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# FDA Accepts sBLA for Self-Administered FluMist
- URL: https://www.fdaweb.com/fda-accepts-sbla-for-self-administered-flumist/
- Published: 2023-10-24T12:00:00.000Z
- Updated: 2026-09-14T14:14:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155631

FDA has accepted for review an AstraZeneca supplemental BLA that seeks approval for a self- or caregiver-administered option for FluMist Quadrivalent*,* a needle-free nasal spray. The submission is based on data from a usability study that the company says “confirmed that individuals over 18 years of age could self-administer or administer FluMist to eligible patients 2-49 years of age when given instructions for use without any additional guidance. FluMist, which is sprayed into the nose, has extensive data demonstrating comparable effectiveness and acceptable safety relative to other flu vaccines.” The agency is expected to provide its review action in the first quarter of next year.

AstraZeneca says that a FluMist self-administered option would provide a convenient new choice for individuals and families who want to protect their loved ones against flu. “Vaccination rates for children and adults under 50 years of age declined in the 2022-2023 flu season, highlighting a need for more accessible solutions,” it notes.