On Sept. 20, 2024, the U.S. Food and Drug Administration approved FluMist for self- or caregiver-administration. FluMist is approved for the prevention of influenza disease caused by influenza virus subtypes A and B in individuals 2 through 49 years of age.

FluMist is sprayed into the nose and has been used safely and effectively for many years. It was initially approved by the FDA in 2003 for use in individuals 5 through 49 years of age, and in 2007, the FDA approved the use of FluMist to include children 2 through 5 years of age.

It was the first vaccine to prevent influenza, more commonly known as the flu, that does not need to be administered by a health care provider.