Originally published by our sister publication Infectious Disease Special Edition
The FDA approved the first nasal spray influenza vaccine that can be administered by the patient or caregiver at home. Influenza Vaccine Live, Intranasal (FluMist, MedImmune) is approved for the prevention of influenza caused by influenza virus subtypes A and B in people 24 months through 49 years of age.
FluMist is a live-attenuated influenza vaccine that is sprayed into the nose and has been used safely and effectively for many years. It was initially approved by the FDA in 2003 for use in people 5 through 49 years of age, and in 2007, the FDA approved its use to include children from 24 months through 5 years of age.
The FDA’s approval was based on a comprehensive submission, which included results from a usability study demonstrating that people older than 18 years of age could self-administer or administer the intranasal vaccine to eligible individuals from 24 months to 49 years of age.
“For the first time, families and caregivers will be able to protect themselves against influenza with a needle-free, self-administered vaccine, from the convenience of their own home. Each year, influenza poses a significant burden for people, society and health systems; additional tools to increase access to vaccinations, while also reducing disparities, are critical,” said Ravi Jhaveri, MD, the division head of infectious disease, the Virginia H. Rogers Professor in Infectious Diseases and a professor of pediatrics (infectious diseases) at Northwestern University Feinberg School of Medicine, in Chicago.
Each flu season is different, and the health impacts can be substantial and vary widely from season to season, with some flu seasons being worse than others. According to the CDC, flu has resulted in about 9.3 million to 41 million illnesses, 100,000 to 710,000 hospitalizations and 4,900 to 51,000 deaths annually between 2010 and 2023. Numerous FDA-approved vaccines are available each flu season to prevent influenza.
A prescription is still required to receive FluMist. There are now two approved options for receiving FluMist. The vaccine may be administered by a healthcare provider in a healthcare setting, including a pharmacy, or it may be administered by the vaccine recipient or a caregiver who is 18 years of age and older.
The most commonly reported side effects of FluMist are a fever greater than 100° F in children 24 months through 6 years of age, runny nose and nasal congestion in individuals 24 months 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.
“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, the 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.”
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 detailed instructions for storage, administration and disposal of FluMist.
For the full prescribing information click here.