The nasal spray flu vaccine is available for self- or caregiver-administration by prescription for individuals aged 2 to 49.
RT’s Three Key Takeaways:
- The FDA has approved FluMist as the first nasal spray flu vaccine that can be self-administered or administered by a caregiver for individuals aged 2 to 49.
- FluMist is available by prescription.
- FluMist has been used since its initial approval in 2003, and this new approval expands its accessibility for at-home administration.
FluMist has been approved by the US Food and Drug Administration (FDA) as the first self-administered influenza vaccine.Â
FluMist, a needle-free nasal spray, was approved to be self-administered by adults up to 49 years of age or administered by a parent/caregiver to individuals 2-17 years of age
FluMist is sprayed into the nose and has been used safely and effectively for many years, according to a release from the FDA. It was initially approved by the FDA in 2003 for use in individuals 5 through 49 years of age, and in 2007, the FDA approved the use of FluMist to include children 2 through 5 years of age.Â
“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,” says Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a release. “Getting vaccinated each year is the best way to prevent influenza, which causes illness in a substantial proportion of the US 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.”
Available by Prescription for Home Use
FluMist contains a weakened form of live influenza virus strains and is sprayed in the nose. A prescription is still required to receive FluMist. There are now two approved options for receiving FluMist. The vaccine may be administered by a health care provider in a health care setting (including a pharmacy), or it may be administered by the vaccine recipient or a caregiver who is 18 years of age or older.
The most commonly reported side effects of FluMist are fever over 100°F in children 2 through 6 years of age, runny nose, and nasal congestion in individuals 2 through 49 years of age, and a sore throat in adults 18 through 49 years of age.
For those interested in self- or caregiver-administration, the vaccine manufacturer plans to make the vaccine available through a third-party online pharmacy. Those who choose this option will complete a screening and eligibility assessment when they order FluMist.
The third-party pharmacy determines eligibility based on the completed screening and, if it is determined that the intended vaccine recipient is eligible, the pharmacy writes the prescription and ships the vaccine to the address provided by the individual who placed the order. The vaccine can then be administered to the prescribed household member(s) at their convenience.
A caregiver should administer FluMist to individuals 2 through 17 years of age, as individuals in this age group should not self-administer the vaccine.
A study was conducted with vaccine recipients and caregivers to evaluate whether the instructions for use were appropriately designed so that recipients and caregivers could safely and effectively use the vaccine.
Vaccine recipients and caregivers who administer FluMist will be sent the vaccine, the prescribing information, information for patients and their caregivers, and instructions for use. The instructions for use provides instructions for storage, administration, and disposal of FluMist.
The FDA granted this approval of FluMist to MedImmune LLC.
