Medical Device Network

FDA clears FluMist nasal influenza vaccine for self-administration

The clearance means that patients will soon be able to administer their own influenza vaccine in a bid to take stress away from healthcare services.

The US Food and Drug Administration (FDA) has given the green light for market clearance to AstraZeneca’s nasal spray vaccine for influenza types A and B.

Cleared for both individual and care-giver use, the prescription-based nasal spray was cleared just in time for the 2024 flu season with the aim of making access to the vaccine more widely available by circumventing the need for a clinician to administer it.

The prescription vaccine has only been cleared for individuals aged two to 49 years of age. The vaccine was cleared for clinical use in 2007, but this new clearance puts the spray in the hands of patients for the first time in a bid to improve vaccine uptake through convenience.

Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said: “Today's approval of the first influenza vaccine for self- or caregiver administration provides a new option for receiving a safe and effective seasonal influenza vaccine potentially with greater convenience, flexibility and accessibility for individuals and families.

“Getting vaccinated each year is the best way to prevent influenza, which causes illness in a substantial proportion of the U.S. population every year and may result in serious complications, including hospitalization and death. This approval adds another option for vaccination against influenza disease and demonstrates the FDA's commitment to advancing public health."

FluMist, like most vaccines, works by containing a weakened strain of the virus sprayed directly into the nose. Forecasts made by GlobalData’s Pharmaceutical database estimate that in 2023 FluMist stood at a general market value of approximately $216m, with that figure expected to rise to $280m by the end of 2030.

The US Centers for Disease Control (CDC) claims that flu has resulted in about 9.3 million to 41 million illnesses, 100,000 to 710,000 hospitalisations and 4,900 to 51,000 deaths annually between 2010 and 2023. Every year across both the US and European markets influenza and the common cold take responsibility for a large portion of increased stress on healthcare systems. Following the onset of the Covid-19 pandemic, many services are keen to find any way to stave off the yearly spike in respiratory conditions.