The FDA has amended the Emergency Use Authorizations (EUAs) for both Moderna and Janssen/Johnson & Johnson (J&J) to allow for a single booster doses for both COVID-19 vaccine products.
The Moderna COVID-19 vaccine is authorized for booster dose administration at least six months after completion of primary series for individuals:
- 65 years of age and older
- 18 through 64 years of age at high risk of severe COVID-19
- 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
The use of a single Janssen/J&J booster dose is authorized for administration at least two months following completion of the primary dose for individuals age 18 years and older.
The EUA amendments also allow for use of any of the available COVID-19 vaccines as a booster dose in heterologous or mix-and-match administration.
The CDC Advisory Committee on Immunization Practices (ACIP) voted unanimously to endorse the booster dose recommendations for Moderna and Janssen/J&J COVID-19 vaccines and will issue additional clinical guidance recommendations to aid in appropriate dosing and administration.
Additional details on the most recent FDA authorizations are available in the FDA News Release.IMS will share the updated clinical guidance recommendations as soon as they become available.