FDA Approves First At-Home Nasal Spray Flu Vaccine

The FDA has approved FluMist (AstraZeneca) for self- or caregiver administration for the prevention of influenza virus subtypes A and B in individuals 2 through 49 years of age, opening the door for more convenient flu immunization.¹

FluMist is sprayed into the nose and has been safely and effectively used for many years, since its initial FDA approval in 2003 for use in individuals 5 through 49 years of age. It was also approved in 2007 for children 2 through 5 years of age.¹

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“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, director of the FDA’s Center for Biologics Evaluation and Research, in a news release.¹

For this approval, the FDA required human factors/usability studies to evaluate whether individuals 18 through 49 years of age could properly administer FluMist when given instructions for use. Results showed that 100% of intended users administered a full dose, and efficacy, immunogenicity, and adverse events with self-administration are similar to those seen with health care professional-administered vaccination.² These include a fever over 100°F in children 2 through 6 years of age, and runny nose and nasal congestion in individuals 2 through 49 years of age as well as a sore throat in adults.¹

FluMist contains a weakened form of live influenza virus strains. A prescription is still required for the self-administered option, and the manufacturer plans to make the vaccine available through a third-party online pharmacy. Individuals who choose the self- or caregiver-administered option will complete a screening and eligibility assessment when ordering FluMist. If the third-party pharmacy determines that the intended recipient is eligible, the pharmacy will write the prescription and ship it to the address provided.¹

“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,” said Ravi Jhaveri, MD, divison head of infectious disease at AstraZeneca and Virginia H. Rogers Professor in Infectious Diseases and professor of pediatrics at the Northwestern University School of Medicine, in a news release. “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 crucial.”²

Influenza can cause mild to severe illness with varying symptoms that can appear suddenly, including body aches, fever, cough, sore throat, fatigue, and congestion. It can be life-threatening and can cause serious complications leading to hospitalization or death, particularly in high-risk groups such as older adults, young children, and individuals with certain medical conditions.¹

Immunization is the easiest and safest way to prevent infection and serious illness from influenza. According to CDC data, influenza vaccine coverage among all adults is approximately 47% and coverage increases by age, with the lowest coverage among adults aged 18 to 29 (32%) and highest coverage among adults 75 years and older (80%).³

“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,” Marks said in the news release.¹

References

1. FDA Approves Nasal Spray Influenza Vaccine for Self- or Caregiver-Administration. News release. FDA. 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

2. FluMist approved for self-administration in the US. News release. AstraZeneca. September 20, 2024. Accessed September 20, 2024. https://www.astrazeneca-us.com/media/press-releases/2024/flumist-approved-for-self-administration-in-the-us.html

3. Flu Vaccination Coverage Update. CDC. January 19, 2024. Accessed September 20, 2024. https://www.cdc.gov/flu/spotlights/2023-2024/vaccination-coverage-update.htm#:~:text=In%202020%2D2021%2C%20an%20estimated,and%20older%20to%20be%2070%25