AstraZeneca Korea's nasal spray, four-valent influenza vaccine 'FluMist' is set to launch domestically in the second half of the year, and new competition is expected.

According to industry sources, AstraZeneca Korea is preparing to introduce FluMist for the 2025–2026 influenza vaccination season.

FluMist is a live‐attenuated, four-valent influenza vaccine administered via nasal spray.

This drug was approved by the Ministry of Food and Drug Safety (MFDS) on May 22 last year and is indicated for the prevention of influenza in children and adolescents aged 24 months to 17 years, and in adults up to 49 years of age.

FluMist was first approved by the U.S. Food and Drug Administration (FDA) in 2003 and its indication was expanded to four-valent vaccine in 2012.

Notably, in September of last year, it became the first self‐administered influenza vaccine approved by the FDA. Globally, FluMist recorded sales of KRW 252.7 billion (USD 175 million) in 2023.

In South Korea, GC launched FluMist in 2009 after acquiring it from MedImmune but discontinued sales in 2014 after underperforming.

At that time, it was introduced as a three-valent formulation. Thus, a nasal spray-type influenza vaccine will be launched approximately ten years later as a four-valent formulation.

Furthermore, it is also the first influenza vaccine to be launched in South Korea by AstraZeneca. The company has reportedly begun preparations for launch, including hiring dedicated staff.

In a recent organizational restructuring, AstraZeneca Korea consolidated all its product lines, excluding oncology and rare diseases, into a single division where it will be responsible for the influenza vaccine business.

Once FluMist is introduced domestically in the second half of the year, it will provide a new option in a market dominated by injectable vaccines.

The Korean market for influenza vaccination includes domestic and foreign manufacturers designated in the National Immunization Program (NIP). Currently, available vaccines are all injectable formulations.

The introduction of a nasal spray delivery method is expected to be particularly attractive for children and adolescents who fear needles.

According to the Korea Disease Control and Prevention Agency (KDCA), the pediatric influenza vaccination rate in 2024 is approximately 60%, lower than the adult rate (over 80%), with needle phobia identified as a significant barrier. FluMist's nasal delivery could help overcome this.

However, several constraints, notably price, remain before FluMist can gain significant market traction.

In North America, FluMist is priced about 20–30% higher than injectable vaccines, suggesting it may also be positioned as a premium product in Korea.

A further hurdle is that FluMist's primary target population, children and adolescents, is already covered by free NIP vaccinations. There may be little incentive to choose a paid nasal spray alternative.

Additionally, the storage and administration requirements for a nasal spray differ from those for injectables, posing an adaptation challenge for healthcare institutions. As a result, some industry observers expect FluMist to be adopted initially by large tertiary hospitals.

A vaccine industry employee said, "A nasal spray influenza vaccine can offer an alternative for those with needle phobia, but factors such as price, consumer perception, and competition remain variables. We expect AstraZeneca Korea to monitor the market closely before finalizing its marketing strategy."