FDA will review self-administered flu vaccine for approval
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Key takeaways:
- The FDA will review what could be the first self-administered influenza vaccine.
- The vaccine, FluMist, is already approved to be administered by a health care professional.
The FDA is set to review what could be the country’s first self-administered influenza vaccine.
AstraZeneca announced Tuesday that the FDA accepted a supplemental biologics license application for FluMist — the company’s nasal spray influenza vaccine — as a self- or caregiver-administered vaccine based on data from a usability study showing that people aged 18 years or older could follow instructions for the vaccine’s use without additional guidance.
FluMist is already approved for use in the United States for people aged 2 to 49 years, but only as administered by a health care professional.
“Vaccination rates for children and adults under 50 years of age declined in the 2022-2023 flu season, highlighting a need for more accessible solutions,” Ravi Jhaveri, MD, professor of infectious diseases and pediatric infectious diseases at Northwestern University School of Medicine, said in a press release.
“The ability for individuals and parents to choose where to administer an injection-free flu vaccine could help increase access and, subsequently, vaccination rates, and greatly benefit those most impacted by this serious and contagious respiratory illness,” Jhaveri said.
FluMist is a live-attenuated vaccine. Unlike the inactivated influenza vaccines given as injections, it contains live, weakened virus. Decreased effectiveness compared with inactivated vaccines led the American Academy of Pediatrics and CDC to recommend against its use during the 2016-2017 and 2017-2018 influenza seasons.
A reformulated version of the vaccine has been recommended since then, but according to the CDC, its limited use means there are no effectiveness estimates for the vaccine in the U.S. Data from other countries, however, have shown the vaccine to have an effectiveness similar to standard inactivated influenza vaccines.
Iskra Reic, executive vice president for vaccines and immune therapies at AstraZeneca, said self-administered influenza vaccines “could revolutionize flu vaccination. Our ambition is for FluMist to be ordered directly to people’s homes, providing an innovative, more accessible option for individuals, families and communities.”
The company expects a regulatory decision from the FDA sometime in the first quarter of 2024 and for the self-administered vaccine to be available for use in the 2024-2025 influenza season.
References:
- CDC. Influenza (flu): Live attenuated influenza vaccine [LAIV] (The nasal spray flu vaccine). https://www.cdc.gov/flu/prevent/nasalspray.htm. Last reviewed Aug. 25, 2022. Accessed Oct. 24, 2023.
- US Food and Drug Administration accepts for review AstraZeneca’s supplemental biologics license application for self-administration of FluMist quadrivalent. https://www.astrazeneca.com/media-centre/press-releases/2023/us-food-drug-administration-accepts-review-astrazeneca-supplemental-biologics-license-application-self-administration-flumist-quadrivalent.html. Published Oct. 24, 2023. Accessed Oct. 24, 2023.
Perspective
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Having a self-administered flu vaccine available would go a long way to increasing vaccination rates against influenza. This is an innovative approach that will harness the convenience of using the needle-free nasal flu vaccine. Hopefully this will be able to clear regulatory obstacles and create momentum for more self-administered vaccines.
Perspective
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It is well recognized that improved influenza vaccines are badly needed. Perhaps less often discussed is that there is a comparable need for improved ways of administering vaccines, making them more accessible. The potential availability of a self- or caregiver-administered influenza vaccines is an innovative effort to get a greater proportion of children and young adults vaccinated.
Always under-vaccinated, influenza vaccination rates in these groups dipped even further during the last influenza season in 2022-2023. Will making influenza vaccines more accessible result in increased vaccine acceptance? The answer is not a foregone conclusion. Will parents pick up a nasal spray influenza vaccine to give to themselves and to their children? Will college students and younger adults be motivated to do likewise? Will it make influenza vaccine more acceptable to those who are needle-phobic? Importantly, will medical insurance plans pay for self-administered influenza vaccine and, if so, how cumbersome will the process be?
As with similar self-administered measures — at-home COVID-19 tests, for example — public health authorities will be challenged to assess the extent of self- and caregiver-administered influenza vaccine. In any event, the innovation deserves support, and we await the results of its implementation.
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