US Food and Drug Administration accepts for review AstraZeneca’s Supplemental Biologics License Application for self-administration of FLUMIST® QUADRIVALENT (Influenza Vaccine Live, Intranasal)
24 Oktober 2023 - 1:00PM
Business Wire
Potential to be the first and only
self-administered flu vaccine
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
- Centers for Disease Control and Prevention. Key Facts About
Influenza (Flu). URL:
https://www.cdc.gov/flu/about/keyfacts.htm
- 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
- 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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