First Influenza Vaccine That Can Be Self-Administered

Often barriers to care can create seemingly unsurmountable roadblocks for patients to get preventative care they need. One example might be vaccines. If they cannot get to a provider or for those who are vaccine-adverse or fearful to get shots, there is a new hope to overcome both barriers: a nasal influenza spray vaccine, FluMist, was FDA approved today. This spray can be self-administered by individuals or given to other by caregivers. In fact, the FDA recommends that a caregiver should administer the nasal vaccine to individuals 2 through 17 years of age, as individuals in this age group should not self-administer the vaccine.¹

“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, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

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. FluMist 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 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. It is the first vaccine to prevent influenza, more commonly known as the flu, that does not need to be administered by a health care provider.

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.

Where to Get the Vaccines

According to the FDA release, 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.

“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,” Marks said. “This approval adds another option for vaccination against influenza disease and demonstrates the FDA’s commitment to advancing public health.”

Reference
1. FDA Approves Nasal Spray Influenza Vaccine for Self- or Caregiver-Administration. FDA press release. September 20, 2024. Accessed September 20, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-nasal-spray-influenza-vaccine-self-or-caregiver-administration