The U.S. Food and Drug Administration (FDA) has approved FluMist, a nasal spray influenza vaccine, for self-administration, marking a significant milestone in the accessibility of flu prevention. This is the first flu vaccine that individuals can administer themselves or have a caregiver administer at home, without requiring a visit to a healthcare provider. The approval aims to provide a more convenient, flexible, and accessible option for seasonal influenza vaccination, potentially increasing vaccination rates across the population.
FluMist: A New Era of Flu Vaccination
FluMist, manufactured by MedImmune, a subsidiary of AstraZeneca, is approved for individuals aged 2 to 49 years. It protects against influenza disease caused by influenza virus subtypes A and B. The vaccine, administered as a nasal spray, has been used safely and effectively for many years, with initial FDA approval dating back to 2003 for individuals aged 5 to 49, and later expanded to include children aged 2 to 5 in 2007.
"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.
How to Obtain and Administer FluMist
To access FluMist for self-administration, individuals will need a prescription and can order the vaccine through a third-party online pharmacy. The process involves completing a screening and eligibility assessment, which will be reviewed by a pharmacist to ensure the vaccine is appropriate for the individual. Once approved, the pharmacy will ship the vaccine directly to the patient’s home with detailed instructions on how to administer, store, and dispose of the product.
Adults aged 18 and older are authorized to administer FluMist to themselves or to a child in their care. The FDA recommends that a caregiver administer the spray to children between the ages of 2 and 17.
Impact on Public Health
Influenza remains a significant public health concern in the United States, causing millions of illnesses, hundreds of thousands of hospitalizations, and thousands of deaths annually. According to the U.S. Centers for Disease Control and Prevention (CDC), the flu has resulted in approximately 9.3 million to 41 million illnesses, 100,000 to 710,000 hospitalizations, and 4,900 to 51,000 deaths annually between 2010 and 2023.
The availability of a self-administered flu vaccine option could help reduce these numbers by increasing vaccination rates, particularly among those who find it difficult to visit a healthcare provider or who have a fear of needles. Iskra Reic, executive vice president of vaccines and immune therapies at AstraZeneca, stated, "The approval of FluMist for self-administration is an important step forward in making vaccines more accessible to fight the high annual burden of influenza."
Potential Side Effects
Like all vaccines, FluMist can cause side effects. The most commonly reported side effects include fever over 100°F in children aged 2 through 6, runny nose and nasal congestion in individuals aged 2 through 49, and a sore throat in adults aged 18 through 49.
Looking Ahead
FluMist for self-administration is expected to be available for the 2025-2026 influenza season. This new option represents a significant advancement in public health efforts to combat influenza and improve vaccination rates by providing a convenient and accessible alternative to traditional flu shots.
