• 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 18 years of age and older.

  • 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 Fact Sheets for Healthcare Providers Administering Vaccine (Vaccine Providers) and Full Prescribing Information.

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Who Is Moderna?

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

Every cell in the body uses mRNA to provide
real-time instructions to make the proteins necessary to drive many aspects of biology, including in human health and disease.

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

Founded in 2010

What Is the Mechanism of Action of the Vaccine?

The nucleoside-modified mRNA in the Moderna COVID‑19 Vaccine is formulated in lipid particles, which enable delivery of the nucleoside‑modified mRNA into host cells to allow expression of the SARS‑CoV‑2 Spike antigen. The vaccine elicits an immune response to the Spike antigen, which protects against COVID‑19.

mRNA in a fatty particle

What Does It Mean That the Vaccine Is Based on mRNA Technology?

A vaccine based on messenger RNA (mRNA) technology does not use inactivated virus, attenuated virus, or any other kind of virus.

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

This allows the body to generate an antibody response, and to retain the information in memory immune cells, with the goal of attacking the virus if the vaccinated individual is exposed.

No virus within vaccine

What is the
mRNA Vaccine Platform Video

Video Transcript: What is the mRNA Vaccine Platform?

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What is the mRNA Vaccine Platform? For Healthcare Professionals

[SPEECH]

Let’s take a quick look at Moderna’s mRNA platform, which forms the basis of the Moderna COVID‑19 Vaccine.

But first, please be aware of the following 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.

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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.

For information on the authorized use of the Moderna COVID‑19 Vaccine and mandatory requirements of the EUA, please review the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information available at https://www.modernatx.com/covid19vaccine-eua/eua-fact-sheet-providers.pdf.

For information regarding SPIKEVAX, see SPIKEVAX Full Prescribing Information at https://www.modernatx.com/covid19vaccine-eua/spikevax-prescribing-information.pdf.

[DESCRIPTION]

The image of a scientific journal is displayed, with the words “Moderna”,“mRNA”, and “Est.2010” on the cover.

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IMPORTANT SAFETY INFORMATION

Contraindications

Do not administer the Moderna COVID‑19 Vaccine to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID‑19 Vaccine.

[SPEECH]

The name Moderna might be new to you, but we’ve been focused on research and development of new medicines since 2010.

[DESCRIPTION]

The logos of several national and international health agencies and research organizations appear: NIH, NIAID, BARDA, Institut Pasteur, Karolinska Institutet.

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Our research, including partnerships with leading health agencies and research organizations, has focused on a new class of medicines and vaccines based on messenger RNA, or mRNA.

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FIGURE 1. THE CENTRAL DOGMA

A visual representation of DNA appears with an arrow pointing to a strand of mRNA, which has an arrow pointing to a protein.

[SPEECH]

As you know from basic biology, mRNA is used by every cell in the body to make the proteins that drive many aspects of human health and disease.

[DESCRIPTION]

The image of a vial appears. Next to it is a large image of different viruses with an X over them.

Then the image changes to a vial with an mRNA strand next to it.

The image zooms into the mRNA as a ribosome appears alongside it within a cell. The image shows the ribosome-mRNA complex producing a viral antigen.

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Ribosome
Nucleoside-modified mRNA
Viral Antigen

[SPEECH]

A vaccine based on mRNA does not include any virus, but instead a sequence of nucleoside-modified mRNA encoding viral antigens.

This technology helps the body itself produce the viral antigen, against which the body mounts an immune response.

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Everything fades except for the image of the mRNA strand.

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Nucleoside-modified mRNA

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The mRNA is nonreplicating, and is only present in the cell transiently. It does not enter the cell nucleus or interact with DNA.

[DESCRIPTION]

The image fades out and is replaced with the image of an mRNA strand enclosed within a lipid particle.

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No adjuvants or preservatives

Can be stored under refrigeration up to 30 days after thawing

No dilution required

[SPEECH]

Moderna has developed lipid particles as vehicles to deliver the mRNA into cells. This lipid technology means that the Moderna COVID‑19 Vaccine does not require adjuvants or preservatives and can be stored under refrigerated conditions for up to 30 days, once it is thawed. Please check the Fact Sheet for Vaccination Providers for details on storage and handling of the Moderna COVID‑19 Vaccine.

[DESCRIPTION]

A representation of the SARS‑CoV‑2 virus appears next to the lipid particle. Then the virus changes and the mRNA changes at the same time.

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All of this research into Moderna’s mRNA platform allows for an approach that can be adapted to target specific viruses, including SARS‑CoV‑2, the virus that causes COVID‑19, by placing the mRNA code for the viral target within the platform.

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

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Important Safety Information for Moderna COVID‑19 Vaccine

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AUTHORIZED USE

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

IMPORTANT SAFETY INFORMATION

Contraindications

Do not administer the Moderna COVID‑19 Vaccine to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID‑19 Vaccine.

Warnings and Precautions

  • Management of Acute Allergic Reactions: Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Moderna COVID‑19 Vaccine. Monitor Moderna COVID‑19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html)
  • Myocarditis and Pericarditis: Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 18 through 24 years of age. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).
  • Syncope (fainting): May occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.
  • Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to the Moderna COVID‑19 Vaccine.
  • Limitations of Vaccine Effectiveness: The Moderna COVID‑19 Vaccine may not protect all vaccine recipients.

Adverse Reactions

Adverse reactions reported in clinical trials following administration of the Moderna COVID‑19 Vaccine include pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, erythema at the injection site, and rash.

Anaphylaxis and other severe allergic reactions, myocarditis, pericarditis, and syncope have been reported following administration of the Moderna COVID‑19 Vaccine during mass vaccination outside of clinical trials.

Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Moderna COVID‑19 Vaccine.

Reporting Adverse Events and Vaccine Administration Errors

The vaccination provider is responsible for mandatory reporting of the following to the Vaccine Adverse Event Reporting System (VAERS):

  • vaccine administration errors whether or not associated with an adverse event
  • serious adverse events (irrespective of attribution to vaccination)
  • cases of Multisystem Inflammatory Syndrome (MIS) in adults
  • cases of COVID‑19 that result in hospitalization or death

Complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS, call 1-800-822-7967. Reports should include the words “Moderna COVID‑19 Vaccine EUA” in the description section of the report.

Report to ModernaTX, Inc. by calling 1-866-MODERNA (1-866-663-3762) or provide a copy of the VAERS form by faxing 1-866-599-1342 or emailing .

For more information, see the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information at https://www.modernatx.com/covid19vaccine-eua/eua-fact-sheet-providers.pdf.

For information regarding SPIKEVAX, see SPIKEVAX Full Prescribing Information at https://www.modernatx.com/covid19vaccine-eua/spikevax-prescribing-information.pdf.

[DESCRIPTION]

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

[SPEECH]

Visit ModernaTX.com to learn more about mRNA technology.

[DESCRIPTION]

Job code is displayed on screen:

US-COV-2200038 02/2022

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