AstraZeneca Korea said that the Ministry of Food and Drug Safety has approved its FluMist Intranasal Spray, a needle-free influenza vaccine.

FluMist is the world’s first and only intranasal influenza vaccine. It is indicated for the prevention of influenza caused by influenza A and B virus strains contained in the vaccine, and is approved for use in healthy children and adults from 24 months to 49 years of age.

The age range was set as clinical trials have found that FluMist is less effective at preventing influenza in adults aged 50 and older than in younger individuals.

Notably, one study involving participants aged 50 to 64 failed to show adequate protection against febrile illness, which ultimately led to the vaccine not being approved for this age group.

According to the company, children aged 24 months to 8 years with no prior flu vaccination history should receive two doses of 0.2 mL (0.1 mL per nostril) at least one month apart. Those with a previous flu vaccination history and individuals aged 9 to 49 require a single dose of 0.2 mL.

Unlike traditional inactivated influenza vaccines, FluMist is a live attenuated vaccine administered directly through the nose.

This enables the vaccine to trigger a strong mucosal and cellular immune response, more closely mimicking natural infection and potentially offering broader protection. Research shows the vaccine is particularly effective in pediatric populations, with evidence of cross-reactivity even to antigenically drifted virus strains.

FluMist also stands out for its ease of administration and favorable safety profile. The vaccine is sprayed once into each nostril and does not require needles, making it a more comfortable option for children and needle-averse individuals.

Since its first approval as a trivalent vaccine in the U.S. in 2003, FluMist has been used in over 20 countries for more than two decades and is often recommended as the first-line choice for children aged two and older.

Real-world data support the vaccine’s efficacy.

A U.K. study during the 2015–2016 influenza season showed that FluMist had an adjusted vaccine effectiveness of 41.9 percent in preventing flu-related illness and hospitalization in children aged two to 16, compared to 28.8 percent for inactivated vaccines.

In the 2022–2023 season, FluMist demonstrated a vaccine effectiveness of 64 percent in children aged two to 17, closely matching that of cell-based quadrivalent vaccines of 72 percent.

“FluMist’s approval in Korea introduces a novel, needle-free option for flu prevention,” AstraZeneca Korea Biopharmaceuticals Business Unit Director Kim Ji-young said. “We believe it will provide a more comfortable vaccination experience, especially for children and adolescents who may fear needles, ultimately helping to boost flu vaccination rates and public health.”