FDA Accepts sBLA for AstraZeneca’s Intranasal Influenza Vaccine


If approved, it would become the first nasal flu vaccine to be self-administered.

AstraZeneca announced today the FDA had accepted its supplemental biologic application license (sBLA) for the company’s influenza vaccine live, Intranasal (Flumist Quadrivalent). If approved, the vaccine would become the first influenza vaccine available to be self-administered by eligible patients or given by caregivers.

“A self-administered option for Flumist Quadrivalent would leverage the unique attributes of the product, providing a convenient new choice for individuals and families who want to protect their loved ones against flu,” Ravi Jhaveri, MD, division head, Infectious Disease; Virginia H. Rogers professor in Infectious Diseases, professor of Pediatrics (Infectious Diseases), Northwestern University School of Medicine, said in a statement.

During the 2021-2022 influenza season, influenza was associated with an estimated 9 million illnesses, 4 million medical visits, and 10,000 hospitalizations, according to the Centers for Disease Control and Prevention (CDC).

“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,” Jhaveri said.

The hope is that nasal vaccines and can be given at home, may help to turn the tide and improve immunization rates, especially as the immunization statistics do not prove to be very good right now.

“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

What You Need to Know

AstraZeneca's influenza vaccine, Flumist Quadrivalent, is currently under review by the FDA for self-administration.

During the 2021-2022 flu season, influenza was associated with millions of illnesses, medical visits, and hospitalizations. Vaccination rates for children and adults under 50 years of age declined during the 2022-2023 flu season, emphasizing the need for more accessible vaccination options.

The hope is that vaccines that do not require needles and can be given at home may help improve vaccination rates, especially in populations most affected by influenza.

AstraZeneca’s product is a quadrivalent live attenuated influenza vaccine (LAIV), which is administered as a nasal spray for the prevention of influenza. Flumist Quadrivalent was first FDA approved in the US in 2003, and since then, almost 200 million doses have been distributed around the world.

The vaccine can be used in appropriate children and adults 2 through 49 years of age. Flumist Quadrivalent is an Advisory Committee on Immunization Practices (ACIP) and American Academy of Pediatrics (AAP) recommended flu vaccine option.

Ready for Next Year's Respiratory Virus Season?

The Prescription Drug User Fee Act (PDUFA) date is expected to occur during the first quarter of 2024. If the vaccine is approved next year, AstraZeneca said it anticipated to be available for self-administration in the US for the 2024/2025 flu season.

“For more than 20 years, Flumist Quadrivalent has served as a critical public health tool as the only intranasal flu vaccine providing protection to communities around the world,” Iskra Reic, executive vice president, Vaccines and Immune Therapies, AstraZeneca, said in a statement. “Flumist Quadrivalent now has the potential to be the first and only self-administered flu vaccine, which could revolutionize flu vaccination. Our ambition is for Flumist Quadrivalent to be ordered directly to people’s homes, providing an innovative, more accessible option for individuals, families and communities.”


1. US Food and Drug Administration accepts for review AstraZeneca’s Supplemental Biologics License Application for self-administration of FLUMIST® QUADRIVALENT (Influenza Vaccine Live, Intranasal). News Release, AstraZeneca. October 24, 2023. https://www.astrazeneca-us.com/media/press-releases/2023/us-food-and-drug-administration-accepts-for-review-astrazenecas-supplemental-biologics-license-application-for-self-administration-of-flumist-quadrivalent-influenza-vaccine-live-intranasal.html

2.Influenza. 2022-2023 Preliminary In-Season Burden Estimate. CDC. Last reviewed September 28, 2023. Accessed October 24, 2023. https://www.cdc.gov/flu/about/burden/preliminary-in-season-estimates.htm

Related Videos
© 2024 MJH Life Sciences

All rights reserved.