FDA Approves Self-Administered Nasal Flu Vaccine

The U.S. Food and Drug Administration's White Oak campus in Silver Spring, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

The U.S. Food and Drug Administration (FDA) has approved an AstraZeneca nasal flu vaccine that can be self-administered or administered by an adult caregiver without a health care provider being present.

On Sept. 20, the FDA announced that FluMist has been approved for the prevention of influenza subtypes A and B in individuals ages 2 to 49 years old.

Initially approved in 2003 for people ages 5 to 49, the FluMist nasal spray has been used “safely and effectively for many years,” according to the FDA’s Sept. 20 statement.

In 2007, the federal drug agency approved FluMist for children ages 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,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said. “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.”

The severity of flu season varies from year to year. Between 2010 and 2023, the flu caused from about 9.3 million to 41 million illnesses, from 100,000 to 710,000 hospitalizations, and from 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 stated.

Although a health care provider will not be needed to administer the nose spray, FluMist contains a weakened form of live influenza virus strains and will still require a prescription.

The FDA said the most common side effect has been a fever of higher than 100 degrees in children ages 2 to 6.

Recipients ages 2 to 49 have experienced nasal congestion and a runny nose after receiving the vaccine, and some ages 18 to 49 have reported having a sore throat as a side effect.

According to the package insert, Guillain-Barré Syndrome “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.”

Guillain-Barré Syndrome 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, according to the package insert.

“This approval adds another option for vaccination against influenza disease and demonstrates the FDA’s commitment to advancing public health,” Marks said.