FLUMIST approved for self-administration in the US
20 Septembre 2024 - 10:34PM
Business Wire
Only influenza vaccine approved for self- or
caregiver-administration at home, expanding options for influenza
protection
FLUMIST® has been approved in the US as the only
self-administered influenza vaccine. FLUMIST, a needle-free nasal
spray, was approved to be self-administered by adults up to 49
years of age or administered by a parent/caregiver to individuals
2-17 years of age.1
The approval by the US Food and Drug Administration (FDA) was
based on a comprehensive submission, which included results from a
usability study demonstrating that individuals over 18 years of age
could self-administer or administer FLUMIST to eligible individuals
2-49 years of age.1
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, US, said: "For the first time, families and caregivers
will be able to protect themselves against influenza with a
needle-free, self-administered vaccine, from the convenience of
their own home. Each year, influenza poses a significant burden for
people, society and health systems; additional tools to increase
access to vaccinations, while also reducing disparities, are
critical."
Iskra Reic, Executive Vice President, Vaccines and Immune
Therapies, AstraZeneca, said: “The approval of FLUMIST for
self-administration is an important step forward in making vaccines
more accessible to fight the high annual burden of influenza. For
more than 20 years, FLUMIST has been the only nasal spray flu
vaccine licensed in the US and now it is also the only vaccine to
help individuals, families and communities access an influenza
vaccine conveniently through self- and caregiver administration
outside of traditional healthcare settings.”
Seasonal influenza causes up to 1 billion infections each year
and may result in severe outcomes for about 3-5 million patients
including hospitalizations, complications and death.2 Influenza has
been shown to impact school attendance and employment with 47% of
days of school and 1-2 days of work missed annually.3,4 Vaccination
rates for influenza have declined in adults in the US since the
2020–21 season by 3.3%.5 In a US survey, a common reason for adults
not to receive a vaccination included failure to attend regular
well-care visits, while having access to at-home vaccination
options were shown to potentially increase influenza vaccination
uptake.6
Once available, individuals 18 and older will be able to have
FLUMIST delivered directly to their homes via FLUMIST Home. FLUMIST
Home will utilize an online pharmacy where eligible individuals
complete a questionnaire that is reviewed by a pharmacist prior to
receiving their vaccine for shipment. FLUMIST will continue to be
available in offices and pharmacies for administration by
healthcare professionals. More information is available at
www.FluMist.com.
Important Safety Information
- You should not get FLUMIST 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 unless your healthcare provider tells
you otherwise.
- Children under 2 years old have an increased risk of wheezing
(difficulty with breathing) after getting FLUMIST.
- 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 antiviral drugs
for the treatment of influenza.
- The most common side effects are runny or stuffy nose, sore
throat, and fever over 100 °F.
Approved Use
FLUMIST is a vaccine that is sprayed into the nose to help
protect against influenza. It can be used in children, adolescents,
and adults ages 2 through 49 years. FLUMIST may not prevent
influenza in everyone who gets vaccinated.
Please see full Prescribing Information for FLUMIST, including
Patient Information.
You may report side effects related to AstraZeneca products.
Notes
Influenza
On average, about 8% of the US population becomes ill from
influenza each season, with a range of between 3 percent and 11
percent, depending on the season.7 During the 2022-2023 influenza
season, an estimated 31 million people developed illness from
influenza, 14 million visited a healthcare provider for influenza,
with 360,000 hospitalizations, and 21,000 deaths.8
About FLUMIST Live Attenuated Influenza Vaccine
FLUMIST is a live attenuated influenza vaccine (LAIV), which is
administered as a nasal spray for the prevention of influenza.
FLUMIST is an Advisory Committee on Immunization Practices (ACIP)
and American Academy of Pediatrics (AAP) recommended influenza
vaccine option. FLUMIST was originally approved in the US in 2003
and since then almost 200 million doses have been distributed
around the world.1
Human Factors Usability Study for FluMist Self
Administration
In FDA-required human factors/usability studies, AstraZeneca
evaluated if individuals 18 through 49 years of age could
appropriately administer FLUMIST when given instructions for use.
The results showed that 100% of intended users administered a full
dose. In addition, data show that efficacy, immunogenicity and
adverse events with self-administration of FLUMIST are similar to
that seen with HCP-administered vaccination.1,9 The FLUMIST label
has been updated to provide additional instructions for ordering
and administration for eligible self and caregiver use. Children
2-8 years of age with an uncertain vaccination history may not be
eligible for caregiver use and should consult their healthcare
provider for further information.1
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 125 countries, and its innovative
medicines are used by millions of patients worldwide. For more
information, please visit www.astrazeneca-us.com and follow us on
social media @AstraZeneca.
References
- FluMist Prescribing Information. March 2024.
- World Health Organization. Influenza (Seasonal. URL:
https://www.who.int/news-room/fact-sheets/detail/influenza(seasonal)#:~:text=There%20are%20around%20a%20billion,infections%20are%20in%20developing%20countries.
- 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
- Blanchet Zumofen, MH., Frimpter, J. & Hansen, S.A. Impact
of Influenza and Influenza-Like Illness on Work Productivity
Outcomes: A Systematic Literature Review. PharmacoEconomics 41,
253–273 (2023). https://doi.org/10.1007/s40273-022-01224-9
- Centers for Disease Control and Prevention. Flu Vaccination
Coverage, United States, 2022–23 Influenza Season. URL:
https://www.cdc.gov/fluvaxview/coverage-by-season/2022-2023.html?CDC_AAref_Val=https://www.cdc.gov/flu/fluvaxview/coverage-2223estimates.htm
- Anderson EL. Recommended solutions to the barriers to
immunization in children and adults. Mo Med. 2014
Jul-Aug;111(4):344-8. PMID: 25211867; PMCID: PMC6179470.
- 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. Preliminary
Estimated Influenza Illnesses, Medical Visits, Hospitalizations,
and Deaths in the United States — 2022–2023 Influenza Season. URL:
https://www.cdc.gov/flu-burden/php/data-vis/2022-2023.html?CDC_AAref_Val=https://www.cdc.gov/flu/about/burden/2022-2023.htm
- Burgess, T.H., Murray, C.K., Bavaro, M.F., Landrum, M.L.,
O'bryan, T., Rosas, J.G., Cammarata, S.M., Martin, N.J., Ewing,
D.F., Raviprakash, K., Mor, D., Zell, E.R., Wilkins, K.J., &
Millar, E.V. (2015). Self-administration of intranasal influenza
vaccine: Immunogenicity and volunteer acceptance. Vaccine, 33 32,
3894-9 . DOI:10.1016/j.vaccine.2015.06.061
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