EUA Fact Sheet Update for Moderna COVID-19 Vaccine - Educational Resource for 6 Months – 5 Years

This article is to inform you of updates to the EUA Fact Sheets and Full EUA Prescribing Information for the Moderna COVID-19 Vaccine.

Attached to this email is an educational resource specific to the Moderna COVID-19 Vaccine indication for children 6 months – 5 years of age for your use as a vaccination provider. 

 

For more information, please see the Moderna COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccine Providers) and Full Prescribing Information.

 

Moderna Call Center

The Moderna Call Center is available from 8am to 8pm EST, Monday through Friday, and can be reached at 1-866-MODERNA (1-866-663-3762).

 

AUTHORIZED USE

 

• 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) in either individuals 6 months of age and older or as a booster dose in individuals 18 years of age and older, as appropriate.

 

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

 

 

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 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 for individuals 6 years of age and older following administration of the Moderna COVID-19 Vaccine include pain at the injection site, fatigue, headache, myalgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, erythema at the injection site, swelling at the injection site, and arthralgia.

 

Adverse reactions in children 6 months through 5 years of age following administration of Moderna COVID-19 Vaccine include pain at the injection site, irritability/crying, fatigue, sleepiness, loss of appetite, headache, fever, myalgia, chills, nausea/vomiting, axillary (or groin) swelling/tenderness, arthralgia, erythema at the injection site, and swelling at the injection site.

 

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)
• cases of COVID-19 that result in hospitalization or death

 

Complete and submit reports to VAERS online athttps://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 emailingModernaPV@modernatx.com.

 

Please see the Moderna COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccine Providers) and Full Prescribing Information for:

• Booster dose for 18+ years
• Primary series for 12+ and Booster dose 18+ years
• Primary series for 6 - 11 years
• Primary series for 6 months - 5 years

 

Respectfully,

 

Jennifer Clarke

Regional Account Manager

Mobile (916)719-4740

 

Dosing Administration pdf

Storage and Handling pdf

Prescribing Info pdf