The Food and Drug Administration on Friday approved AstraZeneca’s bid to allow its nasal spray influenza vaccine, FluMist, to be sold for home administration.
Starting in fall 2025, people who want to order the vaccine to give it to themselves or their children at home will be able to do so.
FluMist is the only flu vaccine administered by nasal spray, not injection. It is licensed for individuals between the ages of 2 and 49. This FDA approval makes it the only flu vaccine in the United States that can be administered at home and that does not need to be administered by a health care professional.
“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,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
While the vaccine will continue to be available through doctors’ offices and pharmacies for administration by a health care provider, this new option means that it can be ordered for home use, as long as it will be administered by an individual 18 or older.
Supplies for home administration will be ordered through an online portal, FluMist Home. Individuals will need to fill in an online questionnaire, which will be reviewed by a pharmacist to determine if they are eligible for self-administration; those approved will have their vaccine delivered to them.
“The approval of FluMist for self-administration is an important step forward in making vaccines more accessible to fight the high annual burden of influenza,” Iskra Reic, AstraZeneca’s executive vice president for vaccines and immune therapies, said in a statement.
Side effects reported after receipt of FluMist include fever over 100 degrees Fahrenheit in children from ages 2 through 6, runny nose and nasal congestion in individuals ages 2 through 49, and a sore throat in adults 18 through 49 years of age.