FluMist Nasal Flu Vaccine Gets FDA Consideration for Self-Administration

FluMist Nasal Flu Vaccine Gets FDA Consideration for Self-Administration

AstraZeneca’s FluMist was approved in 2003 and remains the only intranasal spray vaccine option against influenza.

The US Food and Drug Administration (FDA) has accepted AstraZeneca’s supplemental biologics license application (sBLA) for a self-administered option of its nasal influenza vaccine FluMist Quadrivalent.

FluMist has been in the market since 2003 and is the only intranasal spray vaccine option against flu.

Currently, only healthcare practitioners are authorized to administer FluMist. If the FDA green lights the self-administration option, individuals two to 49 years of age could be self-administered FluMist by people between 18 and 49 years of age. Adults may also administer the vaccine to children between the ages of two and 17.

The FDA’s decision on AstraZeneca’s sBLA for FluMist is anticipated in the first quarter of next year. If the application is accepted, FluMist could be available for self-administration during the 2024 to 2025 flu season next year, making it the first and only self-administered flu vaccine.

The needle-free, live-attenuated vaccine is sprayed directly into the nose and previous studies have shown it to have comparable effectiveness and acceptable safety to other flu vaccines.

In the US, it is estimated that on average, eight percent of the population gets sick each season from the influenza virus that causes flu. Flu can cause serious complications in certain groups including young children, adults 65 years of age and older and individuals with certain health conditions.

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Children five to 17 years of age represent 39 percent of acute respiratory infection medical visits, even though they only make up about 22 percent of the US population, outlined AstraZeneca in the press release announcing the sBLA for FluMist. Influenza impacts work and school, as 47 percent of missed school days are due to flu and working caregivers miss one to two days of work to care for household members.

In the press release, AstraZeneca said the sBLA is backed by a usability study which confirmed that individuals over 18 years of age could self-administer or administer FluMist to eligible patients two to 49 years of age when given instructions for use without any additional guidance.

The US Centers for Disease Control and Prevention (CDC) recommends individuals six months of age and older get a seasonal flu vaccine every year. However, less than half of people in the US get a flu vaccine. During the 2021 to 2022 season, the CDC estimates that 50 percent to 74 percent of people in the US got vaccinated against flu.

The self-administered FluMist would offer convenience and flexibility to recipients, which would help promote its usage.

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Iskra Reic, executive vice president, Vaccines and Immune Therapies, AstraZeneca, said in the company’s press release that: “For more than 20 years, FluMist Quadrivalent has served as a critical public health tool as the only intranasal flu vaccine providing protection to communities around the world. FluMist now has the potential to be the first and only self-administered flu vaccine, which could revolutionize flu vaccination. Our ambition is for FluMist to be ordered directly to people’s homes, providing an innovative, more accessible option for individuals, families and communities.”

Dr. Ashish Jha, dean of the Brown School of Public Health and the former White House COVID-19 response coordinator, told CNN that a self-administered flu vaccine option could be even more accessible if it were available to buy on pharmacy shelves, rather than through a gatekeeper.

Moreover, he explained that ten to 15 percent of people may be needle-phobic and hesitant to get vaccines, and thus increasing ways to access a needle-free version could help boost uptake.

Despite being on the market for 20 years, AstraZeneca saw an opportunity to increase uptake of its vaccine amid declining flu vaccinations, especially during the COVID-19 pandemic.

“One of the things we’ve learned from the pandemic is that actually people can do things for themselves, they can take maybe more responsibility for their own health care in their own hands than perhaps we realized or even thought possible,” Lisa Glasser, AstraZeneca’s head of US Medical Affairs, Vaccines and Immune Therapies, said in an interview.

During the COVID-19 pandemic, Glasser explained, “we put nasal swab tests in people’s hands and they used them successfully.”

AstraZeneca anticipates that the ease and convenience of a self-administered FluMist could attract new users, helping increase overall uptake of the vaccine.

Sales of FluMist have been yo-yoing for the past several years for AstraZeneca. Sales hit $288 million in 2015 before the CDC’s recommendation against the use of FluMist in the 2016 to 2017 flu season. After that was reversed and a few manufacturing hiccups, sales climbed to $295 million in 2020, but fell to $175 million last year, with $151 million coming from Europe.

If approved, FluMist will be available through an online pharmacy request system. The vaccine would be delivered to people’s homes in temperature-controlled packages.