FDA approves nasal spray as first self-administered flu vaccine
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Key takeaways:
- FluMist is now approved for self- or caregiver-administration for people aged 2 to 49 years.
- The nasal spray is the first influenza vaccine that does not have to be given by a health care provider.
The FDA on Friday approved the first ever influenza vaccine that does not have to be given by a health care professional.
FluMist, an existing nasal spray vaccine, is now approved for self- or caregiver-administration in people aged 2 to 49 years, the FDA announced.
The live-attenuated vaccine contains weakened influenza viruses, as opposed to influenza vaccines given as injections, which contain inactivated viruses.
AstraZeneca announced last year that the FDA had accepted its supplemental biologics license application for FluMist to be approved as a self-administered vaccine. The application was based on a study that showed people aged 18 years or older could follow instructions for using the vaccine without additional guidance.
Under the new approval, the FDA said an adult caregiver should administer the spray to children and adolescents aged 2 to 17 years.
“This approval adds another option for vaccination against influenza disease,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release, noting further that the nasal vaccine offers “greater convenience, flexibility and accessibility for individuals and families.”
AstraZeneca said the vaccine will be available via an online pharmacy through its FluMist Home program. People aged 18 years or older will have to complete an online questionnaire that will be reviewed by a pharmacist before the vaccine is shipped to their homes. The vaccine also will continue to be administered by health care professionals at offices and pharmacies, the company said.
“The approval of FluMist for self-administration is an important step forward in making vaccines more accessible to fight the high annual burden of influenza,” Iskra Reic, PhD, MBA, executive vice president for vaccines and immune therapies at AstraZeneca, said in a press release.
Seasonal influenza vaccination is recommended for people aged 6 months or older.
From 2010 to 2023, the CDC estimates that 9.3 million to 41 million people were infected with seasonal influenza annually, 100,000 to 710,000 people were hospitalized and 4,900 to 51,000 people died as a result of infection.
References:
- CDC. Influenza (flu): Who needs a flu vaccine. https://www.cdc.gov/flu/prevent/vaccinations.htm. Last reviewed March 21, 2024. Accessed Sept. 20, 2024.
- CDC. Flu burden: About estimated flu burden. https://www.cdc.gov/flu-burden/php/about/index.html. Updated Aug. 2, 2024. Accessed Sept. 20, 2024.
- FDA approves nasal spray influenza vaccine for self- or caregiver-administration. https://www.fda.gov/news-events/press-announcements/fda-approves-nasal-spray-influenza-vaccine-self-or-caregiver-administration. Published Sept. 20, 2024. Accessed Sept. 20, 2024.
- FluMist approved for self-administration in the U.S. https://www.astrazeneca.com/media-centre/press-releases/2024/flumist-approved-for-self-administration-in-the-us.html. Published Sept. 20, 2024. Accessed Sept. 20, 2024.
Perspective
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A self-administered influenza vaccine is an important advance that will, hopefully, increase vaccination rates against influenza. This is an innovative approach that will harness the convenience of using the needle-free nasal influenza vaccine, FluMist. Now that regulatory approval has been granted for this first self-administration, it will provide an impetus and momentum for additional types of self-administered vaccines.
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