20 September 2024
FluMist approved for
self-administration in the US
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 hospitalisations, 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 utilise 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.
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 hospitalisations, 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
(LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical
company that focuses on the discovery, development, and
commercialisation of prescription medicines in Oncology, Rare
Diseases, and BioPharmaceuticals, including Cardiovascular, Renal
& Metabolism, and Respiratory & Immunology. Based in
Cambridge, UK, AstraZeneca's innovative medicines are sold in more
than 125 countries and used by millions of patients worldwide.
Please visit astrazeneca.com
and follow the Company on social media
@AstraZeneca.
Contacts
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References
1. FluMist Prescribing
Information. March 2024.
2. 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.
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
4. 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
5. Centers for Disease Control and Prevention. Flu Vaccination
Coverage, United States, 2022-23 Influenza Season. URL:
https://www.cdc.gov/flu/fluvaxview/coverage-2223estimates.htm
6. 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.
7. Centers for Disease Control and Prevention. Key Facts About
Influenza (Flu). URL: https://www.cdc.gov/flu/about/keyfacts.htm
8. 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/about/burden/2022-2023.htm
9. 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
Adrian
Kemp
Company
Secretary AstraZeneca PLC