AstraZeneca’s sBLA for FluMist Quadrivalent accepted by FDA
Betsy Goodfellow | October 24, 2023 | News story | Medical Communications | AstraZeneca, FDA, FluMist, Immunology, flu vaccine, sBLA
AstraZeneca has announced that the US Food and Drug Administration (FDA) has accepted for review its Supplemental Biologics License Agreement (sBLA) for the approval of a self- or caregiver-administered option for FluMist Quadrivalent, a needle-free nasal spray flu vaccine.
The sBLA follows a usability study which demonstrated that patients over the age of 18 were able to administer or self-administer the vaccine to eligible patients between two and 49 years of age when given sufficient instructions and without any additional guidance. FluMist already has significant data which proves comparable effectiveness and safety relative to existing flu vaccines.
The FDA is expected to set a Prescription Drug User Fee Act (PDUFA) date during the first quarter of 2024, meaning FluMist will be available for self-administration in the US during the 2024/2025 flu season, depending on its approval by the FDA.
Iskra Reic, executive vice president of Vaccines and Immune Therapies at AstraZeneca, commented: “For more than 20 years, FluMist Quadrivalent has served as a critical public health tool as the only intranasal flu vaccine providing protection to communities around the world. FluMist now has the potential to be the first and only self-administered flu vaccine, which could revolutionise flu vaccination. Our ambition is for FluMist to be ordered directly to people’s homes, providing an innovative, more accessible option for individuals, families and communities.”
Betsy Goodfellow
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