First-Ever Flu Vaccine for Home Use Gets FDA Approval

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By Staff
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People who prefer a needle-free alternative to the flu shot will soon be able to vaccinate themselves or their children at home with the nasal spray version of the flu vaccine.

Now that the U.S. Food and Drug Administration (FDA) has given its okay, FluMist has become the first flu vaccine that adults can self-administer or give to their children outside of a pharmacy, doctor’s office, or other healthcare setting.

As with the version of FluMist administered in healthcare settings, the new home version is approved for adults under age 50 and children age 2 and up.

“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, PhD, the director of the FDA’s Center for Biologics Evaluation and Research, in a statement announcing the approval.
FluMist Home should become available next year in time for the 2025–2026 flu season.

A Nasal Flu Vaccine Has Been Around for Years

A nasal spray version of the flu vaccine is nothing new. The FDA initially green-lighted FluMist in 2003 for people ages 5 through 49, and then extended its approval to children ages 2 through 5 in 2007.
Just like the nasal spray vaccine that’s been around for 20 years, the self-administered version stimulates the immune system by using inactivated (weakened) versions of the two main types of human flu virus, subtypes A and B.
Adults 50 and older and children between 6 months and 2 years old should get the flu shot, not the nasal flu vaccine, according to the Centers for Disease Control and Prevention (CDC). The agency also says that people who are pregnant or who have certain chronic health conditions, such as HIV, should get the flu shot, not the nasal spray flu vaccine.

The Home Nasal Spray Flu Vaccine Is Easy to Use

The FDA granted its approval to FluMist Home after reviewing study results confirming that instructions for use were appropriately designed so that adults could safely and effectively administer the vaccine to themselves or to children.

“It’s easy to do — similar to spraying saline solution in your nose,” says Carlene Muto, MD, the medical director of infection prevention and control with Temple University Health System in Philadelphia.

The most commonly reported side effects of the nasal spray vaccine include runny nose and nasal congestion. Adults might experience a sore throat, while kids 6 and under may develop a low fever.
The drug’s maker, AstraZeneca, plans to make the vaccine available exclusively via home delivery through a FluMist Home website.

“Instead of taking a few hours to go to a pharmacy or to your medical provider, you can just go online, complete a questionnaire [which will be reviewed by a pharmacist], and then have the order shipped to your home,” says Edward Jones-Lopez, MD, an infectious disease specialist with Keck Medicine of USC in Los Angeles.

Who Is Most Likely to Choose the New Home Flu Vaccine?

Dr. Muto notes that the nasal spray flu vaccine may appeal especially to people with trypanophobia — fear of needles.

“I remember myself being afraid of needles as a child,” says Dr. Jones-Lopez. “I think most kids, if given a choice between an injection and a little fluid squirted up their nose, would prefer the spray.”

He adds that being able to give the vaccination in a home setting may be much more comfortable both for children and adults.

Convenience is also a factor. “I could see self-administration being welcomed in populations where traveling to a clinic or pharmacy is difficult,” says Andrew Dwenger, PharmD, a clinical pharmacist at University of Utah Health in Salt Lake City. These groups include people who live in rural areas or who have a debilitating illness that makes it hard for them to get around, according to Dr. Dwenger.

The Flu Vaccine Can Save Lives

During the 2022–2023 U.S. flu season, influenza was related to an estimated 31 million illnesses, 14 million medical visits, 360,000 hospitalizations, and 21,000 deaths, according to the CDC.
Even so, just under half of children and adults in the United States get the annual flu vaccine.

The FDA stresses that FluMist Home adds another option for vaccination against flu and that might encourage more people to get vaccinated.

“Influenza kills tens of thousands of people every year,” says Muto. “It doesn’t matter what vaccine you pick, just please pick one to protect yourself and your loved ones.”

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