On April 18, 2023, the Food and Drug Administration amended the emergency use authorization (EUA) of Moderna COVID-19 Vaccine, Bivalent to simplify the vaccination schedule for most individuals. This action includes authorizing the current bivalent vaccine (Original and Omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older. The monovalent Moderna COVID-19 Vaccine is no longer authorized for use in the United States.

Moderna COVID-19 Vaccine, Bivalent is now authorized for use as follows:

Individuals 6 months through 5 years of age:

• Unvaccinated individuals:  Two doses of Moderna COVID-19 Vaccine, Bivalent are administered. The second dose is administered 1 month after the first.
• Individuals who have received one dose of Moderna COVID-19 Vaccine: A single dose of Moderna COVID-19 Vaccine, Bivalent is administered 1 month after the dose of Moderna COVID-19 Vaccine.
• Individuals who have received two doses of Moderna COVID-19 Vaccine: A single dose of Moderna COVID-19 Vaccine, Bivalent is administered at least 2 months after the last dose of Moderna COVID-19 Vaccine.

Individuals 6 years of age and older:

• Unvaccinated individuals: A single dose of Moderna COVID-19 Vaccine, Bivalent.
• Individuals who have received one or more doses of a monovalent COVID-19 vaccine: A single dose of Moderna COVID-19 Vaccine, Bivalent is administered at least 2 months after any monovalent COVID-19 vaccine.
• Individuals 65 years of age and older who have received one dose of a bivalent COVID-19 vaccine:  A dose of Moderna COVID-19 Vaccine, Bivalent may be administered at least 4 months after the dose of the bivalent COVID-19 vaccine.

Immunocompromised individuals 6 months of age and older:

• For immunocompromised individuals 6 months through 5 years of age who have received two doses (Moderna COVID-19 Vaccine or Moderna COVID-19 Vaccine, Bivalent), a single additional dose of Moderna COVID-19 Vaccine, Bivalent may be administered at least 1 month following the most recent dose of Moderna COVID-19 Vaccine, Bivalent; additional doses of Moderna COVID-19 Vaccine, Bivalent may be administered at the discretion of the healthcare provider, taking into consideration the individual’s clinical circumstances.
• For immunocompromised individuals 6 years of age and older, a single additional age-appropriate dose of Moderna COVID-19 Vaccine, Bivalent may be administered at least 2 months following the initial dose of a bivalent COVID-19 vaccine; additional age-appropriate doses of Moderna COVID-19 Vaccine, Bivalent may be administered at the discretion of the healthcare provider, taking into consideration the individual’s clinical circumstances.

Moderna COVID-19 Vaccine Fact Sheets and Materials

Moderna COVID-19 Vaccine Regulatory Information (Emergency Use Authorization)

Federal Register Notices

Translations of the Fact Sheet for Recipients and Caregivers