FDA Greenlights FluMist for Self- and Caregiver-Administration

Food and Drug AdministrationFood and Drug Administration

WASHINGTON, D.C. — The U.S. Food and Drug Administration has approved FluMist for self- or caregiver-administration, expanding accessibility for influenza prevention. FluMist, designed to combat influenza virus subtypes A and B, is now available for individuals aged 2 to 49. Originally approved in 2003 for ages 5 to 49, its scope was extended in 2007 to include younger children from the age of 2. This nasal spray vaccine represents the first influenza preventative measure that can be administered without a healthcare professional, offering enhanced convenience.

Influenza remains a prevalent and highly contagious respiratory illness, with significant health impacts seasonally. Symptoms range from mild coughs and fevers to severe complications that may necessitate hospitalization. The Centers for Disease Control and Prevention reports annual flu-related statistics spanning millions of illnesses and thousands of deaths between 2010 and 2023.

The administration process for FluMist involves spraying a weakened live virus strain into the nasal cavity, requiring a prescription. The vaccine can be administered by healthcare providers or by individuals 18 years and older, for themselves or others in their care. For children aged 2 to 17, caregiver administration is advised.

The FDA’s approval followed a comprehensive study to ascertain the safe and effective use of FluMist by non-professionals. Participants received instruction materials detailing storage, administration, and disposal to ensure correct usage. Side effects reported include fever in younger children, and nasal congestion and sore throat in older recipients.

This new approval, granted to MedImmune LLC, paves the way for a more flexible influenza vaccination approach, potentially reducing the strain on healthcare systems during flu seasons and enhancing public health outcomes.

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