FDA Approves First Nasal Spray Flu Vaccine for At-Home Use

In a landmark decision, the U.S. Food and Drug Administration (FDA) has approved FluMist, a nasal spray influenza vaccine, for self- or caregiver-administration. This approval, announced on September 20, 2024, marks the first time an influenza vaccine can be administered without the direct involvement of a healthcare provider.

FluMist, manufactured by AstraZeneca, is designed for individuals aged 2 through 49. The vaccine contains weakened live influenza virus strains and is administered via nasal spray. A prescription remains necessary, and AstraZeneca plans to distribute FluMist through a third-party online pharmacy. Individuals will complete a screening and eligibility assessment to order the vaccine for home delivery. This development aims to provide a more convenient, flexible, and accessible option for seasonal influenza vaccination.

"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."

FluMist was initially approved by the FDA in 2003 for individuals aged 5 to 49 and expanded in 2007 to include children aged 2 to 5. The vaccine has been used safely and effectively for many years. 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 sore throat in adults aged 18 through 49.

AstraZeneca plans to make FluMist available through a third-party online pharmacy. Individuals aged 18 and older will complete an online questionnaire reviewed by a pharmacist before the vaccine is shipped to their homes. For individuals aged 2 through 17, a caregiver should administer the vaccine, as self-administration is not recommended for this age group.

The FDA's approval was based on a comprehensive submission, including results from a usability study demonstrating that individuals over 18 years of age could self-administer or administer FluMist to eligible individuals aged 2-49. 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 sore throat in adults aged 18 through 49.

The approval of FluMist for self-administration has several potential societal impacts:

• Increased Accessibility: By allowing individuals to administer the vaccine at home, this approval may reduce logistical barriers, such as the need to schedule appointments or travel to healthcare facilities, potentially increasing vaccination rates.

• Public Health Impact: Higher vaccination rates can lead to reduced transmission of influenza, decreasing the overall burden on healthcare systems and improving public health outcomes.

• Equity Considerations: Self-administration may particularly benefit individuals in rural or underserved areas with limited access to healthcare providers, promoting health equity.

The FDA's approval of FluMist for self- or caregiver-administration represents a significant advancement in vaccine accessibility and public health strategy. By enabling individuals to receive influenza vaccinations without direct healthcare provider involvement, this development has the potential to increase vaccination rates, reduce the burden of influenza, and promote health equity across diverse populations.