The U.S. Food and Drug Administration (FDA) has green-lit AstraZeneca’s nasal flu vaccine that can be self-administered without a health care provider.
On Friday, the FDA announced that it approved FluMist for the prevention of influenza subtypes A and B in individuals aged 2 to 49 years old.
FluMist is a nasal spray and has been used “safely and effectively for many years,” having initially been approved in 2003 for people aged 5 to 49, the FDA said.
The FDA later approved it in 2007 for children 2 to 5 years old.
“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 FDA’s Center for Biologics Evaluation and Research. “Getting vaccinated each year is the best way to prevent influenza, which causes illness in a substantial proportion of the U.S. population every year and may result in serious complications, including hospitalization and death.”
Between 2010 and 2023, the flu has resulted in about 9.3 million to 41 million illnesses, 100,000 to 710,000 hospitalizations, and 4,900 to 51,000 deaths annually, according to the FDA.
“Flu can be life-threatening and cause serious complications that can lead to hospitalization or death, particularly in high-risk groups such as the elderly, young children and people with certain chronic medical conditions,” the FDA said.
Despite not needing a health care provider to administer the spray, it will still require a prescription.
The FDA said the most common side effect has been a fever of over 100 degrees in children aged 2 to 6.
Individuals aged 2 to 49 have experienced nasal congestion and a runny nose.
Individuals aged 18 to 49 have reported having a sore throat as a side effect.
According to the package insert, Guillain-Barré Syndrome (GBS) “has occurred within 6 weeks of any prior influenza vaccination,” so “the decision to give FluMist should be based on careful consideration of the potential benefits and potential risks.”
GBS is a rare, incurable condition in which the immune system attacks the nerves, causing weakness, numbness, and paralysis, according to the Mayo Clinic.
Children younger than 5 years old have been reported to experience wheezing following a dose of FluMist, the package insert said.
“This approval adds another option for vaccination against influenza disease and demonstrates the FDA’s commitment to advancing public health,” Marks said.