US FDA Nods AstraZeneca's Nasal Spray for Self Administration

AstraZeneca, a worldwide biopharmaceutical company focused on science, declared that FluMist is now the sole self-administered flu vaccine approved in the United States. FluMist, a nasal spray without needles, was authorized for self-administration by adults under 49 years old or for administration by a parent/caregiver to those between 2-17 years old.

The FDA approval was made on a detailed submission, which included findings from a study on usability showing that adults could give themselves or their children aged 2-49 FluMist.

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.”