The F.D.A. authorized AstraZeneca’s treatment to be given outside a health care setting, although it will still need a prescription.
By Christina Jewett in the NYT (thanks to Pam P.)
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.
FluMist was first approved by the F.D.A. in 2003 for people ages 5 to 49; since 2007, it has been authorized for people as young as 2 years old. The spray contains a weakened form of live flu virus that is applied inside the nose.
According to the C.D.C., the nasal spray has largely been found to be as effective as the shot, except for children in 2009, a year of particularly high levels of flu cases. Since then, the formula of the spray has changed, according to the agency, which said studies outside the United States found it to have similar efficacy to the shot.
Dr. Abraar Karan, a Stanford infectious disease doctor, said he saw a lot of flu patients in urgent care. He added that many said they had meant to get a vaccine, but found that the major challenge was basic logistics: making an appointment, missing work and building in time to feel tired or achy after receiving the vaccine.
He said the new approval would ideally go a long way toward preventing more flu cases.
“A lot of it is actually just reducing those logistical barriers,” Dr. Karan said. “And so an at-home platform, I think, will increase uptake, and that will increase uptake quickly, which is really the key before the season starts picking up.”