FDA Approval of FluMist Vaccine for At-Home Flu Care

Overview of FluMist Approval

The FDA has granted approval for the FluMist nasal influenza vaccine for self- or caregiver-administration, as announced in a recent FDA news release. This step marks the first instance where a flu vaccine can be administered at home without a healthcare professional.

Background of FluMist

Initially approved by the FDA in 2003 for use in individuals aged 5 to 49, the approval was expanded in 2007 to include children aged 2 to 5. This latest approval is based on a pivotal study that confirmed participants could administer FluMist correctly with clear instructions, achieving a perfect success rate.

Accessing FluMist

Individuals interested in FluMist can easily obtain it through online pharmacies. A screening and eligibility assessment must be completed prior to receiving a prescription, and only individuals aged 18 or older can administer the vaccine.

Benefits of Self-Administration

Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, emphasized that this approval enhances convenience, flexibility, and accessibility in obtaining seasonal influenza vaccines.

Common Side Effects

• Fever over 100 degrees in small children
• Runny nose
• Congestion
• Sore throat

Flu Impact in the U.S.

The flu, which circulates predominantly in the fall and winter, can lead to a range of symptoms from mild to severe. Among specific groups, including young children, the elderly, and the immunocompromised, influenza can result in serious health complications.

According to CDC estimates, between 2010 and 2023, flu infections led to 9.3 million to 41 million cases, resulting in 100,000 to 710,000 hospitalizations and 4,900 to 51,000 fatalities.