FDA accepts for review AstraZeneca’s Supplemental Biologics License Application for self-administration of FluMist Quadrivalent
On Oct. 24, AstraZeneca announced via a press release that its Supplemental Biologics License Application (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 US Food and Drug Administration (FDA). According to the press release, that would make FluMist the first flu vaccine that is available to be self-administered by eligible patients or caregivers.
The press release states, “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.”
Further, “The Prescription Drug User Fee Act (PDUFA) date, the FDA’s date for a regulatory decision, is expected during the first quarter of 2024. If approved at that time, FluMist is anticipated to be available for self-administration in the US for the 2024/2025 flu season.”
Ravi Jhaveri, MD, division head, Infectious Disease; Virginia H. Rogers Professor in Infectious Diseases, professor of Pediatrics (Infectious Diseases), Northwestern University School of Medicine, Chicago was quoted in the release saying that “A self-administered option for FluMist Quadrivalent would leverage the unique attributes of the product, providing a convenient new choice for individuals and families who want to protect their loved ones against flu. Vaccination rates for children and adults under 50 years of age declined in the 2022-2023 flu season, highlighting a need for more accessible solutions. The ability for individuals and parents to choose where to administer an injection-free flu vaccine could help increase access and, subsequently, vaccination rates, and greatly benefit those most impacted by this serious and contagious respiratory illness.”
AstraZeneca has the press release.
