FDA Reviews AstraZeneca’s Self-Administered Flu Vaccine, FluMist

October 25, 2023 - In a landmark development in the world of healthcare, AstraZeneca's FluMist Quadrivalent is set to revolutionize flu vaccination by potentially becoming the first and only self-administered flu vaccine, awaiting approval from the United States Food and Drug Administration (FDA).

The FDA has accepted AstraZeneca's Supplemental Biologics License Application (sBLA) for FluMist Quadrivalent's self-administration option. If approved, FluMist will become the inaugural flu vaccine that can be self-administered by eligible patients or administered by caregivers, thereby expanding the choices available for influenza vaccination.

The sBLA submission is substantiated by a usability study that unequivocally demonstrated that individuals aged 18 and above could self-administer or administer FluMist to eligible patients aged 2–49 years without the need for additional guidance. This intranasal spray has extensive data supporting its efficacy and safety, establishing its standing alongside traditional flu vaccines.

The Prescription Drug User Fee Act (PDUFA) date for the regulatory decision is expected in the first quarter of 2024. If approved, FluMist is anticipated to be accessible for self-administration during the 2024–2025 flu season. This marks a pivotal moment in influenza vaccination, providing the general public with an innovative, accessible method to protect themselves and their loved ones against the flu.

Ravi Jhaveri, MD, Division Head of Infectious Disease at Northwestern University School of Medicine, emphasized the importance of a self-administered option for the flu vaccine. He stated, "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."

Iskra Reic, Executive Vice President of Vaccines and Immune Therapies at AstraZeneca, articulated the company's ambition: "For more than 20 years, FluMist Quadrivalent has served as a critical public health tool. Now, it has the potential to be the first and only self-administered flu vaccine, which could revolutionize flu vaccination. Our ambition is for FluMist Quadrivalent to be ordered directly to people’s homes, providing an innovative, more accessible option for individuals, families, and communities."