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FDA Approves the First Flu Vaccine for At Home Use, Providing a Needle Free Option Outside of Traditional Health Care Settings

October 10, 2024

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By: Nathan A. Brown, Marlee P. Gallant, Caroline D. Kessler, Olive Lee

On September 20, 2024, the U.S. Food and Drug Administration (FDA) approved the first influenza (flu) vaccine for at‑home use.

The vaccine, FluMist, is administered by nasal spray and prevents the flu by using a weakened form of live influenza virus strains A and B to create a lasting immune response. FluMist was initially approved by FDA in 2003 for individuals ages 5 to 49, and in 2007, FDA extended the approval of its use to children ages 2 to 5. Until recently, the vaccine could only be administered by medical providers at a doctor’s office or pharmacy. FDA expects that this new option for receiving a flu vaccine with potentially greater convenience and flexibility will increase access.

Under the new approval, FluMist may be self-administered by adults up to 49 years of age or administered by a caregiver for those between ages 2 through 17. A prescription is still required, however, for at‑home use. Beginning next fall, individuals 18 years and older will be able to order FluMist through a third‑party online pharmacy by visiting FluMist’s website and completing an eligibility assessment. If they are eligible, a pharmacist will approve their order, and the vaccine will be shipped to them.

The vaccine is expected to be available for at‑home use for the 2025‑26 flu season.

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