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(Alliance News) - AstraZeneca PLC on Tuesday said the US health watchdog has approved a review for its FluMist Quadrivalent self-administered flu vaccine, for which the drugmaker is seeking a green light.
The US Food & Drug Administration has accepted the drugmaker's supplemental biologics licence application for the needle-free nasal spray. It expects a regulatory decision on the product during the first quarter of 2024. If approved then, FluMist is expected to be available in the US for the 2024/2025 flu season.
If the product is reviewed, it will be the first flu vaccine available to be self-administered, "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 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," AstraZeneca explained.
AstraZeneca shares rose 1.3% to 10,226.00 pence each in London on Tuesday morning.
By Eric Cunha, Alliance News news editor
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