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The days of waiting for a flu shot at your doctor's office or local pharmacy may be over: The U.S. Food and Drug Administration on Friday approved FluMist nasal spray as the first influenza vaccine that can be self-administered at home.
It's 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, who directs the FDA's Center for Biologics Evaluation and Research.
It's been a long time coming, however: MedImmune's FluMist was first approved in 2003 for folks ages 5 to 49 to prevent flu, and then approval was extended to kids ages 2 to 5 in 2007. It's a nasal spritz that contains a weakened form of the live influenza virus.
However, it was always administered by a health care provider. Until now.
You'll still need a prescription to get FluMist, the FDA said, and only folks aged 18 and older are authorized to administer it to themselves or a child in their care.
"For those interested in self or caregiver administration, the vaccine manufacturer plans to make the vaccine available through a third-party online pharmacy," the FDA said. "Those who choose this option will complete a screening and eligibility assessment when they order FluMist."
Friday's approval was based on a study "conducted with vaccine recipients and caregivers to evaluate whether the instructions for use were appropriately designed so that recipients and caregivers could safely and effectively use the vaccine," the FDA noted.
Anyone who is prescribed FluMist will receive the vaccine as well as detailed instructions on how to administer, store and dispose of the product.
According to the U.S. Centers for Disease Control and Prevention, influenza remains a dire threat to the health of millions of Americans. Between 2010 and 2023, the viral illness caused up to 41 million illnesses, anywhere from 100,000 to 710,000 hospitalizations and up to 51,000 deaths.
Like any vaccine, side effects can occur with FluMist. According to the FDA, these include "fever over 100°F in children 2 through 6 years of age, runny nose and nasal congestion in individuals 2 through 49 years of age and a sore throat in adults 18 through 49 years of age."
More information
There's more on flu vaccines at the Mayo Clinic.
SOURCE: U.S. Food and Drug Administration, news release, Sept. 20, 2024