AstraZeneca’s FluMist Influenza Vaccine FDA Approved for Self-Administration
In a landmark approval, the U.S. Food and Drug Administration (FDA) has cleared AstraZeneca’s FluMist, the only influenza vaccine that can now be self-administered at home in the U.S. FluMist, a needle-free nasal spray, is available for self-administration by adults aged 18 to 49 or by caregivers for children aged 2 to 17. This approval represents a significant advancement in making influenza prevention more accessible and convenient.
FluMist is a live attenuated influenza vaccine (LAIV) delivered via nasal spray to prevent the flu. It is recommended as an influenza vaccination option by both the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP). First approved in the U.S. in 2003, FluMist has seen nearly 200 million doses distributed globally since its launch. With the latest FDA approval for self-administration, the FluMist label has been revised to include new instructions for ordering and administering the vaccine, either by oneself or a caregiver.
The FDA’s decision was based on extensive data, including a usability study showing that adults could safely and effectively self-administer FluMist or administer it to eligible individuals within the approved age range. With seasonal influenza infecting up to 1 billion people worldwide annually and causing severe illness in 3 to 5 million cases, expanding access to flu vaccines is critical for public health. Influenza complications can result in hospitalization, missed work and school days, and even death.
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.”
Recent U.S. influenza vaccination rates have dropped, particularly among adults, declining by 3.3% since the 2020–2021 flu season. A survey identified missed healthcare appointments as a major reason adults forgo vaccination. FluMist’s home-administration approval aims to address this gap, as studies suggest that at-home vaccination options could boost vaccination rates, reducing flu-related illnesses and work disruptions.
Once FluMist Home becomes available, eligible individuals aged 18 and older will be able to order the vaccine through an online pharmacy. After completing a questionnaire reviewed by a licensed pharmacist, the vaccine will be shipped directly to the individual’s home for self-administration. FluMist will also remain available in healthcare settings for professional administration.
FluMist’s approval provides a new, accessible option in the fight against seasonal flu, especially for those who face barriers in visiting traditional vaccination sites. More information on the availability of FluMist and its administration process can be found at FluMist.com.
Original Source: Press Release – AstraZeneca
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