According to AstraZeneca, the FDA has accepted for review the company’s supplemental biologics license application (sBLA) for self-administration of FluMist Quadrivalent nasal spray vaccine against influenza. AstraZeneca says that it expects a PDUFA date in the first quarter of 2024, which would allow for self administration of FluMist for the 2024-25 flu season if the sBLA is approved.
FluMist Quadrivalent was initially approved by the FDA in 2012 for the prevention of flu in people aged 2-49. At that time, the agency approved MedImmune’s sBLA to add a fourth flu strain to FluMist, which previously included three strains.
AstraZeneca Executive VP, Vaccines and Immune Therapies, Iskra Reic 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 revolutionize 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.”
Read the AstraZeneca press release.
