AstraZeneca’s Supplemental Biologics License Application (sBLA) for the approval of a self- or caregiver-administered option for Flumist Quadrivalent, a nasal spray, has been accepted for review by the US Food and Drug Administration for the non-elderly
If approved, Flumist will be the such vaccine available to be self-administered by eligible patients or administered by caregivers, adding an additional option to be vaccinated against influenza.
The applicatio is supported by a usability study which confirmed that individuals over 18 years of age or a caregiver could self-administer the spray for those ages two to 49.
A decision is possible in the first quarter of 2024 and if approved would be available for next year’s flu season.
Iskra Reic, executive vice president, Vaccines and Immune Therapies at AstraZeneca, said: “For more than 20 years, Flumist Quadrivalenthas served as a critical public health tool as the only intranasal flu vaccine providing protection to communities around the world. Flumist Quadrivalent now has the potential to be the first and only self-administered flu vaccine, which could revolutionize flu vaccination. Our ambition is for Flumist Quadrivalentto be ordered directly to people’s homes, providing an innovative, more accessible option for individuals, families and communities.”
Influenza (flu) is a contagious respiratory illness caused by the influenza virus, which can cause serious complications to some groups, such as people 65 years and older, young children, and people with certain health conditions.
The FDA has determined that older adults need a different type of flu vaccine than the Flumist Quadrivalent formula.
AstraZeneca has headquarters, manufacturing and logistics sites in northern Delaware.
