The U.S. Food and Drug Administration (FDA) has approved the at-home use of nasal spray flu vaccine which can be self-administered without the help of a healthcare provider.
FluMist nasal spray manufactured by AstraZeneca is now approved for home use against influenza infection caused by subtypes A and B from ages 2 through 49. It was initially approved for prescription-based use in healthcare settings from 5 to 49 years of age in 2003. Later in 2007, the FDA approval included use in children from 2 through 5 years of age.
"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 in a 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. This approval adds another option for vaccination against influenza disease and demonstrates the FDA's commitment to advancing public health," Dr. Marks said.
Influenza affects people of all ages and can present with symptoms such as body aches, fever, coughing, sore throat, fatigue, and a stuffy or runny nose. Although many people recover within days of mild infection, the flu can pose serious risks, particularly to vulnerable groups like the elderly, young children, and those with chronic health conditions. For high-risk individuals, complications can escalate, potentially leading to hospitalization or even death.
According to the U.S. Centers for Disease Control and Prevention report from 2010 to 2023, the flu has resulted in 9.3 million and 41 million illnesses, 100,000 to 710,000 hospitalizations, and 4,900 to 51,000 deaths annually. Getting vaccinated against the flu is the best recommended strategy to reduce the risk of severe infection and hospitalization.
FluMist contains a weakened form of live influenza virus strains delivered as a nasal spray. Although the new approval allows both home use and administration in healthcare settings such as a pharmacy, a prescription is still necessary to obtain FluMist.
For home use, the nasal spray can be self-administered by individuals aged 18 and older, while a caregiver over 18 must administer FluMist to children aged 2 to 17, as they should not self-administer the vaccine. The vaccine manufacturer plans to offer FluMist through a third-party online pharmacy. When ordering, individuals will need to complete a screening and eligibility assessment. If assessed as eligible, the pharmacy will write a prescription and ship the vaccine to the provided address, allowing it to be administered at the recipient's convenience.
According to the FDA, the most common side effects of FluMist include fever over 100 degrees Fahrenheit in children ages 2-6, runny nose and nasal congestion in individuals ages 2-49, and sore throat in adults.
"Improving access to vaccines is one strategy to improve immunization rates. I anticipate parents and pediatricians will have a lot of questions about self-administration of intranasal flu vaccine. The AAP and COID look forward to reviewing the data on this product and taking it into consideration when we develop our annual influenza vaccine recommendations in the spring," said Dr. Kristina A. Bryant, a member of the AAP Committee on Infectious Diseases (COID) and lead author of the AAP's flu policy statement and technical report in a news release.
