The U.S. Food and Drug Administration (FDA) has approved FluMist, an influenza vaccine, for self- or caregiver-administration, making it the first flu vaccine available in the U.S. that does not require administration by a healthcare provider. FluMist is designed to prevent influenza (the flu) caused by influenza virus subtypes A and B in individuals aged 2 through 49 years. The vaccine is administered intranasally, offering a needle-free alternative to traditional flu shots.
Originally approved by the FDA in 2003 for use in individuals aged 5 through 49, FluMist's approved use was extended to children aged 2 through 5 in 2007. With this latest approval, FluMist offers more flexibility and convenience, allowing individuals and families to get vaccinated at their convenience without visiting a healthcare facility.
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| FDA Approves FluMist for Self- or Caregiver-Administration |
A New Option for Seasonal Influenza Vaccination
Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, emphasized the importance of this new option. “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. Marks. He also highlighted that getting vaccinated each year is the best way to prevent influenza, which can cause severe illness, hospitalization, and even death, particularly among high-risk groups.
The Importance of Preventing Influenza
Influenza, commonly referred to as the flu, is a highly contagious respiratory disease caused by influenza viruses. It circulates primarily in the fall and winter months in the U.S., causing symptoms like body aches, fever, coughing, sore throat, tiredness, and nasal congestion. The flu can vary in severity, sometimes leading to hospitalization or even death, especially among vulnerable groups such as the elderly, young children, and individuals with chronic health conditions.
Each flu season differs in impact, and the health effects can range significantly. Between 2010 and 2023, the flu caused an estimated 9.3 million to 41 million illnesses, 100,000 to 710,000 hospitalizations, and 4,900 to 51,000 deaths annually, according to the U.S. Centers for Disease Control and Prevention (CDC).
FluMist: A Safe and Effective Alternative
FluMist contains weakened forms of live influenza virus strains and is delivered through a nasal spray. A prescription is required to receive FluMist, and individuals now have two approved options for administration:
- Healthcare provider: The vaccine can be administered in healthcare settings, including pharmacies.
- Self- or caregiver-administration: Eligible individuals or caregivers (18 years of age or older) can now administer the vaccine at home. Caregivers must administer FluMist to children aged 2 through 17, as individuals in this age group should not self-administer the vaccine.
Common Side Effects
The most commonly reported side effects include:
- Fever over 100°F in children aged 2 through 6.
- Runny nose and nasal congestion in individuals aged 2 through 49.
- Sore throat in adults aged 18 through 49.
These side effects are typically mild and resolve on their own.
How to Access FluMist for Self-Administration
FluMist for self- or caregiver-administration will be made available through a third-party online pharmacy. Interested individuals must complete a screening and eligibility assessment when ordering the vaccine. If deemed eligible, the pharmacy will write the prescription and ship the vaccine directly to the customer’s provided address. Recipients will receive the vaccine, along with Prescribing Information, Information for Patients and Caregivers, and detailed Instructions for Use on how to store, administer, and dispose of FluMist properly.
Evaluation and Safety of Self-Administration
A study was conducted to evaluate whether vaccine recipients and caregivers could safely and effectively use FluMist based on the provided instructions. The results demonstrated that with the proper guidance, FluMist could be administered successfully by individuals and caregivers in home settings.
Conclusion
The FDA’s approval of FluMist for self- or caregiver-administration marks a significant step forward in improving access to seasonal flu vaccines. By offering an alternative to traditional healthcare provider-administered vaccines, FluMist provides individuals and families with more flexibility and convenience, potentially increasing vaccination rates and protecting public health.
The FDA granted this approval to MedImmune LLC, the manufacturer of FluMist, demonstrating the agency's commitment to advancing public health by providing safe, effective, and accessible medical products.