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FDA EUA Letter
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Moderna COVID-19 Vaccine

Moderna COVID-19 Vaccine

EUA Fact Sheets for Vaccine Providers

Bivalent Booster Dose 18+ years
Primary Series for
12+ years
Primary Series
for 6-11 years
Primary Series for
6 months-5 years

EUA Fact Sheets for Vaccine Recipients

For 12+ years of age (primary series) and 18+ (bivalent booster)
For 6-11 years of age
For 6 months-5 years of age

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Introducing Moderna COVID-19 Vaccine, Bivalent

The updated mRNA vaccine from Moderna that can help provide protection against today's COVID-19 variants.

The Emergency Use Authorization (EUA) Fact Sheets for Vaccination Providers have updates related to age group, vial presentation, and dosing. See below for details.

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). The Moderna COVID-19 Vaccine is authorized in individuals 6 months of age and older as a primary series. The Moderna COVID-19 Vaccine, Bivalent is authorized as a booster dose in individuals 18 years of age and older.
The EUA for these products 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 Sheets for Healthcare Providers Administering Vaccine (Vaccine Providers) and Full Prescribing Information.

EUA Fact Sheet and full PI for Vaccination Providers, Bivalent Booster Dose 18+

Download the Bivalent Booster Guide Dear HCP Letter for Bivalent Booster Doses for ages 18+