• For certain indications, 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 the FDA, under an Emergency Use Authorization (EUA), to prevent Coronavirus Disease 2019 (COVID‑19) in individuals 18 years of age and older. There are two presentations/formulations of the Moderna COVID‑19 Vaccine authorized for use.

  • 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 product, unless the declaration is terminated or the authorization is revoked sooner.

See below for Moderna COVID‑19 Vaccine authorized uses.

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?

Certain authorized uses of Moderna COVID‑19 Vaccine, including booster dose and third dose for immunocompromised individuals, 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 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

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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.

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FDA has approved SPIKEVAX (COVID‑19 Vaccine, mRNA) as a two-dose primary series for the prevention of COVID‑19 in individuals ages 18 years of age and older.

The Moderna COVID‑19 Vaccine has not been approved by the FDA, but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA), to provide a two-dose primary series (0.5 mL) to individuals 18 years of age and older. Additionally, the Moderna COVID‑19 Vaccine has been authorized to provide a third primary series dose (0.5 mL) to individuals ages 18 years of age and older who have been determined to have certain kinds of immunocompromise. The EUA also authorizes a single (0.25 mL) booster dose of the Moderna COVID‑19 Vaccine at least 5 months after completing a primary series of the Moderna COVID‑19 Vaccine or SPIKEVAX to individuals 18 years of age and older. Under the EUA, the booster dose may also be administered to individuals 18 years of age or older as a heterologous booster dose following completion of primary vaccination with another authorized or approved COVID‑19 vaccine. 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 the declaration is terminated or authorization revoked sooner.

FDA-approved SPIKEVAX and the EUA-authorized Moderna COVID‑19 Vaccine have the same formulation and can be used interchangeably without presenting any safety or effectiveness concerns.

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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 in Vaccine” 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.

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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 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.

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On-screen text:

Important Safety Information for Moderna COVID‑19 Vaccine

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On-screen text and voice:

What is the Moderna COVID‑19 Vaccine?

The Moderna COVID‑19 Vaccine has been authorized by the FDA under an Emergency Use Authorization (EUA) to provide:

  • a two-dose primary series to individuals 18 years of age and older
  • a third primary series dose to individuals 18 years of age and older who have been determined to have certain kinds of immunocompromise
  • a single booster dose to the individuals 18 years of age and older who have completed a primary series with the Moderna COVID‑19 Vaccine or SPIKEVAX (COVID‑19 Vaccine, mRNA)
  • a single booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID‑19 vaccine

FDA has approved SPIKEVAX as a two-dose series for the prevention of COVID‑19 in individuals 18 years of age and older.

How is SPIKEVAX related to the Moderna COVID‑19 Vaccine?
SPIKEVAX can be used interchangeably.

IMPORTANT SAFETY INFORMATION

What should you mention to your vaccination provider before you get the vaccine?

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

  • 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

Who should not get the vaccine?
You should not get the 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 vaccine given?
The Moderna COVID‑19 Vaccine or SPIKEVAX will be given to you as an injection into the muscle.

Primary Series: The vaccine is administered as a 2-dose series, one month apart. A third primary series dose may be administered at least one month after the second dose to individuals who are determined to have certain kinds of immunocompromise.

Booster Dose:

  • A single booster dose of the vaccine may be administered at least 5 months after completion of a primary series of the Moderna COVID‑19 Vaccine or SPIKEVAX in individuals 18 years of age and older.
  • A single booster dose of the vaccine may be administered to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID‑19 vaccine. Please check with your healthcare provider regarding timing of the booster dose.

What are the risks of the vaccine?
There is a remote chance that the 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 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

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine, more commonly in males under 40 years of age than among females and older males. In most of these people, symptoms began within a few days following receipt of the second dose of the vaccine. The chance of having this occur is very low. You should seek medical attention right away if you have any of the following symptoms after receiving the vaccine:

  • Chest pain
  • Shortness of breath
  • Feelings of having a fast-beating, fluttering, or pounding heart

Side effects that have been reported in clinical trials with the 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, fever, and rash

Side effects that have been reported during post-authorization use of the vaccine include:

  • Severe allergic reactions
  • Myocarditis (inflammation of the heart muscle)
  • Pericarditis (inflammation of the lining outside the heart)
  • Fainting in association with injection of the vaccine

These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are 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 either “SPIKEVAX (COVID‑19 Vaccine, mRNA)” or “Moderna COVID‑19 Vaccine 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).

What if I am immunocompromised?
If you are immunocompromised, you may receive a third primary series dose of the vaccine. The third dose may still not provide full immunity to COVID‑19 in people who are immunocompromised, and you should continue to maintain physical precautions to help prevent COVID‑19. In addition, your close contacts should be vaccinated as appropriate.

What if I am pregnant or breastfeeding?
If you are pregnant or breastfeeding, discuss your options with your healthcare provider.

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

For information regarding SPIKEVAX, please see SPIKEVAX Full Prescribing Information and Information for Recipients and Caregivers at https://www.modernatx.com/covid19vaccine-eua/spikevax-prescribing-information.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.

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Job code is displayed on screen:

US-COV-2200040 02/2022

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