AstraZeneca sBLA for Flumist Quadrivalent accepted for review by FDA

AstraZeneca’s supplemental biologics license application, or sBLA, for the approval of a self- or caregiver-administered option for Flumist Quadrivalent, a needle-free nasal spray, has been accepted for review by the FDA. If approved, Flumist Quadrivalent will be the first flu vaccine available to be self-administered by eligible patients or administered by caregivers, adding an additional option to be vaccinated against influenza. The sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer or administer Flumist Quadrivalent to eligible patients 2-49 years of age when given instructions for use without any additional guidance. Flumist Quadrivalent, which is sprayed into the nose, has extensive data demonstrating comparable effectiveness and acceptable safety relative to other flu vaccines. The Prescription Drug User Fee Act date is expected during the first quarter of 2024. If approved at that time, Flumist Quadrivalent is anticipated to be available for self-administration in the US for the 2024/2025 flu season.