AstraZeneca's self-administered nasal flu vaccine gets one step closer to FDA approval

On the market for two decades, AstraZeneca’s nasal spray flu vaccine, FluMist, may become available for self-administration as soon as next year.

The FDA has accepted AZ’s supplemental biologics license application (sBLA) for self-administered FluMist Quadrivalent. The company expects a decision in the first quarter of next year and is making plans to launch the product in the 2024-2025 flu season.

The needle-free vaccine, already endorsed for patients ages 2 to 49, could be self-administered by people between the ages of 18 and 49. Adults could also administer FluMist to children ages 2 to 17. Healthcare practitioners are the only ones currently authorized to administer the spray.

Since it was approved by the FDA in 2003, FluMist has remained the lone nasal flu vaccine on the market. So why now after 20 years?

With the uptake of flu vaccines declining during the coronavirus pandemic, AZ saw an opportunity to attract potential users, Lisa Glasser, AZ’s head of U.S. medical affairs for vaccines and immune therapies, said in an interview.

“We viewed this as an opportunity to provide a convenient way for people to get access to flu vaccine,” Glasser said. “Indeed, the pandemic provided us with a lot of difficulties but also a lot of opportunities to realize people really can take care of themselves. They can test themselves for COVID, with a swab in their nose.”

If approved, the FluMist would become available through an online pharmacy request system. The vaccine would be shipped to homes in temperature-controlled packages.

Despite the CDC recommending seasonal flu vaccinations for everyone older than 6 months, less than half of the U.S. population complies. In rural areas, not even a third of adults were vaccinated in the 2021-2022 flu season.

AZ expects that the self-administered vaccine would gain users who currently receive flu shots and would be attracted to the convenience. The longer-range hope, Glasser said, is that it would also draw new people to flu vaccination and increase overall uptake.

Backing AZ’s application is a usability study that confirmed that people older than age 18 could administer the product without guidance when given instructions for use. In previous studies, FluMist has been shown to have comparable efficacy and safety profiles to other flu vaccines.

AZ has had a bumpy ride with sales of FluMist. They reached $288 million in 2015 before the CDC recommended against its use in the 2016-17 flu season. Sales bottomed out in 2017 at $78 million, as the company had difficulty making the product in bulk after the World Health Organization tweaked its guidelines for manufacturing flu vaccines.

The pandemic sparked a resurgence in sales, which reached $295 million in 2020. Last year, the company reported $175 million in revenue from FluMist, with $151 million coming in Europe.