AstraZeneca FluMist gets USFDA nod for self-administered influenza vaccine

The approval by the US Food and Drug Administration (FDA) was based on a comprehensive submission, which included results from a usability study demonstrating that individuals over 18 years of age could self-administer or administer FluMist to eligible individuals 2-49 years of age.

Ravi Jhaveri, MD, Division Head, Infectious Disease; Virginia H. Rogers Professor in Infectious Diseases, Professor of Pediatrics (Infectious Diseases), Northwestern University School of Medicine, Chicago, US, said, "For the first time, families and caregivers will be able to protect themselves against influenza with a needle-free, self-administered vaccine, from the convenience of their own home. Each year, influenza poses a significant burden for people, society and health systems; additional tools to increase access to vaccinations, while also reducing disparities, are critical."

Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca, said, “The approval of FluMist for self-administration is an important step forward in making vaccines more accessible to fight the high annual burden of influenza. For more than 20 years, FluMist has been the only nasal spray flu vaccine licensed in the US and now it is also the only vaccine to help individuals, families and communities access an influenza vaccine conveniently through self- and caregiver administration outside of traditional healthcare settings.”

Seasonal influenza causes up to 1 billion infections each year and may result in severe outcomes for about 3-5 million patients including hospitalisations, complications and death. Influenza has been shown to impact school attendance and employment with 47% of days of school and 1-2 days of work missed annually. Vaccination rates for influenza have declined in adults in the US since the 2020–21 season by 3.3%. In a US survey, a common reason for adults not to receive a vaccination included failure to attend regular well-care visits, while having access to at-home vaccination options were shown to potentially increase influenza vaccination uptake.

"Once available, individuals 18 and older will be able to have FluMist delivered directly to their homes via FluMist Home. FluMist Home will utilise an online pharmacy where eligible individuals complete a questionnaire that is reviewed by a pharmacist prior to receiving their vaccine for shipment. FluMist will continue to be available in offices and pharmacies for administration by healthcare professionals," the Company stated in a release.

Fasenra (benralizumab) is currently approved in more than 80 countries, including the US, EU, Japan and China. Fasenra has been prescribed to over 130,000 patients globally.

Fasenra is in development for other diseases including chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps and hypereosinophilic syndrome.

Fasenra was developed by AstraZeneca and is in-licensed from BioWa, Inc., a wholly owned subsidiary of Kyowa Kirin Co., Ltd., Japan.

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