Regulatory AstraZeneca’s Self-Administered Flu Vaccine Inches Closer to FDA Green...

AstraZeneca’s Self-Administered Flu Vaccine Inches Closer to FDA Green Light


FluMist, AstraZeneca’s nasal spray influenza vaccine, has been on the market for the past two decades. As early as next year, the vaccine may be made accessible for self-administration.

The supplementary biologics license application (sBLA) for self-administered FluMist Quadrivalent submitted by AZ has been accepted by the FDA. The firm anticipates reaching a decision within the first three months of the next year, and it is now formulating preparations to introduce the product during the flu season of 2024-2025.

Individuals between the ages of 18 and 49 would be able to self-administer the needle-free vaccination, which has previously been approved for use in those between the ages of 2 and 49. Children between 2 and 17 might also be given FluMist by an adult. At this time, only those working in the medical field are allowed to administer the spray.

FluMist has been the only nasal influenza vaccination available to consumers ever since it was granted approval by the FDA in 2003. So the question is why is it only now becoming available for self-administration?

According to Lisa Glasser, AZ’s chief of U.S. medical affairs for vaccines and immunological treatments, the company saw a chance to attract prospective consumers as the number of people getting flu vaccinations dropped during the coronavirus outbreak.

Glasser added, “We viewed this as an opportunity to provide a convenient way for people to get access to flu vaccine. 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.”

In the event that it is given the go-ahead, the FluMist will be made available through a request system for online pharmacies. Temperature-controlled containers holding the vaccination would be shipped to people’s homes.

Even though the Centers for Disease Control and Prevention (CDC) advises that everyone older than six months should get vaccinated against seasonal flu, fewer than half of the population in the U.S. actually does so. Even less than a third of individuals living in rural regions received a flu shot during the 2021-2022 influenza season.

AZ anticipates that the self-administered vaccine will attract consumers who are already receiving seasonal flu vaccinations – mainly because of its attractiveness as a convenient alternative. According to Glasser, the objective is that, over the long term, it will also attract more individuals to the flu vaccine and raise overall uptake.

A usability study supporting AZ’s application found that those over 18 could self-administer the product after being provided instructions. Studies have proven that FluMist is just as effective and safe as other flu vaccinations.

Sales of FluMist in Arizona have been turbulent. In 2015, they hit $288 million, although the CDC advised against using it during the 2016–17 flu season. After the World Health Organization revised its criteria for manufacturing flu vaccinations, the firm had trouble producing the product in volume, causing sales to fall to a low of $78 million in 2017.

In 2020, revenues increased to $295 million, thanks in large part to the pandemic. The business made $175 million in total sales from FluMist last year, with $151 million of it generated in Europe.

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