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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.