FDA Approves First Self-Administered Nasal Spray Influenza Vaccine

The FDA approved the first self- or caregiver-administered nasal spray influenza vaccine for the prevention of influenza disease caused by influenza virus subtypes A and B in those 2 through 49 years of age.

According to the CDC, influenza has resulted in about 9.3 million to 41 million illnesses, 100,000 to 710,000 hospitalizations, and 4900 to 51,000 deaths annually between 2010 and 2023. And although numerous FDA-approved vaccines are available each influenza season to prevent the viral infection, the nasal spray is the first vaccine for the prevention of influenza that does not need to be administered by a health care provider.

The nasal spray was initially approved by the FDA in 2003 for use in individuals 5 through 49 years of age, and in 2007, the FDA approved its use to include children 2 through 5 years of age.

“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 press 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.”

The nasal spray contains a weakened form of live influenza virus strains. Although patients still need a prescription, the vaccine manufacturer plans to make the vaccine available through a third-party online pharmacy. Those interested in self- or caregiver-administration will complete a screening and eligibility assessment when they order the nasal spray. The third-party pharmacy will then determine eligibility based on the completed screening. If the intended vaccine recipient is eligible, the pharmacy writes the prescription and ships the vaccine to the recipient’s provided address.

Vaccine recipients and caregivers will be sent the vaccine, the prescribing information, instructions for use, and information for patients and their caregivers. It is recommended that a caregiver administer the nasal spray to individuals 2 through 17 years of age.

The most common adverse events associated with the nasal spray are fever over 100°F in children 2 through 6 years of age, runny nose, nasal congestion in individuals 2 through 49 years of age, and a sore throat in adults 18 through 49 years of age.

Reference:
FDA approves nasal spray influenza vaccine for self- or caregiver-administration. News release. US Food and Drug Administration; 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