In late September, the FDA granted approval to MedImmune, LLC, a subsidiary of AstraZeneca, for FluMist (Influenza Vaccine Live, Intranasal) for self- or caregiver-administration for the prevention of influenza disease caused by influenza virus subtypes A and B in individuals aged 2 through 49 years. FluMist, which is sprayed into the nose, was initially approved by the FDA in 2003 for use in individuals aged 5 through 49 years, and in 2007 the FDA approved the use of FluMist to include children aged 2 through 5 years.
It is the first vaccine to prevent influenza in the United States that does not need to be administered by a healthcare provider, the FDA noted.
The vaccination rate for adults aged 18 to 49 years is only about 35%, compared with 70% for those aged 65 years and older, who are not eligible to receive FluMist. Plus, the product will still be available for healthcare professional administration.
“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 Peter Marks, MD, PhD, 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. This approval adds another option for vaccination against influenza disease and demonstrates the FDA’s commitment to advancing public health.”
FluMist contains a weakened form of live influenza virus strains and still requires a prescription. It can be administered by either a provider in a healthcare setting, including a pharmacy, or by the vaccine recipient or a caregiver who is aged 18 years or older.
The FDA pointed out that the most commonly reported side effects of FluMist are fever over 100 °F in children aged 2 through 6 years, runny nose, and nasal congestion in individuals aged 2 through 49 years, and a sore throat in adults aged 18 through 49 years.
AstraZeneca pointed out that vaccination rates for influenza have declined in adults in the U.S. since the 2020–2021 season by 3.3%. The company added in a press release that based on a survey, a common reason for adults to not receive a vaccination included failure to attend regular well-care visits. Having access to at-home vaccination options was shown to potentially increase influenza vaccination uptake.
“Once available, individuals 18 and older will be able to have FluMist delivered directly to their homes via FluMist Home,” according to the company. “FluMist Home will utilize an online pharmacy where eligible individuals complete a questionnaire that is reviewed by a pharmacist prior to receiving their vaccine for shipment.”
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