AstraZeneca said on Tuesday the U.S. Food and Drug Administration (FDA) has accepted for review the company's application seeking approval for patients or caregivers to administer its nasal flu vaccine.
If approved, the vaccine – branded as FluMist Quadrivalent – could become the first self-administered flu vaccine which does not necessitate a healthcare practitioner for administration.
FluMist was first approved by the FDA in 2003.
The company said it expects the FDA to decide on the vaccine by the first quarter of 2024, adding that it expects the vaccine to be made available for self-administration in the United States during the 2024-2025 flu season, if approved.
The supplemental application is based on data from a usability study which 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, AstraZeneca said.