Moderna, Inc. invites you to their event

MSL Briefings: Understanding the Updated Moderna COVID-19 Vaccine (2023-2024 Formulation)

About this event

Over the next few weeks, Moderna MSLs will host several virtual briefings to review details about the Moderna COVID-19 Vaccine (2023–2024 Formulation), including:

  • ACIP recommendations
  • Dosing and administration
  • Storage and handling
  • Safety and efficacy data

Briefings will be 15-minute presentations, followed by a live Q&A.


· Moderna COVID-19 Vaccine (2023-2024 Formula) has not been approved or licensed by the FDA, but has been authorized by the FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 6 months through 11 years of age.

· The EUA for this product 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 Sheet for Healthcare Providers Administering Vaccine.



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

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 vaccine. Monitor vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (

· Myocarditis and Pericarditis: Postmarketing data with authorized or approved mRNA COVID-19 vaccines demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following vaccination. 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 (

· 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 Moderna COVID-19 Vaccine.

· Limitations of Vaccine Effectiveness: The Moderna COVID-19 Vaccine may not protect all vaccine recipients.

Adverse Reactions

Solicited adverse reactions included:

· 6 months through 36 months of age: Injection site erythema, pain and swelling; axillary (or groin) swelling/tenderness, fever, irritability/crying, loss of appetite and sleepiness

· 37 months of age and older: Injection site erythema, pain and swelling; arthralgia, axillary (or groin) swelling/tenderness, chills, fatigue, fever, headache, myalgia, nausea/vomiting, and rash

Reporting Adverse Events and Vaccine Administration Errors

Vaccination providers must report the listed events following administration of the Moderna COVID-19 Vaccine (2023-2024 Formula) 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 myocarditis

· cases of pericarditis

· cases of Multisystem Inflammatory Syndrome (MIS)

· cases of COVID-19 that result in hospitalization or death

Complete and submit reports to VAERS online at For further assistance with reporting to VAERS, call 1-800-822-7967. Reports should include the words “Moderna COVID-19 Vaccine (2023-2024 Formula) EUA” in the description section of the report.

In addition, you can report side effects to ModernaTX, Inc. at 1-866-MODERNA (1-866-663-3762) or by visiting

Please see the accompanying Moderna COVID-19 Vaccine (2023-2024 Formula) Fact Sheet for Healthcare Providers Administering Vaccine and Letter of Authorization for more information.

MED-US-mRNA1273.815-2300003 09/2023

Moderna, Inc.

Our mission is to deliver the greatest possible impact to people through mRNA medicines.