18 years of age and older. There is no FDA-approved vaccine to prevent COVID‑19.
  • The EUA for the Moderna COVID‑19 Vaccine is in effect for the duration of the COVID‑19 EUA declaration justifying emergency use of the vaccine, unless terminated or revoked (after which the vaccine may no longer be used).

Overview for Vaccine Recipients

What Is Moderna COVID-19 Vaccine?

The Moderna COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19. There is no FDA-approved vaccine to prevent COVID-19. In clinical trials, approximately 15,400 individuals 18 years of age and older have received at least 1 dose of the Moderna COVID-19 Vaccine.

Learn more about the vaccine
mRNA in a fatty particle

Who Is Getting Vaccinated?

Responding to the COVID-19 emergency, the United States Government has made recommendations on who can get vaccinated, and when.

See who can get the vaccine now

Frequently Asked
Questions

Do you have more questions about the Moderna COVID-19 Vaccine? Take a look at our answers to the questions we hear most often.

What is an Emergency Use Authorization (EUA) and why was it granted? Do I still have to wear a mask and socially distance after the first vaccine? After the second vaccine?
View FAQs

What is the Moderna COVID‑19 Vaccine?

The Moderna COVID‑19 Vaccine is an unapproved vaccine that may prevent COVID‑19. There is no FDA‑approved vaccine to prevent COVID‑19. The FDA has authorized the emergency use of the Moderna COVID‑19 Vaccine to prevent COVID‑19 in individuals 18 years of age and older under an Emergency Use Authorization (EUA).

Important Safety Information

What should you mention to your vaccination provider before you get the Moderna COVID‑19 Vaccine?

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

  • have any allergies
  • 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

Who should not get the Moderna COVID‑19 Vaccine?

You should not get the Moderna COVID‑19 Vaccine if you:

  • had a severe allergic reaction after a previous dose of this vaccine
  • had a severe allergic reaction to any ingredient of this vaccine

How is the Moderna COVID‑19 Vaccine given?

The Moderna COVID‑19 Vaccine will be given to you as an injection into the muscle. The Moderna COVID‑19 Vaccine vaccination series is 2 doses given 1 month apart. If you receive one dose of the Moderna COVID‑19 Vaccine, you should receive a second dose of the same vaccine 1 month later to complete the vaccination series.

What are the risks of the Moderna COVID‑19 Vaccine?

There is a remote chance that the Moderna COVID‑19 Vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Moderna COVID‑19 Vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. 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

Side effects that have been reported with the Moderna COVID‑19 Vaccine include:

  • Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm of the injection, swelling (hardness), and redness
  • General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea and vomiting, and fever

Side effects that have been reported during post‑authorization use of the Moderna COVID‑19 Vaccine include:

  • Severe allergic reactions

These may not be all the possible side effects of the Moderna COVID‑19 Vaccine. Serious and unexpected side effects may occur. The Moderna COVID‑19 Vaccine is still being studied in clinical trials.

What should I do about side effects?

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

Call the vaccination provider or your healthcare provider if you 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” 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 click for Fact Sheet for Recipients and Caregivers for more information.