EUA Label Update for Moderna COVID-19 Vaccine – Authorized Use for Booster Dose

Moderna

EUA Label Update for Moderna COVID-19 Vaccine – Authorized Use for Booster Dose 

Please note: This webinar series has ended. Contact Heather Hensler (Heather.Hensler@modernatx.com) for more info.

Join Moderna for a webinar for vaccination providers to learn more about the Moderna COVID-19 Vaccine booster dose, which has been authorized for emergency use in the United States. There will be no continuing education offered for this webinar. Please register at the link below for one of our available sessions. 

Webinar: Important updates on the mRNA-1273 50 µg Booster Dose 

  • NJ: Dec 7th @ 8:30 AM EST
  • CA: Dec 7th @ 3:00 PM PST
  • PA: Dec 8th @ 8:00 AM EST
  • NY: Dec 8th @ 12:00 PM EST
  • VA: Dec 8th @ 2:00 PM EST
  • IL: Dec 8th @ 12:00 PM CST
  • OH: Dec 9th @ 11:00 AM CST
  • TX: Dec 9th @ 12:00 PM CST
  • TX: Dec 9th @ 6:00 PM CST
  • CA: Dec 9th @ 4:00 PM PST
  • NC: Dec 9th @ 3:00 PM EST
  • FL: Dec 10th @ 8:00 AM EST
  • FL: Dec 10th @ 2:00 PM EST
  • National: Dec 14th @ 11:00 AM PST
  • National: Dec 15th @ 3:00 PM EST
  • National: Dec 16th @ 12:00 PM EST
  • National: Dec 17th @ 12:00 PM PST

Please note: Registration for each event closes 1 hour before the listed start time.

EUA Information

The Moderna COVID-19 Vaccine has not been approved or licensed by the U.S. 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. 

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.

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

Moderna COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. Moderna COVID-19 Vaccine is investigational and not approved by FDA.

IMPORTANT SAFETY INFORMATION

Contraindications

Do not administer the Moderna COVID-19 Vaccine to individuals with a known history of 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 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 ModernaPV@modernatx.com.

Pregnancy and Lactation

Available data on Moderna COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. Data are not available to assess the effects of Moderna COVID-19 Vaccine on the breastfed infant or on milk production/excretion.

For more information please see Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information, EUA Letter of Authorization and Dear HCP Letter.

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