Nasal Flu Vaccine FluMist Gets FDA Approval for At-Home Use

A fear of needles and logistical hurdles are just two reasons some people may skip their annual flu vaccine. Recently, the Food and Drug Administration (FDA) removed those obstacles by approving the at-home use of FluMist®, an influenza vaccine administered by nasal spray.

Made by AstraZeneca, FluMist will be available for home use starting in the fall of 2025. It is approved for people ages 2 through 49 (the vaccine doesn’t help prevent flu in people ages 50 and older). Getting annual vaccinations against flu is highly recommended by health experts. Each year, the flu causes up to 41 million illnesses, 710,000 hospitalizations, and 51,000 deaths, according to the Centers for Disease Control and Prevention (CDC).

“Making this vaccine available to use at home is a great step for public health purposes,” says Scott Roberts, MD, a Yale Medicine infectious diseases specialist. “There are always patients who don’t get vaccinated because they can't get to the clinic, or it's not top of mind. If you can offer this at home via self-administration, I imagine it's only going to increase the percentage of people who are vaccinated against the flu. Plus, it’s the only needle-free option. So, it’s helpful for patients who have a needle—or doctor—phobia.”

FluMist contains a weakened form of live influenza virus strains A and B and is sprayed into the nose. It was first approved by the FDA in 2003, and, until the approval for at-home use, was administered only by a health care provider in a medical setting (including pharmacies).

A prescription will be required for at-home use. Beginning in fall 2025, an individual can get one by visiting the FluMist website and entering information to determine if they are eligible. If they are, a pharmacist will grant approval, and the vaccine will be shipped to them. A caregiver should administer the vaccine to anyone between the ages of 2 and 18.

Below, we talk more with Dr. Roberts about FluMist as a nasal spray vaccine used at home.

Effectiveness for all flu vaccines, according to the CDC, can vary from year to year among different ages, risk groups, vaccine types, and virus types and subtypes.

Before the 2009 H1N1 virus, or swine flu, pandemic, the nasal spray vaccine was found to be effective against different flu viruses, including influenza A and B viruses. But after the 2009 pandemic, several U.S. studies of 2- through 17-year-olds found that the nasal spray was less effective than the traditional injectable vaccine against the influenza A H1N1 pandemic strain—even though it provided the same protection against other influenza A (H3N2) and B viruses as the standard flu shot. Still, the CDC recommended against the use of the nasal spray vaccine for the 2016-2017 and 2017-2018 flu seasons.

“Since then, they updated the formulation of the nasal vaccine, and now it is just as efficacious as injectables for H1N1 and A and B influenza viruses in non-U.S.-based studies,” Dr. Roberts says.

Because of its limited use, there have not been effectiveness estimates in the U.S. since the nasal spray was endorsed again by the CDC for the 2018-2019 season. But, as Dr. Roberts mentions, data from other countries have shown protection to be similar to standard-dose, egg-based inactivated flu vaccines in 2- to 17-year-olds.

The most common reported side effects of FluMist include a fever over 100 degrees Fahrenheit in children ages 2 through 6, a runny nose and nasal congestion in people ages 2 through 49, and a sore throat in adults ages 18 through 49.

“FluMist is a live attenuated, or weakened, virus, so it’s not fully inactivated­—as is the case with the standard injectable flu vaccine. Because of that, theoretically, you could have more side effects, including nasal congestion,” Dr. Roberts says. “But you can’t get the flu from it.”

Side effects shouldn’t last more than a few days, he adds. The CDC offers a full list of side effects.

As noted, the nasal spray vaccine is for people between ages 2 and 49. It should not be administered, according to the CDC, to the following groups:

• Anyone with a history of severe allergic reactions to any vaccine ingredient (except for egg protein) or to a previous dose of any flu vaccine.

• Children ages 2 to 17 who take aspirin or medicines containing salicylate

• Children ages 2 to 4 who have a history of wheezing in the past 12 months

• Anyone with a weakened immune system
  
• Pregnant people

• People with an active leak between the cerebrospinal fluid and the mouth, nose, ear, or other place in the skull

• People with cochlear implants

• People who have taken antiviral flu drugs within a certain amount of time.

The CDC provides a full list of those who should not get the nasal vaccine.

“Nasal congestion changes the local immune dynamics of the nasal mucosa, which means there is a chance the vaccine is not going to reach all the mucosa and instead is going to be bound up in the debris of a runny nose,” says Dr. Roberts. “In a perfect world, if someone is healthy and feeling good, they can administer this and I wouldn't have any concerns. But if someone has nasal congestion, then I think the injectable may be a better route, since it is a more tried-and-true strategy.”

It really depends on your comfort level, but overall, using FluMist at home is a convenient option for the right individual, says Dr. Roberts.

“For instance, some people might worry that they are administering it incorrectly and wonder if that changes its efficacy,” he says. “But as long as there is room for user error and the instructions are clear, which I expect them to be, this may not be an issue.”

However, if someone is anxious about logistics and can get to a clinic that administers flu vaccines, there’s no reason not to stick with the “tried-and-true” option, he notes.

“But, if you qualify for the at-home nasal vaccine, I have no qualms about someone getting it,” Dr. Roberts says.