FluMist Receives Approval for Self-Administration in the US

FluMist has become the first self-administered influenza vaccine approved in the US. This needle-free nasal spray can now be self-administered by adults up to 49 years old or given by a parent or caregiver to children aged 2-17.

The US Food and Drug Administration (FDA) granted approval based on a comprehensive submission that included results from a usability study. This study demonstrated that adults over 18 could successfully administer FluMist to themselves or to eligible individuals aged 2-49.

Dr. Ravi Jhaveri, Division Head of Infectious Disease at Northwestern University’s School of Medicine, stated: “For the first time, families and caregivers can protect themselves against the flu with a needle-free, self-administered vaccine from the convenience of home. Each year, influenza poses a major burden on people, society, and healthcare systems. Increasing access to vaccinations while reducing disparities is critical.”

Iskra Reic, Executive Vice President of Vaccines and Immune Therapies at AstraZeneca, added: “FluMist’s approval for self-administration is a significant step toward making vaccines more accessible. For over 20 years, FluMist has been the only nasal spray flu vaccine licensed in the US, and now it’s the only one that allows for self-administration outside of traditional healthcare settings, making it more convenient for individuals, families, and communities.”

Each year, seasonal influenza causes up to 1 billion infections worldwide, with 3-5 million severe cases, often leading to hospitalization or death. The flu also impacts school attendance and employment, causing 47% of school absences and 1-2 missed workdays annually. In the US, adult flu vaccination rates have declined by 3.3% since the 2020-2021 season. One common reason for not receiving a flu shot is the lack of regular well-care visits, but at-home vaccination options like FluMist may help boost vaccination rates.

Once available, adults 18 and older will be able to order FluMist directly to their homes through FluMist Home. Using an online pharmacy, eligible individuals can complete a questionnaire, which will be reviewed by a pharmacist before the vaccine is shipped. FluMist will also remain available at healthcare facilities and pharmacies for professional administration.

Each flu season, an average of 8% of the US population contracts influenza, with seasonal variations ranging between 3% and 11%. During the 2022-2023 flu season, approximately 31 million people fell ill from the virus, 14 million sought medical care, and there were 360,000 hospitalizations. Tragically, the season also saw 21,000 deaths attributed to influenza.

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