The Food and Drug Administration (FDA) has approved the first flu vaccine that does not need to be administered by a health care provider.
AstraZeneca’s FluMist nasal spray for at-home use is expected to be available next fall for people ages 2-49 years.
"Improving access to vaccine is one strategy to improve immunization rates,” said Kristina A. Bryant, M.D., FAAP, a member of the AAP Committee on Infectious Diseases (COID) and lead author of the AAP’s flu policy statement and technical report. “I anticipate parents and pediatricians will have a lot of questions about self-administration of intranasal flu vaccine. The AAP and COID look forward to reviewing the data on this product and taking it into consideration when we develop our annual influenza vaccine recommendations in the spring.”
FluMist contains a weakened form of the live influenza virus and has been in use since 2003. Under the new approval, patients would still need a prescription for the vaccine. They would go through a third-party online pharmacy and answer screening and eligibility questions, and the pharmacy would determine eligibility. The pharmacy would write the prescription for eligible patients and ship the vaccine to them.
Adults will be able to administer FluMist to themselves while a caregiver would need to administer FluMist to children ages 2-17 years. The FDA said a study was conducted as to whether vaccine recipients and caregivers could understand the instructions and safely use the vaccine.
"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, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, said in a press release.
The most common side effects of FluMist are fever over 100 degrees Fahrenheit in children ages 2-6 years, runny nose and nasal congestion in people ages 2-49 years, and sore throat in adults, according to the FDA. Until the new at-home system is in place next fall, FluMist remains available through a health care provider.
Pediatric flu deaths in the 2023-’24 season tied a record for a non-pandemic season with 199. Among children with known vaccination or medical status, 83% were not fully vaccinated and 49% had a pre-existing medical condition.
Across all ages, the Centers for Disease Control and Prevention (CDC) estimates flu caused at least 35 million illnesses, 400,000 hospitalizations and 25,000 deaths during the 2023-’24 season. Just 54% of children and adolescents were vaccinated, down from 62% in the 2019-’20 season. The AAP and CDC recommend everyone 6 months and older get vaccinated.
Resources
- Information from the FDA on FluMist
- AAP policy Recommendations for Prevention and Control of Influenza in Children, 2024-2025
- AAP technical report Recommendations for Prevention and Control of Influenza in Children, 2024-2025
- AAP clinical report Strategies for Improving Vaccine Communication and Uptake
- Information on flu from the CDC
- Information from the AAP on setting up a flu vaccine clinic
- AAP flu vaccine promotion toolkit
- Information for parents on flu from HealthyChildren.org
- Information on flu from the AAP Red Book
