The U.S. Food and Drug Administration (FDA) has approved FluMist — the nasal spray flu vaccine — for home use by a patient or adult caregiver, the agency announced.
FluMist has been in use for a couple of decades, but this is the first time a vaccine for influenza has been approved for self-administration without a health care provider.
“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 Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in the Sept. 20 announcement.
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The home version of FluMist will be available starting next year, according to Fox News medical contributor Dr. Nicole Saphier.
Saphier appeared on “Fox and Friends” to discuss how the home version of FluMist will make it easier for people to get the vaccine.
“A lot of people don’t get the flu shot because of the logistics of going to the doctor’s office or the pharmacy, or because of severe needle phobia,” she said.
“This is a good alternative for those people — especially because over the last two decades, [FluMist] has shown just about the same efficacy as the traditional vaccines.”
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Dr. Marc Siegel, senior medical analyst for Fox News and clinical professor of medicine at NYU Langone Medical Center, stated that the FluMist vaccine is “particularly useful” in children who may have needle phobias.
“I am glad it is being made available over the counter beginning next year,” he told Fox News Digital.
“It can help to overcome vaccine non-compliance.”
It is still important for doctors to be “kept in the loop,” Siegel added.
“It is a live virus vaccine, and so it should not be given to those who are immunocompromised or to pregnant women.”
FluMist is approved to protect against influenza virus subtypes A and B in people 2 through 49 years of age, according to the FDA’s website.
It was first approved in 2003 for people ages 5 through 49, and was extended to include children ages 2 through 5 in 2007.
The most common side effects of FluMist include fever in children between 2 and 6, runny nose and nasal congestion in people aged 2 through 49, and sore throat in adults aged 18 through 49, the FDA noted.
A prescription will be required to obtain the home version of FluMist, which will be shipped directly from a third-party online pharmacy to eligible patients, the FDA stated.
The U.S. Centers for Disease Control and Prevention (CDC) recommends that everyone 6 months and older is advised to get vaccinated against influenza.
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Last year’s vaccine had an efficacy of a little less than 50% in terms of keeping people out of the doctor’s office and the hospital, according to Saphier.
“Does that mean that everyone needs to go get one? That’s really up to the individual,” she said, adding that people should talk to their doctor, especially if they are high-risk.
In the FDA’s announcement, Marks stated that getting annual vaccinations 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.”
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Each year between 2010 and 2023, the flu caused between 9.3 million and 41 million illnesses, 100,000 to 710,000 hospitalizations, and 4,900 to 51,000 deaths, according to the CDC.
Fox News Digital reached out to AstraZeneca, manufacturer of FluMist, requesting comment.
