US Food and Drug Administration accepts for review AstraZeneca’s Supplemental Biologics License Application for self-administration of FLUMIST® QUADRIVALENT (Influenza Vaccine Live, Intranasal)

WILMINGTON, Del.–()–AstraZeneca’s Supplemental Biologics License Application (sBLA) for the approval of a self- or caregiver-administered option for FLUMIST® QUADRIVALENT (Influenza Vaccine Live, Intranasal), a needle-free nasal spray, has been accepted for review by the US Food and Drug Administration (FDA). If approved, FLUMIST QUADRIVALENT will be the first flu vaccine available to be self-administered by eligible patients or administered by caregivers, adding an additional option to be vaccinated against influenza.

The sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer or administer FLUMIST QUADRIVALENT to eligible patients 2-49 years of age when given instructions for use without any additional guidance. FLUMIST QUADRIVALENT, which is sprayed into the nose, has extensive data demonstrating comparable effectiveness and acceptable safety relative to other flu vaccines.

The Prescription Drug User Fee Act (PDUFA) date, the FDA’s date for a regulatory decision, is expected during the first quarter of 2024. If approved at that time, FLUMIST QUADRIVALENT is anticipated to be available for self-administration in the US for the 2024/2025 flu season.

Ravi Jhaveri, MD, Division Head, Infectious Disease; Virginia H. Rogers Professor in Infectious Diseases, Professor of Pediatrics (Infectious Diseases), Northwestern University School of Medicine, Chicago, USA said: “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. 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. 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.”

Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca, said: “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. 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.”

Influenza (flu) is a contagious respiratory illness caused by the influenza virus, which can cause serious complications to some groups, such as people 65 years and older, young children, and people with certain health conditions.

FLUMIST QUADRIVALENT IMPORTANT SAFETY INFORMATION

  • You should not get FLUMIST QUADRIVALENT if you have a severe allergy to eggs or to any inactive ingredient in the vaccine; have ever had a life-threatening reaction to influenza vaccinations; or are 2 through 17 years old and take aspirin or medicines containing aspirin – children or adolescents should not be given aspirin for 4 weeks after getting FLUMIST QUADRIVALENT unless your healthcare provider tells you otherwise.
  • Children under 2 years old have an increased risk of wheezing (difficulty with breathing) after getting FLUMIST QUADRIVALENT.
  • Tell your healthcare provider if you or your child are currently wheezing; have a history of wheezing if under 5 years old; have had Guillain-Barré syndrome; have a weakened immune system or live with someone who has a severely weakened immune system; have problems with your heart, kidneys, or lungs; have diabetes; are pregnant or nursing; or are taking a medication used to treat influenza like Tamiflu®*, Relenza®*, amantadine, or rimantadine.
  • The most common side effects are runny or stuffy nose, sore throat, and fever over 100°F.

Approved Use

FLUMIST QUADRIVALENT is a vaccine that is sprayed into the nose to help protect against influenza. It can be used in people 2 through 49 years old. FLUMIST QUADRIVALENT may not prevent influenza in everyone who gets vaccinated.

Please see full Prescribing Information, including Patient Information.

*Tamiflu and Relenza are registered trademarks of their respective owners.

You may report side effects related to AstraZeneca products.

Notes

Influenza

On average, about 8% of the US population gets sick from flu each season, with a range of between 3% and 11%, depending on the season.1 Children 5 to 17 years of age represent 39% of acute respiratory infection medical visits, even though they only make up about 22% of the US population.2 The impact of influenza extends to work and school, as 47% of days of school missed are due to the illness and working caregivers miss 1-2 days of work to care for household members.3

FLUMIST QUADRIVALENT Live Attenuated Influenza Vaccine

FLUMIST QUADRIVALENT is a quadrivalent live attenuated influenza vaccine (LAIV), which is administered as a nasal spray for the prevention of influenza. FLUMIST QUADRIVALENT 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. FLUMIST QUADRIVALENT was originally approved in the US in 2003 and since then almost 200 million doses have been distributed around the world.

AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit www.astrazeneca-us.com and follow us on social media @AstraZeneca.

References

  1. Centers for Disease Control and Prevention. Key Facts About Influenza (Flu). URL: https://www.cdc.gov/flu/about/keyfacts.htm
  2. Centers for Disease Control and Prevention. 2021–2022 Estimated Flu Illnesses, Medical Visits, Hospitalizations, and Deaths Prevented by Flu Vaccination. URL: https://www.cdc.gov/flu/about/burden-averted/2021-2022.htm#references
  3. McLean, HQ, Peterson, SH, King, JP, Meece, JK, and Belongia, EA. School absenteeism among school-aged children with medically attended acute viral respiratory illness during three influenza seasons, 2012-2013 through 2014-2015. Influenza Other Respi Viruses. 2017; 11, 220–229. https://doi.org/10.1111/irv.12440

 

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