AstraZeneca submits FDA application for self-administered FluMist

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AstraZeneca submits FDA application for self-administered FluMist

News brief

October 24, 2023

Lisa Schnirring

AstraZeneca today announced that the US Food and Drug Administration (FDA) has agreed to review its application for the option for its FluMist flu vaccine to be self- or caregiver-administered, which if approved will be the first vaccine available for self-administration or by caregivers, offering another option for flu vaccination.

nasal spray flu administrationCDC /Dr. Bill Atkinson
In a statement, the company said its application is supported by a usability study that confirmed that people ages 18 and older can self-administer or give the vaccine to people ages 2 though 49 years old when given instructions, but not other guidance.

AstraZeneca said it expects a decision from the FDA during the first quarter of 2024, which would pave the way for its availability through that new route for the United States’ 2024-25 flu season.

The ability for individuals and parents to choose where to administer an injection-free flu vaccine could help increase access and, subsequently, vaccination rates.
Ravi Jhaveri, MD, who heads the company’s infectious diseases division, said the self-administered option leverages FluMist’s unique attributes and provides a convenient new choice. “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,” he said. “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.”

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