FDA Reviews AstraZeneca's Self-administered FluMist Quadrivalent
AstraZeneca announced on Tuesday that the U.S. Food and Drug Administration (FDA) has officially accepted their application for review. The application pertains to the approval of their nasal flu vaccine for administration by patients or caregivers, as reported by Reuters.
The vaccine named FluMist Quadrivalent could potentially be the first self-administered flu vaccine. FluMist was originally granted FDA approval in 2003, the report stated.
The company foresees the FDA reaching a decision on the vaccine in the first quarter of 2024. They also anticipate that, upon approval, the vaccine will be available for self-administration in the United States during the 2024-2025 flu season.
This supplementary application is founded on data obtained from a usability study, which confirmed that individuals aged 18 and above can successfully self-administer FluMist to eligible patients aged 2-49 when following provided instructions, without requiring additional guidance, as reported by AstraZeneca, Reuters reported.
