AstraZeneca's sBLA for Self-Administered FluMist Quadrivalent Nasal Spray Vaccine Accepted by FDA

▎WuXi

Edited by Kant Content Team

Recently, AstraZeneca's supplemental Biologics License Application (sBLA) for the needle-free nasal spray FluMist Quadrivalent (live attenuated influenza vaccine, nasal spray) has been accepted by the U.S. FDA. The sBLA seeks FDA approval for FluMist Quadrivalent to be self-administered by patients or administered by caregivers.If approved, FluMist Quadrivalent will become the first influenza vaccine that can be self-administered by eligible patients or administered by caregivers, adding a new option for influenza vaccination.

Influenza is a contagious respiratory disease caused by the influenza virus, which can lead to severe complications in certain populations, such as people aged 65 and over, young children, and individuals with certain health conditions.

FluMist Quadrivalent is a live attenuated vaccine administered as a nasal spray to prevent influenza.The vaccine contains four screened attenuated influenza virus strains, which are able to replicate on the nasal mucosa, causing a minor infection. This infection stimulates both mucosal and systemic immune responses.The vaccine was first approved in the United States in 2003 for use in children and adults aged 2 to 49. The approval of this vaccine provided an important precedent for the development of nasal spray vaccines, demonstrating that mucosal immune responses can be protective. This vaccine is also one of the influenza vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP).

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This sBLA was supported by an usability study, which confirmed,Individuals aged 18 and above can self-administer FluMist Quadrivalent without any additional instructions, or administer it to eligible patients aged 2-49. There is substantial data indicating that the efficacy and safety of FluMist Quadrivalent are comparable to other influenza vaccines.

FluMist Quadrivalent is currently under review by the U.S. FDA, with a PDUFA date in the first quarter of 2024. If approved at that time, FluMist Quadrivalent is expected to be available for self-administration by patients in the U.S. during the 2024 or 2025 flu season.

References:

[1] US Food and Drug Administration accepts for review AstraZeneca’s Supplemental Biologics License Application for self-administration of FLUMIST® QUADRIVALENT (Influenza Vaccine Live, Intranasal). Retrieved October 25, 2023, from https://www.businesswire.com/news/home/20231024664223/en