The U.S. Food and Drug Administration (FDA) has approved FluMist, the nasal spray flu vaccine, for at-home use.
This is the first time an influenza vaccine has been cleared for self-administration without requiring a healthcare provider.
The approval was announced by the FDA on September 20, with Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, highlighting the potential benefits.
“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,” Marks said.
FluMist, which has been in use for nearly two decades, will now be available for self-administration by patients or their caregivers starting next year.
Fox News medical contributor Dr. Nicole Saphier appeared on “Fox and Friends” to discuss how the home-use option will simplify the vaccination process for many Americans.
“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,” Saphier explained.
“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.”
Dr. Marc Siegel, a senior medical analyst for Fox News and clinical professor of medicine at NYU Langone Medical Center, noted that the new option could be especially helpful for children who are afraid of needles.
“I am glad it is being made available over the counter beginning next year,” Siegel told Fox News Digital. “It can help to overcome vaccine non-compliance.”
While the approval opens up new opportunities for flu prevention, Siegel also cautioned that medical professionals should remain involved in the process.
“It is a live virus vaccine, and so it should not be given to those who are immunocompromised or to pregnant women,” he added.
Doctors will still need to prescribe FluMist, and the vaccine will be shipped directly from a third-party pharmacy to eligible patients.
FluMist is approved to protect against influenza virus subtypes A and B in individuals aged 2 through 49, according to the FDA.
It was initially approved in 2003 for those aged 5 through 49, with eligibility extended to children aged 2 through 5 in 2007.
Although FluMist presents a convenient alternative, it is important to recognize potential side effects.
The most common side effects include fever in children between ages 2 and 6, runny nose and nasal congestion in people aged 2 through 49, and sore throat in adults aged 18 through 49.
The Centers for Disease Control and Prevention (CDC) recommends that everyone 6 months and older receive an annual flu vaccine.
The flu causes millions of illnesses in the U.S. each year, and in some cases, it can lead to severe complications, hospitalization, or even death.
Between 2010 and 2023, the flu was responsible for 9.3 to 41 million illnesses annually, resulting in 100,000 to 710,000 hospitalizations and 4,900 to 51,000 deaths.
Despite these recommendations, last year’s flu vaccine had an efficacy of less than 50%, raising questions about its effectiveness.
Dr. Saphier suggested that while vaccination is important, individuals should assess their personal health risks and consult with their doctors to determine the best course of action.
As FluMist becomes available for home use next year, it may encourage more people to protect themselves against the flu, especially those who avoid traditional vaccines due to inconvenience or fear of needles.