FDA approves MedImmune’s nasal spray flu vaccine FluMist

The U.S. Food and Drug Administration has approved FluMist, a nasal spray flu vaccine by MedImmune LLC, for self-administration or caregiver-administration. This marks a significant development in the prevention of influenza, as FluMist becomes the first flu vaccine that does not require administration by a healthcare provider. The vaccine is approved for individuals aged 2 through 49 and offers an alternative to traditional flu shots.

FluMist has been in use since 2003 when it was first approved for individuals aged 5 through 49. The FDA later extended approval in 2007 to include children as young as 2. This new approval makes it possible for eligible individuals or their caregivers to administer the vaccine at home, providing greater convenience and flexibility.

Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research, stated that this approval adds another convenient option for flu vaccination. He highlighted the importance of annual flu vaccination, noting that the flu continues to affect a large proportion of the U.S. population each year, often leading to serious health complications.

Influenza, commonly referred to as the flu, is a contagious respiratory disease caused by circulating influenza viruses. It tends to peak in fall and winter and can cause symptoms ranging from mild to severe, including fever, body aches, coughing, sore throat, and fatigue. In severe cases, particularly among vulnerable groups such as young children, the elderly, and individuals with chronic health conditions, the flu can result in hospitalisation or death. According to the U.S. Centers for Disease Control and Prevention, annual flu cases have ranged from 9.3 million to 41 million, with as many as 710,000 hospitalisations and 51,000 deaths in some years.

FluMist, which contains a live, weakened form of the virus, is sprayed directly into the nose. Though a prescription is still required, the vaccine is now available for administration by individuals or caregivers aged 18 and older. For children aged 2 through 17, a caregiver must administer the vaccine. The most commonly reported side effects include fever in children, nasal congestion, and sore throat in adults.

FluMist is expected to be available through a third-party online pharmacy, where users will undergo a screening process to determine eligibility before receiving the vaccine by mail. Recipients will also receive detailed instructions for use, including how to store and administer the vaccine safely.

This new FDA approval of FluMist offers a practical, at-home option for flu prevention, aligning with broader efforts to improve public health accessibility. The approval granted to MedImmune LLC reflects the growing demand for flexible healthcare solutions, particularly for common seasonal illnesses like influenza.