The F.D.A. authorized AstraZeneca’s treatment to be given outside a health care setting, although it will still need a prescription.
The Food and Drug Administration on Friday authorized at-home use of FluMist, opening the door for needle-shy people to have easy access to a nasal spray vaccine that is potentially lifesaving.
The approval will allow, for the first time, an alternative to the annual flu shot that parents and caregivers can give to children and that adults can use on their own outside of a health-care setting. It would still require a prescription and is expected to be available from an online pharmacy next fall.
AstraZeneca, which makes the treatment, said it would start a FluMist Home website, where people can fill out a questionnaire that will be reviewed by a pharmacist before the treatment is shipped to a person’s home. The mist will remain available from prescribers as an in-office treatment. The current out-of-pocket cost for a dose is about $35 to $45, but may be less depending on insurance coverage.
“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 F.D.A.’s vaccine center, which authorized the at-home option.
The agency required the company to study whether its instructions were clear and whether at-home administration was feasible. The agency concluded that it was, but advised caregivers to give the spray to those who are 2 to 17 years old.
The flu takes a steep toll that varies greatly from year to year, according to an F.D.A. summary of data from the Centers for Disease Control and Prevention. From 2010 through 2023, hospitalizations have ranged from 100,000 to 700,000 each year, and from about 4,900 to 51,000 people have died.