FDA Approves FluMist Vaccine for Self-Administration

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The FDA has approved nasal influenza vaccine FluMist, for self- or caregiver- administration, according to an FDA news release published today. This makes it the first flu vaccine that does not need to be administered by a healthcare professional.

FluMist was originally approved by the FDA in 2003 for people ages 5 to 49. In 2007, that approval was extended to include children ages 2 to 5.

This approval is based on the results of a study that examined whether FluMist’s instructions were clear enough to safely and effectively administer the vaccine at home. In the study, 100% of participants administer FluMist correctly.

Those interested in FluMist can get it through an online pharmacy where they will first have to complete a screening and eligibility assessment. If approved, the pharmacy writes the prescription and FluMist is shipped to the provided address. People must be 18 years or older to administer.

“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,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research said in the news release. “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 most common side effects of FluMist were a fever of over 100 degrees in small children. Patients ages 2 to 49 might get a runny nose, congestion or sore throat after taking the vaccine.

In the United States, the flu commonly circulates in the fall and winter, causing a mild to severe illness that can include fever, body aches and coughing. It can be fatal for those in high-risk groups such as young children, the elderly and immunocompromised individuals.

Between 2010 and 2023, the flu has led to 9.3 million to 41 million illnesses, 100,000 to 710,000 hospitalizations and 4,900 to 51,000 deaths, the CDC estimates.