FDA Greenlights FluMist Nasal Vaccine for At-Home Use by Patients and Caregivers

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The US Food and Drug Administration has approved FluMist for either self- or caregiver-administration for the prevention of influenza disease caused by influenza virus subtypes A and B. The vaccine is available for people aged two through 49 years of age and is administered directly into the nose. It is the first vaccine that does not need to be dispensed by a health care provider.

“Today’s approval…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, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

Initially approved in 2003 for individuals aged five through 49 years, the FDA expanded its usage to include those aged two through four.

Common symptoms of the flu include body aches, fever, tiredness, coughing, sore throat and congestion, and can range in severity from mild to severe illness. Life-threatening complications can include hospitalization or death, particularly among those with in high-risk groups, such as older adults, young children and patients with chronic conditions. Between 2010 and 2023, approximately 100,00 to 710,000 hospitalizations and 4,900 to 51,000 deaths were attributed to the flu, so vaccination is crucial.

The most common adverse events include a fever over 100°F in young children aged two through six, as well as nasal congestion, runny nose and sore throat. A prescription is required to receive FluMist, although it is available in both a health care setting or administered by the vaccine recipient or caregiver aged 18 years or older.

“Getting vaccinated each year is the best way to prevent influenza, which causes illness in a substantial proportion of the US population every year and may result in serious complications, including hospitalization and death,” Marks said. “This approval adds another option for vaccination against influenza disease and demonstrates the FDA’s commitment to advancing public health.”