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FDA Approves First At-Home Flu Vaccine, FluMist, Expanding Access for 2025-26 Season

• The FDA has approved FluMist, the first influenza vaccine for at-home use, administered as a nasal spray, for individuals aged 2-49 years. • This approval expands access to flu vaccination by allowing self-administration for adults up to 49 and caregiver administration for those aged 2-17 with a prescription. • Starting in the 2025-26 flu season, adults 18 and older can order FluMist online after completing an eligibility assessment, with pharmacist approval and direct shipment. • FluMist uses a weakened live influenza virus to stimulate a lasting immune response against influenza A and B strains, offering a needle-free alternative to traditional flu shots.

The U.S. Food and Drug Administration (FDA) has approved FluMist, the first influenza (flu) vaccine for at-home use, marking a significant step in expanding access to flu prevention. Approved on September 20, 2024, this nasal spray vaccine offers a needle-free option for individuals aged 2 to 49 years, potentially increasing vaccination rates and reducing the burden of seasonal influenza.

FluMist: A Needle-Free Alternative

FluMist utilizes a weakened form of live influenza virus strains A and B to stimulate a lasting immune response. Initially approved in 2003 for individuals aged 5 to 49, and later expanded to include children aged 2 to 5 in 2007, FluMist has been administered by medical providers in traditional healthcare settings. The new approval allows for self-administration by adults up to 49 years of age and administration by a caregiver for those between 2 and 17 years old.

Expanding Access Through At-Home Administration

The FDA anticipates that this convenient and flexible option will increase access to flu vaccination. Beginning in the 2025-26 flu season, individuals 18 years and older can order FluMist through a third-party online pharmacy via the FluMist website. After completing an eligibility assessment, a pharmacist will review and approve the order, and the vaccine will be shipped directly to the individual's home. A prescription is required for at-home use.

Impact on Public Health

Influenza remains a significant public health concern, causing substantial morbidity and mortality each year. The CDC estimates that influenza has resulted in between 9 million and 41 million illnesses and between 140,000 and 710,000 hospitalizations annually in the United States over the past decade. By offering a more accessible and convenient vaccination option, FluMist has the potential to significantly reduce the impact of seasonal influenza, particularly among populations with limited access to traditional healthcare services.
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[1]
FDA Approves the First Flu Vaccine for At Home Use, Providing a Needle Free Option ... - Akin Gump
akingump.com · Nov 8, 2024

FDA approved the first at-home flu vaccine, FluMist, on September 20, 2024. FluMist, a nasal spray, can be self-administ...

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