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Moderna COVID-19 Vaccine, Bivalent (BA.4/BA.5) EUA Professional ISI
· Moderna COVID-19 Vaccine, Bivalent 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). Moderna COVID-19 Vaccine, Bivalent is authorized for use in individuals 6 months through 5 years of age who were previously unvaccinated or vaccinated with one or two doses of Moderna COVID-19 Vaccine (no longer authorized). Moderna COVID-19 Vaccine, Bivalent is authorized for use in individuals 6 years of age and older who were previously unvaccinated or vaccinated with one or more doses of an approved or authorized monovalent COVID-19 vaccine at least 2 months after receipt of any monovalent COVID-19 vaccine. Certain additional uses are authorized for immunocompromised patients and patients 65 years and older.
· 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.
IMPORTANT SAFETY INFORMATION
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 (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 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 (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 Moderna COVID-19 Vaccine, Bivalent.
· Limitations of Vaccine Effectiveness: The Moderna COVID-19 Vaccine, Bivalent may not protect all vaccine recipients.
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
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 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 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, Bivalent 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 https://report.moderna.convergehealthsafety.com/.
Please see the attached Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) Fact Sheet for Healthcare Providers Administering Vaccine for more information.
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