FDA approves self-administered nasal influenza vaccine

As influenza season rapidly approaches, the FDA has approved a self-administered nasal spray influenza vaccine: FluMist. With this new approval, the nasal influenza vaccine can be self-administered at home for adults ages 18-49 or by a caregiver for individuals ages 2-17, marking the first influenza vaccine that does not require healthcare provider administration.

"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," said Peter Marks, MD, Ph.D., director of the FDA's Center for Biologics Evaluation and Research, in the FDA press release. "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 has been approved in the United States since 2003, initially for individuals ages 5 through 49. In 2007, the FDA expanded approval to include individuals as young as 2.

The nasal vaccine is a live attenuated influenza vaccine that includes a weakened form of live influenza virus strains administered via a nasal spray. However, this vaccine still must be prescribed.

For individuals looking to self-administer the vaccine or administer it as a caregiver, the manufacturer will offer sales through a third-party online pharmacy that will screen and assess eligibility and provide eligible patients with a prescription. Once that's done, the vaccine will be shipped to whatever address they provide with prescribing information, information for patients and their caregivers, and instructions for use. The instructions for use will also include storage, administration and disposal guidance.

"For the first time, families and caregivers will be able to protect themselves against influenza with a needle-free, self-administered vaccine from the convenience of their own home. Each year, influenza poses a significant burden for people, society and health systems; additional tools to increase access to vaccinations, while also reducing disparities, are critical," said Ravi Jhaveri, MD, division head of Infectious Disease at AstraZeneca, in the company press release.

According to the FDA, influenza infections contribute to up to 41 million illnesses annually in the U.S. Of these illnesses, up to 710,000 result in hospitalization, and as many as 51,000 are fatal.

Although influenza is a relatively common infectious respiratory disease that can be mild for many individuals, specific populations are at a greater risk of severe complications, including those with chronic diseases, such as diabetes or asthma.

Getting vaccinated for influenza annually is the best way to prevent infection, hospitalization, complications, and fatalities. Once available, the self- or caregiver-administered FluMist will provide another tool for protecting against influenza.

Veronica Salib has covered news related to the pharmaceutical and life sciences industry since 2022.