• 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).

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?

The Moderna COVID‑19 Vaccine has 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 Does the Vaccine Do in the Body?

The Moderna COVID‑19 Vaccine uses 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 Vaccine does not contain SARS‑CoV‑2, or any virus—just the blueprint to help fight against it. The Moderna COVID‑19 Vaccine may not protect everyone.

What is the
Moderna COVID‑19 Vaccine Video

Video Transcript: What is the Moderna COVID‑19 Vaccine?

[DESCRIPTION]

On-screen text:

What is the Moderna COVID‑19 Vaccine?

Understanding mRNA Science

[SPEECH]

Let’s take a quick look at the science behind the Moderna COVID‑19 Vaccine.

But first, here is some important information about the Moderna COVID‑19 Vaccine.

[DESCRIPTION AND SPEECH]

On-screen text and voice:

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).

On-screen text:

Please see Full Important Safety Information at the conclusion of this video.

[DESCRIPTION]

The image of a scientific journal is displayed, with the words “Moderna”, “mRNA”, and “Est. 2010” on the cover. This fades to an image of an mRNA strand inside a fatty particle labeled with the words “mRNA” and “Fatty Particle”. A vial appears with the word “Vaccine” underneath.

On-screen text:

PLEASE SEE FULL IMPORTANT SAFETY INFORMATION AT THE CONCLUSION OF THIS VIDEO

IMPORTANT SAFETY INFORMATION

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

[SPEECH]

Moderna has developed a COVID‑19 vaccine based on the science of mRNA, an area of focus for Moderna since 2010. Using knowledge of mRNA science based on 10 years of research findings, Moderna developed a vaccine designed to prevent COVID‑19. The vaccine was then studied in clinical trials.

[DESCRIPTION]

A blueprint map appears next to the vaccine vial.

An image of a virus appears in a circle next to the vaccine vial. An X appears over the virus, and the words “No Virus” appear.

[SPEECH]

The Moderna COVID‑19 Vaccine uses mRNA to provide a blueprint for your cells to build your body’s defense against the virus.

The Moderna COVID‑19 Vaccine does not contain SARS‑CoV‑2, the virus that causes COVID‑19.

[DESCRIPTION]

Three other icons appear next to an icon of the vaccine vial:

  • social distancing: two people with an arrow and “6 ft” between them
  • a mask, and a hand under water running from a tap.

[SPEECH]

While a vaccine does not guarantee protection from a virus, in addition to safeguards like social distancing, wearing a mask, and washing hands, it helps provide protection against infection.

[DESCRIPTION]

Four icons fade. On-screen text appears:

Moderna COVID‑19 Vaccine

The image of the vaccine vial with the word “Vaccine” underneath appears to the left of a list.

The items on the list are:

  • No preservatives
  • No products of human or animal origin
  • No aluminum
  • No formaldehyde
  • No antibiotics

Each item on the list appears next to a checkbox with an X through it.

[SPEECH]

Moderna COVID‑19 Vaccine does not contain preservatives, products of human or animal origin, aluminum, formaldehyde, or antibiotics.

[DESCRIPTION]

The list disappears. The image of an mRNA strand inside a fatty particle, labeled “mRNA” and “Fatty Particle”, appears in a circle next to the vaccine vial.

[SPEECH]

Moderna COVID‑19 Vaccine contains mRNA, which is the blueprint, and fatty particles that carry the mRNA into cells.

[DESCRIPTION]

The image fades. The vaccine vial moves into the image of an open carton that appears. The carton contains ten vials. The name “Moderna COVID‑19 Vaccine” appears on the carton. The lid of the carton closes.

[SPEECH]

The FDA has now authorized Moderna COVID‑19 Vaccine for emergency use in the COVID‑19 pandemic.

Please note the following important safety information about the Moderna COVID‑19 Vaccine.

[DESCRIPTION]

On-screen text:

Important Safety Information for Moderna COVID‑19 Vaccine

[SPEECH AND DESCRIPTION]

On-screen text and voice:

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?

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

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

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).

For more information, please see the Fact Sheet for Recipients and Caregivers at https://www.modernatx.com/covid19vaccine-eua/eua-fact-sheet-recipients.pdf.

[DESCRIPTION]

The Moderna logo is displayed, along with the URL ModernaTX.com.

[SPEECH]

Now you have learned how the Moderna COVID‑19 Vaccine is designed to work. For more information visit ModernaTX.com.

[DESCRIPTION]

Job code is displayed on screen:

US-COV-2000011 12/2020

[END OF TRANSCRIPT]

A diverse group of over 15,000 people

How Many People Have Received the Vaccine in the Clinical Trials?

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.

In the largest trial, about 25% of trial participants were 65 years of age and older. About 21% were Hispanic or Latino and 10% were Black.

What Is Known About the Safety of the Vaccine?

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

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

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 if I Have a Side Effect?

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

Call your 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 Moderna at 1-866-MODERNA (1‑866‑663‑3762).

You may also be given an option to enroll in v-safe. V-safe is a new voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID‑19 vaccination. V-safe asks questions that help CDC monitor the safety of COVID‑19 vaccines. V-safe also provides second-dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID‑19 vaccination. For more information on how to sign up, visit: www.cdc.gov/vsafe.