In a step aimed at more widespread and convenient influenza vaccination this season, officials with the U.S. Food and Drug Administration (FDA) have approved FluMist, an intranasal vaccine, as the first vaccine to prevent influenza that does not need to be administered by a health care provider.
“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,” Peter Marks, MD PhD, who is director of the FDA’s Center for Biologics Evaluation and Research said in a news release about the approval. “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.”
FDA officials noted that a prescription will still be required to receive FluMist, but there are now two approved options for receiving the vaccine, either 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.
For those interested in self- or caregiver-administration, the vaccine will be available through a third-party online pharmacy. Those who choose this option will complete a screening and eligibility assessment when they order. 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.
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.
FluMist is approved for the prevention of influenza disease caused by influenza virus subtypes A and B in individuals 2 through 49 years of age. 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. FDA officials advised in the news release that a caregiver should administer the vaccine to children younger than age 17.
The FDA granted this approval of FluMist (Influenza Vaccine Live, Intranasal) to MedImmune LLC.
According to the US Centers for Disease Control and Prevention, 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.
Reference
1. FDA. FDA Approves Nasal Spray Influenza Vaccine for Self- or Caregiver-Administration. Press release. FDA. September 20, 2024. Accessed September 23, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-nasal-spray-influenza-vaccine-self-or-caregiver-administration