FDA Approves New At-Home Flu Vaccine — No Needles Needed

There’s a new way for people to protect themselves from the flu, and it’s one that doesn’t require a trip to the doctor’s office — or even a needle.

The U.S. Food and Drug Administration (FDA) recently approved a nasal spray flu vaccine, called FluMist, for people ages 2 to 49 that can be ordered from an online pharmacy and administered at home. Doctors and public health experts are hopeful the at-home option, which should be available for the 2025–26 flu season, will help boost declining vaccination rates and protect more Americans from the common but sometimes deadly illness.

An estimated 490,000 people were hospitalized with flu during the 2023–24 season and roughly 25,000 people died from an infection, according to data from the Centers for Disease Control and Prevention (CDC). Meanwhile, less than half of U.S. adults (45 percent) got a flu shot last year, and only 38 percent plan to get a flu vaccine this year, a new report from the National Foundation for Infectious Diseases finds.

FluMist itself isn’t new. The vaccine was initially approved in 2003, but a health care provider was required to administer it. Having a spray vaccine that you can give yourself at home — or have a caregiver administer if you are under the age of 18 — “is probably going to capture a whole bunch of people” who skip out on their flu shots because they are afraid of needles or too busy to make an appointment, says Scott Roberts, M.D., an infectious disease specialist at Yale School of Medicine.

“I think that access is really key. I think it’s a step in the right direction for public health,” he adds.

Why aren’t adults 50 and older eligible?

FluMist has not been approved for adults 50 and older. In clinical trials, researchers found that while the vaccine can lower the risk of illness from an influenza infection in adults ages 18 to 49, it was not as effective in people 50 and older.

“The immune system really starts to get weaker” as you age, says Kenneth Koncilja, M.D., a geriatrician at Cleveland Clinic. This is why doctors and health officials recommend that adults 65 and older get a high-dose version of the vaccine when they go in for their annual shot.

Even though older adults aren’t eligible for the at-home nasal vaccine, Koncilja says it will still benefit them. That’s because this specific vaccine will likely appeal to school-aged children and busy individuals who can’t take time off from work. And vaccinating more young people against influenza will help keep flu from spreading.